{"site":"https://takefridayoff.com","sections":["beliefs","benefitLadder","brand","caseStudies","clientLogos","clients","contact","differentiators","dna","experience","faqs","footerPages","formats","formatsLine","founders","home","joinListHref","launchEngine","legacy","naming","narrative","nav","ownBrandLogos","partner","people","pillars","proofLines","stats","system","systemPage","team","testimonials","values","vocabulary","whyNow","work","journal","pages"],"beliefs":[{"quote":"You don’t need 24 months to get effective, compliant products on shelf, and you don’t need to compromise on quality to get there.","name":"Brand belief","role":"Take Friday Off"},{"quote":"We’re not a consultancy. We’re the task force team that gets your product from concept to compliant and shelf-ready in less time and with less internal friction.","name":"How we work","role":"Take Friday Off"},{"quote":"Full-stack delivery from commercials to formulation to compliance and managed manufacturing. One team carries the outcome.","name":"What you get","role":"Take Friday Off"}],"benefitLadder":[{"level":"Emotional","text":"You feel in control of your product development."},{"level":"Functional","text":"Concept to compliant to shelf in as little as six months: commercial, compliant and complete."},{"level":"Brand truth","text":"Full-stack delivery from commercials to formulation to compliance and managed manufacturing."},{"level":"Brand belief","text":"You don’t need 24 months to get effective, compliant products on shelf, and you don’t need to compromise on quality to get there."}],"brand":{"name":"Take Friday Off","short":"TFO","tagline":"Wellness Product Development","masterLine":"Reducing your product development timeline from 24 months to as little as 6.","positioningShort":"Take Friday Off turns breakthrough ideas into compliant, customer-ready wellness products in as little as six months, through one proven system: Friday Launch Engine™.","positioningLong":["Take Friday Off helps wellness brands take a product from concept to compliant and shelf-ready in as little as six months, up to 4x faster than the industry norm.","With evidence-based standards, regulatory expertise, established manufacturing partnerships and intelligent systems, we turn your concept into a compliant, ready-to-ship and category-leading product without the cost or complexity of building in-house."],"usp":"Take Friday Off compresses timelines, de-risks compliance and delivers high-performance wellness products through one proven system, Friday Launch Engine™. We’ve run 190 projects since 2020.","mission":"To simplify and accelerate compliant product innovation for the world’s best wellness brands.","vision":"To become the behind-the-scenes engine powering the next generation of natural health product leaders.","supportingThought":"We’re not a consultancy. We’re the task force team that gets your product from concept to compliant and shelf-ready in less time and with less internal friction.","essence":["On-demand product development, run as one system.","Precise.","Quiet confidence.","Carries the outcome.","Total product delivery."],"email":"hello@takefridayoff.com","bookingUrl":"https://calendly.com/gabriel_perera/tfo-vip-strategy-call","socials":{"instagram":"https://www.instagram.com/takefridayoff","linkedin":"https://www.linkedin.com/company/takefridayoff"},"location":{"city":"Brookvale, Sydney","street":"37/42-46 Wattle Road","suburb":"Brookvale NSW 2100","tz":"Australia/Sydney","coords":"33.76° S, 151.27° E"},"googleReviewsUrl":"https://www.google.com/maps?cid=14325266214136607916","analytics":{"ga4":"G-FF27TL0KYW"}},"caseStudies":[{"id":"brief-to-dispatch","slug":"everleanbody-saffron-capsule","title":"Signed brief to dispatch in under six months","seoDescription":"EverLeanBody's premium daily saffron capsule for women 35 and over, built on affron®: TGA-listed, and 5.8 months from signed brief to dispatch.","client":"EverLeanBody","tag":"First launch","lead":true,"status":"shipped","glance":["Capsule","TGA-listed medicine","Built on affron®, a clinically studied saffron extract","Brief to 3PL"],"brand":"EverLeanBody, a founder-led Australian women's wellness brand for perimenopause and menopause, started by a former firefighter and athlete, built around an engaged online community, selling direct and piloting in pharmacy.","challenge":"The founder wanted a premium daily capsule for women 35 and over, at a set retail price, with the evidence and listing to sell it with confidence.","built":"A four-ingredient capsule built around affron®, a clinically studied saffron extract, with L-theanine, lemon balm and active-form B vitamins. We ran the brief workshop, designed the formula, built the claims evidence, secured the TGA listing, drafted the label and set up a 24-month stability program.","manufacturing":"We managed manufacturing end to end, and dispatch to the brand's third-party logistics partner.","result":["5.8 months from signed brief to dispatch","A second product, built on Eriomin®, a clinically studied lemon flavonoid extract, now in development with us"],"quote":{"text":"Gabriel understood our brief straight away, then challenged us to make it better. He would not let us settle for what was already in the mainstream, and the formulation is better for it... Six months from our first meeting, my first product was on a shelf. The communication is what sets them apart. Real updates, straight answers, no chasing.","by":"EverLeanBody","source":"Google review"},"formats":["capsules"],"pathways":["listed-medicines"],"seoTitle":"EverLeanBody: TGA-listed saffron capsule in 5.8 months","published":"2026-10-22"},{"id":"first-product-to-pharmacy","slug":"the-belly-solution-travel-gut-health-powder","title":"From a first product to a national pharmacy rollout","seoDescription":"The Belly Solution's travel gut-health powder on Saccharomyces boulardii: TGA-listed, and about eight months from formulation to dispatch.","seoTitle":"The Belly Solution: gut-health powder to national pharmacy","client":"The Belly Solution","tag":"First launch","lead":true,"status":"shipped","glance":["Powder in a 14-day pouch","TGA-listed medicine","Built on Saccharomyces boulardii, the most studied probiotic yeast","Formula to pharmacy shelf"],"brand":"The Belly Solution, a science-led Australian travel-health brand, started by a husband-and-wife team, launching its first product.","challenge":"A new company with a range of five products in mind. The founders needed a first hero product that was evidence-based, TGA-listed and ready for pharmacy.","built":"A travel gut-health powder combining the clinically studied probiotic yeast Saccharomyces boulardii, a prebiotic and electrolytes, in a 14-day pouch. We designed the formula, built the claims evidence, secured the TGA listing, drafted and reviewed the label, designed the stability protocol and set up a 36-month stability program.","manufacturing":"We managed manufacturing, release testing and delivery. The second batch is now in production.","result":["About eight months from formulation to dispatch","A second batch now ordered","A national pharmacy distribution trial, with more than 30 new stockists in the first week","A 5.0 rating from 24 verified customer reviews","A second product now in design with us"],"quote":{"text":"It's a big thing to put complete and total trust in someone to build something for you from scratch... we've enjoyed the process so much, we've just hit the green light on our second product!","by":"Sally Towell, Director and Co-founder, The Belly Solution","source":"Google review"},"formats":["powders"],"pathways":["listed-medicines"],"published":"2026-10-22"},{"id":"nine-products","slug":"bwellness-practitioner-range","title":"Nine products and a long partnership","seoDescription":"A practitioner tablet built on EnXtra® for BWellness: developed, its manufacture managed and kept in supply, with five production batches from 2021 to 2025.","client":"BWellness","tag":"Established brand","lead":true,"status":"shipped","glance":["Tablet","TGA-listed medicine","Built on EnXtra®, with Wellmune®, life's®OMEGA and VitaShine™ in sister products","Nine products, five years"],"brand":"BWellness, a practitioner-channel brand and distributor serving naturopaths and nutritionists across Australia and New Zealand, acquired in 2024 by an ASX-listed company for A$7 million.","challenge":"The brand needed a tablet built around a clinically studied branded extract, developed, manufactured and kept in supply.","built":"A 60-tablet formula built on EnXtra®, a clinically studied Alpinia galanga extract, taken from quoting specification to manufacture. We managed production, a custom label and a stability program at 3 and 12 months, then every reorder since.","manufacturing":"We've managed every production run, including imported ingredients, customs and freight, through to delivery to the brand's warehouse.","result":["Five production batches from 2021 to 2025","A sixth order now in the pipeline","Nine products developed for the same brand, including an immune powder built on Wellmune®, an algal omega-3 capsule built on life's®OMEGA with VitaShine™ vegan vitamin D3, a vitamin D product, an adrenal formula and a women's health formula"],"quote":{"text":"Take Friday Off is the future of a product design service... Crazy not to consider you for all NPD.","by":"Peter Ochsenham ND, former Managing Director and owner, BWellness"},"formats":["tablets","powders","capsules"],"pathways":["listed-medicines"],"seoTitle":"BWellness: practitioner tablet on EnXtra®, nine products","published":"2026-10-22"},{"id":"sports-core-range","slug":"sports-brand-core-range","title":"Rebuilding a sports brand's core range","tag":"Established brand","lead":false,"status":"shipped","glance":["Capsules and a powder","TGA-listed medicines and food","Includes Testofen®, a clinically studied fenugreek extract","Five products, reformulation to reorder"],"brand":"A private-equity-backed Australian sports and wellness brand, turning over A$24 million a year by 2019 and exporting to New Zealand, the UK and the UAE.","challenge":"Several of its best-known formulas had room to improve on ingredient quality, dose and permitted indications.","built":"Four TGA-listed capsules, reformulated from scratch (one built on Testofen®, a clinically studied fenugreek extract), plus a food-pathway performance powder. We handled the TGA listings, stability protocols and label review, and managed manufacturing.","manufacturing":"We managed manufacturing for all five products and every reorder, and worked through a co-packer delay, through to delivery.","result":["Five products in production from late 2023","Reorders on three of them within a year"],"formats":["capsules","powders"],"pathways":["listed-medicines","foods"],"client":"ATP Science","seoTitle":"ATP Science: four TGA-listed capsules and a sports powder","seoDescription":"ATP Science's core range rebuilt: four TGA-listed capsules, one on Testofen® fenugreek, and a food-pathway powder, with three reordered within a year.","published":"2026-10-22"},{"id":"joint-formula","slug":"sports-nutrition-joint-formula","title":"A joint formula for an established sports nutrition brand","seoDescription":"A TGA-listed joint formula for an established Australian sports nutrition brand: formula, evidence, listing and managed manufacture (2023).","tag":"Established brand","lead":false,"status":"shipped","glance":["TGA-listed medicine","Formula, evidence, listing and managed manufacture"],"brand":"An established Australian sports nutrition brand.","challenge":"Bring a joint-support formula into its range as a TGA-listed medicine.","built":"The formula, the claims evidence, the TGA listing, managed production, and a later listing update to keep it current.","manufacturing":"We managed manufacturing and freight through to the brand's warehouse.","result":["Delivered in 2023, alongside further products we scoped for the brand."],"formats":[],"pathways":["listed-medicines"],"seoTitle":"TGA-listed joint formula for a sports nutrition brand","published":"2026-10-22"},{"id":"skincare-regulatory","slug":"skincare-brand-regulatory-partner","title":"The regulatory partner behind an international skincare brand","seoDescription":"Formula and evidence work on two supplements and a sunscreen for an international skincare brand, and its Australian regulatory work since 2024.","seoTitle":"TGA regulatory partner to a global skincare brand","tag":"Established brand","lead":false,"status":"shipped","glance":["Supplements and a sunscreen","TGA","Ongoing regulatory retainer"],"brand":"An international skincare brand.","challenge":"Develop and keep a growing range of supplements and a sunscreen compliant in Australia.","built":"Formula and evidence work across three products, two supplements and a sunscreen, with stability studies out to 36 months. Since 2024 we have run their regulatory work on a monthly retainer.","manufacturing":"","result":["A regulatory partnership now in its third year."],"formats":[],"pathways":["listed-medicines"],"published":"2026-10-22"},{"id":"hair-care-returns","slug":"pump-haircare-hair-supplement","title":"A hair care brand that keeps coming back","seoDescription":"Pump Haircare's TGA-listed hair supplement capsules: working together since 2021, a 2024 reorder ready ahead of schedule, and an upgraded formula in 2026.","client":"Pump Haircare","tag":"Established brand","lead":false,"status":"shipped","glance":["Capsules","TGA-listed medicine","Repeat client since 2021"],"brand":"Pump Haircare, a hairdresser-founded, private-equity-backed Australian hair care brand, stocked in more than 300 salons and sold in over 100 countries (2022), that moved into supplements.","challenge":"Turn its hair expertise into TGA-listed hair growth supplements, then upgrade the formula as the range grew.","built":"A TGA-listed hair growth formula, its reorders, and later an upgraded version with a full new listing package and stability testing.","manufacturing":"We managed manufacturing, imports and air freight, and fixed issues along the way, through to delivery for every order.","result":["Working together since 2021","A 2024 reorder, ready ahead of schedule","An upgraded formula shipped in 2026, with another reorder in the pipeline"],"quote":{"text":"Was a lovely process, the team are great to work with, patient, understanding and responsive.","by":"Heidi Doig, Pump Haircare","source":"Google review"},"formats":["capsules"],"pathways":["listed-medicines"],"seoTitle":"Pump Haircare: TGA-listed hair growth supplement capsules","published":"2026-10-22"},{"id":"format-rescue","slug":"eye-health-tablet-format-rescue","title":"Rescuing a product that wouldn't encapsulate","tag":"Established brand","lead":false,"status":"shipped","glance":["Tablet and capsules","TGA-listed medicines","A format rescue, then a range"],"brand":"An established Australian natural health company with a multi-product range and export customers.","challenge":"An eye-health formula kept failing in encapsulation because the ingredient mix was too wet, and hand-filling would have added one to two more months.","built":"We moved the formula to a direct-compression tablet, got samples approved, and designed the stability protocol needed to support a three-year expiry. Across the relationship we developed and quoted nine products for the brand, spanning eye health, omega-3s, probiotics, liver, immune, prostate and more, and took three into production.","manufacturing":"We managed every production run through to delivery, including the change of format mid-project.","result":["The eye-health tablet shipped in 2024","A fish oil and a krill oil capsule also in production, with the fish oil reordered"],"formats":["tablets","softgels"],"pathways":["listed-medicines"],"seoTitle":"Eye-health formula rescued: from capsule to tablet","seoDescription":"An eye-health formula kept failing in encapsulation, so we moved it to a direct-compression tablet, with stability for a three-year expiry. Shipped 2024.","published":"2026-10-22"},{"id":"eye-health-reorder","slug":"areds2-eye-health-formula","title":"An eye-health formula, from design to reorder","seoDescription":"A TGA-listed eye-health formula on AREDS2 nutrient levels: design to production order in under seven weeks, then reordered a year later.","tag":"Established brand","lead":false,"status":"shipped","glance":["TGA-listed medicine","Built on the nutrient levels of the AREDS2 clinical trial","Design to reorder"],"brand":"An established Australian health brand.","challenge":"A premium eye-health formula built on the landmark AREDS2 nutrient levels, with a sample pack to drive trial, and a certification to reach more customers.","built":"The formula, updated to AREDS2 vitamin E levels before build, a 60-count pack and a trial pack, the certification, and a 24-month stability program.","manufacturing":"We managed manufacturing of both pack sizes, for both runs, through to delivery.","result":["From design to production order in under seven weeks","Reordered a year later, with the certification renewed"],"formats":[],"pathways":["listed-medicines"],"seoTitle":"TGA-listed eye-health supplement on AREDS2 levels","published":"2026-10-22"},{"id":"32-days","slug":"ashwagandha-capsule-32-days","title":"Design to production order in 32 days","seoDescription":"A complex herbal capsule on KSM-66® ashwagandha, with an evidence package covering more than 13 ingredients: design to production order in 32 days.","tag":"First launch","lead":false,"status":"shipped","glance":["TGA-listed medicine","Built on KSM-66®, a clinically studied ashwagandha extract","32 days, design to production order"],"brand":"A founder-led start-up.","challenge":"A complex herbal formula built around branded KSM-66 ashwagandha, needed on a tight timeline.","built":"The formula, an evidence package covering more than 13 ingredients, the TGA listing and a long-term stability program.","manufacturing":"We managed manufacturing through to delivery.","result":["From design to production order in 32 days."],"formats":["capsules"],"pathways":["listed-medicines"],"seoTitle":"Ashwagandha capsule: design to production order in 32 days","published":"2026-10-22"},{"id":"postnatal-six-versions","slug":"mother-daily-postnatal-supplement","title":"Six versions to get a postnatal formula right","client":"Mother Daily","tag":"First launch","lead":false,"status":"shipped","glance":["Postnatal supplement","Six formula versions","Evidence to full production run"],"brand":"Mother Daily, an Australian mothers' health brand, backed by a venture fund.","challenge":"A postnatal supplement with evidence behind every key ingredient.","built":"An evidence package covering eight key ingredients, six versions of the formula until it was right, the nutrition panel, label press proofs and management of a full production run.","manufacturing":"We managed manufacturing and the freight of the full run to the brand's warehouse.","result":["A first production run of 4,935 units, one of our largest, shipped in 2024."],"formats":[],"pathways":[],"seoTitle":"Mother Daily: a postnatal supplement in six formula versions","seoDescription":"Mother Daily's postnatal supplement: evidence on eight key ingredients, six formula versions, label proofs and one of our largest first production runs (2024).","published":"2026-10-22"},{"id":"preconception","slug":"arxi-preconception-supplement","title":"A preconception formula that keeps reordering","seoDescription":"Arxi's TGA-listed female preconception supplement, a capsule with a 7-day pack, with the evidence to support it: three production orders since 2024.","client":"Arxi","tag":"First launch","lead":false,"status":"shipped","glance":["Capsule plus 7-day pack","TGA-listed medicine","Three production orders"],"brand":"Arxi, a fertility brand founded by a fertility dietitian, a national Dietitian of the Year finalist, and a clinical nutritionist.","challenge":"A TGA-listed female preconception supplement, with the evidence to support it.","built":"The formula, the claims evidence, the TGA listing, the label and the product specification, plus a 24-month stability program. We later added a 7-day sample pack for events and sampling.","manufacturing":"We managed manufacturing for every order, troubleshooting the first run with the maker, through to delivery.","result":["Three production orders since 2024."],"formats":["capsules"],"pathways":["listed-medicines"],"seoTitle":"Arxi: a TGA-listed preconception supplement, reordered","published":"2026-10-22"},{"id":"prenatal-capsule","slug":"prenatal-multivitamin-capsule","title":"A prenatal built on plant powders","tag":"First launch","lead":false,"status":"shipped","glance":["Capsule","TGA-listed medicine","Built as much as possible on plant powders"],"brand":"A new supplement brand.","challenge":"A prenatal multivitamin built as much as possible on plant powders.","built":"Three versions of the formula, quotes from three manufacturers, an evidence package covering 13 or more ingredients, the TGA listing, the label and the stability protocol. We also sourced a replacement supply of the formula's lead plant ingredient.","manufacturing":"We managed production and troubleshooting through to delivery for launch.","result":["The brand launched in 2025."],"formats":["capsules"],"pathways":["listed-medicines"],"client":"Client Confidential","seoTitle":"A TGA-listed prenatal capsule built on plant powders","seoDescription":"A TGA-listed prenatal capsule built as much as possible on plant powders, with evidence for 13+ ingredients, three formula versions and a 2025 launch.","published":"2026-10-22"},{"id":"hair-range-recycled","slug":"vitable-hair-growth-range","title":"A hair range in recycled packaging","seoDescription":"Vitable's hair range: a TGA-listed capsule on a clinically studied Biota orientalis extract and a cosmetic serum, both delivered in 2024 and 2025.","client":"Vitable","tag":"First launch","lead":false,"status":"shipped","glance":["Capsule and serum","TGA-listed medicine and cosmetic","Built on a clinically studied Biota orientalis extract, AnaGain™ under licence and Quatrefolic®","100% recycled PET"],"brand":"Vitable, a venture-backed Sydney personalised-vitamin brand operating across five countries, whose founders were named among Australia's Top 100 Young Entrepreneurs (2024), now being acquired by ASX-listed Elixinol Wellness.","challenge":"A hair growth range: an evidence-based capsule and a matching serum.","built":"A complex TGA-listed capsule with more than 13 ingredients, including a clinically studied Biota orientalis extract, AnaGain™ under licence and Quatrefolic® active folate, in a 100% recycled PET bottle, plus a matching topical serum on the cosmetics pathway. We formulated both, managed their manufacture and sourced the recycled bottles.","manufacturing":"We managed manufacturing of both products, including the recycled bottle supply, through to delivery.","result":["Both products delivered in 2024 and 2025."],"formats":["capsules","creams"],"pathways":["listed-medicines","cosmetics"],"seoTitle":"Vitable: hair growth capsule and serum, recycled PET","published":"2026-10-22"},{"id":"skin-program","slug":"probiotic-skin-supplement","title":"A skin program built on probiotics","seoDescription":"An Australian skincare brand's probiotic skin supplement, reformulated as a two-a-day TGA-listed medicine: design to production order in 12 weeks.","tag":"First launch","lead":false,"status":"shipped","glance":["Two-a-day supplement","TGA-listed medicine","Probiotics at the core","12 weeks, design to production order"],"brand":"An Australian skincare brand.","challenge":"Turn its skin program into a daily supplement, the second version of its formula, with probiotics at its core.","built":"The reformulated two-a-day product, the claims evidence, the TGA listing, the label and a stability program.","manufacturing":"We managed manufacturing through to delivery.","result":["From design to production order in 12 weeks, shipped in 2025."],"formats":[],"pathways":["listed-medicines"],"seoTitle":"Probiotic skin supplement, reformulated and TGA-listed","published":"2026-10-22"},{"id":"own-brand-small-business","slug":"your-skin-scan-nicotinamide-tablet","title":"An own-brand launch for a clinical skin service","seoDescription":"Your Skin Scan's first own-brand product: a TGA-listed nicotinamide tablet at 500 mg, from first enquiry to delivery within the year.","client":"Your Skin Scan","tag":"First launch","lead":false,"status":"shipped","glance":["Tablet","TGA-listed medicine","Nicotinamide at the 500 mg strength used in published clinical research","Enquiry to delivery within the year"],"brand":"Your Skin Scan, a community skin-check and mole-mapping service, led by a clinical nurse consultant who wanted her own supplement for her clients.","challenge":"The founder wanted to sell her own vitamin B3 (nicotinamide) product but wasn't sure which regulatory pathway applied.","built":"A single-ingredient 500 mg tablet, 120 per bottle, as a TGA-listed medicine. We handled the formula, the quote, the claims evidence, the TGA listing, label compliance and the stability protocol.","manufacturing":"We managed manufacturing through to delivery, so the founder never had to deal with a factory.","result":["A first own-brand product, from first enquiry to delivery within the year.","From signed quote to delivery: about 6.5 months."],"quote":{"text":"5 Star business. From concept to manufacturing to completion, Take Friday Off were thorough, professional and understood the needs of a small business. Highly recommended.","by":"Sharon Hudson, Managing Director, Your Skin Scan","source":"Google review"},"formats":["tablets"],"pathways":["listed-medicines"],"seoTitle":"Your Skin Scan: a TGA-listed nicotinamide 500 mg tablet","published":"2026-10-22"},{"id":"first-product-launch-ready","slug":"nivari-powder-supplement","title":"A founder's first product, launch-ready","client":"Nivari","tag":"First launch","lead":false,"status":"shipped","glance":["Powder in the brand's own pouch","First product","Idea to launch-ready"],"brand":"Nivari, a founder-led wellness brand, with a CEO and COO team, launching its first product.","challenge":"Take a powder supplement from idea to a finished, launch-ready product.","built":"The formula and the full development and managed manufacturing process, packed into the brand's own pouch.","manufacturing":"We managed manufacturing and delivery, including the founder's own pouch.","result":["Produced and delivered for a mid-August 2026 launch."],"quote":{"text":"Working with the Take Friday Off team to develop my supplement has been a great experience from start to finish. The entire job was smooth and the communication during the job was clear and professional... I would highly recommend Take Friday Off to anyone looking to develop a product.","by":"Minaret Shore, CEO, Nivari","source":"Google review"},"formats":["powders"],"pathways":[],"format":"Powder in a pouch","seoTitle":"Nivari: a founder's first powder supplement, launch-ready","seoDescription":"Nivari's first product: a powder supplement formulated, its manufacture managed, and packed in the brand's own pouch for a mid-August 2026 launch.","published":"2026-10-22"},{"id":"cross-border-oil","slug":"deeply-rooted-organic-oil","title":"A cross-border organic oil for little ones","client":"Deeply Rooted","tag":"First launch","lead":false,"status":"shipped","glance":["Organic essential oil","Made in New Zealand","Cross-border supply chain"],"brand":"Deeply Rooted, a founder-led natural baby-care brand, working with lactation consultants and midwives.","challenge":"An organic essential oil blend for children, made in New Zealand and sold in Australia.","built":"Product development and the whole cross-border supply chain, from the New Zealand maker to delivery in Australia.","manufacturing":"","result":["Delivered in 2025."],"quote":{"text":"Fantastic company to engage with. Gabriel is super knowledgeable and has assisted me greatly in my business.","by":"Founder, Deeply Rooted","source":"Google review"},"formats":["liquids"],"pathways":[],"seoTitle":"Deeply Rooted: an organic essential oil for children","seoDescription":"Deeply Rooted's organic essential oil blend for children: product development and a cross-border supply chain from the New Zealand maker to Australia, in 2025.","published":"2026-10-22"},{"id":"ora","slug":"ora-practitioner-natural-medicine","title":"Practitioner-recommended natural medicine, formulated from clinical evidence","seoTitle":"Ora: practitioner-recommended natural medicine","client":"Ora","tag":"Our own brand","lead":false,"status":"own","glance":["Capsules, powders, tonics and chewable tablets","TGA-listed medicines and premium functional foods","Built on affron®, KSM-66®, GutGard®, Ferrochel®, life's®OMEGA, Vitashine™, ioPea™, PANMOL® and SIRTCell™","Our founder's own brand"],"brand":"Ora, a premium Australian natural medicine brand founded by Gabriel Perera, recommended by naturopaths, herbalists and functional medicine practitioners and carried by premium retailers across Australia and New Zealand.","challenge":"Build a full practitioner range across healthy longevity, women's hormonal health, gut health, and sleep, stress and recovery, with every formula therapeutically dosed, plant-based and backed by evidence.","built":"A range of around 19 products, each built on ingredients with gold-standard clinical research behind them, using certified organic ingredients where possible. One formula was co-created with clinical herbalist Erin Lovell Verinder. Ora also runs pilot studies on its own products, and every batch is independently third-party tested.","manufacturing":"Managed end to end through the same process and manufacturing partners we use for every client.","result":["A brand in practitioner clinics and premium retailers across Australia and New Zealand, a member of 1% for the Planet, and expanding into new markets."],"formats":["capsules","powders"],"pathways":["listed-medicines","foods"],"seoDescription":"Ora, our founder's own brand: around 19 practitioner-recommended medicines on affron®, KSM-66® and GutGard®, in clinics and retailers across Australia and NZ.","published":"2026-10-22"},{"id":"nectar-of-the-dogs","slug":"nectar-of-the-dogs-pet-supplements","title":"A new category, then an acquisition","client":"Nectar of the Dogs","tag":"Our own brand","lead":false,"status":"own","glance":["Supplement powders and water treats for dogs","Human-grade ingredients","Formulated with vet surgeons and naturopaths","Acquired"],"brand":"Nectar of the Dogs (People for Pets), founded by Gabriel Perera.","challenge":"Bring human-grade, evidence-based supplement standards to pets, in a format dogs will actually take.","built":"A line of plant-based water treats and supplement powders, added to a dog's water or food, each targeting a specific health and wellness need. They were formulated to evidence-based standards in collaboration with vet surgeons and naturopaths.","manufacturing":"","result":["Three months after launch, Australia's largest pet food manufacturer and brand owner, The Real Pet Food Company, the group behind Ivory Coat, Billy + Margot and Nature's Gift, bought a majority stake. It was the group's first move into pet supplements."],"formats":["powders"],"pathways":[],"seoTitle":"Nectar of the Dogs: human-grade dog supplements, acquired","seoDescription":"Nectar of the Dogs, founded by Gabriel Perera: plant-based supplement powders and water treats for dogs, formulated with vet surgeons. Majority acquired 2022.","published":"2026-10-22"},{"id":"prenatal-chewable","slug":"arxi-prenatal-chewable","title":"Making a prenatal people will actually take","seoDescription":"Arxi's prenatal chewable: a full vitamin and mineral dose in a form pregnant women will accept, with Rocoat® coated B vitamins. Due late October 2026.","client":"Arxi","tag":"First launch","lead":false,"status":"pending","glance":["Chewable","TGA-listed medicine","Rocoat® coated B vitamins","Liquid to chewable"],"brand":"Arxi, a fertility and pregnancy brand founded by a fertility dietitian, a national Dietitian of the Year finalist, and a clinical nutritionist.","challenge":"Deliver a full prenatal vitamin and mineral dose in a form pregnant women will accept. B vitamins and selenium are bitter and smell strongly, and vitamin C fizzes in liquid.","built":"We started with a liquid drop. When trials showed it wasn't stable and the taste couldn't be masked, we traced the main odour to one selenium form and removed it, tested a liposomal liquid, then moved to a two-a-day chewable with Rocoat® coated B vitamins to tame the taste. Our label review caught two errors before print.","manufacturing":"We're managing manufacturing now, through to delivery.","result":["In production, due for dispatch in late October 2026."],"formats":["tablets"],"pathways":["listed-medicines"],"seoTitle":"Arxi: a prenatal chewable with Rocoat® coated B vitamins","published":"2026-10-22"},{"id":"pain-relief-cream","slug":"pain-relief-cream","title":"A pain relief cream built to challenge the category leaders","seoDescription":"A TGA-listed pain relief cream pairing a traditional botanical with proven ingredients, for a founder-led Australian brand. Due late 2026.","tag":"First launch","lead":false,"status":"pending","glance":["Cream","TGA-listed medicine","A traditional botanical","Challenger to the category leaders"],"brand":"A founder-led Australian pain relief brand built on a traditional botanical, with international distribution interest ahead of launch.","challenge":"A TGA-listed pain relief cream that pairs a traditional botanical with proven ingredients, matches the category's leading creams on formula and price, feels non-greasy, doesn't stain, and comes in a pack older users can open easily.","built":"The formula and R&D samples, the claims evidence, the TGA listing (updated after a preservative change), the stability program, the product specification and the label.","manufacturing":"We're managing manufacturing now, including the tube supply, through to delivery.","result":["Due in late 2026."],"quote":{"text":"I've got the first batch and I love them.","by":"Founder, on the R&D samples"},"formats":["creams"],"pathways":["listed-medicines"],"seoTitle":"Pain relief cream, TGA-listed, due late 2026","published":"2026-10-22"}],"clientLogos":[{"name":"Arxi","file":"arxi","width":90,"url":"https://fromarxi.com/"},{"name":"ATP Science","file":"atp-science","width":93,"url":"https://atpscience.com.au/"},{"name":"Australian NaturalCare","file":"australian-naturalcare","width":77,"url":"https://www.ausnaturalcare.com.au/"},{"name":"Bioconcepts","file":"bioconcepts","width":171,"url":"https://www.bioconcepts.com.au/"},{"name":"BWellness","file":"bwellness","width":34,"mark":true},{"name":"Designs for Health","file":"designs-for-health","width":171,"url":"https://www.designsforhealth.com.au/"},{"name":"DMK","file":"dmk","width":92,"url":"https://dannemking.com.au/"},{"name":"Evolution Botanicals","file":"evolution-botanicals","width":133,"url":"https://evolutionbotanicals.com.au/"},{"name":"Lifecykel","file":"lifecykel","width":127,"url":"https://lifecykel.com/"},{"name":"LVL UP","file":"lvl-up","width":103,"url":"https://lvlupsupps.com/"},{"name":"Microba","file":"microba","width":145,"url":"https://www.microba.com/"},{"name":"Mother Daily","file":"mother-daily","url":"https://motherdaily.co/"},{"name":"Orthoplex","file":"orthoplex","width":151,"url":"https://www.bioconcepts.com.au/"},{"name":"Pump Haircare","file":"pump-haircare","width":90,"url":"https://pumphaircare.com/"},{"name":"Vitable","file":"vitable","width":109,"url":"https://www.vitable.com.au/"},{"name":"The Belly Solution","file":"the-belly-solution","width":142,"url":"https://thebellysolution.com.au/"},{"name":"EverLeanBody","file":"everleanbody","width":141,"url":"https://everleanbody.com/"},{"name":"Your Skin Scan","file":"your-skin-scan","width":67,"url":"https://www.yourskinscan.com.au/"},{"name":"Nivari","file":"nivari"}],"clients":{"heading":"Who we work with","intro":"Built for the brands people know and love, and the ones they’re about to.","types":[{"title":"Product & innovation leader","body":"Head of product inside a growing wellness brand whose internal NPD team is at capacity, or struggling to innovate."},{"title":"Commercial leader","body":"A founder or CEO experiencing internal drag: a product idea, investor pressure to move, and a pipeline that isn’t moving fast enough."}],"signals":["Your internal NPD team is at capacity or struggles to innovate","Your regulatory pathway is unclear","You’ve wasted time and budget with freelance formulation labs or disconnected consultants","You have a product idea with investor pressure to move"],"brands":[{"title":"The brands people know and love","who":"Established brands with double-digit growth ambition","holds":"The product team is at capacity, and the pipeline can’t keep pace with the business","give":"Capacity and speed without adding headcount"},{"title":"The ones they’re about to","who":"Brands with ambition, built and backed to scale","holds":"They need big-brand product capability before they can justify building it in-house","give":"The team and system an established brand has, from their next SKU"}]},"contact":{"next":{"h2":"What happens after you press send.","steps":[{"title":"A reply within one business day","body":"Your message goes straight to Gabriel."},{"title":"Fifteen minutes on your product","body":"A call on your pipeline, your regulatory pathway and what the five steps would look like for your next product."},{"title":"Clear next steps, either way","body":"Whether or not we work together, you leave with next steps. No deck, no obligation."}]},"bring":{"h2":"Bring what you have.","body":"A first call doesn't need a finished brief. Just before the call, think about the customer, the format of the product and the cost of goods you want to achieve.","items":[{"title":"The customer","body":"Who the product is for, and the claim it needs to make for them."},{"title":"The format","body":"The one you have in mind, or the choice you're still weighing."},{"title":"The price","body":"The retail price it has to sell at, or the target cost of goods."},{"title":"The timing","body":"When it needs to be on shelf, and what's in the way today."}],"button":{"label":"See the five steps","to":"/system"}},"questions":{"h2":"Questions before you write?","faqs":["Do you work with early-stage or pre-revenue brands?","Can we use you for one stage only?","How does pricing work?","Where are you based?"]}},"differentiators":[{"title":"As little as six months","body":"Up to 4x faster than the industry norm."},{"title":"Global network","body":"Access to established manufacturers, the highest quality raw materials and global innovation partners."},{"title":"Regulatory expertise","body":"Compliance-led development that protects brand, claims and IP."},{"title":"Commercial operators","body":"$1.5B+ revenue generated across 50+ brands."},{"title":"Friday Launch Engine™","body":"Five steps from concept to compliant to shelf: Discover, Design, De-risk, Deliver, Drive."},{"title":"Craftsmanship & formulation design","body":"Category-leading products developed with expert precision and care."}],"dna":[{"title":"Strategic","body":"We align product development with commercial, brand and regulatory requirements."},{"title":"Compressed","body":"We reduce 18 to 24 month timelines to as little as six."},{"title":"Evidence-based","body":"We formulate to evidence-based doses and TGA standards."},{"title":"Quietly powerful","body":"We don’t create more noise. We protect progress and carry the outcome."},{"title":"End-to-end","body":"From concept to commercial strategy, compliance, formulation and packaging."},{"title":"Regulatory as a growth lever","body":"Compliance is integrated from day one, unlocking claims, protecting IP and accelerating launches."},{"title":"Communication first","body":"Real updates, straight answers, no chasing."},{"title":"Seamless","body":"One task force team that replaces up to six, running one proven system: Friday Launch Engine™."}],"experience":["Blackmores","BioCeuticals","TSI Group"],"faqs":[{"q":"How does Take Friday Off get a product to shelf in as little as six months?","a":"Compliance is built in from day one; formulation, regulatory and sourcing run in parallel rather than in sequence; and established manufacturing partners are already in place. Friday Launch Engine™ replaces up to six internal hires or separate vendors with one team."},{"q":"Who is Take Friday Off for?","a":"Two kinds of brand. The ones people know and love: established, with double-digit growth ambition and a product team at capacity. And the ones they’re about to: brands with ambition, built and backed to scale. In both, we work with the head of product, or the founder or commercial leader."},{"q":"What product formats do you develop?","a":"Capsules, tablets and chewables, softgels, gummies, powders and sachets, liquids and oils, and creams and serums, across the TGA, FSANZ and cosmetics pathways."},{"q":"Do you work with early-stage or pre-revenue brands?","a":"Yes, where there is a plan and the backing to scale: a brand with that ambition gets the team and system an established brand has, from its next SKU. If the idea doesn’t yet have backing or a plan to scale, join the list for first access to our notes and sessions as they start.","md":"Yes, where there is a plan and the backing to scale: a brand with that ambition gets the team and system an established brand has, from its next SKU. If the idea doesn’t yet have backing or a plan to scale, [join the list](mailto:hello@takefridayoff.com?subject=Join%20the%20list) for first access to our notes and sessions as they start."},{"q":"How does pricing work?","a":"Fixed fees for a defined outcome at each stage, from discovery to launch, and manufacturing priced per unit. You know the investment before each stage begins."},{"q":"Can we use you for one stage only?","a":"Yes. Evidence packages, TGA listings, label and advertising reviews and stability protocols are available on their own, as are FSANZ and AICIS work. Friday Launch Engine™ runs end to end when you want the whole product carried."},{"q":"Where are you based?","a":"Brookvale, Sydney, working with brands across Australia, New Zealand and the Asia-Pacific region."}],"footerPages":[{"label":"Notes","to":"/notes"},{"label":"AI assistants","to":"/ai"},{"label":"Glossary","to":"/glossary"}],"formats":[{"id":"capsules","title":"Capsules","kicker":"Our most common format, and usually the quickest to develop.","body":"From a four-ingredient formula to complex herbal blends of 13 or more ingredients, in recycled PET bottles and 7-day trial packs.","tone":"ink","slot":"home.format.capsules","types":"Gelatin and vegan hard-shell, delayed-release, acid-resistant and liquid-filled.","popular":"CoQ10, ashwagandha, curcumin, probiotics, magnesium glycinate, sleep and stress blends.","when":"you have powders or extracts at moderate doses, from a single clinically studied extract to a complex herbal blend."},{"id":"tablets","title":"Tablets","kicker":"More dose in one unit, and more control over how it releases.","body":"Direct-compression tablets, including a formula moved from capsule to tablet when the blend would not encapsulate.","tone":"coral","slot":"home.format.tablets","types":"Direct-compression, film-coated, chewable, effervescent, orally disintegrating, sublingual, bilayer and extended-release.","popular":"Magnesium, B-complex, iron, effervescent vitamin C and electrolytes, chewable prenatals.","when":"the dose is high, the taste needs masking, or your customers won't swallow a capsule."},{"id":"softgels","title":"Softgels","kicker":"Oils and oil-soluble nutrients, sealed in an easy-to-swallow shell.","body":"Fish oil and krill oil, taken from formula into production, with the fish oil since reordered.","tone":"sage","slot":"home.format.softgels","types":"Bovine and fish gelatin, vegan, chewable and enteric-coated.","popular":"Fish, krill and algal omega-3, vitamin D3, CoQ10 in oil, vitamin E, evening primrose oil.","when":"your actives are oils or dissolve in oil."},{"id":"gummies","title":"Gummies","kicker":"A daily format your customers look forward to.","types":"Pectin (vegan), gelatin, sugar-free, and centre-filled or coated.","popular":"Vitamin C, elderberry, apple cider vinegar, kids' multivitamins, sleep and relaxation.","when":"taste drives repeat purchase. We stability-test taste and texture across the shelf life.","body":"Pectin (vegan), gelatin, sugar-free, and centre-filled or coated gummies, with taste and texture stability-tested across the shelf life.","tone":"peach","slot":"home.format.gummies"},{"id":"powders","title":"Powders","kicker":"Large serves and flexible packs.","body":"A probiotic powder with electrolytes in a 14-day pouch, and a performance powder on the food pathway.","tone":"peach","slot":"home.format.powders","types":"Tubs, pouches, stick packs and single-serve sachets.","popular":"Gut health and probiotic powders, greens, electrolytes, collagen, protein, creatine, pre- and intra-workout.","when":"the serve is too big for a capsule, or you want sampling and trial packs."},{"id":"liquids","title":"Liquids","kicker":"Doses your customers can measure, drop or spray.","body":"Liquids and organic oil blends, including a supply chain from a New Zealand maker through to delivery in Australia.","tone":"bluegrey","slot":"home.format.liquids","types":"Drops, tinctures, shots, syrups and oral sprays.","popular":"Vitamin D drops, herbal tinctures, iron liquids, B12 sprays.","when":"you need precise or adjustable doses, or your customers prefer a liquid."},{"id":"creams","title":"Topicals","kicker":"For products your customers apply rather than swallow.","body":"Creams and serums on the TGA or cosmetics pathway, from a TGA-listed pain relief cream in tubes to a matching hair serum.","tone":"ink","slot":"home.format.creams","types":"Creams, serums, balms, gels, lotions, ointments and body oils.","popular":"Magnesium cream, vitamin C serum, hair serum, barrier balm, hair and body oils.","when":"you're building a cosmetic or a TGA-listed topical. We confirm the pathway at the brief."}],"formatsLine":"Built across the TGA, FSANZ and cosmetics pathways, from formula to delivery.","founders":[{"name":"Gabriel Perera","role":"Founder and Managing Partner","photoKey":"gabriel","summary":"Gabriel founded Take Friday Off after two decades building some of Australia’s most trusted natural health brands. He holds the big-picture vision, connects market realities with product planning and ensures every decision builds towards commercial success, clinical standards and regulatory requirements.","bio":["Gabriel Perera started in law at DLA Piper and strategy at Accenture, then moved into natural health and stayed. He has run a natural medicine company, built Blackmores' Asian product pipeline, worked in raw materials and set strategy for a contract manufacturer.","He has also founded and grown three multi-million-dollar businesses, including Nectar of the Dogs, which sold at a $3M valuation.","Corporate or founder-led, he knows what your pipeline needs, because he has been on both sides of the table."],"career":[{"years":"1999","org":"DLA Piper","role":"Law"},{"years":"2000–2002","org":"Accenture","role":"Strategy"},{"years":"2002–2007","org":"Phytomedicine & Nutrimedicine","role":"General Manager"},{"years":"2007–2017","org":"Blackmores","role":"Senior executive: the BioCeuticals acquisition, a 200-product pipeline across 11 Asian markets, the Kalbe Farma joint venture"},{"years":"2017","org":"Lifestream","role":"Director, Strategy and Business Development"},{"years":"2017–2020","org":"TSI Group","role":"Chief Strategy Officer: global raw materials, cGMP manufacturing and contract supply"},{"years":"2020–","org":"Take Friday Off","role":"Founder and Managing Partner"},{"years":"2020–","org":"Ora","role":"Founder: around 19 products built on clinically studied ingredients, one formula co-created with clinical herbalist Erin Lovell Verinder"},{"years":"2020–2023","org":"Nectar of the Dogs","role":"Founder; The Real Pet Food Company bought a majority stake in 2022"}],"team":"Gabriel works with a small senior team and a network of regulatory and technical specialists.","firstCaseStudy":"Before we built your product, we built Blackmores' product pipeline: 200 products across 11 markets.","heading":"Twenty years on every side of natural health.","credentials":["Adjunct Fellow, National Institute of Complementary Medicine (NICM)","Graduate, Australian Institute of Company Directors"],"teamClose":"Together, 40+ years across natural health, regulatory affairs, global supply chains and commercialisation. We've run 190 projects since 2020, through one system: Friday Launch Engine™."}],"home":{"hero":{"h1":"Reducing your product development timeline from 24 months to as little as 6.","sub":"We design, formulate and manage manufacturing of natural health products for wellness brands. You get a complete formula, with doses, claims evidence and a quote, in weeks. Then one team carries your product from first idea to compliant launch.","review":{"quote":"Six months from our first meeting, my first product was on a shelf.","by":"EverLeanBody","source":"Google review","stars":5},"buttons":[{"label":"Book a 15-minute call","booking":true},{"label":"See how it works","to":"/system"}],"video":{"src":"/media/la-calma.mp4","webm":"/media/la-calma.webm","srcPortrait":"/media/la-calma-portrait.mp4","webmPortrait":"/media/la-calma-portrait.webm","note":"Death to Stock clip 291, La Calma (Super 8): muted, looping, under 4 MB, playing on phones, a soft dark overlay behind the headline. Until the licensed file is in public/media, the hero shows the still in the home.hero slot; with reduced motion it always does."}},"trusted":{"h2":"Trusted by ASX‑listed groups, PE‑backed and founder‑led brands."},"why":{"h2":"Why ambitious brands choose Take Friday Off.","cards":[{"title":"Natural health products, made to a higher standard.","body":"Our founder grew up in natural health, inside brands like Blackmores and BioCeuticals. Today we formulate across the full spectrum of natural health, from TGA-listed medicines to sports nutrition, functional foods and cosmetics, choosing every ingredient for the evidence behind it.","ticks":["Every TGA-listed batch is tested by an independent lab before release","Foods built to the same quality and formulation standard as our TGA medicines","Branded ingredients with published human clinical research, where the formula calls for it","Evidence-based doses, never token amounts","Compliance built in from day one"]},{"figures":[{"value":"190","label":"projects since 2020"},{"value":"32 days","label":"design to production order"},{"value":"5.8 months","label":"fastest brief to dispatch"},{"value":"5+ years","label":"partnerships with clients"}]},{"title":"Our founder has sat in your seat.","body":"Gabriel Perera has spent more than two decades on every side of natural health.\n\nAt Blackmores, he built a 200-product pipeline across 11 Asian markets and led the acquisition of BioCeuticals. Before that, he ran Phytomedicine & Nutrimedicine, where he led a turnaround before the business was sold to its largest competitor, MediHerb. He worked in raw materials at Pathway International and set strategy for contract manufacturer TSI Group, so he knows the factory floor and the boardroom.\n\nIn the last 5 years, he has also founded and grown three multi-million-dollar businesses: Ora, Take Friday Off and Nectar, which sold at a $3M valuation.\n\nCorporate or founder-led, he knows what your pipeline needs because he has been on both sides of the table.","link":{"label":"Meet the team","to":"/about"}}]},"line":"You carry the idea. We carry the outcome.","how":{"h2":"Five steps. One team. Total product delivery.","steps":[{"title":"Discover","line":"Market, portfolio, pathway and forecast aligned before anything is formulated."},{"title":"Design","line":"Evidence-based formulation, with early access to new ingredients."},{"title":"De-risk","line":"Claims, evidence, labels and listings, prepared alongside the formula, not after it."},{"title":"Deliver","line":"We manage your manufacturing: production, packaging, release testing and freight."},{"title":"Drive","line":"Reorders, range extensions and your next SKU, with the same team."}],"usual":"The usual way: a formulator, a regulatory consultant, a manufacturer and a packaging supplier, each waiting on the last.","engine":"Friday Launch Engine™: one team, every step side by side.","button":{"label":"See Friday Launch Engine™","to":"/system"}},"build":{"h2":"Any format your customers reach for.","body":"Medicines, foods and cosmetics. Every format runs through the same five steps, with the same team.","extra":{"title":"Not on the list?","label":"Tell us what you want to make","to":"/contact"},"alsoHeading":"Also","also":[{"title":"Practitioner-only ranges","body":"Any format above, built for supply through clinics and health practitioners, with doses set by the evidence.","popular":"clinic-only herbal formulas, high-dose minerals, targeted gut health powders.","to":"/practitioner-ranges"},{"title":"New ingredient applications","body":"Is your hero ingredient not yet permitted in Australia? We manage the application, whether that's a TGA new ingredient application for listed medicines, an FSANZ novel food application or an AICIS cosmetic ingredient introduction. We map the approval route at the brief, before the formula is locked.","popular":"new botanical extracts, novel probiotic strains, new skincare actives.","to":"/new-ingredients"}]},"proof":{"h2":"Proof, from our own clients.","cases":["nine-products","sports-core-range","brief-to-dispatch"],"button":{"label":"See all {n} case studies","to":"/work"}},"say":{"h2":"Real updates. Straight answers. No chasing.","reviews":["EverLeanBody","The Belly Solution","BWellness","Blackmores Group"]},"fit":{"h2":"Who we're built for.","segments":[{"title":"Established brands","body":"Double-digit growth plans and a product team already at capacity."},{"title":"Challenger brands","body":"The ambition and the backing to scale."}],"lead":"Sound familiar?","ticks":["Your regulatory pathway is unclear","You've lost time and money to freelance labs and disconnected consultants","Your next launch can't slip","Your capital and reputation are riding on it"],"button":{"label":"Take the readiness check","to":"/partner"}},"close":{"h2":"Close your laptop on Thursday night and relax.","body":"Your launch keeps moving, in hands that care about it as much as you do. That's The Friday Feeling™.","button":{"label":"Book a 15-minute call","booking":true},"note":"15 minutes, no obligation, and a clear next step either way.","email":true}},"joinListHref":"mailto:hello@takefridayoff.com?subject=Join%20the%20list&body=Please%20add%20me%20to%20the%20Take%20Friday%20Off%20list%20for%20new%20masterclasses%20and%20regulatory%20notes.","launchEngine":{"name":"Friday Launch Engine™","line":"Five steps from concept to compliant to shelf, in as little as six months.","note":"Phase content and timing are confirmed against your brief in the first call."},"legacy":{"hero":"We partner with wellness brands to make their product development, sustainable supply chain and regulatory affairs effortless.","intro":["Like you, we’re believers in the power of great natural products to improve people’s lives.","With 40+ years’ collective experience in Australia’s best brands, we know how to bring exceptional products to a demanding global market.","Over six years and close to 50 products in production, we’ve learned what works, who to call and how to make product development run better, faster and more cost-effectively.","The products and businesses we’ve developed have gone on to real results: one was acquired by an ASX-listed company.","You’ve got the breakthrough ideas. We’re here to help you make them a reality."],"context":["Consumers expect high standards for results, manufacturing methods, ingredient sourcing and environmental impact across a product’s whole life.","Businesses have become leaner and need flexible access to specialised skills, facilities and resources as demand changes.","Product development, innovation and the regulatory, quality and technical work behind them have become more important to growth.","Companies need more consumer-focused products, delivered at lower cost, on shorter timelines and with smaller teams.","Take Friday Off offers a streamlined process and service to help brands launch new products, upgrades, relaunches and listing updates faster and with less stress."],"closing":"If you’re ready to create some incredible natural products, let’s talk. We offer a no-obligation initial call.","valuesHeading":"What we value"},"naming":{"heading":"Why “Take Friday Off”?","lines":["“Take Friday Off” was always designed to signal the outcome of working with us.","Through that lens, it’s not just a name, it’s a promise.","Our systems compress your timelines, reduce complexity and free up your team’s capacity.","You’re not hustling to get products over the line.","You’re closing your laptop on Thursday night, knowing it’s handled."],"kicker":"In fact, why not take Friday off?"},"narrative":{"label":"Introduction","statement":"We help great brands innovate faster, and better, without cutting corners: one proven system in place of a fragmented, slow internal process.","paragraphs":["Take Friday Off exists to help great brands innovate faster, and better, without cutting corners. We take what is typically a fragmented, slow and complex internal product development process and replace it with one seamless, intelligent and proven system.","With 40+ years of combined experience across natural health, regulatory affairs, global supply chains and commercialisation, we’ve built brands and products that have generated more than $1.5B in revenue.","Now we’re building for you: faster, smarter and with greater health benefits for the most important person in this whole equation, your customer."]},"nav":[{"label":"Home","to":"/"},{"label":"System","to":"/system"},{"label":"Work","to":"/work"},{"label":"About","to":"/about"},{"label":"Partner","to":"/partner"},{"label":"Contact","to":"/contact"}],"ownBrandLogos":[{"name":"Ora","file":"ora","width":78,"url":"https://orahealth.com.au/"},{"name":"Nectar of the Dogs","file":"nectar-of-the-dogs","width":50,"url":"https://nectarofthedogs.com.au/"}],"partner":{"desks":{"h2":"One brief, every desk covered.","lead":"A product crosses five desks on its way to the shelf. Friday Launch Engine™ carries it across all of them, so nobody waits on anyone else.","items":[{"title":"Product and innovation","body":"The formulation, its specification and an approved sample, built on clinically studied ingredients where the formula calls for them, with the format tested before any production order."},{"title":"Marketing","body":"The claims the product can make, each with the evidence behind it, within the rules of its pathway, and the label and advertising checked before anything is printed."},{"title":"Regulatory","body":"Medicine, food or cosmetic settled at the brief, the ARTG listing for medicines, and every mandatory statement on the pack."},{"title":"Finance","body":"A quote and the cost of goods before anything is ordered. Development stages are fixed fees for a defined outcome; manufacturing is priced per unit."},{"title":"Operations","body":"cGMP manufacturing partners matched to your format, volume and margin, then release testing, imports and freight through to your warehouse or 3PL."}]},"call":{"h2":"Fifteen minutes on your product.","lead":"Focused entirely on your product or brand. You'll leave with clear next steps, and there's no obligation.","items":["Your pipeline: what's in development, what's stuck, and what the market is asking for next.","Your pathway: listed medicine, food or cosmetic, which claims and which risks.","The plan: the five steps mapped to your product, and what drives the timeline."],"button":"Book a 15-minute call"}},"people":{"h1":"The people who carry your product.","close":"We don't just advise. We carry the outcome.","sub":"A small senior team, led by a founder who has built natural health products from raw material to shelf. These are the people on your project."},"pillars":[{"title":"Compliance from day one","body":"Claims, evidence and labelling are designed in at the brief, so nothing is unpicked after formulation."},{"title":"Steps in parallel","body":"Formulation, regulatory and sourcing run alongside each other, not one after another."},{"title":"Partners already in place","body":"We match established ingredient suppliers and cGMP manufacturers to your format before the first run."},{"title":"One team, one point of contact","body":"Up to six hires or vendors become one team on your side, so you make decisions once."},{"title":"Real updates, straight answers","body":"Most of our reviews mention the communication before the speed. You always know where the product is, what happens next and when."}],"proofLines":["Every TGA-listed batch is third-party tested","Where the brief calls for it, we use ingredients backed by double-blind, published clinical trials"],"stats":[{"value":6,"prefix":"","suffix":"","label":"Months to shelf, as little as","note":"Concept to compliant, shelf-ready product"},{"value":32,"prefix":"","suffix":"","label":"Days, design to production order","note":"Our fastest on record, a complex herbal capsule"},{"value":190,"prefix":"","suffix":"","label":"Projects since 2020","note":"Across TGA-listed medicines, foods and cosmetics"},{"value":1.5,"prefix":"$","suffix":"B+","label":"Revenue generated","note":"Across 50+ brands built by our operators","decimals":1},{"value":40,"prefix":"","suffix":"+","label":"Years of team experience","note":"Natural health, regulatory, supply chain, commercial"}],"system":[{"n":"01","title":"Discover","body":"We align the product with your commercial, brand and regulatory requirements from day one: market, portfolio, pathway and forecast. Every decision then builds towards a product that sells and a pipeline that scales.","gives":"A brief, a regulatory pathway and a forecast you can take to the board.","decides":"Go or no-go on the brief, and which regulatory pathway to take.","problem":"A clinical nurse consultant wanted her own vitamin B3 product but wasn't sure which regulatory pathway applied.","solved":"We settled it at the brief: a single-ingredient 500 mg tablet as a TGA-listed medicine. Formula, quote, evidence, listing and label followed in order. From signed quote to delivery: about 6.5 months."},{"n":"02","title":"Design","body":"Evidence-based formulation, with early access to new ingredients, emerging research and the formats your customers are already looking for, sourced through our global ingredient network.","gives":"A formulation, a specification and a quote.","decides":"The formulation, the format and the target unit price.","problem":"A postnatal supplement needed evidence behind every key ingredient, and the first formula wasn't right.","solved":"Six versions until it was, with an evidence package covering eight key ingredients, then a first production run of 4,935 units.","link":{"to":"/formulation","label":"More on formulation"}},{"n":"03","title":"De-risk","body":"Compliance built in, not bolted on. Claims, evidence, labelling and listing are prepared alongside the formula, to TGA, FSANZ and AICIS requirements, so nothing is unpicked later.","gives":"Claims with the evidence behind them, artwork reviewed for compliance, and the listing.","decides":"The claims you will make, and the evidence behind them.","problem":"An eye-health formula needed its vitamin E dose set to the AREDS2 level before it was built.","solved":"We set it before anything was made, and designed a stability program to support the shelf life. We moved from design to production in under seven weeks.","link":{"to":"/pathways","label":"Medicine, food or cosmetic?"}},{"n":"04","title":"Deliver","body":"We manage manufacturing, so you don't have to. cGMP manufacturing partners are matched to your format, volume and margin. One team carries specification, packaging and labelling, and we handle release testing, imports and freight through to your warehouse or 3PL.","gives":"Finished product delivered to your warehouse, with the playbook.","decides":"The first run and the launch date.","problem":"NeurENERGY was already a best-seller that we had designed and formulated, so every run had to land on spec and on time, whatever moved in the supply chain.","solved":"We managed the 2024 production run through to delivery, 5,078 units, with stability testing in place.","link":{"to":"/manufacturing","label":"More on managed manufacturing"}},{"n":"05","title":"Drive","body":"After launch, we track performance against the plan and build range extensions and the next SKU, so the pipeline keeps moving.","gives":"A pipeline, not a one-off.","decides":"What comes next in the pipeline.","problem":"A hair care brand's first TGA-listed formula needed to grow with the range.","solved":"Reorders since 2021, then an upgraded formula with a full new listing package and stability testing, shipped in 2026."}],"systemPage":{"h1":"Your fractional product team.","sub":"Senior formulation, regulatory, manufacturing and supply expertise, without the headcount. One team takes your concept from first idea to a compliant, ready-to-ship product, for a fraction of the cost and complexity of building it in-house.","made":"Made by audited supply partners operating to cGMP. Compliance with TGA and FSANZ requirements is built in from day one.","months":{"eyebrow":"Twenty-four months, or six","h2":"Where the months go","lead":"The usual way runs one supplier after another. Friday Launch Engine™ overlaps every step that can run together, so the same product can land in as little as six months. We confirm timing against your brief on the first call.","usualNote":"Each waiting on the last.","engineNote":"Evidence, label and stability run alongside manufacture. The same product, in as little as a quarter of the time."},"pillarsHeading":"Compliance from day one. Steps in parallel."},"team":[{"name":"Yong Tham","role":"Operations Manager","body":"Supplier relationships and project delivery."},{"name":"Joan Donguines","role":"Customer Service and Support","body":"Project administration and your day-to-day contact."}],"testimonials":[{"quote":"Take Friday Off is the future of a product design service... Crazy not to consider you for all NPD.","name":"Peter Ochsenham ND","role":"Former Managing Director and owner","brand":"BWellness","source":""},{"quote":"It's a big thing to put complete and total trust in someone to build something for you from scratch... we've enjoyed the process so much, we've just hit the green light on our second product!","name":"Sally Towell","role":"Director and co-founder","brand":"The Belly Solution","source":"Google review"},{"quote":"Gabriel understood our brief straight away, then challenged us to make it better. He would not let us settle for what was already in the mainstream, and the formulation is better for it... Six months from our first meeting, my first product was on a shelf. The communication is what sets them apart. Real updates, straight answers, no chasing.","name":"Founder","role":"","brand":"EverLeanBody","source":"Google review"},{"quote":"Working with the Take Friday Off team to develop my supplement has been a great experience from start to finish. The entire job was smooth and the communication during the job was clear and professional... I would highly recommend Take Friday Off to anyone looking to develop a product.","name":"Minaret Shore","role":"CEO","brand":"Nivari","source":"Google review"},{"quote":"Fantastic company to engage with. Gabriel is super knowledgeable and has assisted me greatly in my business.","name":"Founder","role":"","brand":"Deeply Rooted","source":"Google review"},{"quote":"5 Star business. From concept to manufacturing to completion, Take Friday Off were thorough, professional and understood the needs of a small business. Highly recommended.","name":"Sharon Hudson","role":"Managing Director","brand":"Your Skin Scan","source":"Google review"},{"quote":"Was a lovely process, the team are great to work with, patient, understanding and responsive.","name":"Heidi Doig","role":"","brand":"Pump Haircare","source":"Google review"}],"values":[{"title":"This is important work","body":"For you, and for us. We treat everyone as an equal, we do what we say we will, and we respect your time. We partner with brands that care about the people who use their products."},{"title":"We enjoy the work","body":"Great products don't come from a place of stress. Expect clear conversations, a steady process and a few laughs along the way."},{"title":"Excellence, at speed","body":"We work hard, smart and fast to get you to your objectives, because your growth is how we measure ours."},{"title":"We have your back","body":"If you need us, we take the call. We teach you our process as we go, so over time the Take Friday Off way lives inside your business."},{"title":"Priced on outcomes","body":"Fixed fees for a defined outcome at each stage, and manufacturing priced per unit. No hourly meters, no surprises."}],"vocabulary":["Innovation advantage","Precise","Efficient","Compliance-led","Evidence-based","Accelerated","Seamless","Compressed","Agile","Integrated","Regulatory-enabled growth","Shelf-ready","Friday Launch Engine™","Global network"],"whyNow":{"heading":"Why TFO & why now","paragraphs":["The wellness category doesn’t need more products. It needs better ones launched faster. With consumers demanding cleaner formulations and investors expecting rapid traction, speed to market and innovation are no longer trade-offs, they’re dual imperatives.","Take Friday Off offers a new way to build your product pipeline: one proven system, Friday Launch Engine™, that takes a product from concept to shelf in as little as six months.","Built by commercial operators rather than consultants, it integrates global ingredient access, formulation innovation, established manufacturing partnerships and precise regulatory expertise to help high-growth wellness brands launch better products, faster.","We don’t just advise, we carry the outcome. From strategy to forecasting, concept to compliant, label to launch, we replace the need for up to six internal hires or fragmented vendors with one seamless, intelligent system."]},"work":{"heading":"Work","title":"Proof before promises.","intro":"Every number and timeline comes from our records. Clients who've reviewed us publicly are named; the rest are anonymised, because many prefer the market to see the product as their own.","trustLine":"Trusted by PE-backed brands, an ASX-acquired practitioner business and clinician-founded labels.","comingSoon":"More on the way: an eight-product gut-health range across four formats, including Lynside® PRO SCB probiotic yeast, for a brand founded by a practising gastroenterologist and associate professor of medicine, a hair brand in three formats with BCM-95® curcumin and custom glass, a longevity multivitamin with a signature look, a four-product sports launch, a functional energy drink built on enXtra® and BacoMind®, a wellness powder with Sunfiber®, and more. We'll add each as it ships.","records":[{"value":"5 years, 9 products","label":"Our longest partnership","note":"BWellness, five production batches and counting"},{"value":"5.8 months","label":"Signed brief to dispatch","note":"EverLeanBody's first capsule, brief to product in warehouse"},{"value":"32 days","label":"Design to production order","note":"A complex herbal capsule"},{"value":"Under 7 weeks","label":"Design to production order","note":"An eye-health formula built on the AREDS2 vitamin E dose"},{"value":"12 weeks","label":"Design to production order","note":"A two-a-day skin program supplement"}],"ingredientsHeading":"A selection of the clinically studied, branded ingredients we work with","ingredients":["affron®","KSM-66®","EnXtra®","Wellmune®","Testofen®","life's®OMEGA","VitaShine™","Eriomin®","AnaGain™","Quatrefolic®","Rocoat®","BCM-95®","Lynside® PRO SCB","BacoMind®","Sunfiber®","GutGard®","Ferrochel®","ioPea™","PANMOL®","SIRTCell™"],"ingredientsNote":"","heroQuote":{"text":"Six months from our first meeting, my first product was on a shelf.","by":"EverLeanBody","source":"Google review"},"ownBrands":{"heading":"Our own brands","intro":"We build products the way we'd build our own, because we do. These two are the proof."},"sub":"{n} case studies from our own records. Real timelines, real outcomes.","first":["nine-products","sports-core-range","hair-care-returns","hair-range-recycled","brief-to-dispatch","first-product-to-pharmacy"]},"journal":[{"slug":"gmp-clearance-2026","url":"/notes/gmp-clearance-2026","title":"GMP clearance in 2026: the extensions, the three-year rule and the new portal","date":"2026-10-22","summary":"Since mid-2025 the TGA has extended thousands of overseas GMP clearances without an application, gone back to a three-year limit on the inspection evidence it accepts, worked its queue down and put PIC/S version 17 into force. What it means for a supplement made overseas.","tags":["Regulatory","TGA","Manufacturing"],"author":"Take Friday Off","sections":[{"heading":"","anchor":"","markdown":"Each overseas site that carries out a step of a listed medicine's manufacture needs a TGA GMP clearance, obtained by the Australian sponsor, unless that step is exempt. Since the middle of 2025 the TGA has changed how it handles them: it extended thousands without an application, tightened the evidence it accepts, worked down its queue and moved to a new version of the GMP standard, with a new portal to come.","text":"Each overseas site that carries out a step of a listed medicine's manufacture needs a TGA GMP clearance, obtained by the Australian sponsor, unless that step is exempt. Since the middle of 2025 the TGA has changed how it handles them: it extended thousands without an application, tightened the evidence it accepts, worked down its queue and moved to a new version of the GMP standard, with a new portal to come.","items":[],"tables":[]},{"heading":"Two years added, without an application","anchor":"two-years-added-without-an-application","markdown":"To clear a backlog, the TGA extended clearances in bulk. In its words, \"All existing MRA and non-sterile API CV GMP Clearances due to expire between 1 July 2025 and 30 June 2027 will be extended for a period of 2 years\", and \"Sponsors or Agents do not need to apply for this extension.\" That meant MRA clearances, and compliance verification clearances for non-sterile active pharmaceutical ingredients. It processed 6,258 extensions in all, and said it would run abbreviated evaluations for manufacturers performing certain lower-risk activities.","text":"To clear a backlog, the TGA extended clearances in bulk. In its words, \"All existing MRA and non-sterile API CV GMP Clearances due to expire between 1 July 2025 and 30 June 2027 will be extended for a period of 2 years\", and \"Sponsors or Agents do not need to apply for this extension.\" That meant MRA clearances, and compliance verification clearances for non-sterile active pharmaceutical ingredients. It processed 6,258 extensions in all, and said it would run abbreviated evaluations for manufacturers performing certain lower-risk activities.","items":[],"tables":[]},{"heading":"The three-year rule is back","anchor":"the-three-year-rule-is-back","markdown":"At the same time, the TGA returned to its pre-pandemic rule for compliance verification: from 1 July 2025 it no longer accepts evidence from an inspection more than three years old. A site whose last inspection by a recognised regulator was longer ago than that can't be cleared through compliance verification on that evidence.","text":"At the same time, the TGA returned to its pre-pandemic rule for compliance verification: from 1 July 2025 it no longer accepts evidence from an inspection more than three years old. A site whose last inspection by a recognised regulator was longer ago than that can't be cleared through compliance verification on that evidence.","items":[],"tables":[]},{"heading":"The queue is shorter","anchor":"the-queue-is-shorter","markdown":"The TGA's GMP clearance dashboard, with data from 1 June 2026, reports its queue of compliance verification applications falling from 2,185 at the end of June 2025 to 1,203, and says MRA applications have been consistently processed within its target time. The TGA took target processing timeframes out of its guidance in November 2023; the dashboard is where it now reports them.","text":"The TGA's GMP clearance dashboard, with data from 1 June 2026, reports its queue of compliance verification applications falling from 2,185 at the end of June 2025 to 1,203, and says MRA applications have been consistently processed within its target time. The TGA took target processing timeframes out of its guidance in November 2023; the dashboard is where it now reports them.","items":[],"tables":[]},{"heading":"PIC/S version 17","anchor":"pics-version-17","markdown":"From 1 September 2025, version PE009-17 of the PIC/S Guide to GMP applies to the manufacture of medicines in Australia, unless they are exempt, with its Annexes 4, 5 and 14 not adopted.","text":"From 1 September 2025, version PE009-17 of the PIC/S Guide to GMP applies to the manufacture of medicines in Australia, unless they are exempt, with its Annexes 4, 5 and 14 not adopted.","items":[],"tables":[]},{"heading":"A new portal","anchor":"a-new-portal","markdown":"Answering questions from its December 2025 webinar, the TGA said that \"All new GMP clearances will be submitted on the portal once it goes live in mid-late 2026\", with its legacy systems supported until then.","text":"Answering questions from its December 2025 webinar, the TGA said that \"All new GMP clearances will be submitted on the portal once it goes live in mid-late 2026\", with its legacy systems supported until then.","items":[],"tables":[]},{"heading":"What it means for a supplement made overseas","anchor":"what-it-means-for-a-supplement-made-overseas","markdown":"- **The extensions don't help a new site.** They covered only existing MRA clearances and compliance verification clearances for non-sterile active ingredients, so a compliance verification clearance for a finished product wasn't extended. A new overseas site still needs its own clearance, applied for by the sponsor, and each sponsor needs its own even if the factory already supplies other Australian brands.\n- **Supplement factories often need an inspection.** The two desktop routes rest on an inspection by a recognised regulator for a human medicinal product, and the TGA says they are unavailable for some listed medicines, including dietary supplements, that may not be regulated as medicines in other countries.\n- **Check the date of the last inspection.** For compliance verification, evidence older than three years won't do.\n- **Renew early.** The TGA asks for a renewal at least six months before a clearance expires, and one expired for more than 12 months can't be reinstated.\n\nOur [GMP clearance guide](/guides/gmp-clearance) covers the three routes, the evidence, the 2026–27 fees and renewal in full, and our [manufacturing](/manufacturing) page how we choose manufacturing partners.","text":"The extensions don't help a new site. They covered only existing MRA clearances and compliance verification clearances for non-sterile active ingredients, so a compliance verification clearance for a finished product wasn't extended. A new overseas site still needs its own clearance, applied for by the sponsor, and each sponsor needs its own even if the factory already supplies other Australian brands. Supplement factories often need an inspection. The two desktop routes rest on an inspection by a recognised regulator for a human medicinal product, and the TGA says they are unavailable for some listed medicines, including dietary supplements, that may not be regulated as medicines in other countries. Check the date of the last inspection. For compliance verification, evidence older than three years won't do. Renew early. The TGA asks for a renewal at least six months before a clearance expires, and one expired for more than 12 months can't be reinstated. Our GMP clearance guide covers the three routes, the evidence, the 2026–27 fees and renewal in full, and our manufacturing page how we choose manufacturing partners.","items":[{"lead":"The extensions don't help a new site.","text":"They covered only existing MRA clearances and compliance verification clearances for non-sterile active ingredients, so a compliance verification clearance for a finished product wasn't extended. A new overseas site still needs its own clearance, applied for by the sponsor, and each sponsor needs its own even if the factory already supplies other Australian brands."},{"lead":"Supplement factories often need an inspection.","text":"The two desktop routes rest on an inspection by a recognised regulator for a human medicinal product, and the TGA says they are unavailable for some listed medicines, including dietary supplements, that may not be regulated as medicines in other countries."},{"lead":"Check the date of the last inspection.","text":"For compliance verification, evidence older than three years won't do."},{"lead":"Renew early.","text":"The TGA asks for a renewal at least six months before a clearance expires, and one expired for more than 12 months can't be reinstated."}],"tables":[]},{"heading":"Sources","anchor":"sources","markdown":"General information, checked against these sources on 22 October 2026. It isn't advice on a particular product or site.\n\n- [GMP clearance backlog reduction strategy](https://www.tga.gov.au/node/499043) and [the completed extensions](https://www.tga.gov.au/node/504840), Therapeutic Goods Administration\n- [GMP clearance Sponsor Information Dashboard (SID)](https://www.tga.gov.au/gmp-clearance-extension-application-processing-timeframes), Therapeutic Goods Administration\n- [How to obtain GMP clearance through inspection reliance](https://www.tga.gov.au/sites/default/files/2024-11/How-to-obtain-GMP-clearance-through-inspection-reliance.docx), version 18.6, May 2025, and [GMP clearance: application and submission user guide](https://www.tga.gov.au/sites/default/files/2023-12/gmp-clearance-application-submission-user-guide.docx), Therapeutic Goods Administration\n- [The PIC/S Guide to GMP for medicinal products, version 17](https://www.tga.gov.au/node/290180), Therapeutic Goods Administration\n- [TGA digital transformation webinar: questions and answers](https://www.tga.gov.au/sites/default/files/2026-01/tga-digital-transformation-exploring-beta-version-new-tga-business-services-portal-webinar-q-a.pdf), from the webinar of 2 December 2025, Therapeutic Goods Administration","text":"General information, checked against these sources on 22 October 2026. It isn't advice on a particular product or site. GMP clearance backlog reduction strategy and the completed extensions, Therapeutic Goods Administration GMP clearance Sponsor Information Dashboard (SID), Therapeutic Goods Administration How to obtain GMP clearance through inspection reliance, version 18.6, May 2025, and GMP clearance: application and submission user guide, Therapeutic Goods Administration The PIC/S Guide to GMP for medicinal products, version 17, Therapeutic Goods Administration TGA digital transformation webinar: questions and answers, from the webinar of 2 December 2025, Therapeutic Goods Administration","items":[],"tables":[]}]},{"slug":"advertising-code-2026","url":"/notes/advertising-code-2026","title":"The Advertising Code in 2026: TGO 116, a consultation and enforcement","date":"2026-10-22","summary":"The Therapeutic Goods Advertising Code now points to TGO 116, the TGA consulted on changes to it from July to September, and it gave over 75 infringement notices in the second half of 2025, mostly for alleged unlawful advertising. What changed, and what it means for a supplement brand's marketing.","tags":["Regulatory","TGA","Advertising"],"author":"Take Friday Off","sections":[{"heading":"","anchor":"","markdown":"The Therapeutic Goods Advertising Code sets the rules for advertising a supplement sold as a listed medicine. The Therapeutic Goods Act's definition of advertising includes what's on the label, though the Code's mandatory statements, section 19 among them, don't apply to labels. In 2026 the Code was amended to point to the new labelling order, and the TGA consulted on improving it. Its reports on unlawful activity show what it does about ads that break the rules.","text":"The Therapeutic Goods Advertising Code sets the rules for advertising a supplement sold as a listed medicine. The Therapeutic Goods Act's definition of advertising includes what's on the label, though the Code's mandatory statements, section 19 among them, don't apply to labels. In 2026 the Code was amended to point to the new labelling order, and the TGA consulted on improving it. Its reports on unlawful activity show what it does about ads that break the rules.","items":[],"tables":[]},{"heading":"The Code now points to TGO 116","anchor":"the-code-now-points-to-tgo-116","markdown":"TGO 92, the labelling standard for non-prescription medicines, would otherwise have sunset on 1 October 2026, and its replacement, TGO 116, commenced on 30 September. The same day, an amending instrument took effect that replaces the Code's references to TGO 92 with TGO 116.\n\nThe main change is in section 19, the rules on what an ad must say. Section 19 requires most medicine ads to give the medicine's name \"within the meaning of\" the labelling order, now TGO 116, and an online store, or any ad that lets someone buy a medicine they can't inspect first, gives its dosage form and quantity on the same terms. That kind of ad must also list the medicine's health warnings, or link to them, prominently displayed or communicated: the warnings its label must carry under the instruments section 19 lists, which now end with TGO 116, where they are reasonably necessary to inform a consumer's decision to buy.\n\nFor a brand, that means checking the name, dosage form, quantity and warnings in new ads against TGO 116. A label can still follow TGO 92 on medicine released for supply before 1 October 2031, so an ad and its label may not match word for word. More on the label in our note on [TGO 116 replacing TGO 92](/notes/tgo-116-replaces-tgo-92).","text":"TGO 92, the labelling standard for non-prescription medicines, would otherwise have sunset on 1 October 2026, and its replacement, TGO 116, commenced on 30 September. The same day, an amending instrument took effect that replaces the Code's references to TGO 92 with TGO 116. The main change is in section 19, the rules on what an ad must say. Section 19 requires most medicine ads to give the medicine's name \"within the meaning of\" the labelling order, now TGO 116, and an online store, or any ad that lets someone buy a medicine they can't inspect first, gives its dosage form and quantity on the same terms. That kind of ad must also list the medicine's health warnings, or link to them, prominently displayed or communicated: the warnings its label must carry under the instruments section 19 lists, which now end with TGO 116, where they are reasonably necessary to inform a consumer's decision to buy. For a brand, that means checking the name, dosage form, quantity and warnings in new ads against TGO 116. A label can still follow TGO 92 on medicine released for supply before 1 October 2031, so an ad and its label may not match word for word. More on the label in our note on TGO 116 replacing TGO 92.","items":[],"tables":[]},{"heading":"A consultation on improving the Code","anchor":"a-consultation-on-improving-the-code","markdown":"The TGA consulted on \"Improvements to the Therapeutic Goods Advertising Code\" from 9 July to 3 September 2026. In its words, \"It is not a full review of the Code.\" Among its proposals: amending the definition of \"prominently displayed or communicated\", the test for the mandatory statements, to include a reference to \"standing out\" for visual statements, and, as its preferred option, continuing to prohibit paid testimonials in advertising for therapeutic sunscreens.\n\nNo outcome had been published by 22 October 2026. Until one is, the Code applies as it stands.","text":"The TGA consulted on \"Improvements to the Therapeutic Goods Advertising Code\" from 9 July to 3 September 2026. In its words, \"It is not a full review of the Code.\" Among its proposals: amending the definition of \"prominently displayed or communicated\", the test for the mandatory statements, to include a reference to \"standing out\" for visual statements, and, as its preferred option, continuing to prohibit paid testimonials in advertising for therapeutic sunscreens. No outcome had been published by 22 October 2026. Until one is, the Code applies as it stands.","items":[],"tables":[]},{"heading":"Enforcement in 2024–25 and late 2025","anchor":"enforcement-in-202425-and-late-2025","markdown":"The TGA's reports on unlawful activity show what it has been doing. In 2024–25 it gave 30 infringement notices, mostly for alleged unlawful advertising, and asked online platforms to remove over 13,700 alleged unlawful advertisements or user and seller profiles. From July to December 2025 it gave over 75, again mostly for alleged unlawful advertising, asked for over 1,000 removals, and completed a second targeted campaign on compliance by influencers, particularly on social media. The TGA says these half-year figures can't be compared with the full year before.\n\nThe penalty amounts rose. An infringement notice for non-compliant advertising carries up to 12 penalty units for an individual and 60 for a company, and the Commonwealth penalty unit rose to $364 on 1 July 2026: up to $4,368 and $21,840 for an offence from that date.","text":"The TGA's reports on unlawful activity show what it has been doing. In 2024–25 it gave 30 infringement notices, mostly for alleged unlawful advertising, and asked online platforms to remove over 13,700 alleged unlawful advertisements or user and seller profiles. From July to December 2025 it gave over 75, again mostly for alleged unlawful advertising, asked for over 1,000 removals, and completed a second targeted campaign on compliance by influencers, particularly on social media. The TGA says these half-year figures can't be compared with the full year before. The penalty amounts rose. An infringement notice for non-compliant advertising carries up to 12 penalty units for an individual and 60 for a company, and the Commonwealth penalty unit rose to $364 on 1 July 2026: up to $4,368 and $21,840 for an offence from that date.","items":[],"tables":[]},{"heading":"What it means for a brand's marketing","anchor":"what-it-means-for-a-brands-marketing","markdown":"- **Check new ads against TGO 116.** The medicine's name and, for an online store, the health warnings come from the label.\n- **Paid influencers can't give testimonials.** Anyone paid or rewarded, in cash, free product or discounts, counts as engaged in the product's marketing and can't tell their own story of using it. They can endorse it, with the payment disclosed, such as a \"paid partnership\" label, unless they are in a group the Code excludes, such as health practitioners.\n- **Your pages are your advertising.** A testimonial or endorsement made on, or linked to, a brand's own content becomes part of its advertising, including a comment from someone who says they used the product.\n- **The label and the marketing say the same thing.** Advertising must not be inconsistent with the indications on the ARTG, on a website or in a social post as much as on the label. We check the claims at the brief, so the claims are settled before the label or the first post is written.\n\nOur [advertising guide](/guides/tga-advertising) sets out the Code's rules in full, with the statements an ad must carry, the influencer rules and the penalties, and our [claims and indications guide](/guides/permitted-indications) covers what a listed medicine can claim.","text":"Check new ads against TGO 116. The medicine's name and, for an online store, the health warnings come from the label. Paid influencers can't give testimonials. Anyone paid or rewarded, in cash, free product or discounts, counts as engaged in the product's marketing and can't tell their own story of using it. They can endorse it, with the payment disclosed, such as a \"paid partnership\" label, unless they are in a group the Code excludes, such as health practitioners. Your pages are your advertising. A testimonial or endorsement made on, or linked to, a brand's own content becomes part of its advertising, including a comment from someone who says they used the product. The label and the marketing say the same thing. Advertising must not be inconsistent with the indications on the ARTG, on a website or in a social post as much as on the label. We check the claims at the brief, so the claims are settled before the label or the first post is written. Our advertising guide sets out the Code's rules in full, with the statements an ad must carry, the influencer rules and the penalties, and our claims and indications guide covers what a listed medicine can claim.","items":[{"lead":"Check new ads against TGO 116.","text":"The medicine's name and, for an online store, the health warnings come from the label."},{"lead":"Paid influencers can't give testimonials.","text":"Anyone paid or rewarded, in cash, free product or discounts, counts as engaged in the product's marketing and can't tell their own story of using it. They can endorse it, with the payment disclosed, such as a \"paid partnership\" label, unless they are in a group the Code excludes, such as health practitioners."},{"lead":"Your pages are your advertising.","text":"A testimonial or endorsement made on, or linked to, a brand's own content becomes part of its advertising, including a comment from someone who says they used the product."},{"lead":"The label and the marketing say the same thing.","text":"Advertising must not be inconsistent with the indications on the ARTG, on a website or in a social post as much as on the label. We check the claims at the brief, so the claims are settled before the label or the first post is written."}],"tables":[]},{"heading":"Sources","anchor":"sources","markdown":"General information, checked against these sources on 22 October 2026. It isn't legal advice or advice on a particular product.\n\n- [Therapeutic Goods (Therapeutic Goods Advertising Code) Amendment (Standards for Labelling Consequential Amendments) Instrument 2026](https://www.legislation.gov.au/F2026L01329/asmade/2026-09-29/text/original/pdf) and its [explanatory statement](https://www.legislation.gov.au/F2026L01329/asmade/2026-09-29/es/original/pdf), and the [Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021](https://www.legislation.gov.au/F2021L01661/latest/versions), Federal Register of Legislation\n- [Improvements to the Therapeutic Goods Advertising Code](https://consultations.tga.gov.au/tga/improvements-to-the-advertising-code/) and its [consultation paper](https://consultations.tga.gov.au/tga/improvements-to-the-advertising-code/supporting_documents/improvements-to-the-tg-advertising-codepdf), Therapeutic Goods Administration, July 2026\n- [Unlawful activities surrounding therapeutic goods, 2024–25](https://www.tga.gov.au/sites/default/files/2026-04/unlawful-activities-surrounding-therapeutic-goods-2024-25.PDF) and [July to December 2025](https://www.tga.gov.au/sites/default/files/2026-04/unlawful-activities-surrounding-therapeutic-goods-2025-26.PDF), Therapeutic Goods Administration\n- [Sanctions and penalties for non-compliant advertising](https://tga.gov.au/book-page/sanctions-and-penalties-non-compliant-advertising) and [Testimonials and endorsements in advertising](https://www.tga.gov.au/node/491816), Therapeutic Goods Administration\n- [Therapeutic Goods Act 1989](https://www.legislation.gov.au/C2004A03952/latest/text), section 3 (the meaning of advertise), and the [Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026](https://www.legislation.gov.au/F2026L01312/asmade), Federal Register of Legislation\n- [Crimes (Amount of a Penalty Unit) Instrument 2026](https://www.legislation.gov.au/F2026N00424/asmade/2026-06-16/text/original/pdf), Federal Register of Legislation","text":"General information, checked against these sources on 22 October 2026. It isn't legal advice or advice on a particular product. Therapeutic Goods (Therapeutic Goods Advertising Code) Amendment (Standards for Labelling Consequential Amendments) Instrument 2026 and its explanatory statement, and the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021, Federal Register of Legislation Improvements to the Therapeutic Goods Advertising Code and its consultation paper, Therapeutic Goods Administration, July 2026 Unlawful activities surrounding therapeutic goods, 2024–25 and July to December 2025, Therapeutic Goods Administration Sanctions and penalties for non-compliant advertising and Testimonials and endorsements in advertising, Therapeutic Goods Administration Therapeutic Goods Act 1989, section 3 (the meaning of advertise), and the Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026, Federal Register of Legislation Crimes (Amount of a Penalty Unit) Instrument 2026, Federal Register of Legislation","items":[],"tables":[]}]},{"slug":"permissible-ingredients-october-2026","url":"/notes/permissible-ingredients-october-2026","title":"Permissible Ingredients: the third determination of 2026 and the andrographis removal","date":"2026-10-21","summary":"The TGA's list of ingredients a listed medicine can use changed twice in a month: andrographis came off on 17 September, and the third determination of 2026 commenced on 16 October with five new ingredients. What changed, and what it means for a formula in development.","tags":["Regulatory","TGA","Ingredients"],"author":"Take Friday Off","sections":[{"heading":"","anchor":"","markdown":"The Therapeutic Goods (Permissible Ingredients) Determination is the TGA's list of the ingredients a listed medicine can use, with the purposes and limits each one is used within. It changed twice in a month. On 17 September 2026 an amendment removed Andrographis paniculata from the list. On 16 October 2026 the Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026 commenced, repealing and replacing No. 2, with five new ingredients and a changed requirement for one probiotic.","text":"The Therapeutic Goods (Permissible Ingredients) Determination is the TGA's list of the ingredients a listed medicine can use, with the purposes and limits each one is used within. It changed twice in a month. On 17 September 2026 an amendment removed Andrographis paniculata from the list. On 16 October 2026 the Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026 commenced, repealing and replacing No. 2, with five new ingredients and a changed requirement for one probiotic.","items":[],"tables":[]},{"heading":"Andrographis is off the list","anchor":"andrographis-is-off-the-list","markdown":"The amendment removed Andrographis paniculata from the determination from 17 September 2026. The TGA's reason is the risk of anaphylaxis: its explanatory statement says the \"life-threatening risk of anaphylaxis associated with Andrographis cannot be effectively mitigated\" and that warning labels alone don't manage it. Reports of anaphylaxis had reached 317 by 31 July 2026.\n\nA medicine containing andrographis can no longer be listed. The explanatory statement says such a product can still be entered on the Register as a registered medicine, which goes through a full pre-market evaluation. The TGA ran a targeted consultation from 8 April to 8 May 2026 and received 29 submissions; most of the industry and practitioner responses opposed removal and proposed stronger labels, dose limits or practitioner-only supply, and the TGA found those suggestions didn't change its conclusion.","text":"The amendment removed Andrographis paniculata from the determination from 17 September 2026. The TGA's reason is the risk of anaphylaxis: its explanatory statement says the \"life-threatening risk of anaphylaxis associated with Andrographis cannot be effectively mitigated\" and that warning labels alone don't manage it. Reports of anaphylaxis had reached 317 by 31 July 2026. A medicine containing andrographis can no longer be listed. The explanatory statement says such a product can still be entered on the Register as a registered medicine, which goes through a full pre-market evaluation. The TGA ran a targeted consultation from 8 April to 8 May 2026 and received 29 submissions; most of the industry and practitioner responses opposed removal and proposed stronger labels, dose limits or practitioner-only supply, and the TGA found those suggestions didn't change its conclusion.","items":[],"tables":[]},{"heading":"What No. 3 of 2026 adds","anchor":"what-no-3-of-2026-adds","markdown":"The third determination of the year commenced on 16 October 2026. Its explanatory statement lists five new ingredients for listed and assessed listed medicines:\n\n- magnesium L-threonate monohydrate\n- mitoquinol mesilate\n- gamma glutamylcysteine\n- styrene/isoprene/styrene block copolymer\n- hydrocarbons, C6-C20, polymers, hydrogenated\n\nIt also varies the requirements for Bacillus coagulans, makes minor amendments for Bacillus subtilis and Akkermansia muciniphila to reflect the end of a transition period for their requirements, and corrects typographical errors, including in the entry for Terminalia ferdinandiana (Kakadu plum). The TGA consulted the applicants for the five new ingredients and the Bacillus coagulans variation directly, over periods that ran from 2025 into 2026; the other changes weren't consulted on because they don't affect existing medicines.","text":"The third determination of the year commenced on 16 October 2026. Its explanatory statement lists five new ingredients for listed and assessed listed medicines: magnesium L-threonate monohydrate mitoquinol mesilate gamma glutamylcysteine styrene/isoprene/styrene block copolymer hydrocarbons, C6-C20, polymers, hydrogenated It also varies the requirements for Bacillus coagulans, makes minor amendments for Bacillus subtilis and Akkermansia muciniphila to reflect the end of a transition period for their requirements, and corrects typographical errors, including in the entry for Terminalia ferdinandiana (Kakadu plum). The TGA consulted the applicants for the five new ingredients and the Bacillus coagulans variation directly, over periods that ran from 2025 into 2026; the other changes weren't consulted on because they don't affect existing medicines.","items":[],"tables":[]},{"heading":"What it means for a product in development","anchor":"what-it-means-for-a-product-in-development","markdown":"The list has moved three times this year. Three things follow for a formula.\n\n- **Check every ingredient against the current determination, by name.** The entry sets the purpose an ingredient can be used for, its limits and any requirements, such as a label statement. An ingredient that isn't on the list needs [its own application and evaluation](/guides/permissible-ingredients) before any product using it can be listed, and the consultation periods above ran from nine months to over a year.\n- **Check it again before the listing is lodged.** A formula settled months before lodging can be caught by a change in between. We check every ingredient, its form and its dose at the brief, and once more before the listing, so nothing has to be designed twice.\n- **Watch the ingredients the TGA has consulted on.** The andrographis removal followed a consultation in April and May and commenced in September. A consultation is the signal to plan a reformulation, not the commencement date.\n\nThe Permissible Ingredients Determination is one of the steps in our [TGA listing guide](/guides/tga-approval#the-steps-to-an-aust-l-listing), and the [listed-medicines pathway](/pathways/listed-medicines) shows where it sits in a project.","text":"The list has moved three times this year. Three things follow for a formula. Check every ingredient against the current determination, by name. The entry sets the purpose an ingredient can be used for, its limits and any requirements, such as a label statement. An ingredient that isn't on the list needs its own application and evaluation before any product using it can be listed, and the consultation periods above ran from nine months to over a year. Check it again before the listing is lodged. A formula settled months before lodging can be caught by a change in between. We check every ingredient, its form and its dose at the brief, and once more before the listing, so nothing has to be designed twice. Watch the ingredients the TGA has consulted on. The andrographis removal followed a consultation in April and May and commenced in September. A consultation is the signal to plan a reformulation, not the commencement date. The Permissible Ingredients Determination is one of the steps in our TGA listing guide, and the listed-medicines pathway shows where it sits in a project.","items":[{"lead":"Check every ingredient against the current determination, by name.","text":"The entry sets the purpose an ingredient can be used for, its limits and any requirements, such as a label statement. An ingredient that isn't on the list needs its own application and evaluation before any product using it can be listed, and the consultation periods above ran from nine months to over a year."},{"lead":"Check it again before the listing is lodged.","text":"A formula settled months before lodging can be caught by a change in between. We check every ingredient, its form and its dose at the brief, and once more before the listing, so nothing has to be designed twice."},{"lead":"Watch the ingredients the TGA has consulted on.","text":"The andrographis removal followed a consultation in April and May and commenced in September. A consultation is the signal to plan a reformulation, not the commencement date."}],"tables":[]},{"heading":"Sources","anchor":"sources","markdown":"General information, checked against these sources on 21 October 2026. It isn't advice on a particular product.\n\n- [Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026](https://www.legislation.gov.au/F2026L01382/asmade) and its [explanatory statement](https://www.legislation.gov.au/F2026L01382/asmade/2026-10-13/es/original/pdf), Federal Register of Legislation\n- [Therapeutic Goods (Permissible Ingredients) Amendment (Removal of Andrographis Paniculata) Determination 2026](https://www.legislation.gov.au/F2026L01211/asmade) and its [explanatory statement](https://www.legislation.gov.au/F2026L01211/asmade/2026-09-14/es/original/pdf), Federal Register of Legislation","text":"General information, checked against these sources on 21 October 2026. It isn't advice on a particular product. Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026 and its explanatory statement, Federal Register of Legislation Therapeutic Goods (Permissible Ingredients) Amendment (Removal of Andrographis Paniculata) Determination 2026 and its explanatory statement, Federal Register of Legislation","items":[],"tables":[]}]},{"slug":"tgo-116-replaces-tgo-92","url":"/notes/tgo-116-replaces-tgo-92","title":"TGO 116 has replaced TGO 92: what changes for supplement labels","date":"2026-10-20","summary":"TGO 92 was repealed on 30 September 2026 and TGO 116 is now the labelling order for listed medicines. What changed, what the transition to 2031 allows, and what to do with a label you are designing now.","tags":["Regulatory","TGA","Labelling"],"author":"Take Friday Off","sections":[{"heading":"","anchor":"","markdown":"On 30 September 2026 the Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026 commenced, and TGO 92, the labelling standard for listed and other non-prescription medicines, was repealed. TGO 116 now sets the label rules for every supplement sold as a listed medicine. A label written to TGO 92 stays compliant on medicine released for supply before 1 October 2031, so nothing on shelf has to change today.","text":"On 30 September 2026 the Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026 commenced, and TGO 92, the labelling standard for listed and other non-prescription medicines, was repealed. TGO 116 now sets the label rules for every supplement sold as a listed medicine. A label written to TGO 92 stays compliant on medicine released for supply before 1 October 2031, so nothing on shelf has to change today.","items":[],"tables":[]},{"heading":"Why it changed, and how","anchor":"why-it-changed-and-how","markdown":"TGO 92 would otherwise have sunset on 1 October 2026. Its replacement was signed on 25 September 2026, registered three days later and commenced on 30 September. Most of TGO 92 carries over: the explanatory statement says the new order principally replicates it with an updated structure, some requirements eased and some strengthened, after a public consultation from 16 December 2025 to 23 March 2026.\n\nTGO 116 is a disallowable legislative instrument, tabled in both houses of Parliament on 12 October 2026, so Parliament can still disallow it. It is in force now and due to sunset on 1 October 2036.","text":"TGO 92 would otherwise have sunset on 1 October 2026. Its replacement was signed on 25 September 2026, registered three days later and commenced on 30 September. Most of TGO 92 carries over: the explanatory statement says the new order principally replicates it with an updated structure, some requirements eased and some strengthened, after a public consultation from 16 December 2025 to 23 March 2026. TGO 116 is a disallowable legislative instrument, tabled in both houses of Parliament on 12 October 2026, so Parliament can still disallow it. It is in force now and due to sunset on 1 October 2036.","items":[],"tables":[]},{"heading":"What changed for supplement labels","anchor":"what-changed-for-supplement-labels","markdown":"The order applies to every medicine that isn't a prescription medicine (those have TGO 115), with a list of exclusions, such as export-only and compounded medicines. For a listed medicine, the changes most likely to touch your artwork are these.\n\n- **QR codes.** A label can carry one, but what it opens must be in the sponsor's control (or be the TGA's information about the medicine), must not contradict the label or the product details, and must work by scanning alone: no login, no personal details, no payment. A code can't replace information the label must carry unless the order says so.\n- **Small containers.** On a small container, the name of a listed medicine can be as small as 1.5 mm.\n- **Ingredient names.** Actives are still named as the Australian Approved Names List has them. New for listed medicines: the main label may drop the salt, hydrate or solvate from an active's name if the full name appears elsewhere on the label, the strength isn't based on it and it doesn't matter to safety or efficacy.\n- **Large tablets and capsules.** A round tablet more than 13 mm across, a non-round tablet more than 22.4 mm long or 10.5 mm wide, or a capsule more than 24.1 mm long or 9.5 mm wide is a large dosage form. The label needs a swallow-with-water warning and, other than on transparent packaging or a medium container, an actual-size image of the tablet or capsule, marked 'actual size', on the main label or a lid sticker. Small containers are exempt, as are medicines not meant to be swallowed whole, if the directions say so.","text":"The order applies to every medicine that isn't a prescription medicine (those have TGO 115), with a list of exclusions, such as export-only and compounded medicines. For a listed medicine, the changes most likely to touch your artwork are these. QR codes. A label can carry one, but what it opens must be in the sponsor's control (or be the TGA's information about the medicine), must not contradict the label or the product details, and must work by scanning alone: no login, no personal details, no payment. A code can't replace information the label must carry unless the order says so. Small containers. On a small container, the name of a listed medicine can be as small as 1.5 mm. Ingredient names. Actives are still named as the Australian Approved Names List has them. New for listed medicines: the main label may drop the salt, hydrate or solvate from an active's name if the full name appears elsewhere on the label, the strength isn't based on it and it doesn't matter to safety or efficacy. Large tablets and capsules. A round tablet more than 13 mm across, a non-round tablet more than 22.4 mm long or 10.5 mm wide, or a capsule more than 24.1 mm long or 9.5 mm wide is a large dosage form. The label needs a swallow-with-water warning and, other than on transparent packaging or a medium container, an actual-size image of the tablet or capsule, marked 'actual size', on the main label or a lid sticker. Small containers are exempt, as are medicines not meant to be swallowed whole, if the directions say so.","items":[{"lead":"QR codes.","text":"A label can carry one, but what it opens must be in the sponsor's control (or be the TGA's information about the medicine), must not contradict the label or the product details, and must work by scanning alone: no login, no personal details, no payment. A code can't replace information the label must carry unless the order says so."},{"lead":"Small containers.","text":"On a small container, the name of a listed medicine can be as small as 1.5 mm."},{"lead":"Ingredient names.","text":"Actives are still named as the Australian Approved Names List has them. New for listed medicines: the main label may drop the salt, hydrate or solvate from an active's name if the full name appears elsewhere on the label, the strength isn't based on it and it doesn't matter to safety or efficacy."},{"lead":"Large tablets and capsules.","text":"A round tablet more than 13 mm across, a non-round tablet more than 22.4 mm long or 10.5 mm wide, or a capsule more than 24.1 mm long or 9.5 mm wide is a large dosage form. The label needs a swallow-with-water warning and, other than on transparent packaging or a medium container, an actual-size image of the tablet or capsule, marked 'actual size', on the main label or a lid sticker. Small containers are exempt, as are medicines not meant to be swallowed whole, if the directions say so."}],"tables":[]},{"heading":"What the transition allows","anchor":"what-the-transition-allows","markdown":"The order's test is the date a medicine is released for supply, not the date it is sold.\n\n- Released for supply before 1 October 2031: the label may follow TGO 116 in full, TGO 92 in full, or TGO 92 with the TGO 116 provisions listed in the order's equivalence table swapped in.\n- Released for supply on or after 1 October 2031: TGO 116 in full.\n\nThe mix matters: a brand can take up the TGO 116 provisions listed in the order's table now, such as dropping the salt from an active's name, without rewriting the rest of the label. The QR code provisions aren't in that table.","text":"The order's test is the date a medicine is released for supply, not the date it is sold. Released for supply before 1 October 2031: the label may follow TGO 116 in full, TGO 92 in full, or TGO 92 with the TGO 116 provisions listed in the order's equivalence table swapped in. Released for supply on or after 1 October 2031: TGO 116 in full. The mix matters: a brand can take up the TGO 116 provisions listed in the order's table now, such as dropping the salt from an active's name, without rewriting the rest of the label. The QR code provisions aren't in that table.","items":[],"tables":[]},{"heading":"If you are designing a product now","anchor":"if-you-are-designing-a-product-now","markdown":"A new product can still launch on a TGO 92 label, but designing to TGO 116 now saves a second round of artwork before 2031. In practice that means:\n\n- Name each active as the Australian Approved Names List has it.\n- Check the tablet or capsule against the size thresholds above before the artwork is locked: a large softgel or tablet changes the main label.\n- If the pack will carry a QR code, settle what it links to and who controls it first.\n- Confirm the name size on any small container.\n- Have the label reviewed against the order before print. On [Arxi's prenatal chewable](/work/arxi-prenatal-chewable), due for dispatch in late October 2026, our label review caught two errors before print.\n\nAdvertising follows the label: the Therapeutic Goods Advertising Code now refers to TGO 116. More in our [advertising guide](/guides/tga-advertising) and our note on [the Advertising Code in 2026](/notes/advertising-code-2026).","text":"A new product can still launch on a TGO 92 label, but designing to TGO 116 now saves a second round of artwork before 2031. In practice that means: Name each active as the Australian Approved Names List has it. Check the tablet or capsule against the size thresholds above before the artwork is locked: a large softgel or tablet changes the main label. If the pack will carry a QR code, settle what it links to and who controls it first. Confirm the name size on any small container. Have the label reviewed against the order before print. On Arxi's prenatal chewable, due for dispatch in late October 2026, our label review caught two errors before print. Advertising follows the label: the Therapeutic Goods Advertising Code now refers to TGO 116. More in our advertising guide and our note on the Advertising Code in 2026.","items":[],"tables":[]},{"heading":"Where to read more","anchor":"where-to-read-more","markdown":"Our [labelling guide](/guides/supplement-labelling) sets out everything TGO 116 requires on the label. The TGO 116 section of our [TGA listing guide](/guides/tga-approval#tgo-92-is-now-tgo-116) sits inside the full AUST L process, and the [listed-medicines pathway](/pathways/listed-medicines) shows where the label fits in a project. The order and its explanatory statement are linked below.","text":"Our labelling guide sets out everything TGO 116 requires on the label. The TGO 116 section of our TGA listing guide sits inside the full AUST L process, and the listed-medicines pathway shows where the label fits in a project. The order and its explanatory statement are linked below.","items":[],"tables":[]},{"heading":"Sources","anchor":"sources","markdown":"General information, checked against these sources on 20 October 2026. It isn't advice on a particular product.\n\n- [Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026](https://www.legislation.gov.au/F2026L01312/asmade), its [explanatory statement](https://www.legislation.gov.au/F2026L01312/asmade/2026-09-28/es/original/pdf) and its [registration details](https://www.legislation.gov.au/F2026L01312/asmade/details), Federal Register of Legislation","text":"General information, checked against these sources on 20 October 2026. It isn't advice on a particular product. Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026, its explanatory statement and its registration details, Federal Register of Legislation","items":[],"tables":[]}]},{"slug":"masterclass-jeremy-hunt","url":"/notes/masterclass-jeremy-hunt","title":"Masterclass: Jeremy Hunt","date":"2021-11-20","summary":"Are the days of limitless CBEC and Daigou growth gone? Jeremy Hunt, Chief Executive of The Common Good Company and part of the Swisse team that opened China, on where the model is heading.","tags":["Masterclass","China","Export"],"author":"Take Friday Off","sections":[{"heading":"","anchor":"","markdown":"Are the heady days of \"limitless\" growth in cross-border e-commerce (CBEC) and Daigou trade gone for good? How does that square with Chinese consumers' previously insatiable demand for Australian and New Zealand brands? What happened to the market through two years of lockdowns, closed borders and political brinkmanship? What does CBEC and in-country China business look like now, where is the model heading, what do brands have to do to keep winning in Tier-1, 2 and 3 cities, where do the regulations stand, and should brands focus on export-only instead?\n\nWe wanted the answers too, so we asked **Jeremy Hunt, Chief Executive of The Common Good Company**. Jeremy was a key member of the Swisse team under Radek Sali, one of the first people on the ground for Swisse in China, and spent more than seven years as Chief Operating Officer of Health More, a pioneer of CBEC and Daigou trade. The first contact, fittingly, was a WeChat message rather than a phone call.\n\nIn the conversation Jeremy walks through his career and sets out in clear detail the scope of the China opportunity and how brands can adapt their strategies. The main takeaway, reinforced by President Xi Jinping's address at the 4th China International Import Expo: China remains firmly open for business.","text":"Are the heady days of \"limitless\" growth in cross-border e-commerce (CBEC) and Daigou trade gone for good? How does that square with Chinese consumers' previously insatiable demand for Australian and New Zealand brands? What happened to the market through two years of lockdowns, closed borders and political brinkmanship? What does CBEC and in-country China business look like now, where is the model heading, what do brands have to do to keep winning in Tier-1, 2 and 3 cities, where do the regulations stand, and should brands focus on export-only instead? We wanted the answers too, so we asked Jeremy Hunt, Chief Executive of The Common Good Company. Jeremy was a key member of the Swisse team under Radek Sali, one of the first people on the ground for Swisse in China, and spent more than seven years as Chief Operating Officer of Health More, a pioneer of CBEC and Daigou trade. The first contact, fittingly, was a WeChat message rather than a phone call. In the conversation Jeremy walks through his career and sets out in clear detail the scope of the China opportunity and how brands can adapt their strategies. The main takeaway, reinforced by President Xi Jinping's address at the 4th China International Import Expo: China remains firmly open for business.","items":[],"tables":[]}]},{"slug":"masterclass-peter-schwarzer-ingredients-plus","url":"/notes/masterclass-peter-schwarzer-ingredients-plus","title":"Masterclass: Peter Schwarzer, Ingredients Plus","date":"2021-08-10","summary":"Raw materials are over 70% of COGS and drive most of your claims, labels and marketing. A conversation about seed-to-source supply chains, adulteration, forecasting and the rule of seven.","tags":["Masterclass","Sourcing","Supply chain"],"author":"Take Friday Off","sections":[{"heading":"","anchor":"","markdown":"Raw materials make up more than 70% of cost of goods sold and drive about 90% of the claims evidence, labels and marketing behind a product. So we sat down with **Peter Schwarzer of Ingredients Plus**, a former jackaroo, champion footballer and viticulturist who has become the go-to contact for product developers and contract manufacturers looking for raw materials. This is an edited recap of the conversation.","text":"Raw materials make up more than 70% of cost of goods sold and drive about 90% of the claims evidence, labels and marketing behind a product. So we sat down with Peter Schwarzer of Ingredients Plus, a former jackaroo, champion footballer and viticulturist who has become the go-to contact for product developers and contract manufacturers looking for raw materials. This is an edited recap of the conversation.","items":[],"tables":[]},{"heading":"From a farm in Hungary to a vineyard in Mudgee","anchor":"from-a-farm-in-hungary-to-a-vineyard-in-mudgee","markdown":"Peter grew up on a farm in Hungary under communism, finished a master's in agricultural science and took a gap year in Australia in 1999, working on a farm near Mudgee and learning English on the job. He later ran a vineyard maintenance business for about five years before a recruiter connected him with Bronson & Jacobs, then part of Orica, which wanted agricultural knowledge to grow its herbal export business. The early work was import permits, quarantine inspections and the fumigation or irradiation of imported botanicals. Complementary medicine followed, and Ingredients Plus around 2015.","text":"Peter grew up on a farm in Hungary under communism, finished a master's in agricultural science and took a gap year in Australia in 1999, working on a farm near Mudgee and learning English on the job. He later ran a vineyard maintenance business for about five years before a recruiter connected him with Bronson & Jacobs, then part of Orica, which wanted agricultural knowledge to grow its herbal export business. The early work was import permits, quarantine inspections and the fumigation or irradiation of imported botanicals. Complementary medicine followed, and Ingredients Plus around 2015.","items":[],"tables":[]},{"heading":"The connector","anchor":"the-connector","markdown":"Peter's value is not knowing every botanical name; it is knowing the people who do, and being willing to refer a client to a competitor when that is the right answer. Raw-material quality starts at the source, and the people who sit between manufacturer and supplier decide how much of that quality survives.\n\nHe also sells brand-first. Selling only to contract manufacturers gives an incomplete picture, so he approaches marketing companies and practitioners too.","text":"Peter's value is not knowing every botanical name; it is knowing the people who do, and being willing to refer a client to a competitor when that is the right answer. Raw-material quality starts at the source, and the people who sit between manufacturer and supplier decide how much of that quality survives. He also sells brand-first. Selling only to contract manufacturers gives an incomplete picture, so he approaches marketing companies and practitioners too.","items":[],"tables":[]},{"heading":"The rule of seven","anchor":"the-rule-of-seven","markdown":"Sales cycles are long and depend on timing, product roadmaps and budgets. Peter's rule is that an ingredient has to be presented about seven times before it gets traction. One iron chelate took two and a half years to produce a first order. The risk cuts both ways: a brand can adopt an ingredient only after a competitor has heard the same pitch six times.","text":"Sales cycles are long and depend on timing, product roadmaps and budgets. Peter's rule is that an ingredient has to be presented about seven times before it gets traction. One iron chelate took two and a half years to produce a first order. The risk cuts both ways: a brand can adopt an ingredient only after a competitor has heard the same pitch six times.","items":[],"tables":[]},{"heading":"Forecasting floor stock","anchor":"forecasting-floor-stock","markdown":"Forecasting is hard because it depends on contract manufacturers and brands, and many brands forecast poorly. The first batch is the hardest to predict; forecasts improve as sales data accumulates.","text":"Forecasting is hard because it depends on contract manufacturers and brands, and many brands forecast poorly. The first batch is the hardest to predict; forecasts improve as sales data accumulates.","items":[],"tables":[]},{"heading":"Finding and vetting suppliers","anchor":"finding-and-vetting-suppliers","markdown":"Trade shows and industry networks are the main sources. Peter researches new exhibitors before a show and meets them in person. Vetting covers TGA listing, clinical data, origin, manufacturing facilities and whether the supplier is a trader or a producer.\n\nNewcomers should understand the full cost chain from raw material to finished good. Peter will not do business on an ingredient whose price is unrealistically low for its origin: a kilo of raw herb that costs a few dollars cannot support a cheap extract.","text":"Trade shows and industry networks are the main sources. Peter researches new exhibitors before a show and meets them in person. Vetting covers TGA listing, clinical data, origin, manufacturing facilities and whether the supplier is a trader or a producer. Newcomers should understand the full cost chain from raw material to finished good. Peter will not do business on an ingredient whose price is unrealistically low for its origin: a kilo of raw herb that costs a few dollars cannot support a cheap extract.","items":[],"tables":[]},{"heading":"Adulteration and spiking","anchor":"adulteration-and-spiking","markdown":"Spiking is adding cheaper substances to inflate test results or hide substitution. There was a period when it was widespread; DNA identification and better standardisation have improved things, but it remains a live concern, as global curcumin studies and TGA warnings show. Peter described bulk drums where only the top layer is the right product. Testing only the top is not testing.","text":"Spiking is adding cheaper substances to inflate test results or hide substitution. There was a period when it was widespread; DNA identification and better standardisation have improved things, but it remains a live concern, as global curcumin studies and TGA warnings show. Peter described bulk drums where only the top layer is the right product. Testing only the top is not testing.","items":[],"tables":[]},{"heading":"Why distributors still matter","anchor":"why-distributors-still-matter","markdown":"People buy from people they trust. Distributors add warehousing, small-lot distribution and logistics support that suppliers cannot provide to small buyers. Brands should visit their warehouse regularly and see real stock.","text":"People buy from people they trust. Distributors add warehousing, small-lot distribution and logistics support that suppliers cannot provide to small buyers. Brands should visit their warehouse regularly and see real stock.","items":[],"tables":[]},{"heading":"Supply-chain pressure","anchor":"supply-chain-pressure","markdown":"Air freight is expensive, partly because passenger flights carry most air cargo and capacity has been cut. Urgent orders arrive with unrealistic timelines.","text":"Air freight is expensive, partly because passenger flights carry most air cargo and capacity has been cut. Urgent orders arrive with unrealistic timelines.","items":[],"tables":[]},{"heading":"Trends towards 2025","anchor":"trends-towards-2025","markdown":"Gut health and the gut-brain connection keep growing. Fermentation is enabling products like vegetarian chondroitin sulfate. Bioavailability is getting attention. Herbal actives with good clinical data and eye health are expected to grow, and sustainability and upcycling of by-products are increasingly attractive. In Europe, probiotics, organic herbs and origin stories.\n\nBrands find Ingredients Plus through its website, LinkedIn and industry publications; manufacturers usually arrive through purchasing teams, and the process is a conversation about their projects and compliance needs.","text":"Gut health and the gut-brain connection keep growing. Fermentation is enabling products like vegetarian chondroitin sulfate. Bioavailability is getting attention. Herbal actives with good clinical data and eye health are expected to grow, and sustainability and upcycling of by-products are increasingly attractive. In Europe, probiotics, organic herbs and origin stories. Brands find Ingredients Plus through its website, LinkedIn and industry publications; manufacturers usually arrive through purchasing teams, and the process is a conversation about their projects and compliance needs.","items":[],"tables":[]}]},{"slug":"new-ingredient-listing-rules-may-impact-innovative-raw-material-suppliers","url":"/notes/new-ingredient-listing-rules-may-impact-innovative-raw-material-suppliers","title":"New ingredient listing rules may impact innovative raw-material suppliers","date":"2021-06-01","summary":"Proprietary Ingredients have long protected trade-secret manufacturing processes by disclosing them only to the TGA. Changes to how ingredients are listed put that commercial tool under pressure.","tags":["Regulatory","TGA","Sourcing"],"author":"Take Friday Off","sections":[{"heading":"","anchor":"","markdown":"Proprietary Ingredients have long been an important item in the Australian industry's commercial toolbox. They protect a raw material by disclosing the trade-secret manufacturing process only to the TGA, under strict confidentiality, so a supplier can bring a novel ingredient to market without handing its competitors the recipe.\n\nChanges to how ingredients are listed put that tool under pressure, and the suppliers most exposed are the innovative ones: the companies investing in new extraction methods, fermentation and standardisation rather than trading commodity botanicals.\n\nFor sponsors the practical questions are the same as always. What exactly is in the product, how is it specified, what evidence sits behind it, and does the listing still match the label? Those are the questions the Take Friday Off system answers before a formulation is locked, not after a listing is challenged.\n\n*This post is an edited recap of the original article. The full text can be restored through the site CMS.*","text":"Proprietary Ingredients have long been an important item in the Australian industry's commercial toolbox. They protect a raw material by disclosing the trade-secret manufacturing process only to the TGA, under strict confidentiality, so a supplier can bring a novel ingredient to market without handing its competitors the recipe. Changes to how ingredients are listed put that tool under pressure, and the suppliers most exposed are the innovative ones: the companies investing in new extraction methods, fermentation and standardisation rather than trading commodity botanicals. For sponsors the practical questions are the same as always. What exactly is in the product, how is it specified, what evidence sits behind it, and does the listing still match the label? Those are the questions the Take Friday Off system answers before a formulation is locked, not after a listing is challenged. This post is an edited recap of the original article. The full text can be restored through the site CMS.","items":[],"tables":[]}]},{"slug":"masterclass-evan-hayes-factors-group","url":"/notes/masterclass-evan-hayes-factors-group","title":"Masterclass: Evan Hayes, Factors Group","date":"2021-03-15","summary":"Vertical integration from farm to finished product, B Corp, 97-ingredient formulas, first-mover advantage and what keeps one of Australia's most successful natural product developers up at night.","tags":["Masterclass","Product development","Sourcing"],"author":"Take Friday Off","sections":[{"heading":"","anchor":"","markdown":"A Take Friday Off Masterclass is a one-on-one with someone who has built the products, brands or supply chains the rest of the industry benchmarks against. This one was with **Evan Hayes, Managing Director of Factors Group Australia**, taken on the road between appointments. Evan was Technical Director at BioCeuticals and later ran sourcing and procurement at Blackmores; Factors Group Australia is the local arm of Canada's Natural Factors, covering research, development, manufacturing and distribution of nutritional supplements.\n\nWhat follows is an edited recap of the conversation.","text":"A Take Friday Off Masterclass is a one-on-one with someone who has built the products, brands or supply chains the rest of the industry benchmarks against. This one was with Evan Hayes, Managing Director of Factors Group Australia, taken on the road between appointments. Evan was Technical Director at BioCeuticals and later ran sourcing and procurement at Blackmores; Factors Group Australia is the local arm of Canada's Natural Factors, covering research, development, manufacturing and distribution of nutritional supplements. What follows is an edited recap of the conversation.","items":[],"tables":[]},{"heading":"Vertical integration, from catch to batch","anchor":"vertical-integration-from-catch-to-batch","markdown":"Factors grew from a family complementary-medicine business into one of North America's largest, and it did it by moving upstream: from distribution into manufacturing, then into raw-material sourcing and testing, then into farming and its own extraction facilities. Today it runs organic farms growing around seventy ingredients, makes its own ethanol for extraction and owns an MSC-certified fishery in Alaska. Evan calls it close to complete \"catch to batch\" control.\n\nDoes that dilute margins or add complexity? Factors can't grow everything, so it manages around 7,000 raw materials and pairs in-house production with disciplined external sourcing. The reason for keeping so much in-house is simple: outsourcing leaves a lingering doubt about whether a third party's checks are substantive. Customers, Evan says, now expect that level of assurance as the baseline.","text":"Factors grew from a family complementary-medicine business into one of North America's largest, and it did it by moving upstream: from distribution into manufacturing, then into raw-material sourcing and testing, then into farming and its own extraction facilities. Today it runs organic farms growing around seventy ingredients, makes its own ethanol for extraction and owns an MSC-certified fishery in Alaska. Evan calls it close to complete \"catch to batch\" control. Does that dilute margins or add complexity? Factors can't grow everything, so it manages around 7,000 raw materials and pairs in-house production with disciplined external sourcing. The reason for keeping so much in-house is simple: outsourcing leaves a lingering doubt about whether a third party's checks are substantive. Customers, Evan says, now expect that level of assurance as the baseline.","items":[],"tables":[]},{"heading":"B Corp","anchor":"b-corp","markdown":"Factors Australia was the first company in its space in Australia, and the first in the group, to achieve B Corp certification. Building a new facility helped, because processes could be designed for transparency from day one. Evan sees external accountability as the natural next step after self-declared good practice.","text":"Factors Australia was the first company in its space in Australia, and the first in the group, to achieve B Corp certification. Building a new facility helped, because processes could be designed for transparency from day one. Evan sees external accountability as the natural next step after self-declared good practice.","items":[],"tables":[]},{"heading":"Launching bespoke, novel formulations","anchor":"launching-bespoke-novel-formulations","markdown":"In roughly two years Factors launched several bespoke brands across practitioner, grocery and health-food channels, with a weight-loss brand to follow. One health-food formula carried 97 ingredients, seventy of them from Factors' own farms, and every one had to be re-specified and retested to meet Australian GMP. A project planned at three months took about eighteen. The result is one of the most comprehensive formulas on the market; starting with the hardest possible product was, by Evan's own admission, a brave choice.","text":"In roughly two years Factors launched several bespoke brands across practitioner, grocery and health-food channels, with a weight-loss brand to follow. One health-food formula carried 97 ingredients, seventy of them from Factors' own farms, and every one had to be re-specified and retested to meet Australian GMP. A project planned at three months took about eighteen. The result is one of the most comprehensive formulas on the market; starting with the hardest possible product was, by Evan's own admission, a brave choice.","items":[],"tables":[]},{"heading":"Hero ingredients versus \"pixie dust\"","anchor":"hero-ingredients-versus-pixie-dust","markdown":"Everyone on the call rejected products that lean on one headline ingredient with trivial amounts of everything else. Small doses are acceptable where there is a formulation rationale, but any claim has to be backed by evidence. Consumers, Evan argues, are more sophisticated than the industry assumes.","text":"Everyone on the call rejected products that lean on one headline ingredient with trivial amounts of everything else. Small doses are acceptable where there is a formulation rationale, but any claim has to be backed by evidence. Consumers, Evan argues, are more sophisticated than the industry assumes.","items":[],"tables":[]},{"heading":"Price pressure and margins","anchor":"price-pressure-and-margins","markdown":"The industry is often assumed to be high-margin. Doing it properly is expensive: natural ingredients have harvests and shelf lives, testing standards keep rising, and products need education and time on the market. Brands built on export volume or low doses tend not to last; the ones with longevity focus on Australian consumers and believe in what they sell. The squeeze lands on everyone in the supply chain, most of whom are in it out of passion as much as financial need.","text":"The industry is often assumed to be high-margin. Doing it properly is expensive: natural ingredients have harvests and shelf lives, testing standards keep rising, and products need education and time on the market. Brands built on export volume or low doses tend not to last; the ones with longevity focus on Australian consumers and believe in what they sell. The squeeze lands on everyone in the supply chain, most of whom are in it out of passion as much as financial need.","items":[],"tables":[]},{"heading":"Outsourcing product development","anchor":"outsourcing-product-development","markdown":"Product development needs many skills at once and very few people cover more than three. Outsourcing parts of the work is normal in other industries and, done well, produces better solutions at lower cost. Suppliers and manufacturers often contribute to formulation in this sector, and that is a feature, not a weakness.","text":"Product development needs many skills at once and very few people cover more than three. Outsourcing parts of the work is normal in other industries and, done well, produces better solutions at lower cost. Suppliers and manufacturers often contribute to formulation in this sector, and that is a feature, not a weakness.","items":[],"tables":[]},{"heading":"First-mover advantage","anchor":"first-mover-advantage","markdown":"Raw materials usually have no patent protection, so the advantage comes from being first and then using the lead well in your chosen channel. Being first is not always best, though: some of Evan's best work went on to succeed under other companies because his timing or marketing was wrong.","text":"Raw materials usually have no patent protection, so the advantage comes from being first and then using the lead well in your chosen channel. Being first is not always best, though: some of Evan's best work went on to succeed under other companies because his timing or marketing was wrong.","items":[],"tables":[]},{"heading":"What keeps him up at night","anchor":"what-keeps-him-up-at-night","markdown":"Becoming irrelevant. Missing the next trend, ignoring practitioners and customers, or growing arrogant. Evan values open, collaborative idea-sharing over holding information tightly.","text":"Becoming irrelevant. Missing the next trend, ignoring practitioners and customers, or growing arrogant. Evan values open, collaborative idea-sharing over holding information tightly.","items":[],"tables":[]},{"heading":"Advice for someone entering the industry","anchor":"advice-for-someone-entering-the-industry","markdown":"Get a bird's-eye view of the whole chain, from raw-material sourcing and manufacturing through testing, logistics, marketing and the feedback loop. Start from a health concern you actually care about, then study the ingredients and products that address it. There is a role for almost any interest: sourcing, compliance, clinical work, negotiation, people.","text":"Get a bird's-eye view of the whole chain, from raw-material sourcing and manufacturing through testing, logistics, marketing and the feedback loop. Start from a health concern you actually care about, then study the ingredients and products that address it. There is a role for almost any interest: sourcing, compliance, clinical work, negotiation, people.","items":[],"tables":[]},{"heading":"Innovation and probiotics","anchor":"innovation-and-probiotics","markdown":"Evan credits long-running industry relationships for Factors' Scobiotic range, first to market in its form. He traced Australia's probiotic history through early work at Blackmores and BioCeuticals, including what he describes as the first gut-brain-axis clinical trial, and made the point that innovation comes from many sources: reading the research, spotting trends and revisiting ideas whose time has not yet come.\n\nThe conversation closed on a shared philosophy: build formulas from patient problems and clinical needs rather than chasing cheaper versions of existing products, with traceable, correctly sourced ingredients at doses that produce results.","text":"Evan credits long-running industry relationships for Factors' Scobiotic range, first to market in its form. He traced Australia's probiotic history through early work at Blackmores and BioCeuticals, including what he describes as the first gut-brain-axis clinical trial, and made the point that innovation comes from many sources: reading the research, spotting trends and revisiting ideas whose time has not yet come. The conversation closed on a shared philosophy: build formulas from patient problems and clinical needs rather than chasing cheaper versions of existing products, with traceable, correctly sourced ingredients at doses that produce results.","items":[],"tables":[]}]},{"slug":"sharing-our-four-pronged-approach-to-tgas-requirements-with-nutraingredients-asia","url":"/notes/sharing-our-four-pronged-approach-to-tgas-requirements-with-nutraingredients-asia","title":"Sharing our four-pronged approach to TGA's requirements with NutraIngredients Asia","date":"2020-09-22","summary":"Permitted Indications and TGO 92 changed how listed medicines make claims. Our four steps for sponsors: update the evidence, select permitted indications, update the label, verify the label against the ARTG.","tags":["Regulatory","TGA","Press"],"author":"Take Friday Off","sections":[{"heading":"","anchor":"","markdown":"> **Update, October 2026.** TGO 92 has been replaced. The Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026 commenced on 30 September 2026 and is now the labelling order for listed and other non-prescription medicines, with a transition period for labels already on the market. The four steps below still hold; read \"TGO 92\" as \"TGO 116\" and check the current order before any label change. Our [TGO 116 labelling guide](/guides/supplement-labelling) and [what changed from TGO 92](/notes/tgo-116-replaces-tgo-92) cover it.\n\nNutraIngredients Asia interviewed the Take Friday Off team about the TGA's new health-claim rules, the challenges sponsors face, and the approach we use with brands dealing with Permitted Indications and TGO 92. The full interview is on NutraIngredients Asia, and our [press page](/press) lists the rest of our coverage. The short version:\n\n1. **Update the evidence.** Make sure the evidence behind each product is current and meets the current evidence standard.\n2. **Select permitted indications and update the ARTG.** Choose claims from the permitted indications list and update the product's health claims on the Australian Register of Therapeutic Goods.\n3. **Update the label.** Revise the label with the new health claims, to the new labelling order.\n4. **Verify the label against the registration.** Confirm that what is on the label matches what is registered on the ARTG.\n\nCompliance is a growth lever when it is integrated from the start. This is the same logic that sits inside the Take Friday Off system today: regulatory work runs in parallel with formulation and sourcing, not after them.","text":"> Update, October 2026. TGO 92 has been replaced. The Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026 commenced on 30 September 2026 and is now the labelling order for listed and other non-prescription medicines, with a transition period for labels already on the market. The four steps below still hold; read \"TGO 92\" as \"TGO 116\" and check the current order before any label change. Our TGO 116 labelling guide and what changed from TGO 92 cover it. NutraIngredients Asia interviewed the Take Friday Off team about the TGA's new health-claim rules, the challenges sponsors face, and the approach we use with brands dealing with Permitted Indications and TGO 92. The full interview is on NutraIngredients Asia, and our press page lists the rest of our coverage. The short version: Update the evidence. Make sure the evidence behind each product is current and meets the current evidence standard. Select permitted indications and update the ARTG. Choose claims from the permitted indications list and update the product's health claims on the Australian Register of Therapeutic Goods. Update the label. Revise the label with the new health claims, to the new labelling order. Verify the label against the registration. Confirm that what is on the label matches what is registered on the ARTG. Compliance is a growth lever when it is integrated from the start. This is the same logic that sits inside the Take Friday Off system today: regulatory work runs in parallel with formulation and sourcing, not after them.","items":[{"lead":"Update the evidence.","text":"Make sure the evidence behind each product is current and meets the current evidence standard."},{"lead":"Select permitted indications and update the ARTG.","text":"Choose claims from the permitted indications list and update the product's health claims on the Australian Register of Therapeutic Goods."},{"lead":"Update the label.","text":"Revise the label with the new health claims, to the new labelling order."},{"lead":"Verify the label against the registration.","text":"Confirm that what is on the label matches what is registered on the ARTG."}],"tables":[]}]}],"pages":[{"slug":"product-development","kind":"hub","url":"/product-development","title":"Supplement product development, from idea to reorder","name":"Product development","description":"Supplement product development for Australian and overseas brands: first products, range extensions, reformulations and market entry, timed from our records.","eyebrow":"Product development","lead":"One team takes a supplement, natural health product or skincare product from the first idea to the reorder: the formula, the evidence, the listing, the label and managed manufacturing. Where you start decides the journey. These are the journeys we run, with timelines from our own records.","studies":["everleanbody-saffron-capsule","the-belly-solution-travel-gut-health-powder","your-skin-scan-nicotinamide-tablet","bwellness-practitioner-range","sports-brand-core-range","pump-haircare-hair-supplement"],"formats":[],"order":4,"updated":"2026-10-27","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- Product development is the whole journey, not just the formula: the pathway, the formula and its evidence, the claims, the listing, the label, the stability program and managed manufacturing, through to the reorder and the next product.\n- From our records: 190 projects since 2020. Listed medicines have taken 32 days to 12 weeks from design to production order, and 5.8 to about eight months from brief or formulation to dispatch.\n- Where you start decides the journey: a first product, the next one in a range, a product that has to change, an overseas brand coming to Australia, a practitioner-only range or an ingredient that isn't permitted yet.\n- Take Friday Off isn't a contract manufacturer. We match each product to cGMP manufacturing partners and manage them through to your warehouse.","text":"Product development is the whole journey, not just the formula: the pathway, the formula and its evidence, the claims, the listing, the label, the stability program and managed manufacturing, through to the reorder and the next product. From our records: 190 projects since 2020. Listed medicines have taken 32 days to 12 weeks from design to production order, and 5.8 to about eight months from brief or formulation to dispatch. Where you start decides the journey: a first product, the next one in a range, a product that has to change, an overseas brand coming to Australia, a practitioner-only range or an ingredient that isn't permitted yet. Take Friday Off isn't a contract manufacturer. We match each product to cGMP manufacturing partners and manage them through to your warehouse.","items":[],"tables":[]},{"heading":"Five stages, one team","anchor":"five-stages-one-team","markdown":"The same five stages run under every journey. [How the system works](/system) covers each one with a problem we solved in it.\n\n1. **Discover.** We align the product with your commercial, brand and regulatory requirements from day one: market, portfolio, pathway and forecast. The first decision is the pathway: [medicine, food or cosmetic?](/pathways)\n2. **Design.** Evidence-based formulation, in the format your customers reach for ([formulation](/formulation), [formats](/formats)).\n3. **De-risk.** Claims, evidence, labelling and listing are prepared alongside the formula, so nothing is unpicked later ([permitted indications](/guides/permitted-indications), [labelling](/guides/supplement-labelling), [stability testing](/guides/stability-testing)).\n4. **Deliver.** cGMP manufacturing partners matched to your format, volume and margin, with release testing, imports and freight managed through to your warehouse or 3PL ([managed manufacturing](/manufacturing), [packaging](/packaging)).\n5. **Drive.** After launch, reorders, range extensions and the next product, with the same team.","text":"The same five stages run under every journey. How the system works covers each one with a problem we solved in it. Discover. We align the product with your commercial, brand and regulatory requirements from day one: market, portfolio, pathway and forecast. The first decision is the pathway: medicine, food or cosmetic? Design. Evidence-based formulation, in the format your customers reach for (formulation, formats). De-risk. Claims, evidence, labelling and listing are prepared alongside the formula, so nothing is unpicked later (permitted indications, labelling, stability testing). Deliver. cGMP manufacturing partners matched to your format, volume and margin, with release testing, imports and freight managed through to your warehouse or 3PL (managed manufacturing, packaging). Drive. After launch, reorders, range extensions and the next product, with the same team.","items":[{"lead":"Discover.","text":"We align the product with your commercial, brand and regulatory requirements from day one: market, portfolio, pathway and forecast. The first decision is the pathway: medicine, food or cosmetic?"},{"lead":"Design.","text":"Evidence-based formulation, in the format your customers reach for (formulation, formats)."},{"lead":"De-risk.","text":"Claims, evidence, labelling and listing are prepared alongside the formula, so nothing is unpicked later (permitted indications, labelling, stability testing)."},{"lead":"Deliver.","text":"cGMP manufacturing partners matched to your format, volume and margin, with release testing, imports and freight managed through to your warehouse or 3PL (managed manufacturing, packaging)."},{"lead":"Drive.","text":"After launch, reorders, range extensions and the next product, with the same team."}],"tables":[]},{"heading":"Where are you starting from?","anchor":"where-are-you-starting-from","markdown":"- **Your first product.** A founder with an idea, or a clinic with a product it wants to own. Our [guide to starting a supplement brand](/guides/start-a-supplement-brand) sets out the order of work. From our records: Your Skin Scan's first own-brand tablet took about 6.5 months from signed quote to delivery, and Nivari's first powder was produced and delivered for a mid-August 2026 launch.\n- **Your next product.** A range extension, a new format or a sample pack, built on what the first product set up. See [extending a supplement range](/guides/extending-a-supplement-range).\n- **A product that has to change.** A better ingredient or dose, a claim, a format that won't hold, a supply problem or a new manufacturer. See [reformulating a supplement](/guides/reformulating-a-supplement).\n- **An overseas brand coming to Australia.** An Australian sponsor, a listing, a TGA GMP clearance for the overseas maker and an Australian label. See [bringing a supplement brand to Australia](/guides/bringing-a-supplement-brand-to-australia).\n- **A practitioner-only range.** Built for supply through clinics and health practitioners. See [practitioner-only ranges](/practitioner-ranges).\n- **An ingredient that isn't permitted yet.** The TGA, FSANZ or AICIS route, mapped before the formula is locked. See [new ingredient applications](/new-ingredients).","text":"Your first product. A founder with an idea, or a clinic with a product it wants to own. Our guide to starting a supplement brand sets out the order of work. From our records: Your Skin Scan's first own-brand tablet took about 6.5 months from signed quote to delivery, and Nivari's first powder was produced and delivered for a mid-August 2026 launch. Your next product. A range extension, a new format or a sample pack, built on what the first product set up. See extending a supplement range. A product that has to change. A better ingredient or dose, a claim, a format that won't hold, a supply problem or a new manufacturer. See reformulating a supplement. An overseas brand coming to Australia. An Australian sponsor, a listing, a TGA GMP clearance for the overseas maker and an Australian label. See bringing a supplement brand to Australia. A practitioner-only range. Built for supply through clinics and health practitioners. See practitioner-only ranges. An ingredient that isn't permitted yet. The TGA, FSANZ or AICIS route, mapped before the formula is locked. See new ingredient applications.","items":[{"lead":"Your first product.","text":"A founder with an idea, or a clinic with a product it wants to own. Our guide to starting a supplement brand sets out the order of work. From our records: Your Skin Scan's first own-brand tablet took about 6.5 months from signed quote to delivery, and Nivari's first powder was produced and delivered for a mid-August 2026 launch."},{"lead":"Your next product.","text":"A range extension, a new format or a sample pack, built on what the first product set up. See extending a supplement range."},{"lead":"A product that has to change.","text":"A better ingredient or dose, a claim, a format that won't hold, a supply problem or a new manufacturer. See reformulating a supplement."},{"lead":"An overseas brand coming to Australia.","text":"An Australian sponsor, a listing, a TGA GMP clearance for the overseas maker and an Australian label. See bringing a supplement brand to Australia."},{"lead":"A practitioner-only range.","text":"Built for supply through clinics and health practitioners. See practitioner-only ranges."},{"lead":"An ingredient that isn't permitted yet.","text":"The TGA, FSANZ or AICIS route, mapped before the formula is locked. See new ingredient applications."}],"tables":[]},{"heading":"Time and cost","anchor":"time-and-cost","markdown":"The time depends on the formula, the format and the pathway. From our records: 32 days from design to production order for a complex herbal capsule ([sleep and stress supplements](/guides/sleep-and-stress-supplement-development)), under seven weeks for an eye-health formula ([eye health supplements](/guides/eye-health-supplement-development)), 12 weeks for the second version of a probiotic skin supplement, 5.8 months from signed brief to dispatch for EverLeanBody ([women's health supplements](/guides/womens-health-supplement-development)), about 6.5 months from signed quote to delivery for Your Skin Scan, and about eight months from formulation to dispatch for The Belly Solution. The TGA's listing step is short: what holds a launch up is a formula that won't run, an ingredient that isn't on the TGA's list, or a pathway settled late. More in our [development timeline guide](/guides/supplement-development-timeline).\n\nWhat it costs, from the TGA's fees to the first run of at least 3,000 finished retail packs, is in our [development cost guide](/guides/supplement-development-cost).","text":"The time depends on the formula, the format and the pathway. From our records: 32 days from design to production order for a complex herbal capsule (sleep and stress supplements), under seven weeks for an eye-health formula (eye health supplements), 12 weeks for the second version of a probiotic skin supplement, 5.8 months from signed brief to dispatch for EverLeanBody (women's health supplements), about 6.5 months from signed quote to delivery for Your Skin Scan, and about eight months from formulation to dispatch for The Belly Solution. The TGA's listing step is short: what holds a launch up is a formula that won't run, an ingredient that isn't on the TGA's list, or a pathway settled late. More in our development timeline guide. What it costs, from the TGA's fees to the first run of at least 3,000 finished retail packs, is in our development cost guide.","items":[],"tables":[]},{"heading":"Formats and pathways","anchor":"formats-and-pathways","markdown":"We develop supplements and natural health products as [capsules, tablets and softgels](/formats/capsules-tablets-softgels), [gummies](/formats/gummies), [powders and sachets](/formats/powders-sachets), [liquids](/formats/liquids), and [creams, serums and sunscreens](/skincare), as TGA-listed medicines, foods or cosmetics ([medicine, food or cosmetic?](/pathways)).","text":"We develop supplements and natural health products as capsules, tablets and softgels, gummies, powders and sachets, liquids, and creams, serums and sunscreens, as TGA-listed medicines, foods or cosmetics (medicine, food or cosmetic?).","items":[],"tables":[]}],"faqs":[{"q":"What does supplement product development include?","a":"Everything from the brief to the reorder: the pathway decision, the formula and its specification, the evidence for the claims, the TGA listing, the label, the stability program and managed manufacturing through to your warehouse. Each stage is priced as a fixed fee (development costs).","md":"Everything from the brief to the reorder: the pathway decision, the formula and its specification, the evidence for the claims, the TGA listing, the label, the stability program and managed manufacturing through to your warehouse. Each stage is priced as a fixed fee ([development costs](/guides/supplement-development-cost))."},{"q":"How long does it take to develop a supplement?","a":"From our records, listed medicines have taken 32 days to 12 weeks from design to production order, and 5.8 to about eight months from brief or formulation to dispatch. See how long it takes.","md":"From our records, listed medicines have taken 32 days to 12 weeks from design to production order, and 5.8 to about eight months from brief or formulation to dispatch. See [how long it takes](/guides/supplement-development-timeline)."},{"q":"Do you manufacture the product?","a":"We aren't a contract manufacturer. We match each product to cGMP manufacturing partners by format, volume and margin, carry the specification, packaging and labelling, and manage release testing, imports and freight through to your warehouse or 3PL. See managed manufacturing.","md":"We aren't a contract manufacturer. We match each product to cGMP manufacturing partners by format, volume and margin, carry the specification, packaging and labelling, and manage release testing, imports and freight through to your warehouse or 3PL. See [managed manufacturing](/manufacturing)."},{"q":"Do you work with brands outside Australia?","a":"Yes. Since 2024 we have run the regulatory work for an international skincare brand's supplements and sunscreen in Australia, on a monthly retainer, and we managed Deeply Rooted's supply chain from its New Zealand maker to Australia. See bringing a supplement brand to Australia.","md":"Yes. Since 2024 we have run the regulatory work for an international skincare brand's supplements and sunscreen in Australia, on a monthly retainer, and we managed Deeply Rooted's supply chain from its New Zealand maker to Australia. See [bringing a supplement brand to Australia](/guides/bringing-a-supplement-brand-to-australia)."},{"q":"Can you work on a product that's already on the market?","a":"Yes. For ATP Science we reformulated four TGA-listed capsules from scratch, and for Pump Haircare we upgraded a hair growth formula with a full new listing package, shipped in 2026. See reformulating a supplement.","md":"Yes. For ATP Science we reformulated four TGA-listed capsules from scratch, and for Pump Haircare we upgraded a hair growth formula with a full new listing package, shipped in 2026. See [reformulating a supplement](/guides/reformulating-a-supplement)."}],"sources":null},{"slug":"pathways","kind":"hub","url":"/pathways","title":"Medicine, food or cosmetic? How a product's pathway is decided","name":"Medicine, food or cosmetic?","description":"In Australia the same capsule can be a listed medicine or a food, and the same cream a medicine or a cosmetic. How the line is drawn, and what each allows.","eyebrow":"Pathways","lead":"In Australia the same capsule or powder can be a listed medicine or a food, and the same cream a listed medicine or a cosmetic. What decides it is mostly how the product is presented: its claims, its name, its form, its dose, even where it is sold. We settle the pathway at the brief, before the formula, because it decides the ingredients you can use, the claims you can make, the label and who regulates you.","studies":["sports-brand-core-range","vitable-hair-growth-range","ora-practitioner-natural-medicine","the-belly-solution-travel-gut-health-powder","pain-relief-cream","skincare-brand-regulatory-partner"],"formats":[],"order":5,"updated":"2026-10-19","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- In Australia the same capsule or powder can be a listed medicine or a food, and the same cream a listed medicine or a cosmetic.\n- Mostly, presentation decides: the claims, the name, the form, the dose, even where the product is sold.\n- Declared goods, such as beauty supplements, are medicines whatever else applies. Excluded goods, such as an SPF 4 to 15 moisturiser that meets its conditions, are not.\n- The pathway decides the ingredients you can use, the claims you can make, the label and who regulates you.","text":"In Australia the same capsule or powder can be a listed medicine or a food, and the same cream a listed medicine or a cosmetic. Mostly, presentation decides: the claims, the name, the form, the dose, even where the product is sold. Declared goods, such as beauty supplements, are medicines whatever else applies. Excluded goods, such as an SPF 4 to 15 moisturiser that meets its conditions, are not. The pathway decides the ingredients you can use, the claims you can make, the label and who regulates you.","items":[],"tables":[]},{"heading":"Three pathways, three sets of rules","anchor":"three-pathways-three-sets-of-rules","markdown":"| | Listed medicine | Food | Cosmetic |\n| --- | --- | --- | --- |\n| The law | Therapeutic Goods Act 1989, run by the TGA | The Food Standards Code, written by FSANZ and enforced by the states, territories and local councils | Consumer law, with the ACCC as the main regulator of safety, ingredient labelling and claims; AICIS regulates the import and manufacture of cosmetic ingredients under the Industrial Chemicals Act 2019 |\n| Before you sell | Entry on the [Australian Register of Therapeutic Goods (ARTG)](/guides/artg); the AUST L number goes on the label | The product must comply with the Code | A business that imports cosmetics or their ingredients, or makes the chemicals in them, [registers with AICIS](/guides/aicis-registration) for each year it does, with exclusions such as small-batch soap |\n| What you can claim | Therapeutic claims only from the TGA's permitted indications, with evidence held for every indication and claim | Health claims only on foods that meet the Code's nutrient profiling test (special purpose foods, such as sports foods, don't need to): high level claims from its pre-approved list, general level claims from that list or a relationship notified to FSANZ first, and never about preventing, diagnosing, curing or alleviating a disease | Appearance, cleansing, odour, protecting the skin and keeping it in good condition |\n| Ingredients | Only those in the Permissible Ingredients Determination | As the Code allows: novel foods must be listed, vitamins and minerals added only as permitted | Each chemical introduction is categorised under AICIS rules |\n| Examples from our work | Capsules, tablets, powders and a pain relief cream | A sports brand's performance powder; functional foods in [Ora's](/work/ora-practitioner-natural-medicine) range | [Vitable's](/work/vitable-hair-growth-range) hair serum |","text":"The law — Listed medicine: Therapeutic Goods Act 1989, run by the TGA; Food: The Food Standards Code, written by FSANZ and enforced by the states, territories and local councils; Cosmetic: Consumer law, with the ACCC as the main regulator of safety, ingredient labelling and claims; AICIS regulates the import and manufacture of cosmetic ingredients under the Industrial Chemicals Act 2019. Before you sell — Listed medicine: Entry on the Australian Register of Therapeutic Goods (ARTG); the AUST L number goes on the label; Food: The product must comply with the Code; Cosmetic: A business that imports cosmetics or their ingredients, or makes the chemicals in them, registers with AICIS for each year it does, with exclusions such as small-batch soap. What you can claim — Listed medicine: Therapeutic claims only from the TGA's permitted indications, with evidence held for every indication and claim; Food: Health claims only on foods that meet the Code's nutrient profiling test (special purpose foods, such as sports foods, don't need to): high level claims from its pre-approved list, general level claims from that list or a relationship notified to FSANZ first, and never about preventing, diagnosing, curing or alleviating a disease; Cosmetic: Appearance, cleansing, odour, protecting the skin and keeping it in good condition. Ingredients — Listed medicine: Only those in the Permissible Ingredients Determination; Food: As the Code allows: novel foods must be listed, vitamins and minerals added only as permitted; Cosmetic: Each chemical introduction is categorised under AICIS rules. Examples from our work — Listed medicine: Capsules, tablets, powders and a pain relief cream; Food: A sports brand's performance powder; functional foods in Ora's range; Cosmetic: Vitable's hair serum.","items":[],"tables":[{"header":["","Listed medicine","Food","Cosmetic"],"rows":[["The law","Therapeutic Goods Act 1989, run by the TGA","The Food Standards Code, written by FSANZ and enforced by the states, territories and local councils","Consumer law, with the ACCC as the main regulator of safety, ingredient labelling and claims; AICIS regulates the import and manufacture of cosmetic ingredients under the Industrial Chemicals Act 2019"],["Before you sell","Entry on the Australian Register of Therapeutic Goods (ARTG); the AUST L number goes on the label","The product must comply with the Code","A business that imports cosmetics or their ingredients, or makes the chemicals in them, registers with AICIS for each year it does, with exclusions such as small-batch soap"],["What you can claim","Therapeutic claims only from the TGA's permitted indications, with evidence held for every indication and claim","Health claims only on foods that meet the Code's nutrient profiling test (special purpose foods, such as sports foods, don't need to): high level claims from its pre-approved list, general level claims from that list or a relationship notified to FSANZ first, and never about preventing, diagnosing, curing or alleviating a disease","Appearance, cleansing, odour, protecting the skin and keeping it in good condition"],["Ingredients","Only those in the Permissible Ingredients Determination","As the Code allows: novel foods must be listed, vitamins and minerals added only as permitted","Each chemical introduction is categorised under AICIS rules"],["Examples from our work","Capsules, tablets, powders and a pain relief cream","A sports brand's performance powder; functional foods in Ora's range","Vitable's hair serum"]]}]},{"heading":"How the line is drawn","anchor":"how-the-line-is-drawn","markdown":"The rules are applied in roughly this order:\n\n1. **Declared goods are medicines, whatever else applies.** Some products are declared therapeutic goods by form alone: fibre in tablets, capsules or pills; isolated HMB or its salts (or a product promoted to contain them) in tablets, capsules, pills or powders; and shark cartilage in tablets, capsules or pills, or in a powder that isn't a wholesale product for use as a food ingredient. Others are declared by how they are presented: anything swallowed that is labelled or promoted for cosmetic purposes (beauty supplements), and sports supplements presented for a therapeutic use, such as gaining muscle, that contain certain substances or, since 30 November 2023, come as a tablet, capsule or pill.\n2. **Excluded goods are not.** The Excluded Goods Determination takes some products out of the medicines rules if they meet every condition it sets, such as an SPF moisturiser of SPF 4 to 15 that meets its conditions, or an acne product presented as controlling acne only by cleansing, moisturising, exfoliating or drying the skin, with no Schedule 2, 3, 4 or 8 poisons.\n3. **Otherwise, presentation decides.** A product is a therapeutic good if it is presented as, or likely to be taken to be, for therapeutic use: preventing, curing or alleviating a disease, or \"influencing, inhibiting or modifying a physiological process\". The TGA weighs the name, the claims, the form, dosage instructions, warnings, the advertising and even where it is sold.\n4. **Foods have two ways out.** A swallowed product is a food if a food standard covers it, such as Standard 2.9.4 for formulated supplementary sports foods, or if it has a tradition of use as a food in Australia or New Zealand in the form presented. A disease claim, or a health claim the Code doesn't permit, doesn't turn such a product into a medicine; it makes it a food breaking Standard 1.2.7. More on [the food pathway](/pathways/foods).\n5. **Form can move a product across.** A herb eaten as fresh leaves is a food; extracted, concentrated and sold in a capsule, it may be a medicine.\n6. **On the skin, the claim decides.** A cream, serum or lotion is a cosmetic while it only changes appearance, cleanses, perfumes, protects or keeps the skin in good condition. A claim to treat a condition, an ingredient from Schedule 2, 3, 4 or 8 of the Poisons Standard, or the way it is used can make it a therapeutic good. The skincare page has [the claim examples and the sunscreen rules](/skincare).","text":"The rules are applied in roughly this order: Declared goods are medicines, whatever else applies. Some products are declared therapeutic goods by form alone: fibre in tablets, capsules or pills; isolated HMB or its salts (or a product promoted to contain them) in tablets, capsules, pills or powders; and shark cartilage in tablets, capsules or pills, or in a powder that isn't a wholesale product for use as a food ingredient. Others are declared by how they are presented: anything swallowed that is labelled or promoted for cosmetic purposes (beauty supplements), and sports supplements presented for a therapeutic use, such as gaining muscle, that contain certain substances or, since 30 November 2023, come as a tablet, capsule or pill. Excluded goods are not. The Excluded Goods Determination takes some products out of the medicines rules if they meet every condition it sets, such as an SPF moisturiser of SPF 4 to 15 that meets its conditions, or an acne product presented as controlling acne only by cleansing, moisturising, exfoliating or drying the skin, with no Schedule 2, 3, 4 or 8 poisons. Otherwise, presentation decides. A product is a therapeutic good if it is presented as, or likely to be taken to be, for therapeutic use: preventing, curing or alleviating a disease, or \"influencing, inhibiting or modifying a physiological process\". The TGA weighs the name, the claims, the form, dosage instructions, warnings, the advertising and even where it is sold. Foods have two ways out. A swallowed product is a food if a food standard covers it, such as Standard 2.9.4 for formulated supplementary sports foods, or if it has a tradition of use as a food in Australia or New Zealand in the form presented. A disease claim, or a health claim the Code doesn't permit, doesn't turn such a product into a medicine; it makes it a food breaking Standard 1.2.7. More on the food pathway. Form can move a product across. A herb eaten as fresh leaves is a food; extracted, concentrated and sold in a capsule, it may be a medicine. On the skin, the claim decides. A cream, serum or lotion is a cosmetic while it only changes appearance, cleanses, perfumes, protects or keeps the skin in good condition. A claim to treat a condition, an ingredient from Schedule 2, 3, 4 or 8 of the Poisons Standard, or the way it is used can make it a therapeutic good. The skincare page has the claim examples and the sunscreen rules.","items":[{"lead":"Declared goods are medicines, whatever else applies.","text":"Some products are declared therapeutic goods by form alone: fibre in tablets, capsules or pills; isolated HMB or its salts (or a product promoted to contain them) in tablets, capsules, pills or powders; and shark cartilage in tablets, capsules or pills, or in a powder that isn't a wholesale product for use as a food ingredient. Others are declared by how they are presented: anything swallowed that is labelled or promoted for cosmetic purposes (beauty supplements), and sports supplements presented for a therapeutic use, such as gaining muscle, that contain certain substances or, since 30 November 2023, come as a tablet, capsule or pill."},{"lead":"Excluded goods are not.","text":"The Excluded Goods Determination takes some products out of the medicines rules if they meet every condition it sets, such as an SPF moisturiser of SPF 4 to 15 that meets its conditions, or an acne product presented as controlling acne only by cleansing, moisturising, exfoliating or drying the skin, with no Schedule 2, 3, 4 or 8 poisons."},{"lead":"Otherwise, presentation decides.","text":"A product is a therapeutic good if it is presented as, or likely to be taken to be, for therapeutic use: preventing, curing or alleviating a disease, or \"influencing, inhibiting or modifying a physiological process\". The TGA weighs the name, the claims, the form, dosage instructions, warnings, the advertising and even where it is sold."},{"lead":"Foods have two ways out.","text":"A swallowed product is a food if a food standard covers it, such as Standard 2.9.4 for formulated supplementary sports foods, or if it has a tradition of use as a food in Australia or New Zealand in the form presented. A disease claim, or a health claim the Code doesn't permit, doesn't turn such a product into a medicine; it makes it a food breaking Standard 1.2.7. More on the food pathway."},{"lead":"Form can move a product across.","text":"A herb eaten as fresh leaves is a food; extracted, concentrated and sold in a capsule, it may be a medicine."},{"lead":"On the skin, the claim decides.","text":"A cream, serum or lotion is a cosmetic while it only changes appearance, cleanses, perfumes, protects or keeps the skin in good condition. A claim to treat a condition, an ingredient from Schedule 2, 3, 4 or 8 of the Poisons Standard, or the way it is used can make it a therapeutic good. The skincare page has the claim examples and the sunscreen rules."}],"tables":[]},{"heading":"What people often get wrong","anchor":"what-people-often-get-wrong","markdown":"- **\"A health claim makes it a medicine.\"** Not on its own. A food that a food standard covers stays a food. It can carry a health claim that meets Standard 1.2.7, but a claim to prevent, cure or alleviate a disease is not allowed on any food.\n- **\"Capsules and powders are medicines.\"** The TGA says the fact that a product \"comes in capsules or powders, or is labelled as a 'dietary supplement'\" doesn't decide it, though form is one of the factors it weighs.\n- **\"Listed medicines have been evaluated by the TGA.\"** They are not individually evaluated. The sponsor certifies that the product meets the rules, and the TGA can review any listing afterwards. Our [TGA listing guide](/guides/tga-approval) explains what that means.\n- **\"FSANZ approves self-substantiated claims.\"** It doesn't assess them, and publishing a notification is not approval. Nor can one business rely on another's notification.\n- **\"AICIS registers products.\"** It registers businesses, not products or ingredients, and it doesn't set or enforce labelling rules.\n- **\"A pet supplement follows the same rules.\"** These rules are for products for people. A product for a dog, cat or horse is a different system, with the APVMA, not the TGA, registering what counts as a veterinary product: see our [pet supplements guide](/guides/pet-supplements).","text":"\"A health claim makes it a medicine.\" Not on its own. A food that a food standard covers stays a food. It can carry a health claim that meets Standard 1.2.7, but a claim to prevent, cure or alleviate a disease is not allowed on any food. \"Capsules and powders are medicines.\" The TGA says the fact that a product \"comes in capsules or powders, or is labelled as a 'dietary supplement'\" doesn't decide it, though form is one of the factors it weighs. \"Listed medicines have been evaluated by the TGA.\" They are not individually evaluated. The sponsor certifies that the product meets the rules, and the TGA can review any listing afterwards. Our TGA listing guide explains what that means. \"FSANZ approves self-substantiated claims.\" It doesn't assess them, and publishing a notification is not approval. Nor can one business rely on another's notification. \"AICIS registers products.\" It registers businesses, not products or ingredients, and it doesn't set or enforce labelling rules. \"A pet supplement follows the same rules.\" These rules are for products for people. A product for a dog, cat or horse is a different system, with the APVMA, not the TGA, registering what counts as a veterinary product: see our pet supplements guide.","items":[{"lead":"\"A health claim makes it a medicine.\"","text":"Not on its own. A food that a food standard covers stays a food. It can carry a health claim that meets Standard 1.2.7, but a claim to prevent, cure or alleviate a disease is not allowed on any food."},{"lead":"\"Capsules and powders are medicines.\"","text":"The TGA says the fact that a product \"comes in capsules or powders, or is labelled as a 'dietary supplement'\" doesn't decide it, though form is one of the factors it weighs."},{"lead":"\"Listed medicines have been evaluated by the TGA.\"","text":"They are not individually evaluated. The sponsor certifies that the product meets the rules, and the TGA can review any listing afterwards. Our TGA listing guide explains what that means."},{"lead":"\"FSANZ approves self-substantiated claims.\"","text":"It doesn't assess them, and publishing a notification is not approval. Nor can one business rely on another's notification."},{"lead":"\"AICIS registers products.\"","text":"It registers businesses, not products or ingredients, and it doesn't set or enforce labelling rules."},{"lead":"\"A pet supplement follows the same rules.\"","text":"These rules are for products for people. A product for a dog, cat or horse is a different system, with the APVMA, not the TGA, registering what counts as a veterinary product: see our pet supplements guide."}],"tables":[]},{"heading":"What happens on the wrong side","anchor":"what-happens-on-the-wrong-side","markdown":"A product that is really a medicine must, unless it is exempt or otherwise authorised, be on the ARTG before it is imported, supplied or advertised. The TGA's own guidance lists civil and criminal penalties, with civil penalties for a company of up to 50,000 penalty units for a single contravention: $18.2 million at the $364 penalty unit that applies from 1 July 2026. A food making disease claims, or health claims the Code doesn't permit, breaks the Food Standards Code, which the states and territories enforce. Either way, finding out after launch means relabelling, reformulating or withdrawing stock.","text":"A product that is really a medicine must, unless it is exempt or otherwise authorised, be on the ARTG before it is imported, supplied or advertised. The TGA's own guidance lists civil and criminal penalties, with civil penalties for a company of up to 50,000 penalty units for a single contravention: $18.2 million at the $364 penalty unit that applies from 1 July 2026. A food making disease claims, or health claims the Code doesn't permit, breaks the Food Standards Code, which the states and territories enforce. Either way, finding out after launch means relabelling, reformulating or withdrawing stock.","items":[],"tables":[]},{"heading":"How we settle it","anchor":"how-we-settle-it","markdown":"At the brief, before anyone designs a formula, we test the product against these rules: its ingredients and doses, the claims the brand needs to make, the format and where it will be sold. Then we build for that pathway. A sports brand's four capsules went through as [TGA-listed medicines and its performance powder as a food](/work/sports-brand-core-range). Vitable's capsule is a listed medicine and its matching serum a cosmetic. A pain relief cream we developed is a [listed medicine](/pathways/listed-medicines), not a cosmetic, because of what it is for.\n\nTo test a product of your own against these rules, ask your AI assistant: [the same check runs in Claude, ChatGPT and other assistants](/ai), with each rule quoted from this page.","text":"At the brief, before anyone designs a formula, we test the product against these rules: its ingredients and doses, the claims the brand needs to make, the format and where it will be sold. Then we build for that pathway. A sports brand's four capsules went through as TGA-listed medicines and its performance powder as a food. Vitable's capsule is a listed medicine and its matching serum a cosmetic. A pain relief cream we developed is a listed medicine, not a cosmetic, because of what it is for. To test a product of your own against these rules, ask your AI assistant: the same check runs in Claude, ChatGPT and other assistants, with each rule quoted from this page.","items":[],"tables":[]}],"faqs":[{"q":"Is a supplement in a capsule always a medicine?","a":"No. Form alone doesn't decide it. But capsules and tablets weigh towards a medicine, and some are declared medicines by form alone: fibre, isolated HMB or shark cartilage in a tablet, capsule or pill. Since 30 November 2023, a sports supplement in tablet, capsule or pill form is declared too when it is presented for a therapeutic use, or in a way likely to be taken as one.","md":"No. Form alone doesn't decide it. But capsules and tablets weigh towards a medicine, and some are declared medicines by form alone: fibre, isolated HMB or shark cartilage in a tablet, capsule or pill. Since 30 November 2023, a sports supplement in tablet, capsule or pill form is declared too when it is presented for a therapeutic use, or in a way likely to be taken as one."},{"q":"Can a powder supplement be a food?","a":"Yes. A sports powder covered by Standard 2.9.4, the formulated supplementary sports foods standard, is a food, unless it is declared a medicine, as a powder with isolated HMB is. The standard sets its own label statements and, since 9 June 2026, limits caffeine to 200 mg in the amount for one day, as directed on the label, with a transition period to 9 June 2028. More on the food pathway.","md":"Yes. A sports powder covered by Standard 2.9.4, the formulated supplementary sports foods standard, is a food, unless it is declared a medicine, as a powder with isolated HMB is. The standard sets its own label statements and, since 9 June 2026, limits caffeine to 200 mg in the amount for one day, as directed on the label, with a transition period to 9 June 2028. More on [the food pathway](/pathways/foods)."},{"q":"Is a beauty supplement a food or a cosmetic?","a":"Neither. Anything swallowed that is labelled or promoted for cosmetic purposes is declared a therapeutic good, so it goes through the medicines rules.","md":"Neither. Anything swallowed that is labelled or promoted for cosmetic purposes is declared a therapeutic good, so it goes through the medicines rules."},{"q":"Who enforces the food rules?","a":"The states and territories, and local councils. FSANZ writes the Food Standards Code but has no enforcement powers, and the Department of Agriculture, Fisheries and Forestry enforces it at the border.","md":"The states and territories, and local councils. FSANZ writes the Food Standards Code but has no enforcement powers, and the Department of Agriculture, Fisheries and Forestry enforces it at the border."},{"q":"Can one range include medicines, foods and cosmetics?","a":"Yes. Ora's range spans TGA-listed medicines and functional foods, and Vitable's hair range pairs a listed capsule with a cosmetic serum. Each product follows its own pathway's rules.","md":"Yes. Ora's range spans TGA-listed medicines and functional foods, and Vitable's hair range pairs a listed capsule with a cosmetic serum. Each product follows its own pathway's rules."},{"q":"Who decides whether my product is a medicine or a food?","a":"The business that supplies it. Neither the TGA nor FSANZ gives a ruling on a product before it is sold, so the sponsor or supplier has to get the pathway right and be able to show why. The TGA's Food-Medicine Interface Guidance Tool sets out the questions it asks, and the regulators apply them when they review a product or act on a complaint. We work the pathway through at the brief, against the same questions.","md":"The business that supplies it. Neither the TGA nor FSANZ gives a ruling on a product before it is sold, so the sponsor or supplier has to get the pathway right and be able to show why. The TGA's Food-Medicine Interface Guidance Tool sets out the questions it asks, and the regulators apply them when they review a product or act on a complaint. We work the pathway through at the brief, against the same questions."},{"q":"Is an energy or focus powder a medicine or a food?","a":"It depends on what is in it and how it is presented. A powder made only of food ingredients and sold in a traditional food form can be a food, and since 9 June 2026 a sports food may contain up to 200 mg of caffeine a day. A powder presented for a therapeutic use, or built on herbal extracts that are only permitted in medicines, is likely to be a listed medicine. The ingredient list and the claims the brand needs decide it, so we settle both at the brief.","md":"It depends on what is in it and how it is presented. A powder made only of food ingredients and sold in a traditional food form can be a food, and since 9 June 2026 a sports food may contain up to 200 mg of caffeine a day. A powder presented for a therapeutic use, or built on herbal extracts that are only permitted in medicines, is likely to be a listed medicine. The ingredient list and the claims the brand needs decide it, so we settle both at the brief."}],"sources":{"note":"General information, checked against these sources on 19 October 2026. It isn't advice on a particular product.","markdown":"General information, checked against these sources on 19 October 2026. It isn't advice on a particular product.\n\n- [Therapeutic Goods Act 1989](https://www.legislation.gov.au/C2004A03952/latest/text), section 3 (definitions) and section 7, Federal Register of Legislation\n- [Food-Medicine Interface Guidance Tool](https://www.tga.gov.au/node/287500), Therapeutic Goods Administration\n- [Food and medicine regulation](https://www.tga.gov.au/community-qa/food-and-medicine-regulation), Therapeutic Goods Administration\n- [Therapeutic Goods (Declared Goods) Order 2019](https://www.legislation.gov.au/F2019L01352/latest/text), Federal Register of Legislation\n- [Therapeutic Goods (Excluded Goods) Determination 2018](https://www.legislation.gov.au/F2018L01350/latest/text), Federal Register of Legislation\n- [Permissible Indications Determination consultation](https://www.tga.gov.au/node/565426), Therapeutic Goods Administration\n- [Cosmetics or therapeutic goods: guidance for advertisers and suppliers](https://www.tga.gov.au/sites/default/files/2024-06/cosmetics-therapeutic-goods-guidance-for-advertisers-suppliers.pdf), Therapeutic Goods Administration, June 2024\n- [Standard 1.2.7: Nutrition, health and related claims](https://www.legislation.gov.au/F2015L00394/latest/text), [Standard 2.9.4: Formulated supplementary sports foods](https://www.legislation.gov.au/F2015L00421/latest/text), [Standard 1.5.1: Novel foods](https://www.legislation.gov.au/F2015L00403/latest/text) and [Standard 1.3.2: Vitamins and minerals](https://www.legislation.gov.au/F2015L00400/latest/text), Federal Register of Legislation\n- [Crimes (Amount of a Penalty Unit) Instrument 2026](https://www.legislation.gov.au/F2026N00424/asmade/2026-06-16/text/original/pdf), Federal Register of Legislation\n- [What we do](https://www.foodstandards.gov.au/about-us/whatwedo) and [Nutrition content claims and health claims](https://www.foodstandards.gov.au/consumer/labelling/nutrition), Food Standards Australia New Zealand\n- [Notifying a self-substantiated food-health relationship](https://www.foodstandards.gov.au/business/labelling/nutrition-health-and-related-claims/notifying-fhr), Food Standards Australia New Zealand\n- [Industrial Chemicals Act 2019](https://www.legislation.gov.au/C2019A00012/latest/text), section 9 (cosmetic), Federal Register of Legislation\n- [Is my product a cosmetic?](https://www.industrialchemicals.gov.au/cosmetics-and-soap/my-product-cosmetic), Australian Industrial Chemicals Introduction Scheme","items":[{"text":"Therapeutic Goods Act 1989, section 3 (definitions) and section 7, Federal Register of Legislation","links":[{"title":"Therapeutic Goods Act 1989","url":"https://www.legislation.gov.au/C2004A03952/latest/text"}]},{"text":"Food-Medicine Interface Guidance Tool, Therapeutic Goods Administration","links":[{"title":"Food-Medicine Interface Guidance Tool","url":"https://www.tga.gov.au/node/287500"}]},{"text":"Food and medicine regulation, Therapeutic Goods Administration","links":[{"title":"Food and medicine regulation","url":"https://www.tga.gov.au/community-qa/food-and-medicine-regulation"}]},{"text":"Therapeutic Goods (Declared Goods) Order 2019, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Declared Goods) Order 2019","url":"https://www.legislation.gov.au/F2019L01352/latest/text"}]},{"text":"Therapeutic Goods (Excluded Goods) Determination 2018, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Excluded Goods) Determination 2018","url":"https://www.legislation.gov.au/F2018L01350/latest/text"}]},{"text":"Permissible Indications Determination consultation, Therapeutic Goods Administration","links":[{"title":"Permissible Indications Determination consultation","url":"https://www.tga.gov.au/node/565426"}]},{"text":"Cosmetics or therapeutic goods: guidance for advertisers and suppliers, Therapeutic Goods Administration, June 2024","links":[{"title":"Cosmetics or therapeutic goods: guidance for advertisers and suppliers","url":"https://www.tga.gov.au/sites/default/files/2024-06/cosmetics-therapeutic-goods-guidance-for-advertisers-suppliers.pdf"}]},{"text":"Standard 1.2.7: Nutrition, health and related claims, Standard 2.9.4: Formulated supplementary sports foods, Standard 1.5.1: Novel foods and Standard 1.3.2: Vitamins and minerals, Federal Register of Legislation","links":[{"title":"Standard 1.2.7: Nutrition, health and related claims","url":"https://www.legislation.gov.au/F2015L00394/latest/text"},{"title":"Standard 2.9.4: Formulated supplementary sports foods","url":"https://www.legislation.gov.au/F2015L00421/latest/text"},{"title":"Standard 1.5.1: Novel foods","url":"https://www.legislation.gov.au/F2015L00403/latest/text"},{"title":"Standard 1.3.2: Vitamins and minerals","url":"https://www.legislation.gov.au/F2015L00400/latest/text"}]},{"text":"Crimes (Amount of a Penalty Unit) Instrument 2026, Federal Register of Legislation","links":[{"title":"Crimes (Amount of a Penalty Unit) Instrument 2026","url":"https://www.legislation.gov.au/F2026N00424/asmade/2026-06-16/text/original/pdf"}]},{"text":"What we do and Nutrition content claims and health claims, Food Standards Australia New Zealand","links":[{"title":"What we do","url":"https://www.foodstandards.gov.au/about-us/whatwedo"},{"title":"Nutrition content claims and health claims","url":"https://www.foodstandards.gov.au/consumer/labelling/nutrition"}]},{"text":"Notifying a self-substantiated food-health relationship, Food Standards Australia New Zealand","links":[{"title":"Notifying a self-substantiated food-health relationship","url":"https://www.foodstandards.gov.au/business/labelling/nutrition-health-and-related-claims/notifying-fhr"}]},{"text":"Industrial Chemicals Act 2019, section 9 (cosmetic), Federal Register of Legislation","links":[{"title":"Industrial Chemicals Act 2019","url":"https://www.legislation.gov.au/C2019A00012/latest/text"}]},{"text":"Is my product a cosmetic?, Australian Industrial Chemicals Introduction Scheme","links":[{"title":"Is my product a cosmetic?","url":"https://www.industrialchemicals.gov.au/cosmetics-and-soap/my-product-cosmetic"}]}]}},{"slug":"manufacturing","kind":"service","url":"/manufacturing","title":"Supplement manufacturing, managed from formula to your warehouse","name":"Manufacturing","description":"Supplement contract manufacturers matched to your product and managed end to end: specification, release testing, imports and freight to your warehouse.","eyebrow":"Manufacturing","lead":"We manage the factory, so you don't have to. We match your product to cGMP contract manufacturers by format, volume and margin, then run the specification, packaging, labelling, release testing, imports and freight through to your warehouse or 3PL.","studies":["bwellness-practitioner-range","the-belly-solution-travel-gut-health-powder","pump-haircare-hair-supplement","sports-brand-core-range","arxi-preconception-supplement","eye-health-tablet-format-rescue"],"formats":[],"order":10,"updated":"2026-10-19","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- We develop the product, then manage its manufacture through cGMP partners matched to its format, volume and margin.\n- For a TGA-listed medicine, every step is made under the TGA manufacturing licence or GMP clearance it needs, and every batch is third-party tested before release.\n- The minimum run is 3,000 finished retail packs per batch, for listed medicines and foods alike.\n- A production run takes 12 to 14 weeks once the specification is signed. Payment is 50% with the purchase order and 50% before dispatch.","text":"We develop the product, then manage its manufacture through cGMP partners matched to its format, volume and margin. For a TGA-listed medicine, every step is made under the TGA manufacturing licence or GMP clearance it needs, and every batch is third-party tested before release. The minimum run is 3,000 finished retail packs per batch, for listed medicines and foods alike. A production run takes 12 to 14 weeks once the specification is signed. Payment is 50% with the purchase order and 50% before dispatch.","items":[],"tables":[]},{"heading":"Managed manufacturing, not a single factory","anchor":"managed-manufacturing-not-a-single-factory","markdown":"Take Friday Off is not a contract manufacturer. We develop the product, then manage its manufacture through cGMP manufacturing partners chosen for that product: its format, its volume and the margin it has to make. One team carries the specification, the packaging and the labelling, so nothing is lost between the formula and the production line. How a manufacturer, a consultant and a development partner differ is in our guide to [choosing a development partner](/guides/choosing-a-product-development-partner); we work from [Brookvale, Sydney](/supplement-development-sydney).\n\n| | A contract manufacturer | Take Friday Off |\n| --- | --- | --- |\n| Where it is made | In the manufacturer's own facility | With cGMP partners matched to your format, volume and margin |\n| Formula and claims evidence | Varies by manufacturer | Designed by us, with the evidence behind every claim |\n| TGA listing, label and stability | Varies by manufacturer | Part of the work: listing, label review and a stability program |\n| After the production run | Varies by manufacturer | Release testing, imports, customs and freight to your warehouse or 3PL |","text":"Take Friday Off is not a contract manufacturer. We develop the product, then manage its manufacture through cGMP manufacturing partners chosen for that product: its format, its volume and the margin it has to make. One team carries the specification, the packaging and the labelling, so nothing is lost between the formula and the production line. How a manufacturer, a consultant and a development partner differ is in our guide to choosing a development partner; we work from Brookvale, Sydney. Where it is made — A contract manufacturer: In the manufacturer's own facility; Take Friday Off: With cGMP partners matched to your format, volume and margin. Formula and claims evidence — A contract manufacturer: Varies by manufacturer; Take Friday Off: Designed by us, with the evidence behind every claim. TGA listing, label and stability — A contract manufacturer: Varies by manufacturer; Take Friday Off: Part of the work: listing, label review and a stability program. After the production run — A contract manufacturer: Varies by manufacturer; Take Friday Off: Release testing, imports, customs and freight to your warehouse or 3PL.","items":[],"tables":[{"header":["","A contract manufacturer","Take Friday Off"],"rows":[["Where it is made","In the manufacturer's own facility","With cGMP partners matched to your format, volume and margin"],["Formula and claims evidence","Varies by manufacturer","Designed by us, with the evidence behind every claim"],["TGA listing, label and stability","Varies by manufacturer","Part of the work: listing, label review and a stability program"],["After the production run","Varies by manufacturer","Release testing, imports, customs and freight to your warehouse or 3PL"]]}]},{"heading":"What we manage","anchor":"what-we-manage","markdown":"- **The specification**: what every batch must meet, written before the first order.\n- **Packaging and labelling**: from 60-count bottles and 100% recycled PET to 14-day pouches, 7-day trial packs and a brand's own pouch, with the label reviewed before print. More on [packaging and labelling](/packaging). On one project our label review caught two errors before print.\n- **Release testing**: every TGA-listed batch is third-party tested.\n- **Imports, customs and freight**: imported ingredients, air freight and interstate freight, through to your warehouse or 3PL, including a supply chain from a New Zealand maker to delivery in Australia.\n- **Reorders**: BWellness has had five production batches since 2021; Arxi's preconception capsule has had three production orders since 2024.\n- **Problems on the line**: a first run troubleshot with the maker, a co-packer delay worked through, and a capsule moved to a tablet mid-project when the blend wouldn't encapsulate.","text":"The specification: what every batch must meet, written before the first order. Packaging and labelling: from 60-count bottles and 100% recycled PET to 14-day pouches, 7-day trial packs and a brand's own pouch, with the label reviewed before print. More on packaging and labelling. On one project our label review caught two errors before print. Release testing: every TGA-listed batch is third-party tested. Imports, customs and freight: imported ingredients, air freight and interstate freight, through to your warehouse or 3PL, including a supply chain from a New Zealand maker to delivery in Australia. Reorders: BWellness has had five production batches since 2021; Arxi's preconception capsule has had three production orders since 2024. Problems on the line: a first run troubleshot with the maker, a co-packer delay worked through, and a capsule moved to a tablet mid-project when the blend wouldn't encapsulate.","items":[{"lead":"The specification","text":": what every batch must meet, written before the first order."},{"lead":"Packaging and labelling","text":": from 60-count bottles and 100% recycled PET to 14-day pouches, 7-day trial packs and a brand's own pouch, with the label reviewed before print. More on packaging and labelling. On one project our label review caught two errors before print."},{"lead":"Release testing","text":": every TGA-listed batch is third-party tested."},{"lead":"Imports, customs and freight","text":": imported ingredients, air freight and interstate freight, through to your warehouse or 3PL, including a supply chain from a New Zealand maker to delivery in Australia."},{"lead":"Reorders","text":": BWellness has had five production batches since 2021; Arxi's preconception capsule has had three production orders since 2024."},{"lead":"Problems on the line","text":": a first run troubleshot with the maker, a co-packer delay worked through, and a capsule moved to a tablet mid-project when the blend wouldn't encapsulate."}],"tables":[]},{"heading":"TGA licences and GMP","anchor":"tga-licences-and-gmp","markdown":"A listed medicine must be made under good manufacturing practice (GMP), and the law says who can make it:\n\n- **In Australia**, every step, from making the active ingredients to testing, packaging, labelling and release for supply, needs a TGA manufacturing licence unless it is exempt.\n- **Overseas**, a site needs a TGA GMP clearance or certification; only Australian sites can hold a TGA licence. The Australian sponsor (or an agent for it) applies, should hold evidence of GMP compliance for every overseas site, and applies to renew a clearance at least six months before it expires.\n- **The standard** the TGA holds manufacturers to is the PIC/S Guide to GMP, version PE 009-17, which has applied since 1 September 2025.\n\nSo for a listed medicine, every step is made under the licence or clearance it needs; within that, we match on format, volume and margin. The routes to a clearance, the fees and why supplement factories overseas often need a TGA inspection are in our [GMP clearance guide](/guides/gmp-clearance). How to check a manufacturer's licence, what a GMP agreement covers and the standards each batch is tested to are in our [guide to choosing a supplement manufacturer](/guides/choosing-a-supplement-manufacturer).","text":"A listed medicine must be made under good manufacturing practice (GMP), and the law says who can make it: In Australia, every step, from making the active ingredients to testing, packaging, labelling and release for supply, needs a TGA manufacturing licence unless it is exempt. Overseas, a site needs a TGA GMP clearance or certification; only Australian sites can hold a TGA licence. The Australian sponsor (or an agent for it) applies, should hold evidence of GMP compliance for every overseas site, and applies to renew a clearance at least six months before it expires. The standard the TGA holds manufacturers to is the PIC/S Guide to GMP, version PE 009-17, which has applied since 1 September 2025. So for a listed medicine, every step is made under the licence or clearance it needs; within that, we match on format, volume and margin. The routes to a clearance, the fees and why supplement factories overseas often need a TGA inspection are in our GMP clearance guide. How to check a manufacturer's licence, what a GMP agreement covers and the standards each batch is tested to are in our guide to choosing a supplement manufacturer.","items":[{"lead":"In Australia","text":", every step, from making the active ingredients to testing, packaging, labelling and release for supply, needs a TGA manufacturing licence unless it is exempt."},{"lead":"Overseas","text":", a site needs a TGA GMP clearance or certification; only Australian sites can hold a TGA licence. The Australian sponsor (or an agent for it) applies, should hold evidence of GMP compliance for every overseas site, and applies to renew a clearance at least six months before it expires."},{"lead":"The standard","text":"the TGA holds manufacturers to is the PIC/S Guide to GMP, version PE 009-17, which has applied since 1 September 2025."}],"tables":[]},{"heading":"Formats we manage","anchor":"formats-we-manage","markdown":"[Capsules, tablets and softgels](/formats/capsules-tablets-softgels), [gummies](/formats/gummies), [powders and sachets](/formats/powders-sachets), [liquids](/formats/liquids), and [creams, serums and sunscreens](/skincare), as [TGA-listed medicines, foods or cosmetics](/pathways).","text":"Capsules, tablets and softgels, gummies, powders and sachets, liquids, and creams, serums and sunscreens, as TGA-listed medicines, foods or cosmetics.","items":[],"tables":[]},{"heading":"How long it takes","anchor":"how-long-it-takes","markdown":"From our records: design to production order in 32 days for a complex herbal capsule, under seven weeks for an eye-health formula, and 12 weeks for a two-a-day skin supplement. EverLeanBody's first capsule took 5.8 months from signed brief to dispatch to its 3PL. The stages, and what holds a launch up, are in [how long it takes to develop a supplement](/guides/supplement-development-timeline).","text":"From our records: design to production order in 32 days for a complex herbal capsule, under seven weeks for an eye-health formula, and 12 weeks for a two-a-day skin supplement. EverLeanBody's first capsule took 5.8 months from signed brief to dispatch to its 3PL. The stages, and what holds a launch up, are in how long it takes to develop a supplement.","items":[],"tables":[]},{"heading":"How manufacturing is priced","anchor":"how-manufacturing-is-priced","markdown":"Manufacturing is priced per unit, and the development stages before it are fixed fees for a defined outcome. You know the investment before each stage begins.","text":"Manufacturing is priced per unit, and the development stages before it are fixed fees for a defined outcome. You know the investment before each stage begins.","items":[],"tables":[]}],"faqs":[{"q":"Are you a supplement manufacturer?","a":"No. We develop the product and manage its manufacture through cGMP manufacturing partners matched to your format, volume and margin. You deal with one team from the brief to delivery; we deal with the factory.","md":"No. We develop the product and manage its manufacture through cGMP manufacturing partners matched to your format, volume and margin. You deal with one team from the brief to delivery; we deal with the factory."},{"q":"Do you manage reorders and ongoing supply?","a":"Yes. BWellness has had five production batches of its tablet since 2021, with a sixth in the pipeline. Pump Haircare has worked with us since 2021, through reorders and an upgraded formula, and Arxi's preconception capsule has had three production orders since 2024.","md":"Yes. BWellness has had five production batches of its tablet since 2021, with a sixth in the pipeline. Pump Haircare has worked with us since 2021, through reorders and an upgraded formula, and Arxi's preconception capsule has had three production orders since 2024."},{"q":"Is every batch tested?","a":"Every TGA-listed batch is third-party tested. For The Belly Solution we managed manufacturing, release testing and delivery, and we are managing its second batch now.","md":"Every TGA-listed batch is third-party tested. For The Belly Solution we managed manufacturing, release testing and delivery, and we are managing its second batch now."},{"q":"Can you take on a product we already sell?","a":"Yes, existing products are often where we start. A sports brand's best-known formulas were reformulated from scratch, and we managed manufacturing for all five products. A hair care brand's formula was upgraded with a full new listing package and stability testing. More in reformulating a supplement.","md":"Yes, existing products are often where we start. A sports brand's best-known formulas were reformulated from scratch, and we managed manufacturing for all five products. A hair care brand's formula was upgraded with a full new listing package and stability testing. More in [reformulating a supplement](/guides/reformulating-a-supplement)."},{"q":"Are your manufacturers TGA licensed?","a":"For listed medicines, unless a step is exempt: Australian sites need a TGA manufacturing licence for each step they carry out, and overseas sites, which can't hold a TGA licence, need TGA GMP clearance or certification.","md":"For listed medicines, unless a step is exempt: Australian sites need a TGA manufacturing licence for each step they carry out, and overseas sites, which can't hold a TGA licence, need TGA GMP clearance or certification."},{"q":"What happens if something goes wrong in production?","a":"We fix it with the maker. We troubleshot a first production run with the maker for Arxi, worked through a co-packer delay for a sports brand, and moved an eye-health formula from capsule to tablet mid-project when the blend was too wet to encapsulate.","md":"We fix it with the maker. We troubleshot a first production run with the maker for Arxi, worked through a co-packer delay for a sports brand, and moved an eye-health formula from capsule to tablet mid-project when the blend was too wet to encapsulate."},{"q":"What is the minimum order quantity for supplement manufacturing?","a":"Our minimum is 3,000 finished retail packs per batch, for TGA-listed medicines and foods alike. The batch is made in one run, so the whole quantity is ordered and paid for together. Some pack formats also have their own minimum from the packaging supplier, such as around 150,000 for single-serve sachets.","md":"Our minimum is 3,000 finished retail packs per batch, for TGA-listed medicines and foods alike. The batch is made in one run, so the whole quantity is ordered and paid for together. Some pack formats also have their own minimum from the packaging supplier, such as around 150,000 for single-serve sachets."},{"q":"How long does a production run take?","a":"Once the specification is signed, plan for 12 to 14 weeks in manufacture, then about a week to ship and deliver. Most Australian manufacturers close over the Christmas and January period, so a launch early in the year needs its production order placed the spring before.","md":"Once the specification is signed, plan for 12 to 14 weeks in manufacture, then about a week to ship and deliver. Most Australian manufacturers close over the Christmas and January period, so a launch early in the year needs its production order placed the spring before."},{"q":"How is manufacturing paid for?","a":"Per unit, on the accepted quote: 50% with your purchase order, before the build starts, and the 50% balance before the product is dispatched.","md":"Per unit, on the accepted quote: 50% with your purchase order, before the build starts, and the 50% balance before the product is dispatched."},{"q":"Who is the sponsor of the product, you or us?","a":"For a listed medicine, normally the brand. The sponsor is the business that holds the ARTG entry and is legally responsible for the product, so most brands sponsor their own. We prepare the listing, the evidence and the label for the sponsor to certify.","md":"For a listed medicine, normally the brand. The sponsor is the business that holds the ARTG entry and is legally responsible for the product, so most brands sponsor their own. We prepare the listing, the evidence and the label for the sponsor to certify."}],"sources":{"note":"General information, checked against these sources on 19 October 2026. It isn't advice on a particular product.","markdown":"General information, checked against these sources on 19 October 2026. It isn't advice on a particular product.\n\n- [Manufacturing therapeutic goods](https://www.tga.gov.au/products/regulations-all-products/manufacturing), Therapeutic Goods Administration\n- [General guidance for listed medicines](https://www.tga.gov.au/node/289506), Therapeutic Goods Administration\n- [Sponsor responsibilities related to GMP clearance and certification](https://www.tga.gov.au/sponsor-responsibilities-related-gmp-clearance-and-certification), Therapeutic Goods Administration\n- [Therapeutic Goods (Manufacturing Principles) Amendment (PIC/S Guide) Determination 2025](https://www.legislation.gov.au/F2025L00990/asmade), Federal Register of Legislation","items":[{"text":"Manufacturing therapeutic goods, Therapeutic Goods Administration","links":[{"title":"Manufacturing therapeutic goods","url":"https://www.tga.gov.au/products/regulations-all-products/manufacturing"}]},{"text":"General guidance for listed medicines, Therapeutic Goods Administration","links":[{"title":"General guidance for listed medicines","url":"https://www.tga.gov.au/node/289506"}]},{"text":"Sponsor responsibilities related to GMP clearance and certification, Therapeutic Goods Administration","links":[{"title":"Sponsor responsibilities related to GMP clearance and certification","url":"https://www.tga.gov.au/sponsor-responsibilities-related-gmp-clearance-and-certification"}]},{"text":"Therapeutic Goods (Manufacturing Principles) Amendment (PIC/S Guide) Determination 2025, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Manufacturing Principles) Amendment (PIC/S Guide) Determination 2025","url":"https://www.legislation.gov.au/F2025L00990/asmade"}]}]}},{"slug":"packaging","kind":"service","url":"/packaging","title":"Product packaging and labelling, from format to print-ready artwork","name":"Packaging","description":"Product packaging and labelling for supplements, foods and skincare, managed with the product: pack format, compliant label, barcodes and artwork, by one team.","eyebrow":"Packaging","lead":"We carry the packaging and the label with the product. The pack format, its components, the label written to the rules of its pathway, the barcode and the print-ready artwork are managed by the team that wrote the specification and built the claims evidence, through cGMP manufacturing partners to your warehouse or 3PL.","studies":["vitable-hair-growth-range","the-belly-solution-travel-gut-health-powder","nivari-powder-supplement","areds2-eye-health-formula","arxi-prenatal-chewable","pain-relief-cream"],"formats":[],"order":15,"updated":"2026-10-20","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- We choose the pack with the formula and the target cost of goods, source it through our supplier network and manage it with the production run.\n- We draft and review the label against the rules of the product's pathway: TGO 116 for listed medicines, the Food Standards Code for foods, and the cosmetics information standard for cosmetics.\n- Some medicines need child-resistant packaging under TGO 95, and a change of pack can mean a new stability study.\n- Bottles, blisters, sachets, pouches, tubs and tubes, plus trial packs and a brand's own pack.","text":"We choose the pack with the formula and the target cost of goods, source it through our supplier network and manage it with the production run. We draft and review the label against the rules of the product's pathway: TGO 116 for listed medicines, the Food Standards Code for foods, and the cosmetics information standard for cosmetics. Some medicines need child-resistant packaging under TGO 95, and a change of pack can mean a new stability study. Bottles, blisters, sachets, pouches, tubs and tubes, plus trial packs and a brand's own pack.","items":[],"tables":[]},{"heading":"Packaging, carried with the product","anchor":"packaging-carried-with-the-product","markdown":"The pack has to work as hard as the product inside it. From choosing the format to checking the label, we manage the detail, so the pack sells on the shelf, holds up in transit and meets every requirement that applies to it. Where a brand has a pack in mind that goes beyond the standard formats, we can help make it.\n\nAs with manufacturing, we don't make the packaging: we source it through our supplier network and manage it, with the same team that wrote the specification and built the claims evidence. So nothing is lost between the formula, the label and the production line. See [managed manufacturing](/manufacturing).","text":"The pack has to work as hard as the product inside it. From choosing the format to checking the label, we manage the detail, so the pack sells on the shelf, holds up in transit and meets every requirement that applies to it. Where a brand has a pack in mind that goes beyond the standard formats, we can help make it. As with manufacturing, we don't make the packaging: we source it through our supplier network and manage it, with the same team that wrote the specification and built the claims evidence. So nothing is lost between the formula, the label and the production line. See managed manufacturing.","items":[],"tables":[]},{"heading":"Where packaging sits in Friday Launch Engine™","anchor":"where-packaging-sits-in-friday-launch-engine","markdown":"- **Design, step 02.** The format is chosen with the formula and the target cost of goods, in the formats your customers are already looking for: bottles and 7-day packs for capsules, tubs, pouches and sachets for powders, tubes for creams. See [formulation](/formulation).\n- **De-risk, step 03.** The claims, the evidence and the label are settled to TGA, FSANZ and AICIS standards. The step ends with substantiated claims, compliant artwork and the listing. See [medicine, food or cosmetic?](/pathways)\n- **Deliver, step 04.** The specification, the packaging and the labelling are carried by one team through cGMP manufacturing partners matched to your format, volume and margin, then release testing, imports and freight through to your warehouse or 3PL.","text":"Design, step 02. The format is chosen with the formula and the target cost of goods, in the formats your customers are already looking for: bottles and 7-day packs for capsules, tubs, pouches and sachets for powders, tubes for creams. See formulation. De-risk, step 03. The claims, the evidence and the label are settled to TGA, FSANZ and AICIS standards. The step ends with substantiated claims, compliant artwork and the listing. See medicine, food or cosmetic? Deliver, step 04. The specification, the packaging and the labelling are carried by one team through cGMP manufacturing partners matched to your format, volume and margin, then release testing, imports and freight through to your warehouse or 3PL.","items":[{"lead":"Design, step 02.","text":"The format is chosen with the formula and the target cost of goods, in the formats your customers are already looking for: bottles and 7-day packs for capsules, tubs, pouches and sachets for powders, tubes for creams. See formulation."},{"lead":"De-risk, step 03.","text":"The claims, the evidence and the label are settled to TGA, FSANZ and AICIS standards. The step ends with substantiated claims, compliant artwork and the listing. See medicine, food or cosmetic?"},{"lead":"Deliver, step 04.","text":"The specification, the packaging and the labelling are carried by one team through cGMP manufacturing partners matched to your format, volume and margin, then release testing, imports and freight through to your warehouse or 3PL."}],"tables":[]},{"heading":"What we manage","anchor":"what-we-manage","markdown":"- **The format.** Bottles in glass, HDPE and recycled PET ([sustainable packaging](/guides/sustainable-supplement-packaging)); blister packs, for products that need tamper evidence, dose convenience and shelf presence; sachets in stick, square or rectangular formats, for powders, single serves and subscription products; pouches in a range of sizes, materials and closures, printed in full colour; tubs; tubes for creams; and shrink wrapping, to your brand and retailer requirements.\n- **The components and their supply.** Sourced to your specification and managed with the production run: a 100% recycled PET bottle for [Vitable's](/work/vitable-hair-growth-range) hair capsule, the tubes for [a pain relief cream](/work/pain-relief-cream), and the brand's own pouch for [Nivari's](/work/nivari-powder-supplement) powder.\n- **The label.** Drafted and reviewed by us, from the design brief to print-ready artwork, with every claim, the ingredient list and every mandatory statement checked against the rules of the product's pathway. On [Arxi's prenatal](/work/arxi-prenatal-chewable), our label review caught two errors before print.\n- **Barcodes.** Barcodes for retail and direct-to-consumer channels, checked so every product scans and works in your systems before stock reaches the warehouse.\n- **Pack sizes and trial packs** ([sample and trial packs](/guides/supplement-sample-packs)). A 60-count pack and a trial pack for [an eye-health formula](/work/areds2-eye-health-formula), both made in both production runs; a 7-day sample pack added to [Arxi's preconception capsule](/work/arxi-preconception-supplement) for events and sampling; 60-count and 120-count bottles; a 14-day pouch.\n- **The pack in the stability program.** TGA guidance says ongoing stability testing is of the finished packed product, and a different pack, such as a glass bottle, a particular plastic bottle, a blister or a laminated tube, may need its own study. So the pack is part of the stability protocol we design for the shelf life the label will carry. See [the stability testing guide](/guides/stability-testing).","text":"The format. Bottles in glass, HDPE and recycled PET (sustainable packaging); blister packs, for products that need tamper evidence, dose convenience and shelf presence; sachets in stick, square or rectangular formats, for powders, single serves and subscription products; pouches in a range of sizes, materials and closures, printed in full colour; tubs; tubes for creams; and shrink wrapping, to your brand and retailer requirements. The components and their supply. Sourced to your specification and managed with the production run: a 100% recycled PET bottle for Vitable's hair capsule, the tubes for a pain relief cream, and the brand's own pouch for Nivari's powder. The label. Drafted and reviewed by us, from the design brief to print-ready artwork, with every claim, the ingredient list and every mandatory statement checked against the rules of the product's pathway. On Arxi's prenatal, our label review caught two errors before print. Barcodes. Barcodes for retail and direct-to-consumer channels, checked so every product scans and works in your systems before stock reaches the warehouse. Pack sizes and trial packs (sample and trial packs). A 60-count pack and a trial pack for an eye-health formula, both made in both production runs; a 7-day sample pack added to Arxi's preconception capsule for events and sampling; 60-count and 120-count bottles; a 14-day pouch. The pack in the stability program. TGA guidance says ongoing stability testing is of the finished packed product, and a different pack, such as a glass bottle, a particular plastic bottle, a blister or a laminated tube, may need its own study. So the pack is part of the stability protocol we design for the shelf life the label will carry. See the stability testing guide.","items":[{"lead":"The format.","text":"Bottles in glass, HDPE and recycled PET (sustainable packaging); blister packs, for products that need tamper evidence, dose convenience and shelf presence; sachets in stick, square or rectangular formats, for powders, single serves and subscription products; pouches in a range of sizes, materials and closures, printed in full colour; tubs; tubes for creams; and shrink wrapping, to your brand and retailer requirements."},{"lead":"The components and their supply.","text":"Sourced to your specification and managed with the production run: a 100% recycled PET bottle for Vitable's hair capsule, the tubes for a pain relief cream, and the brand's own pouch for Nivari's powder."},{"lead":"The label.","text":"Drafted and reviewed by us, from the design brief to print-ready artwork, with every claim, the ingredient list and every mandatory statement checked against the rules of the product's pathway. On Arxi's prenatal, our label review caught two errors before print."},{"lead":"Barcodes.","text":"Barcodes for retail and direct-to-consumer channels, checked so every product scans and works in your systems before stock reaches the warehouse."},{"lead":"Pack sizes and trial packs","text":"(sample and trial packs). A 60-count pack and a trial pack for an eye-health formula, both made in both production runs; a 7-day sample pack added to Arxi's preconception capsule for events and sampling; 60-count and 120-count bottles; a 14-day pouch."},{"lead":"The pack in the stability program.","text":"TGA guidance says ongoing stability testing is of the finished packed product, and a different pack, such as a glass bottle, a particular plastic bottle, a blister or a laminated tube, may need its own study. So the pack is part of the stability protocol we design for the shelf life the label will carry. See the stability testing guide."}],"tables":[]},{"heading":"The rules a pack must meet","anchor":"the-rules-a-pack-must-meet","markdown":"Which rules apply depends on the product's pathway, settled at the brief: a listed medicine, a food or a cosmetic. See [medicine, food or cosmetic?](/pathways) The guides cover each pathway in full; the essentials:\n\n### Listed medicines\n\n- **The label follows TGO 116.** Since 30 September 2026, labels of non-prescription medicines follow TGO 116; a medicine released for supply before 1 October 2031 can still follow TGO 92. The main label carries the medicine's name, each active ingredient and its quantity, the dosage form and the quantity in the pack. The label as a whole adds the batch number, the expiry date, storage conditions, the sponsor's name and contact details, declarations of any Schedule 1 substance, warning statements, directions for use and the indications. The Therapeutic Goods Regulations add the medicine's [AUST L number](/guides/artg) on the main label. A QR code can't stand in for what the label must say, except where the Order allows it. Blister and strip packs and small containers have their own rules. More in [the TGA listing guide](/guides/tga-approval#tgo-92-is-now-tgo-116).\n- **Some medicines need child-resistant packaging.** Under TGO 95, a listed medicine needs it if it contains one of the substances the Order lists, in the strength or pack size it sets, or if its pack says or implies it is child-resistant. Among the substances a supplement might contain: iron compounds, in a pack with more than 250 mg of elemental iron, unless it is a divided preparation (one made in separate doses, such as tablets, capsules or sachets) in which the iron is combined with other actives and each dose has 5 mg or less of elemental iron; and potassium salts, in a pack with more than 4,000 mg of elemental potassium, unless it is a divided preparation with 40 mg or less in each dose, or the potassium is there as glucosamine sulfate potassium chloride complex. Individually wrapped powders are exempt. A blister pack generally counts when it seals each tablet or capsule on its own and isn't made of cellulose film or unlaminated paper.\n- **A pack presented as tamper-evident should say so.** The TGA's code of practice for tamper-evident packaging isn't mandatory, but it applies to a pack presented as tamper-evident: at least one tamper-evident feature, two for two-piece capsules, and a statement on the pack describing it.\n- **Packaging and labelling are manufacturing steps.** In Australia they need a TGA manufacturing licence unless exempt; overseas, GMP clearance, which is mandatory before listing. Every partner we use holds the licence or clearance its step needs. See [TGA licences and GMP](/manufacturing#tga-licences-and-gmp).\n\n### Foods\n\nA packaged food for retail sale must bear a label with the name of the food, lot identification, the supplier's name and address, advisory and warning statements and declarations, the statement of ingredients, date marking, storage conditions and directions for use, nutrition information and characterising ingredients, plus the statements its own standard requires, such as Standard 2.9.4 for a sports food. An individual portion pack of 30 cm² or more that isn't sold separately needs its own label too, with the mandatory warning statements and declarations, such as allergens. Most packaged food sold at retail carries country of origin labelling. See [the food pathway](/pathways/foods#labels).\n\n### Cosmetics\n\nUnder the Consumer Goods (Cosmetics) Information Standard 2020, which the ACCC administers, every ingredient is listed on the container in descending order by volume or mass, with ingredients under 1% and colour additives allowed to follow in any order. If the container is too small to carry the list, it is displayed alongside the product. The standard doesn't apply to therapeutic goods, free samples or testers. See [skincare and cosmetics](/skincare#selling-cosmetics-registration-and-labels).","text":"Which rules apply depends on the product's pathway, settled at the brief: a listed medicine, a food or a cosmetic. See medicine, food or cosmetic? The guides cover each pathway in full; the essentials: Listed medicines The label follows TGO 116. Since 30 September 2026, labels of non-prescription medicines follow TGO 116; a medicine released for supply before 1 October 2031 can still follow TGO 92. The main label carries the medicine's name, each active ingredient and its quantity, the dosage form and the quantity in the pack. The label as a whole adds the batch number, the expiry date, storage conditions, the sponsor's name and contact details, declarations of any Schedule 1 substance, warning statements, directions for use and the indications. The Therapeutic Goods Regulations add the medicine's AUST L number on the main label. A QR code can't stand in for what the label must say, except where the Order allows it. Blister and strip packs and small containers have their own rules. More in the TGA listing guide. Some medicines need child-resistant packaging. Under TGO 95, a listed medicine needs it if it contains one of the substances the Order lists, in the strength or pack size it sets, or if its pack says or implies it is child-resistant. Among the substances a supplement might contain: iron compounds, in a pack with more than 250 mg of elemental iron, unless it is a divided preparation (one made in separate doses, such as tablets, capsules or sachets) in which the iron is combined with other actives and each dose has 5 mg or less of elemental iron; and potassium salts, in a pack with more than 4,000 mg of elemental potassium, unless it is a divided preparation with 40 mg or less in each dose, or the potassium is there as glucosamine sulfate potassium chloride complex. Individually wrapped powders are exempt. A blister pack generally counts when it seals each tablet or capsule on its own and isn't made of cellulose film or unlaminated paper. A pack presented as tamper-evident should say so. The TGA's code of practice for tamper-evident packaging isn't mandatory, but it applies to a pack presented as tamper-evident: at least one tamper-evident feature, two for two-piece capsules, and a statement on the pack describing it. Packaging and labelling are manufacturing steps. In Australia they need a TGA manufacturing licence unless exempt; overseas, GMP clearance, which is mandatory before listing. Every partner we use holds the licence or clearance its step needs. See TGA licences and GMP. Foods A packaged food for retail sale must bear a label with the name of the food, lot identification, the supplier's name and address, advisory and warning statements and declarations, the statement of ingredients, date marking, storage conditions and directions for use, nutrition information and characterising ingredients, plus the statements its own standard requires, such as Standard 2.9.4 for a sports food. An individual portion pack of 30 cm² or more that isn't sold separately needs its own label too, with the mandatory warning statements and declarations, such as allergens. Most packaged food sold at retail carries country of origin labelling. See the food pathway. Cosmetics Under the Consumer Goods (Cosmetics) Information Standard 2020, which the ACCC administers, every ingredient is listed on the container in descending order by volume or mass, with ingredients under 1% and colour additives allowed to follow in any order. If the container is too small to carry the list, it is displayed alongside the product. The standard doesn't apply to therapeutic goods, free samples or testers. See skincare and cosmetics.","items":[{"lead":"The label follows TGO 116.","text":"Since 30 September 2026, labels of non-prescription medicines follow TGO 116; a medicine released for supply before 1 October 2031 can still follow TGO 92. The main label carries the medicine's name, each active ingredient and its quantity, the dosage form and the quantity in the pack. The label as a whole adds the batch number, the expiry date, storage conditions, the sponsor's name and contact details, declarations of any Schedule 1 substance, warning statements, directions for use and the indications. The Therapeutic Goods Regulations add the medicine's AUST L number on the main label. A QR code can't stand in for what the label must say, except where the Order allows it. Blister and strip packs and small containers have their own rules. More in the TGA listing guide."},{"lead":"Some medicines need child-resistant packaging.","text":"Under TGO 95, a listed medicine needs it if it contains one of the substances the Order lists, in the strength or pack size it sets, or if its pack says or implies it is child-resistant. Among the substances a supplement might contain: iron compounds, in a pack with more than 250 mg of elemental iron, unless it is a divided preparation (one made in separate doses, such as tablets, capsules or sachets) in which the iron is combined with other actives and each dose has 5 mg or less of elemental iron; and potassium salts, in a pack with more than 4,000 mg of elemental potassium, unless it is a divided preparation with 40 mg or less in each dose, or the potassium is there as glucosamine sulfate potassium chloride complex. Individually wrapped powders are exempt. A blister pack generally counts when it seals each tablet or capsule on its own and isn't made of cellulose film or unlaminated paper."},{"lead":"A pack presented as tamper-evident should say so.","text":"The TGA's code of practice for tamper-evident packaging isn't mandatory, but it applies to a pack presented as tamper-evident: at least one tamper-evident feature, two for two-piece capsules, and a statement on the pack describing it."},{"lead":"Packaging and labelling are manufacturing steps.","text":"In Australia they need a TGA manufacturing licence unless exempt; overseas, GMP clearance, which is mandatory before listing. Every partner we use holds the licence or clearance its step needs. See TGA licences and GMP."}],"tables":[]},{"heading":"Packs from our records","anchor":"packs-from-our-records","markdown":"- [Vitable](/work/vitable-hair-growth-range): a TGA-listed hair capsule in a 100% recycled PET bottle, with the recycled bottle supply managed through to delivery, beside a serum on the cosmetics pathway.\n- [The Belly Solution](/work/the-belly-solution-travel-gut-health-powder): a travel gut-health powder in a 14-day pouch. We drafted and reviewed the label and set up a 36-month stability program.\n- [Nivari](/work/nivari-powder-supplement): a founder's first powder, packed into the brand's own pouch for a mid-August 2026 launch.\n- [An eye-health formula](/work/areds2-eye-health-formula): a 60-count pack and a smaller pack to drive trial, both pack sizes manufactured in both runs.\n- [Arxi's preconception capsule](/work/arxi-preconception-supplement): a 7-day sample pack added later for events and sampling, with three production orders since 2024.\n- [Mother Daily](/work/mother-daily-postnatal-supplement): the nutrition panel and the label press proofs for one of our largest first production runs.\n- [Arxi's prenatal chewable](/work/arxi-prenatal-chewable): our label review caught two errors before print.\n- [A pain relief cream](/work/pain-relief-cream): a pack older users can open easily was part of the brief. We are managing manufacturing now, including the tube supply.\n- [Your Skin Scan](/work/your-skin-scan-nicotinamide-tablet): a single-ingredient tablet, 120 per bottle, with label compliance handled with the listing.","text":"Vitable: a TGA-listed hair capsule in a 100% recycled PET bottle, with the recycled bottle supply managed through to delivery, beside a serum on the cosmetics pathway. The Belly Solution: a travel gut-health powder in a 14-day pouch. We drafted and reviewed the label and set up a 36-month stability program. Nivari: a founder's first powder, packed into the brand's own pouch for a mid-August 2026 launch. An eye-health formula: a 60-count pack and a smaller pack to drive trial, both pack sizes manufactured in both runs. Arxi's preconception capsule: a 7-day sample pack added later for events and sampling, with three production orders since 2024. Mother Daily: the nutrition panel and the label press proofs for one of our largest first production runs. Arxi's prenatal chewable: our label review caught two errors before print. A pain relief cream: a pack older users can open easily was part of the brief. We are managing manufacturing now, including the tube supply. Your Skin Scan: a single-ingredient tablet, 120 per bottle, with label compliance handled with the listing.","items":[],"tables":[]},{"heading":"How packaging is priced","anchor":"how-packaging-is-priced","markdown":"Packaging and labelling are managed within the stages of Friday Launch Engine™. The development stages are fixed fees for a defined outcome, and manufacturing is priced per unit, so you know the investment before each stage begins.","text":"Packaging and labelling are managed within the stages of Friday Launch Engine™. The development stages are fixed fees for a defined outcome, and manufacturing is priced per unit, so you know the investment before each stage begins.","items":[],"tables":[]}],"faqs":[{"q":"Do you offer contract manufacturing and packaging?","a":"We manage both as one job, but we make neither. cGMP manufacturing partners matched to your format, volume and margin make the product, the packaging is sourced through our supplier network, and one team carries the specification, the packaging and the labelling from the formula to the production line, then release testing, imports and freight through to your warehouse or 3PL. See managed manufacturing.","md":"We manage both as one job, but we make neither. cGMP manufacturing partners matched to your format, volume and margin make the product, the packaging is sourced through our supplier network, and one team carries the specification, the packaging and the labelling from the formula to the production line, then release testing, imports and freight through to your warehouse or 3PL. See [managed manufacturing](/manufacturing)."},{"q":"Can you use our own bottle or pouch?","a":"Yes. Nivari's powder was packed into the brand's own pouch. Where the component is ours to source, we manage its supply with the run: Vitable's 100% recycled PET bottle and the tubes for a pain relief cream. Where a pack goes beyond the standard formats, we can help make it.","md":"Yes. Nivari's powder was packed into the brand's own pouch. Where the component is ours to source, we manage its supply with the run: Vitable's 100% recycled PET bottle and the tubes for a pain relief cream. Where a pack goes beyond the standard formats, we can help make it."},{"q":"Which pack formats do you work with?","a":"Bottles in glass, HDPE and recycled PET, blister packs, sachets in stick, square or rectangular formats, pouches, tubs, tubes and shrink wrapping. From our records: 60-count and 120-count bottles, 100% recycled PET, 7-day trial packs, a 14-day pouch and a brand's own pouch.","md":"Bottles in glass, HDPE and recycled PET, blister packs, sachets in stick, square or rectangular formats, pouches, tubs, tubes and shrink wrapping. From our records: 60-count and 120-count bottles, 100% recycled PET, 7-day trial packs, a 14-day pouch and a brand's own pouch."},{"q":"Who writes the label?","a":"We draft it and review it, and manage the process from the design brief to print-ready artwork, checking every claim, the ingredient list and every mandatory statement against the rules of the product's pathway. On Arxi's prenatal, our review caught two errors before print.","md":"We draft it and review it, and manage the process from the design brief to print-ready artwork, checking every claim, the ingredient list and every mandatory statement against the rules of the product's pathway. On Arxi's prenatal, our review caught two errors before print."},{"q":"What has to be on a supplement label in Australia?","a":"For a listed medicine, what TGO 116 requires: the medicine's name, each active ingredient and its quantity, the dosage form, the quantity in the pack, the batch number, the expiry date, storage conditions, the sponsor's name and contact details, declarations of any Schedule 1 substance, warning statements, directions for use and the indications. The Therapeutic Goods Regulations add the AUST L number on the main label. Our labelling guide sets out each rule. A supplement sold as a food follows the Food Standards Code instead: the name of the food, lot identification, the supplier's name and address, advisory and warning statements and declarations, the ingredients, date marking, storage conditions and directions for use, nutrition information and, for most retail food, country of origin.","md":"For a listed medicine, what TGO 116 requires: the medicine's name, each active ingredient and its quantity, the dosage form, the quantity in the pack, the batch number, the expiry date, storage conditions, the sponsor's name and contact details, declarations of any Schedule 1 substance, warning statements, directions for use and the indications. The Therapeutic Goods Regulations add the AUST L number on the main label. Our [labelling guide](/guides/supplement-labelling) sets out each rule. A supplement sold as a food follows the Food Standards Code instead: the name of the food, lot identification, the supplier's name and address, advisory and warning statements and declarations, the ingredients, date marking, storage conditions and directions for use, nutrition information and, for most retail food, country of origin."},{"q":"Do you handle barcodes?","a":"Yes. Barcodes for retail and direct-to-consumer channels, checked so every product scans and works in your systems before stock reaches the warehouse.","md":"Yes. Barcodes for retail and direct-to-consumer channels, checked so every product scans and works in your systems before stock reaches the warehouse."},{"q":"Does my supplement need child-resistant packaging?","a":"Under TGO 95, only if it contains one of the substances the Order lists, in the strength or pack size it sets, or if its pack says or implies it is child-resistant. Among the substances a supplement might contain, the Order names iron compounds, in a pack with more than 250 mg of elemental iron, unless it is a divided preparation, such as tablets, capsules or sachets, in which the iron is combined with other actives and each dose has 5 mg or less of elemental iron, and potassium salts, in a pack with more than 4,000 mg of elemental potassium, unless it is a divided preparation with 40 mg or less in each dose, or the potassium is there as glucosamine sulfate potassium chloride complex. A blister pack that seals each tablet or capsule on its own generally counts, as long as it isn't made of cellulose film or unlaminated paper.","md":"Under TGO 95, only if it contains one of the substances the Order lists, in the strength or pack size it sets, or if its pack says or implies it is child-resistant. Among the substances a supplement might contain, the Order names iron compounds, in a pack with more than 250 mg of elemental iron, unless it is a divided preparation, such as tablets, capsules or sachets, in which the iron is combined with other actives and each dose has 5 mg or less of elemental iron, and potassium salts, in a pack with more than 4,000 mg of elemental potassium, unless it is a divided preparation with 40 mg or less in each dose, or the potassium is there as glucosamine sulfate potassium chloride complex. A blister pack that seals each tablet or capsule on its own generally counts, as long as it isn't made of cellulose film or unlaminated paper."},{"q":"Can you add a trial or sample pack?","a":"Yes. An eye-health formula shipped in a 60-count pack and a trial pack, and Arxi's preconception capsule gained a 7-day sample pack for events and sampling after launch.","md":"Yes. An eye-health formula shipped in a 60-count pack and a trial pack, and Arxi's preconception capsule gained a 7-day sample pack for events and sampling after launch."},{"q":"Does changing the pack affect the shelf life?","a":"It can. TGA guidance says ongoing stability testing is of the finished packed product, that products grouped in one study should share the same primary packaging materials, and that a change to a product needs a risk assessment to decide whether a new stability study is needed. A different pack, such as a glass bottle, a particular plastic bottle, a blister or a laminated tube, may need its own study. We design the stability protocol for the shelf life the label will carry. More in our stability testing guide.","md":"It can. TGA guidance says ongoing stability testing is of the finished packed product, that products grouped in one study should share the same primary packaging materials, and that a change to a product needs a risk assessment to decide whether a new stability study is needed. A different pack, such as a glass bottle, a particular plastic bottle, a blister or a laminated tube, may need its own study. We design the stability protocol for the shelf life the label will carry. More in [our stability testing guide](/guides/stability-testing)."},{"q":"Sachets or a tub: which suits a powder?","a":"Single-serve sachets suit a product taken on the go, sampled, or sold as a trial: one dose, no scoop, nothing to measure. A tub or pouch with a scoop suits daily use at home and larger serves, with less packaging per dose. Many brands launch one and add the other later, and each pack goes through its own label and stability check. We quote the formats side by side so the choice rests on the cost per serve as well as the customer.","md":"Single-serve sachets suit a product taken on the go, sampled, or sold as a trial: one dose, no scoop, nothing to measure. A tub or pouch with a scoop suits daily use at home and larger serves, with less packaging per dose. Many brands launch one and add the other later, and each pack goes through its own label and stability check. We quote the formats side by side so the choice rests on the cost per serve as well as the customer."},{"q":"Does a sachet need its own label?","a":"If it is sold on its own, yes, in full. Inside an outer pack, the rules depend on the pathway: a food's individual portion pack of 30 cm² or more needs its own label with the mandatory warnings and declarations, and a medicine's small containers and strip packs have their own rules under TGO 116. We set the sachet and outer-pack labels together.","md":"If it is sold on its own, yes, in full. Inside an outer pack, the rules depend on the pathway: a food's individual portion pack of 30 cm² or more needs its own label with the mandatory warnings and declarations, and a medicine's small containers and strip packs have their own rules under TGO 116. We set the sachet and outer-pack labels together."}],"sources":{"note":"General information, checked against these sources on 20 October 2026. It isn't advice on a particular product.","markdown":"General information, checked against these sources on 20 October 2026. It isn't advice on a particular product.\n\n- [Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026](https://www.legislation.gov.au/F2026L01312/asmade), sections 2, 9, 11, 12, 15, 17 and 36, Federal Register of Legislation\n- [Therapeutic Goods Order No. 95 (Child-Resistant Packaging Requirements for Medicines) 2017](https://www.legislation.gov.au/F2017L01577/asmade), sections 6, 7 and 10 and Schedule 1, Federal Register of Legislation, and [Child-resistant packaging requirements for medicines: guidance on TGO 95](https://www.tga.gov.au/sites/default/files/child-resistant-packaging-requirements-medicines-guidance-tgo-95.pdf), Therapeutic Goods Administration, May 2018\n- [Code of practice for the tamper-evident packaging of therapeutic goods](https://www.tga.gov.au/node/289301), Therapeutic Goods Administration\n- [AUST numbers on medicine labels](https://www.tga.gov.au/products/medicines/labelling-and-advertising/medicines-and-biologicals-labelling-and-packaging/aust-numbers-medicine-labels), Therapeutic Goods Administration\n- [General guidance for listed medicines](https://www.tga.gov.au/node/289506) and [Manufacturing therapeutic goods](https://www.tga.gov.au/products/regulations-all-products/manufacturing), Therapeutic Goods Administration\n- [Performing ongoing stability testing](https://www.tga.gov.au/node/452227), Therapeutic Goods Administration\n- [Standard 1.2.1: Requirements to have labels or otherwise provide information](https://www.legislation.gov.au/F2015L00386/latest/text), sections 6 and 8 of the Standard, Federal Register of Legislation\n- [Country of origin food labelling](https://www.accc.gov.au/business/advertising-and-promotions/country-of-origin-food-labelling), Australian Competition and Consumer Commission\n- [Cosmetics ingredients labelling mandatory standard](https://www.productsafety.gov.au/business/search-mandatory-standards/cosmetics-ingredients-labelling-mandatory-standard), ACCC Product Safety Australia","items":[{"text":"Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026, sections 2, 9, 11, 12, 15, 17 and 36, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026","url":"https://www.legislation.gov.au/F2026L01312/asmade"}]},{"text":"Therapeutic Goods Order No. 95 (Child-Resistant Packaging Requirements for Medicines) 2017, sections 6, 7 and 10 and Schedule 1, Federal Register of Legislation, and Child-resistant packaging requirements for medicines: guidance on TGO 95, Therapeutic Goods Administration, May 2018","links":[{"title":"Therapeutic Goods Order No. 95 (Child-Resistant Packaging Requirements for Medicines) 2017","url":"https://www.legislation.gov.au/F2017L01577/asmade"},{"title":"Child-resistant packaging requirements for medicines: guidance on TGO 95","url":"https://www.tga.gov.au/sites/default/files/child-resistant-packaging-requirements-medicines-guidance-tgo-95.pdf"}]},{"text":"Code of practice for the tamper-evident packaging of therapeutic goods, Therapeutic Goods Administration","links":[{"title":"Code of practice for the tamper-evident packaging of therapeutic goods","url":"https://www.tga.gov.au/node/289301"}]},{"text":"AUST numbers on medicine labels, Therapeutic Goods Administration","links":[{"title":"AUST numbers on medicine labels","url":"https://www.tga.gov.au/products/medicines/labelling-and-advertising/medicines-and-biologicals-labelling-and-packaging/aust-numbers-medicine-labels"}]},{"text":"General guidance for listed medicines and Manufacturing therapeutic goods, Therapeutic Goods Administration","links":[{"title":"General guidance for listed medicines","url":"https://www.tga.gov.au/node/289506"},{"title":"Manufacturing therapeutic goods","url":"https://www.tga.gov.au/products/regulations-all-products/manufacturing"}]},{"text":"Performing ongoing stability testing, Therapeutic Goods Administration","links":[{"title":"Performing ongoing stability testing","url":"https://www.tga.gov.au/node/452227"}]},{"text":"Standard 1.2.1: Requirements to have labels or otherwise provide information, sections 6 and 8 of the Standard, Federal Register of Legislation","links":[{"title":"Standard 1.2.1: Requirements to have labels or otherwise provide information","url":"https://www.legislation.gov.au/F2015L00386/latest/text"}]},{"text":"Country of origin food labelling, Australian Competition and Consumer Commission","links":[{"title":"Country of origin food labelling","url":"https://www.accc.gov.au/business/advertising-and-promotions/country-of-origin-food-labelling"}]},{"text":"Cosmetics ingredients labelling mandatory standard, ACCC Product Safety Australia","links":[{"title":"Cosmetics ingredients labelling mandatory standard","url":"https://www.productsafety.gov.au/business/search-mandatory-standards/cosmetics-ingredients-labelling-mandatory-standard"}]}]}},{"slug":"practitioner-ranges","kind":"service","url":"/practitioner-ranges","title":"Practitioner-only ranges, built for clinics","name":"Practitioner-only ranges","description":"Practitioner-only supplement ranges for brands that sell through clinics: herbal formulas, high-dose minerals and gut health powders, dosed by the evidence.","eyebrow":"Service","lead":"We build practitioner-only ranges in any format, for supply through clinics and health practitioners, with doses set by the evidence and every product listed, labelled and made to the same rules as any other medicine.","studies":["bwellness-practitioner-range","ora-practitioner-natural-medicine"],"formats":[],"order":16,"updated":"2026-10-26","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- Any format, built for supply through clinics and health practitioners, with doses set by the evidence.\n- Popular for clinic-only herbal formulas, high-dose minerals and targeted gut health powders.\n- The product follows the same rules as any listed medicine: permitted ingredients and their limits, permitted indications, a GMP-licensed manufacturer and a TGO 116 label. What changes is how it is promoted.\n- Advertising directed only at health professionals is outside the Advertising Code, and the TGA says the public must not be able to access it.\n- From our records: nine products for BWellness, a practitioner-channel brand, and Ora, our founder's own practitioner-recommended range.","text":"Any format, built for supply through clinics and health practitioners, with doses set by the evidence. Popular for clinic-only herbal formulas, high-dose minerals and targeted gut health powders. The product follows the same rules as any listed medicine: permitted ingredients and their limits, permitted indications, a GMP-licensed manufacturer and a TGO 116 label. What changes is how it is promoted. Advertising directed only at health professionals is outside the Advertising Code, and the TGA says the public must not be able to access it. From our records: nine products for BWellness, a practitioner-channel brand, and Ora, our founder's own practitioner-recommended range.","items":[],"tables":[]},{"heading":"What a practitioner range needs","anchor":"what-a-practitioner-range-needs","markdown":"- **A formula built on the evidence.** The dose follows the clinical research behind each ingredient, within the limits the Permissible Ingredients Determination sets. We build the evidence package with the formula ([formulation](/formulation)).\n- **Claims a practitioner can stand behind.** On a listed medicine, every claim is a permitted indication, backed by evidence the sponsor holds ([permitted indications](/guides/permitted-indications)).\n- **Promotion kept to practitioners.** Advertising directed only at health professionals, and the others named in section 42AA of the Therapeutic Goods Act, is outside the Advertising Code. But the TGA says \"the public must not be able to access advertising meant for health professionals\", and a brand's public website and social posts are advertising to the public. More in our [advertising guide](/guides/tga-advertising).\n- **A range that reorders the same.** Each product is specified, stability-tested and made the same way every batch ([managed manufacturing](/manufacturing)).","text":"A formula built on the evidence. The dose follows the clinical research behind each ingredient, within the limits the Permissible Ingredients Determination sets. We build the evidence package with the formula (formulation). Claims a practitioner can stand behind. On a listed medicine, every claim is a permitted indication, backed by evidence the sponsor holds (permitted indications). Promotion kept to practitioners. Advertising directed only at health professionals, and the others named in section 42AA of the Therapeutic Goods Act, is outside the Advertising Code. But the TGA says \"the public must not be able to access advertising meant for health professionals\", and a brand's public website and social posts are advertising to the public. More in our advertising guide. A range that reorders the same. Each product is specified, stability-tested and made the same way every batch (managed manufacturing).","items":[{"lead":"A formula built on the evidence.","text":"The dose follows the clinical research behind each ingredient, within the limits the Permissible Ingredients Determination sets. We build the evidence package with the formula (formulation)."},{"lead":"Claims a practitioner can stand behind.","text":"On a listed medicine, every claim is a permitted indication, backed by evidence the sponsor holds (permitted indications)."},{"lead":"Promotion kept to practitioners.","text":"Advertising directed only at health professionals, and the others named in section 42AA of the Therapeutic Goods Act, is outside the Advertising Code. But the TGA says \"the public must not be able to access advertising meant for health professionals\", and a brand's public website and social posts are advertising to the public. More in our advertising guide."},{"lead":"A range that reorders the same.","text":"Each product is specified, stability-tested and made the same way every batch (managed manufacturing)."}],"tables":[]},{"heading":"From our records","anchor":"from-our-records","markdown":"- [BWellness](/work/bwellness-practitioner-range), a practitioner-channel brand and distributor serving naturopaths and nutritionists across Australia and New Zealand: nine products, including an immune powder built on Wellmune®, an algal omega-3 capsule built on life's®OMEGA with VitaShine™ vegan vitamin D3, a vitamin D product, an adrenal formula and a women's health formula. Five production batches from 2021 to 2025, a sixth order in the pipeline, and an acquisition in 2024 by an ASX-listed company for A$7 million.\n- [Ora](/work/ora-practitioner-natural-medicine), our founder's own brand: around 19 natural medicines built on clinically studied ingredients, recommended by naturopaths, herbalists and functional medicine practitioners and carried by premium retailers across Australia and New Zealand.\n\nBefore Take Friday Off, our founder, Gabriel Perera, ran Phytomedicine & Nutrimedicine and led Blackmores' acquisition of BioCeuticals ([about Gabriel](/about)).","text":"BWellness, a practitioner-channel brand and distributor serving naturopaths and nutritionists across Australia and New Zealand: nine products, including an immune powder built on Wellmune®, an algal omega-3 capsule built on life's®OMEGA with VitaShine™ vegan vitamin D3, a vitamin D product, an adrenal formula and a women's health formula. Five production batches from 2021 to 2025, a sixth order in the pipeline, and an acquisition in 2024 by an ASX-listed company for A$7 million. Ora, our founder's own brand: around 19 natural medicines built on clinically studied ingredients, recommended by naturopaths, herbalists and functional medicine practitioners and carried by premium retailers across Australia and New Zealand. Before Take Friday Off, our founder, Gabriel Perera, ran Phytomedicine & Nutrimedicine and led Blackmores' acquisition of BioCeuticals (about Gabriel).","items":[],"tables":[]}],"faqs":[{"q":"Does a practitioner-only product follow different rules?","a":"The product doesn't. It is listed, labelled and made like any other listed medicine. The promotion does: advertising directed only at health professionals is outside the Advertising Code, and the public must not be able to see it.","md":"The product doesn't. It is listed, labelled and made like any other listed medicine. The promotion does: advertising directed only at health professionals is outside the Advertising Code, and the public must not be able to see it."},{"q":"Can a practitioner product use higher doses?","a":"Doses are set by the evidence, within the limits of the Permissible Ingredients Determination, which apply to every listed medicine, however it is sold.","md":"Doses are set by the evidence, within the limits of the Permissible Ingredients Determination, which apply to every listed medicine, however it is sold."},{"q":"Which formats can a practitioner range use?","a":"Any of them: capsules, tablets, softgels, gummies, powders, liquids and topicals. See the formats we develop.","md":"Any of them: capsules, tablets, softgels, gummies, powders, liquids and topicals. See [the formats we develop](/formats)."},{"q":"Can you develop a whole range, not one product?","a":"Yes. For BWellness we developed nine products, and we manage every production run, including the imported ingredients, customs and freight.","md":"Yes. For BWellness we developed nine products, and we manage every production run, including the imported ingredients, customs and freight."}],"sources":{"note":"General information, checked against these sources on 26 October 2026. It isn't advice on a particular product.","markdown":"General information, checked against these sources on 26 October 2026. It isn't advice on a particular product.\n\n- [Advertising to health professionals so consumer rules do not apply](https://www.tga.gov.au/resources/guidance/advertising-health-professionals-so-consumer-rules-do-not-apply), Therapeutic Goods Administration\n- [Therapeutic Goods Act 1989](https://www.legislation.gov.au/C2004A03952/latest/text), section 42AA, Federal Register of Legislation","items":[{"text":"Advertising to health professionals so consumer rules do not apply, Therapeutic Goods Administration","links":[{"title":"Advertising to health professionals so consumer rules do not apply","url":"https://www.tga.gov.au/resources/guidance/advertising-health-professionals-so-consumer-rules-do-not-apply"}]},{"text":"Therapeutic Goods Act 1989, section 42AA, Federal Register of Legislation","links":[{"title":"Therapeutic Goods Act 1989","url":"https://www.legislation.gov.au/C2004A03952/latest/text"}]}]}},{"slug":"new-ingredients","kind":"service","url":"/new-ingredients","title":"New ingredient applications: TGA, FSANZ and AICIS","name":"New ingredient applications","description":"Hero ingredient not yet permitted in Australia? How a new ingredient gets approved for a listed medicine, a food or a cosmetic, with the fees and timeframes.","eyebrow":"Service","lead":"Is your hero ingredient not yet permitted in Australia? We manage the application, whether that's a TGA new ingredient application for listed medicines, an FSANZ novel food application or an AICIS cosmetic ingredient introduction. We map the approval route at the brief, before the formula is locked.","studies":[],"formats":[],"order":17,"updated":"2026-10-26","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- Each pathway has its own list of what's allowed, and its own way onto it: the TGA for listed medicines, FSANZ for foods, and AICIS for the chemicals in cosmetics.\n- A listed medicine can only contain ingredients in the Permissible Ingredients Determination. A new one takes a TGA application, IN1 to IN4: in 2026–27, $19,826 for IN1 or IN2 and $33,696 for IN3 or IN4, with up to two years of exclusive use.\n- A food can't be or contain a novel food unless Schedule 25 of the Food Standards Code lists it. A listing takes an application to FSANZ, from $49,627 for a paid one, with up to 15 months of exclusive use.\n- A cosmetic's chemicals are introduced under AICIS: each one is categorised, and an assessed introduction needs an assessment certificate, from $14,530 to apply in 2026–27.\n- Popular for new botanical extracts, novel probiotic strains and new skincare actives.","text":"Each pathway has its own list of what's allowed, and its own way onto it: the TGA for listed medicines, FSANZ for foods, and AICIS for the chemicals in cosmetics. A listed medicine can only contain ingredients in the Permissible Ingredients Determination. A new one takes a TGA application, IN1 to IN4: in 2026–27, $19,826 for IN1 or IN2 and $33,696 for IN3 or IN4, with up to two years of exclusive use. A food can't be or contain a novel food unless Schedule 25 of the Food Standards Code lists it. A listing takes an application to FSANZ, from $49,627 for a paid one, with up to 15 months of exclusive use. A cosmetic's chemicals are introduced under AICIS: each one is categorised, and an assessed introduction needs an assessment certificate, from $14,530 to apply in 2026–27. Popular for new botanical extracts, novel probiotic strains and new skincare actives.","items":[],"tables":[]},{"heading":"Mapped at the brief","anchor":"mapped-at-the-brief","markdown":"The approval route decides the timeline and the budget, so we settle it before the formula is locked. The pathway comes first ([medicine, food or cosmetic?](/pathways)): the same ingredient can need a TGA application in a capsule, an FSANZ application in a food and an AICIS categorisation in a cream. Then the evidence: a new ingredient's safety and quality case, built so the application and the product's claims draw on the same work.","text":"The approval route decides the timeline and the budget, so we settle it before the formula is locked. The pathway comes first (medicine, food or cosmetic?): the same ingredient can need a TGA application in a capsule, an FSANZ application in a food and an AICIS categorisation in a cream. Then the evidence: a new ingredient's safety and quality case, built so the application and the product's claims draw on the same work.","items":[],"tables":[]},{"heading":"A listed medicine: the TGA's Permissible Ingredients Determination","anchor":"a-listed-medicine-the-tgas-permissible-ingredients-determination","markdown":"A listed medicine, AUST L or AUST L(A), can only contain ingredients in the Permissible Ingredients Determination. A new substance needs an application to the TGA, and so does a new role or a change to an ingredient's requirements, such as a higher permitted level.\n\n- **Four levels, IN1 to IN4.** The more of the safety and quality case that rests on an evaluation by a comparable overseas regulator, or on a published monograph, the less the TGA evaluates itself and the shorter the timeframe.\n- **Fees in 2026–27:** $19,826 for an IN1 or IN2 application and $33,696 for IN3 or IN4.\n- **Timeframes:** 40 working days for a preliminary assessment, then 70 to 180 working days for the evaluation, not counting time the clock is stopped.\n- **Exclusivity:** a successful applicant for a new ingredient can opt in, when it applies, to two years of exclusive use.\n\nThe full process is in our [permissible ingredients guide](/guides/permissible-ingredients).","text":"A listed medicine, AUST L or AUST L(A), can only contain ingredients in the Permissible Ingredients Determination. A new substance needs an application to the TGA, and so does a new role or a change to an ingredient's requirements, such as a higher permitted level. Four levels, IN1 to IN4. The more of the safety and quality case that rests on an evaluation by a comparable overseas regulator, or on a published monograph, the less the TGA evaluates itself and the shorter the timeframe. Fees in 2026–27: $19,826 for an IN1 or IN2 application and $33,696 for IN3 or IN4. Timeframes: 40 working days for a preliminary assessment, then 70 to 180 working days for the evaluation, not counting time the clock is stopped. Exclusivity: a successful applicant for a new ingredient can opt in, when it applies, to two years of exclusive use. The full process is in our permissible ingredients guide.","items":[{"lead":"Four levels, IN1 to IN4.","text":"The more of the safety and quality case that rests on an evaluation by a comparable overseas regulator, or on a published monograph, the less the TGA evaluates itself and the shorter the timeframe."},{"lead":"Fees in 2026–27:","text":"$19,826 for an IN1 or IN2 application and $33,696 for IN3 or IN4."},{"lead":"Timeframes:","text":"40 working days for a preliminary assessment, then 70 to 180 working days for the evaluation, not counting time the clock is stopped."},{"lead":"Exclusivity:","text":"a successful applicant for a new ingredient can opt in, when it applies, to two years of exclusive use."}],"tables":[]},{"heading":"A food: an FSANZ novel food application","anchor":"a-food-an-fsanz-novel-food-application","markdown":"A novel food is a non-traditional food, one without a history of human consumption in Australia or New Zealand, that needs an assessment of its public health and safety. A food for retail sale can't be or contain one unless Schedule 25 of the Food Standards Code lists it, used within its conditions.\n\n- **The application** asks FSANZ to change the Code, with a pre-market safety assessment.\n- **Fees:** none unless the applicant stands to gain an exclusive commercial benefit, as when it asks for exclusive use, or pays to start sooner. An unpaid application waits about 12 months for its assessment to start. A paid one costs from $49,627 for the smallest general procedure to $137,767 or more for a major one.\n- **Timeframes:** counted from the start of the assessment, FSANZ's Board decides within 9 months under the general procedure or 12 under the major one, then the Food Ministers have 60 days.\n- **Exclusivity:** up to 15 months of exclusive use after gazettal, tied to the brand, though FSANZ can still approve the same food for others in that time.\n\nThe full process is in our [novel foods guide](/guides/novel-foods).","text":"A novel food is a non-traditional food, one without a history of human consumption in Australia or New Zealand, that needs an assessment of its public health and safety. A food for retail sale can't be or contain one unless Schedule 25 of the Food Standards Code lists it, used within its conditions. The application asks FSANZ to change the Code, with a pre-market safety assessment. Fees: none unless the applicant stands to gain an exclusive commercial benefit, as when it asks for exclusive use, or pays to start sooner. An unpaid application waits about 12 months for its assessment to start. A paid one costs from $49,627 for the smallest general procedure to $137,767 or more for a major one. Timeframes: counted from the start of the assessment, FSANZ's Board decides within 9 months under the general procedure or 12 under the major one, then the Food Ministers have 60 days. Exclusivity: up to 15 months of exclusive use after gazettal, tied to the brand, though FSANZ can still approve the same food for others in that time. The full process is in our novel foods guide.","items":[{"lead":"The application","text":"asks FSANZ to change the Code, with a pre-market safety assessment."},{"lead":"Fees:","text":"none unless the applicant stands to gain an exclusive commercial benefit, as when it asks for exclusive use, or pays to start sooner. An unpaid application waits about 12 months for its assessment to start. A paid one costs from $49,627 for the smallest general procedure to $137,767 or more for a major one."},{"lead":"Timeframes:","text":"counted from the start of the assessment, FSANZ's Board decides within 9 months under the general procedure or 12 under the major one, then the Food Ministers have 60 days."},{"lead":"Exclusivity:","text":"up to 15 months of exclusive use after gazettal, tied to the brand, though FSANZ can still approve the same food for others in that time."}],"tables":[]},{"heading":"A cosmetic: an AICIS introduction","anchor":"a-cosmetic-an-aicis-introduction","markdown":"AICIS regulates the industrial chemicals in cosmetics. Each ingredient is checked against the Australian Inventory of Industrial Chemicals, and each introduction is categorised: listed, exempted, reported or assessed. A reported introduction needs a once-off report before it starts, and an assessed one needs an assessment certificate from AICIS before the chemical is introduced: in 2026–27, applying for one costs from $14,530. The business introducing it also registers with AICIS. More in our [AICIS registration guide](/guides/aicis-registration).","text":"AICIS regulates the industrial chemicals in cosmetics. Each ingredient is checked against the Australian Inventory of Industrial Chemicals, and each introduction is categorised: listed, exempted, reported or assessed. A reported introduction needs a once-off report before it starts, and an assessed one needs an assessment certificate from AICIS before the chemical is introduced: in 2026–27, applying for one costs from $14,530. The business introducing it also registers with AICIS. More in our AICIS registration guide.","items":[],"tables":[]}],"faqs":[{"q":"How do I know if my ingredient is permitted?","a":"For a listed medicine, it has to be in the Permissible Ingredients Determination, within its requirements. For a food, it can't be a novel food unless Schedule 25 lists it. For a cosmetic, its chemicals are checked against the Australian Inventory of Industrial Chemicals. We check this at the brief, before the formula is locked.","md":"For a listed medicine, it has to be in the Permissible Ingredients Determination, within its requirements. For a food, it can't be a novel food unless Schedule 25 lists it. For a cosmetic, its chemicals are checked against the Australian Inventory of Industrial Chemicals. We check this at the brief, before the formula is locked."},{"q":"Can we launch while the application is under way?","a":"Not with the new ingredient in the product. A listed medicine can only contain permitted ingredients, and a food can't contain an unlisted novel food. A product can launch on permitted ingredients, with a reformulated version to follow once the new one is approved.","md":"Not with the new ingredient in the product. A listed medicine can only contain permitted ingredients, and a food can't contain an unlisted novel food. A product can launch on permitted ingredients, with a reformulated version to follow once the new one is approved."},{"q":"Can others use the ingredient once it's approved?","a":"Yes, once any exclusive period ends: the approval adds it to the list. A successful TGA applicant can opt in to two years of exclusive use. An FSANZ applicant can ask for up to 15 months after gazettal, though FSANZ can still approve the same food for others in that time.","md":"Yes, once any exclusive period ends: the approval adds it to the list. A successful TGA applicant can opt in to two years of exclusive use. An FSANZ applicant can ask for up to 15 months after gazettal, though FSANZ can still approve the same food for others in that time."},{"q":"How long does it take?","a":"For a TGA new ingredient, 40 working days of preliminary assessment, then 70 to 180 working days of evaluation, not counting time the clock is stopped. For a paid FSANZ application, a Board decision within 9 or 12 months of the assessment starting, then 60 days for the Food Ministers.","md":"For a TGA new ingredient, 40 working days of preliminary assessment, then 70 to 180 working days of evaluation, not counting time the clock is stopped. For a paid FSANZ application, a Board decision within 9 or 12 months of the assessment starting, then 60 days for the Food Ministers."}],"sources":{"note":"General information, checked against these sources on 26 October 2026. It isn't advice on a particular product.","markdown":"General information, checked against these sources on 26 October 2026. It isn't advice on a particular product.\n\n- [Application requirements for new substances in listed medicines](https://www.tga.gov.au/resources/resource/guidance/application-requirements-new-substances-listed-medicines), Therapeutic Goods Administration\n- [Fees and charges: summary, from 1 July 2026](https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf), Therapeutic Goods Administration\n- [Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026](https://www.legislation.gov.au/F2026L01382/asmade/versions), Federal Register of Legislation\n- [Australia New Zealand Food Standards Code – Standard 1.5.1 – Novel foods](https://www.legislation.gov.au/F2015L00403/latest/text), Federal Register of Legislation\n- [2026-27 Cost Recovery Arrangements](https://consultations.foodstandards.gov.au/fsanz/2026-27-cost-recovery-arrangements/), Food Standards Australia New Zealand\n- [Before you start categorising your introduction](https://www.industrialchemicals.gov.au/node/144) and [Fees and charges for 2026–27](https://www.industrialchemicals.gov.au/node/188362), Australian Industrial Chemicals Introduction Scheme","items":[{"text":"Application requirements for new substances in listed medicines, Therapeutic Goods Administration","links":[{"title":"Application requirements for new substances in listed medicines","url":"https://www.tga.gov.au/resources/resource/guidance/application-requirements-new-substances-listed-medicines"}]},{"text":"Fees and charges: summary, from 1 July 2026, Therapeutic Goods Administration","links":[{"title":"Fees and charges: summary, from 1 July 2026","url":"https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf"}]},{"text":"Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026","url":"https://www.legislation.gov.au/F2026L01382/asmade/versions"}]},{"text":"Australia New Zealand Food Standards Code – Standard 1.5.1 – Novel foods, Federal Register of Legislation","links":[{"title":"Australia New Zealand Food Standards Code – Standard 1.5.1 – Novel foods","url":"https://www.legislation.gov.au/F2015L00403/latest/text"}]},{"text":"2026-27 Cost Recovery Arrangements, Food Standards Australia New Zealand","links":[{"title":"2026-27 Cost Recovery Arrangements","url":"https://consultations.foodstandards.gov.au/fsanz/2026-27-cost-recovery-arrangements/"}]},{"text":"Before you start categorising your introduction and Fees and charges for 2026–27, Australian Industrial Chemicals Introduction Scheme","links":[{"title":"Before you start categorising your introduction","url":"https://www.industrialchemicals.gov.au/node/144"},{"title":"Fees and charges for 2026–27","url":"https://www.industrialchemicals.gov.au/node/188362"}]}]}},{"slug":"formulation","kind":"service","url":"/formulation","title":"Supplement formulation, designed to be made and sold","name":"Formulation","description":"Supplement formulation development for brands in Australia and the Asia-Pacific: the formula, its specification and a quote, built for its pathway.","eyebrow":"Formulation","lead":"We design the formula, write its specification and quote it, with the regulatory pathway settled first. What leaves the design stage is a product a manufacturer can make and you can sell.","studies":["everleanbody-saffron-capsule","mother-daily-postnatal-supplement","arxi-prenatal-chewable","eye-health-tablet-format-rescue","prenatal-multivitamin-capsule","areds2-eye-health-formula"],"formats":[],"order":20,"updated":"2026-10-19","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- Formulation turns the brief into three things you can act on: the formulation, its specification and a quote for making it.\n- Every ingredient, form and dose is chosen for the claim the product needs to make, inside the rules of its pathway, and the price it has to sell at.\n- One round of reformulation and requoting is included, and the physical sample is approved before anything goes into production.\n- From our records, design to production order has taken 32 days to 12 weeks.","text":"Formulation turns the brief into three things you can act on: the formulation, its specification and a quote for making it. Every ingredient, form and dose is chosen for the claim the product needs to make, inside the rules of its pathway, and the price it has to sell at. One round of reformulation and requoting is included, and the physical sample is approved before anything goes into production. From our records, design to production order has taken 32 days to 12 weeks.","items":[],"tables":[]},{"heading":"What formulation covers","anchor":"what-formulation-covers","markdown":"Formulation is the second of the five steps of the [Friday Launch Engine™](/system), after the brief. It ends with three things you can act on:\n\n- **A formulation**: every ingredient, its form and its dose, chosen for the claim you want to make and the price the product has to sell at.\n- **A specification**: what the finished product must be, so any batch can be checked against it.\n- **A quote**: what it costs to make, so the cost of goods is known before anything is ordered.\n\nYou set the brief: the customer, the claim, the format and the target cost of goods. We design the formulation to meet it, with evidence-based formulation, early access to new ingredients and emerging research, and our global ingredient network to source them. You approve it before anything is made.","text":"Formulation is the second of the five steps of the Friday Launch Engine™, after the brief. It ends with three things you can act on: A formulation: every ingredient, its form and its dose, chosen for the claim you want to make and the price the product has to sell at. A specification: what the finished product must be, so any batch can be checked against it. A quote: what it costs to make, so the cost of goods is known before anything is ordered. You set the brief: the customer, the claim, the format and the target cost of goods. We design the formulation to meet it, with evidence-based formulation, early access to new ingredients and emerging research, and our global ingredient network to source them. You approve it before anything is made.","items":[{"lead":"A formulation","text":": every ingredient, its form and its dose, chosen for the claim you want to make and the price the product has to sell at."},{"lead":"A specification","text":": what the finished product must be, so any batch can be checked against it."},{"lead":"A quote","text":": what it costs to make, so the cost of goods is known before anything is ordered."}],"tables":[]},{"heading":"How a formula is designed","anchor":"how-a-formula-is-designed","markdown":"1. **Start from the brief.** The customer, the claim, the format and the retail price come first. EverLeanBody's brief was a premium daily capsule for women 35 and over, at a set retail price, with the evidence and listing to sell it with confidence.\n2. **Settle the pathway.** Whether the product will be a listed medicine, a food or a cosmetic decides which ingredients, doses and claims are open to it. We settle it at the brief, never after the formula. See [medicine, food or cosmetic?](/pathways).\n3. **Build on the evidence.** Where the brief calls for it, we build on ingredients backed by double-blind, published clinical trials, often branded extracts such as affron®, KSM-66®, EnXtra® or Wellmune® ([branded ingredients](/guides/branded-ingredients)). Every claim arrives with the studies behind it and the indication it maps to: the [claims evidence](/guides/permitted-indications) is built alongside the formula, not after it.\n4. **Prove the format.** A formula that reads well can still fail in production: too wet to encapsulate, too bitter to swallow, unstable in liquid. Samples and trials find that out before a production order does.\n5. **Write the specification and quote it.** Then a [stability program](/guides/stability-testing) is designed to support the shelf life the label will carry.","text":"Start from the brief. The customer, the claim, the format and the retail price come first. EverLeanBody's brief was a premium daily capsule for women 35 and over, at a set retail price, with the evidence and listing to sell it with confidence. Settle the pathway. Whether the product will be a listed medicine, a food or a cosmetic decides which ingredients, doses and claims are open to it. We settle it at the brief, never after the formula. See medicine, food or cosmetic?. Build on the evidence. Where the brief calls for it, we build on ingredients backed by double-blind, published clinical trials, often branded extracts such as affron®, KSM-66®, EnXtra® or Wellmune® (branded ingredients). Every claim arrives with the studies behind it and the indication it maps to: the claims evidence is built alongside the formula, not after it. Prove the format. A formula that reads well can still fail in production: too wet to encapsulate, too bitter to swallow, unstable in liquid. Samples and trials find that out before a production order does. Write the specification and quote it. Then a stability program is designed to support the shelf life the label will carry.","items":[{"lead":"Start from the brief.","text":"The customer, the claim, the format and the retail price come first. EverLeanBody's brief was a premium daily capsule for women 35 and over, at a set retail price, with the evidence and listing to sell it with confidence."},{"lead":"Settle the pathway.","text":"Whether the product will be a listed medicine, a food or a cosmetic decides which ingredients, doses and claims are open to it. We settle it at the brief, never after the formula. See medicine, food or cosmetic?."},{"lead":"Build on the evidence.","text":"Where the brief calls for it, we build on ingredients backed by double-blind, published clinical trials, often branded extracts such as affron®, KSM-66®, EnXtra® or Wellmune® (branded ingredients). Every claim arrives with the studies behind it and the indication it maps to: the claims evidence is built alongside the formula, not after it."},{"lead":"Prove the format.","text":"A formula that reads well can still fail in production: too wet to encapsulate, too bitter to swallow, unstable in liquid. Samples and trials find that out before a production order does."},{"lead":"Write the specification and quote it.","text":"Then a stability program is designed to support the shelf life the label will carry."}],"tables":[]},{"heading":"Formats we formulate","anchor":"formats-we-formulate","markdown":"Capsules, tablets and chewables, softgels, powders and sachets, liquids and oils, and creams and serums, across the TGA, FSANZ and cosmetics pathways. See [capsules, tablets and softgels](/formats/capsules-tablets-softgels), [gummies](/formats/gummies), [powders and sachets](/formats/powders-sachets) and [liquids](/formats/liquids).","text":"Capsules, tablets and chewables, softgels, powders and sachets, liquids and oils, and creams and serums, across the TGA, FSANZ and cosmetics pathways. See capsules, tablets and softgels, gummies, powders and sachets and liquids.","items":[],"tables":[]},{"heading":"When the first formula isn't the right one","anchor":"when-the-first-formula-isnt-the-right-one","markdown":"Getting a formula right sometimes takes more than one version, and a product already on the market sometimes needs a new one ([reformulating a supplement](/guides/reformulating-a-supplement)). From our records:\n\n- **Six versions of a postnatal formula** for [Mother Daily](/work/mother-daily-postnatal-supplement), with an evidence package covering eight key ingredients, until it was right.\n- **Three versions of a prenatal** built as much as possible on [plant powders](/work/prenatal-multivitamin-capsule), with a replacement supply of its lead plant ingredient.\n- **A prenatal moved from a liquid to a chewable** for [Arxi](/work/arxi-prenatal-chewable): the liquid wasn't stable and its taste couldn't be masked, so we traced the main odour to one selenium form and removed it, then used coated B vitamins to tame the taste.\n- **An eye-health formula updated before build** to the [AREDS2 vitamin E levels](/work/areds2-eye-health-formula).\n- **A capsule moved to a tablet** when the blend was too wet to encapsulate, [mid-project](/work/eye-health-tablet-format-rescue).","text":"Getting a formula right sometimes takes more than one version, and a product already on the market sometimes needs a new one (reformulating a supplement). From our records: Six versions of a postnatal formula for Mother Daily, with an evidence package covering eight key ingredients, until it was right. Three versions of a prenatal built as much as possible on plant powders, with a replacement supply of its lead plant ingredient. A prenatal moved from a liquid to a chewable for Arxi: the liquid wasn't stable and its taste couldn't be masked, so we traced the main odour to one selenium form and removed it, then used coated B vitamins to tame the taste. An eye-health formula updated before build to the AREDS2 vitamin E levels. A capsule moved to a tablet when the blend was too wet to encapsulate, mid-project.","items":[{"lead":"Six versions of a postnatal formula","text":"for Mother Daily, with an evidence package covering eight key ingredients, until it was right."},{"lead":"Three versions of a prenatal","text":"built as much as possible on plant powders, with a replacement supply of its lead plant ingredient."},{"lead":"A prenatal moved from a liquid to a chewable","text":"for Arxi: the liquid wasn't stable and its taste couldn't be masked, so we traced the main odour to one selenium form and removed it, then used coated B vitamins to tame the taste."},{"lead":"An eye-health formula updated before build","text":"to the AREDS2 vitamin E levels."},{"lead":"A capsule moved to a tablet","text":"when the blend was too wet to encapsulate, mid-project."}],"tables":[]},{"heading":"How formulation is priced","anchor":"how-formulation-is-priced","markdown":"Fixed fees for a defined outcome at each stage, from discovery to launch, and manufacturing priced per unit. You know the investment before each stage begins.","text":"Fixed fees for a defined outcome at each stage, from discovery to launch, and manufacturing priced per unit. You know the investment before each stage begins.","items":[],"tables":[]}],"faqs":[{"q":"Who can formulate and manufacture a supplement for my brand?","a":"We design the formula, the evidence behind its claims and its specification, then manage its manufacture, as one team. Take Friday Off isn't a contract manufacturer: cGMP partners matched to the format, the volume and the margin make the product, and we manage it through to your warehouse or 3PL. See how we manage manufacturing.","md":"We design the formula, the evidence behind its claims and its specification, then manage its manufacture, as one team. Take Friday Off isn't a contract manufacturer: cGMP partners matched to the format, the volume and the margin make the product, and we manage it through to your warehouse or 3PL. See [how we manage manufacturing](/manufacturing)."},{"q":"How long does supplement formulation take?","a":"It depends on the formula and the pathway. From our records: design to production order in 32 days for a complex herbal capsule, under seven weeks for an eye-health formula, and 12 weeks for a two-a-day skin supplement. EverLeanBody's first capsule took 5.8 months from signed brief to dispatch. More in how long it takes to develop a supplement.","md":"It depends on the formula and the pathway. From our records: design to production order in 32 days for a complex herbal capsule, under seven weeks for an eye-health formula, and 12 weeks for a two-a-day skin supplement. EverLeanBody's first capsule took 5.8 months from signed brief to dispatch. More in [how long it takes to develop a supplement](/guides/supplement-development-timeline)."},{"q":"Can you build a formula around a branded, clinically studied ingredient?","a":"Yes. Our formulas are built on ingredients including affron®, KSM-66®, EnXtra®, Wellmune®, Testofen®, life's®OMEGA, Eriomin® and Quatrefolic®.","md":"Yes. Our formulas are built on ingredients including affron®, KSM-66®, EnXtra®, Wellmune®, Testofen®, life's®OMEGA, Eriomin® and Quatrefolic®."},{"q":"Can you reformulate a product we already sell?","a":"Yes. We rebuilt four of a sports brand's best-known capsules from scratch, upgraded a hair care brand's formula with a full new listing package, and redeveloped a skin program supplement as the second version of its formula.","md":"Yes. We rebuilt four of a sports brand's best-known capsules from scratch, upgraded a hair care brand's formula with a full new listing package, and redeveloped a skin program supplement as the second version of its formula."},{"q":"Do you formulate for practitioner brands?","a":"Yes. We developed nine products for BWellness, a practitioner-channel brand serving naturopaths and nutritionists, and the founder's own brand, Ora, is a practitioner-grade range.","md":"Yes. We developed nine products for BWellness, a practitioner-channel brand serving naturopaths and nutritionists, and the founder's own brand, Ora, is a practitioner-grade range."},{"q":"What do you need from us to start?","a":"A product idea, the customer it is for and the price it has to sell at. The brief workshop turns that into the brief everything else is built on. The readiness check takes four questions.","md":"A product idea, the customer it is for and the price it has to sell at. The brief workshop turns that into the brief everything else is built on. The [readiness check](/partner) takes four questions."},{"q":"Can I taste a sample before production?","a":"Yes. You approve the formula on paper at the formulation presentation, with every ingredient and dose and the quote. The R&D sample is then made and sent to you, and nothing goes into production until you approve it. If it isn't right, one round of sample rework is included. Optional prototypes are available for brands that want product in hand earlier.","md":"Yes. You approve the formula on paper at the formulation presentation, with every ingredient and dose and the quote. The R&D sample is then made and sent to you, and nothing goes into production until you approve it. If it isn't right, one round of sample rework is included. Optional prototypes are available for brands that want product in hand earlier."},{"q":"How many rounds of changes are included?","a":"One round of reformulation and requoting at the formulation stage, and one round of sample rework at the sample stage. Each round takes two to three weeks.","md":"One round of reformulation and requoting at the formulation stage, and one round of sample rework at the sample stage. Each round takes two to three weeks."},{"q":"How long does it take from brief to finished product?","a":"About six months at best, and we have done it: EverLeanBody's first capsule took 5.8 months from signed brief to dispatch to its 3PL. That best case is a Design phase of 8 to 10 weeks (the brief, the formulation, the quote and your order) and a Build phase of 20 to 24 weeks (the sample, the specification, the listing and label, then 12 to 14 weeks in manufacture), with every approval made promptly and no rework. Extra rounds of changes, and time waiting on decisions, add to it. More in how long it takes to develop a supplement.","md":"About six months at best, and we have done it: EverLeanBody's first capsule took 5.8 months from signed brief to dispatch to its 3PL. That best case is a Design phase of 8 to 10 weeks (the brief, the formulation, the quote and your order) and a Build phase of 20 to 24 weeks (the sample, the specification, the listing and label, then 12 to 14 weeks in manufacture), with every approval made promptly and no rework. Extra rounds of changes, and time waiting on decisions, add to it. More in [how long it takes to develop a supplement](/guides/supplement-development-timeline)."},{"q":"Are you supplement formulation consultants in Sydney?","a":"We're a product development partner based in Brookvale, Sydney, working with brands across Australia and the Asia-Pacific. Formulation is one stage of that work: we design the formula and the evidence behind its claims, then take it through the listing and managed manufacturing.","md":"We're a product development partner based in Brookvale, Sydney, working with brands across Australia and the Asia-Pacific. Formulation is one stage of that work: we design the formula and the evidence behind its claims, then take it through the listing and managed manufacturing."}],"sources":null},{"slug":"supplement-development-sydney","kind":"service","url":"/supplement-development-sydney","title":"Supplement product development in Sydney, from formula to shelf","name":"Sydney","description":"Supplement product development in Sydney: the formula, the evidence, the TGA listing, the label and managed manufacturing, from our base in Brookvale.","eyebrow":"Sydney","lead":"Take Friday Off is a supplement and natural health product development company in Brookvale, on Sydney's Northern Beaches. We take a product from the first idea to a compliant product on the shelf: the formula, the evidence behind every claim, the TGA listing, the label and the packaging, then we manage its manufacture through audited partners and deliver it to your warehouse. We work with brands across Australia and New Zealand, and the first step is a 15-minute call.","studies":["everleanbody-saffron-capsule","ashwagandha-capsule-32-days","the-belly-solution-travel-gut-health-powder","arxi-preconception-supplement"],"formats":[],"order":25,"updated":"2026-10-28","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- **Where:** 37/42-46 Wattle Road, Brookvale NSW 2100, on Sydney's Northern Beaches. We work with brands across Australia and New Zealand.\n- **What:** one team for the whole job: the brief, the formula, the evidence for every claim, the listing, the label, the packaging, and the manufacture and delivery to your warehouse. You deal with us; we deal with the factory.\n- **Pathways:** TGA-listed medicines, foods and cosmetics, in capsules, tablets and chewables, softgels, gummies, powders and sachets, liquids and oils, and creams and serums.\n- **Track record:** 190 projects since 2020; 32 days from design to production order on a complex herbal capsule; 5.8 months from signed brief to dispatch for EverLeanBody.\n- **Pricing:** fixed fees for a defined outcome at each stage, and manufacturing priced per unit. No hourly meters.","text":"Where: 37/42-46 Wattle Road, Brookvale NSW 2100, on Sydney's Northern Beaches. We work with brands across Australia and New Zealand. What: one team for the whole job: the brief, the formula, the evidence for every claim, the listing, the label, the packaging, and the manufacture and delivery to your warehouse. You deal with us; we deal with the factory. Pathways: TGA-listed medicines, foods and cosmetics, in capsules, tablets and chewables, softgels, gummies, powders and sachets, liquids and oils, and creams and serums. Track record: 190 projects since 2020; 32 days from design to production order on a complex herbal capsule; 5.8 months from signed brief to dispatch for EverLeanBody. Pricing: fixed fees for a defined outcome at each stage, and manufacturing priced per unit. No hourly meters.","items":[{"lead":"Where:","text":"37/42-46 Wattle Road, Brookvale NSW 2100, on Sydney's Northern Beaches. We work with brands across Australia and New Zealand."},{"lead":"What:","text":"one team for the whole job: the brief, the formula, the evidence for every claim, the listing, the label, the packaging, and the manufacture and delivery to your warehouse. You deal with us; we deal with the factory."},{"lead":"Pathways:","text":"TGA-listed medicines, foods and cosmetics, in capsules, tablets and chewables, softgels, gummies, powders and sachets, liquids and oils, and creams and serums."},{"lead":"Track record:","text":"190 projects since 2020; 32 days from design to production order on a complex herbal capsule; 5.8 months from signed brief to dispatch for EverLeanBody."},{"lead":"Pricing:","text":"fixed fees for a defined outcome at each stage, and manufacturing priced per unit. No hourly meters."}],"tables":[]},{"heading":"A development partner, not a single factory","anchor":"a-development-partner-not-a-single-factory","markdown":"A manufacturer makes what it is given. It won't check whether your formula fits its pathway, whether your claims hold up or whether your label is right. That risk sits with you, and it surfaces after launch, when fixing it means relabelling or pulling stock.\n\nWe carry the whole job as one team, and we manage the manufacture: cGMP partners matched to your format, volume and margin, then release testing, imports and freight through to your warehouse or 3PL. More on [managed manufacturing](/manufacturing) and on [choosing a supplement manufacturer](/guides/choosing-a-supplement-manufacturer).","text":"A manufacturer makes what it is given. It won't check whether your formula fits its pathway, whether your claims hold up or whether your label is right. That risk sits with you, and it surfaces after launch, when fixing it means relabelling or pulling stock. We carry the whole job as one team, and we manage the manufacture: cGMP partners matched to your format, volume and margin, then release testing, imports and freight through to your warehouse or 3PL. More on managed manufacturing and on choosing a supplement manufacturer.","items":[],"tables":[]},{"heading":"The five steps","anchor":"the-five-steps","markdown":"Friday Launch Engine™ runs the steps side by side, not one after another:\n\n1. **Discover:** market, portfolio, pathway and forecast aligned before anything is formulated.\n2. **Design:** evidence-based formulation, with early access to new ingredients.\n3. **De-risk:** claims, evidence, labels and listings, prepared alongside the formula, not after it.\n4. **Deliver:** we manage your manufacturing: production, packaging, release testing and freight.\n5. **Drive:** reorders, range extensions and your next SKU, with the same team.\n\n[See Friday Launch Engine™](/system), or start with [how to start a supplement brand in Australia](/guides/start-a-supplement-brand).","text":"Friday Launch Engine™ runs the steps side by side, not one after another: Discover: market, portfolio, pathway and forecast aligned before anything is formulated. Design: evidence-based formulation, with early access to new ingredients. De-risk: claims, evidence, labels and listings, prepared alongside the formula, not after it. Deliver: we manage your manufacturing: production, packaging, release testing and freight. Drive: reorders, range extensions and your next SKU, with the same team. See Friday Launch Engine™, or start with how to start a supplement brand in Australia.","items":[{"lead":"Discover:","text":"market, portfolio, pathway and forecast aligned before anything is formulated."},{"lead":"Design:","text":"evidence-based formulation, with early access to new ingredients."},{"lead":"De-risk:","text":"claims, evidence, labels and listings, prepared alongside the formula, not after it."},{"lead":"Deliver:","text":"we manage your manufacturing: production, packaging, release testing and freight."},{"lead":"Drive:","text":"reorders, range extensions and your next SKU, with the same team."}],"tables":[]},{"heading":"From our records","anchor":"from-our-records","markdown":"- [EverLeanBody](/work/everleanbody-saffron-capsule): a TGA-listed capsule built around affron®, 5.8 months from signed brief to dispatch, with a second product now in development with us.\n- [A complex herbal capsule](/work/ashwagandha-capsule-32-days) built around KSM-66® ashwagandha, with an evidence package covering more than 13 ingredients: 32 days from design to production order.\n- [The Belly Solution](/work/the-belly-solution-travel-gut-health-powder): a TGA-listed travel gut-health powder, about eight months from formulation to dispatch, then a national pharmacy distribution trial with more than 30 new stockists in the first week.\n- [Arxi](/work/arxi-preconception-supplement): a TGA-listed preconception capsule, with three production orders since 2024.","text":"EverLeanBody: a TGA-listed capsule built around affron®, 5.8 months from signed brief to dispatch, with a second product now in development with us. A complex herbal capsule built around KSM-66® ashwagandha, with an evidence package covering more than 13 ingredients: 32 days from design to production order. The Belly Solution: a TGA-listed travel gut-health powder, about eight months from formulation to dispatch, then a national pharmacy distribution trial with more than 30 new stockists in the first week. Arxi: a TGA-listed preconception capsule, with three production orders since 2024.","items":[],"tables":[]}],"faqs":[{"q":"Is Take Friday Off a supplement manufacturer in Sydney?","a":"We're a product development company, not a factory. We develop the product and make it compliant, then manage its manufacture through audited cGMP partners matched to its format, volume and margin, and deliver it to your warehouse or 3PL.","md":"We're a product development company, not a factory. We develop the product and make it compliant, then manage its manufacture through audited cGMP partners matched to its format, volume and margin, and deliver it to your warehouse or 3PL."},{"q":"Do you only work with Sydney brands?","a":"No. We're based in Brookvale and work with brands across Australia and New Zealand, including Melbourne and Brisbane.","md":"No. We're based in Brookvale and work with brands across Australia and New Zealand, including [Melbourne](/supplement-development-melbourne) and [Brisbane](/supplement-development-brisbane)."},{"q":"Can you help me build a TGA-listed supplement brand?","a":"Yes: the formula inside the permitted ingredients and indications, the evidence for every claim, the label, the stability program and the listing, which your company certifies as the sponsor. We're built for established brands and for challenger brands with the backing to scale; the readiness check takes four questions.","md":"Yes: the formula inside the permitted ingredients and indications, the evidence for every claim, the label, the stability program and the listing, which your company certifies as the [sponsor](/guides/tga-sponsor). We're built for established brands and for challenger brands with the backing to scale; the [readiness check](/partner) takes four questions."},{"q":"What does it cost?","a":"Development stages are fixed fees for a defined outcome, and manufacturing is priced per unit. See what a supplement costs to develop.","md":"Development stages are fixed fees for a defined outcome, and manufacturing is priced per unit. See [what a supplement costs to develop](/guides/supplement-development-cost)."},{"q":"How do I start?","a":"Book a 15-minute call, or tell us what you're building on the contact page. Gabriel replies within one business day.","md":"Book a 15-minute call, or tell us what you're building on the [contact page](/contact). Gabriel replies within one business day."}],"sources":null},{"slug":"supplement-development-melbourne","kind":"service","url":"/supplement-development-melbourne","title":"Supplement product development for Melbourne brands","name":"Melbourne","description":"Supplement product development for Melbourne and Victorian brands: the formula, evidence, TGA listing, label and managed manufacturing, delivered to you.","eyebrow":"Melbourne","lead":"Take Friday Off develops supplements and natural health products for brands across Australia and New Zealand, including brands in Melbourne and the rest of Victoria. We're based in Brookvale, Sydney, and the work doesn't depend on where you are: the TGA's rules are the same in every state, and we manage manufacturing through audited partners and deliver to your warehouse or 3PL. This page covers how working with us from Melbourne runs, what's national and what's Victorian, and what we've delivered.","studies":["the-belly-solution-travel-gut-health-powder","everleanbody-saffron-capsule","sports-brand-core-range","arxi-preconception-supplement"],"formats":[],"order":26,"updated":"2026-11-03","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- **Where we are:** 37/42-46 Wattle Road, Brookvale NSW 2100. We work with brands across Australia and New Zealand, and the first step is a 15-minute call.\n- **What we do:** one team for the whole job: the brief, the formula, the evidence for every claim, the listing, the label, the packaging, and the manufacture and delivery to your warehouse or 3PL in Victoria.\n- **National rules:** a TGA-listed medicine is listed, labelled and advertised under the same Commonwealth rules wherever the brand is based.\n- **Victorian rules:** if your product is a food rather than a medicine, the premises that store and handle it in Victoria register with, or notify, their local council under the Food Act 1984.\n- **Track record:** 190 projects since 2020; 32 days from design to production order on a complex herbal capsule; 5.8 months from signed brief to dispatch for EverLeanBody.","text":"Where we are: 37/42-46 Wattle Road, Brookvale NSW 2100. We work with brands across Australia and New Zealand, and the first step is a 15-minute call. What we do: one team for the whole job: the brief, the formula, the evidence for every claim, the listing, the label, the packaging, and the manufacture and delivery to your warehouse or 3PL in Victoria. National rules: a TGA-listed medicine is listed, labelled and advertised under the same Commonwealth rules wherever the brand is based. Victorian rules: if your product is a food rather than a medicine, the premises that store and handle it in Victoria register with, or notify, their local council under the Food Act 1984. Track record: 190 projects since 2020; 32 days from design to production order on a complex herbal capsule; 5.8 months from signed brief to dispatch for EverLeanBody.","items":[{"lead":"Where we are:","text":"37/42-46 Wattle Road, Brookvale NSW 2100. We work with brands across Australia and New Zealand, and the first step is a 15-minute call."},{"lead":"What we do:","text":"one team for the whole job: the brief, the formula, the evidence for every claim, the listing, the label, the packaging, and the manufacture and delivery to your warehouse or 3PL in Victoria."},{"lead":"National rules:","text":"a TGA-listed medicine is listed, labelled and advertised under the same Commonwealth rules wherever the brand is based."},{"lead":"Victorian rules:","text":"if your product is a food rather than a medicine, the premises that store and handle it in Victoria register with, or notify, their local council under the Food Act 1984."},{"lead":"Track record:","text":"190 projects since 2020; 32 days from design to production order on a complex herbal capsule; 5.8 months from signed brief to dispatch for EverLeanBody."}],"tables":[]},{"heading":"Working with us from Melbourne","anchor":"working-with-us-from-melbourne","markdown":"Product development is mostly decisions, documents and samples, so it runs the same way whether a brand is in Melbourne or on the Northern Beaches:\n\n1. **A 15-minute call** to see whether the product and the timing fit. Then a brief.\n2. **The five steps of Friday Launch Engine™**, run side by side: discover, design, de-risk, deliver and drive ([Friday Launch Engine™](/system)).\n3. **Samples and proofs** for your sign-off: formula samples, label proofs and packaging.\n4. **Manufacture through audited cGMP partners** matched to your format, volume and margin, then release testing, imports where needed and freight to your warehouse or 3PL ([managed manufacturing](/manufacturing)).\n\nDevelopment stages are fixed fees for a defined outcome, and manufacturing is priced per unit.","text":"Product development is mostly decisions, documents and samples, so it runs the same way whether a brand is in Melbourne or on the Northern Beaches: A 15-minute call to see whether the product and the timing fit. Then a brief. The five steps of Friday Launch Engine™, run side by side: discover, design, de-risk, deliver and drive (Friday Launch Engine™). Samples and proofs for your sign-off: formula samples, label proofs and packaging. Manufacture through audited cGMP partners matched to your format, volume and margin, then release testing, imports where needed and freight to your warehouse or 3PL (managed manufacturing). Development stages are fixed fees for a defined outcome, and manufacturing is priced per unit.","items":[{"lead":"A 15-minute call","text":"to see whether the product and the timing fit. Then a brief."},{"lead":"The five steps of Friday Launch Engine™","text":", run side by side: discover, design, de-risk, deliver and drive (Friday Launch Engine™)."},{"lead":"Samples and proofs","text":"for your sign-off: formula samples, label proofs and packaging."},{"lead":"Manufacture through audited cGMP partners","text":"matched to your format, volume and margin, then release testing, imports where needed and freight to your warehouse or 3PL (managed manufacturing)."}],"tables":[]},{"heading":"What's national, and what's Victorian","anchor":"whats-national-and-whats-victorian","markdown":"**National.** Most supplements in our records are TGA-listed medicines. The Therapeutic Goods Act is Commonwealth law: the listing on the ARTG, the permitted ingredients and indications, the label under TGO 116 and the Advertising Code are the same for a Melbourne brand as for a Sydney one ([TGA approval](/guides/tga-approval)). The company that lists the medicine is its sponsor: an Australian resident, or a company incorporated and doing business in Australia ([the TGA sponsor](/guides/tga-sponsor)).\n\n**Victorian.** A supplement sold as a food, such as many sports and protein powders, is covered by the Food Standards Code, which the states, territories and local councils enforce ([the food pathway](/pathways/foods)). In Victoria, food premises register with their local council each year, or notify it, under the Food Act 1984, depending on their class. The class is set by the riskiest activity on the premises. A Melbourne council, the City of Darebin, gives examples: class 4 covers premises mainly handling pre-packaged, low-risk foods and needs a one-off notification; class 3 covers handling unpackaged low-risk food or high-risk pre-packaged food, and applies to warehouses and distributors; and penalties apply for selling food without registering. Your council confirms the class.","text":"National. Most supplements in our records are TGA-listed medicines. The Therapeutic Goods Act is Commonwealth law: the listing on the ARTG, the permitted ingredients and indications, the label under TGO 116 and the Advertising Code are the same for a Melbourne brand as for a Sydney one (TGA approval). The company that lists the medicine is its sponsor: an Australian resident, or a company incorporated and doing business in Australia (the TGA sponsor). Victorian. A supplement sold as a food, such as many sports and protein powders, is covered by the Food Standards Code, which the states, territories and local councils enforce (the food pathway). In Victoria, food premises register with their local council each year, or notify it, under the Food Act 1984, depending on their class. The class is set by the riskiest activity on the premises. A Melbourne council, the City of Darebin, gives examples: class 4 covers premises mainly handling pre-packaged, low-risk foods and needs a one-off notification; class 3 covers handling unpackaged low-risk food or high-risk pre-packaged food, and applies to warehouses and distributors; and penalties apply for selling food without registering. Your council confirms the class.","items":[],"tables":[]},{"heading":"From our records","anchor":"from-our-records","markdown":"- [The Belly Solution](/work/the-belly-solution-travel-gut-health-powder): a TGA-listed travel gut-health powder, about eight months from formulation to dispatch, then a national pharmacy distribution trial with more than 30 new stockists in the first week.\n- [EverLeanBody](/work/everleanbody-saffron-capsule): a TGA-listed capsule built around affron®, 5.8 months from signed brief to dispatch, delivered to the brand's third-party logistics partner.\n- [ATP Science's core range](/work/sports-brand-core-range): four TGA-listed capsules reformulated from scratch and a food-pathway performance powder, with reorders on three within a year.\n- [Arxi](/work/arxi-preconception-supplement): a TGA-listed preconception capsule, with three production orders since 2024.","text":"The Belly Solution: a TGA-listed travel gut-health powder, about eight months from formulation to dispatch, then a national pharmacy distribution trial with more than 30 new stockists in the first week. EverLeanBody: a TGA-listed capsule built around affron®, 5.8 months from signed brief to dispatch, delivered to the brand's third-party logistics partner. ATP Science's core range: four TGA-listed capsules reformulated from scratch and a food-pathway performance powder, with reorders on three within a year. Arxi: a TGA-listed preconception capsule, with three production orders since 2024.","items":[],"tables":[]}],"faqs":[{"q":"Do you work with brands in Melbourne?","a":"Yes. We're based in Brookvale, Sydney, and work with brands across Australia and New Zealand. Development runs through calls, documents and samples, and we deliver the finished product to your warehouse or 3PL.","md":"Yes. We're based in Brookvale, Sydney, and work with brands across Australia and New Zealand. Development runs through calls, documents and samples, and we deliver the finished product to your warehouse or 3PL."},{"q":"Is Take Friday Off a supplement manufacturer?","a":"We're a product development company, not a factory. We develop the product and make it compliant, then manage its manufacture through audited cGMP partners and deliver it to you. See choosing a supplement manufacturer.","md":"We're a product development company, not a factory. We develop the product and make it compliant, then manage its manufacture through audited cGMP partners and deliver it to you. See [choosing a supplement manufacturer](/guides/choosing-a-supplement-manufacturer)."},{"q":"Are the TGA rules different in Victoria?","a":"No. A listed medicine follows the same Commonwealth rules in every state. What differs is the state law for foods: in Victoria, food premises register with, or notify, their local council under the Food Act 1984.","md":"No. A listed medicine follows the same Commonwealth rules in every state. What differs is the state law for foods: in Victoria, food premises register with, or notify, their local council under the Food Act 1984."},{"q":"What does it cost?","a":"Development stages are fixed fees for a defined outcome, and manufacturing is priced per unit. See what a supplement costs to develop.","md":"Development stages are fixed fees for a defined outcome, and manufacturing is priced per unit. See [what a supplement costs to develop](/guides/supplement-development-cost)."},{"q":"How do I start?","a":"Book a 15-minute call, or tell us what you're building on the contact page.","md":"Book a 15-minute call, or tell us what you're building on the [contact page](/contact)."}],"sources":{"note":"General information, checked against these sources on 3 November 2026. It isn't advice on a particular product. Our work is from Take Friday Off's records.","markdown":"General information, checked against these sources on 3 November 2026. It isn't advice on a particular product. Our work is from Take Friday Off's records.\n\n- [Permits and requirements for running a food business](https://www.darebin.vic.gov.au/Business-and-industry/Business-permits/Food-business-registration/Permits-and-requirements-for-running-a-food-business), Darebin City Council (Food Act 1984 (Vic))\n- [Therapeutic Goods Act 1989](https://www.legislation.gov.au/C2004A03952/latest/text), Federal Register of Legislation\n- [Food and medicine regulation](https://www.tga.gov.au/community-qa/food-and-medicine-regulation), Therapeutic Goods Administration","items":[{"text":"Permits and requirements for running a food business, Darebin City Council (Food Act 1984 (Vic))","links":[{"title":"Permits and requirements for running a food business","url":"https://www.darebin.vic.gov.au/Business-and-industry/Business-permits/Food-business-registration/Permits-and-requirements-for-running-a-food-business"}]},{"text":"Therapeutic Goods Act 1989, Federal Register of Legislation","links":[{"title":"Therapeutic Goods Act 1989","url":"https://www.legislation.gov.au/C2004A03952/latest/text"}]},{"text":"Food and medicine regulation, Therapeutic Goods Administration","links":[{"title":"Food and medicine regulation","url":"https://www.tga.gov.au/community-qa/food-and-medicine-regulation"}]}]}},{"slug":"supplement-development-brisbane","kind":"service","url":"/supplement-development-brisbane","title":"Supplement product development for Brisbane brands","name":"Brisbane","description":"Supplement product development for Brisbane and Queensland brands: the formula, evidence, TGA listing, label and managed manufacturing, delivered to you.","eyebrow":"Brisbane","lead":"Take Friday Off develops supplements and natural health products for brands across Australia and New Zealand, including brands in Brisbane and the rest of Queensland. We're based in Brookvale, Sydney, and the work doesn't depend on where you are: the TGA's rules are the same in every state, and we manage manufacturing through audited partners and deliver to your warehouse or 3PL. This page covers how working with us from Brisbane runs, what's national and what's Queensland's, and what we've delivered.","studies":["ashwagandha-capsule-32-days","the-belly-solution-travel-gut-health-powder","sports-brand-core-range","everleanbody-saffron-capsule"],"formats":[],"order":27,"updated":"2026-11-03","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- **Where we are:** 37/42-46 Wattle Road, Brookvale NSW 2100. We work with brands across Australia and New Zealand, and the first step is a 15-minute call.\n- **What we do:** one team for the whole job: the brief, the formula, the evidence for every claim, the listing, the label, the packaging, and the manufacture and delivery to your warehouse or 3PL in Queensland.\n- **National rules:** a TGA-listed medicine is listed, labelled and advertised under the same Commonwealth rules wherever the brand is based.\n- **Queensland rules:** if your product is a food rather than a medicine, most food businesses in Queensland need a licence from their local council under the Food Act 2006, including one that manufactures food.\n- **Track record:** 190 projects since 2020; 32 days from design to production order on a complex herbal capsule; 5.8 months from signed brief to dispatch for EverLeanBody.","text":"Where we are: 37/42-46 Wattle Road, Brookvale NSW 2100. We work with brands across Australia and New Zealand, and the first step is a 15-minute call. What we do: one team for the whole job: the brief, the formula, the evidence for every claim, the listing, the label, the packaging, and the manufacture and delivery to your warehouse or 3PL in Queensland. National rules: a TGA-listed medicine is listed, labelled and advertised under the same Commonwealth rules wherever the brand is based. Queensland rules: if your product is a food rather than a medicine, most food businesses in Queensland need a licence from their local council under the Food Act 2006, including one that manufactures food. Track record: 190 projects since 2020; 32 days from design to production order on a complex herbal capsule; 5.8 months from signed brief to dispatch for EverLeanBody.","items":[{"lead":"Where we are:","text":"37/42-46 Wattle Road, Brookvale NSW 2100. We work with brands across Australia and New Zealand, and the first step is a 15-minute call."},{"lead":"What we do:","text":"one team for the whole job: the brief, the formula, the evidence for every claim, the listing, the label, the packaging, and the manufacture and delivery to your warehouse or 3PL in Queensland."},{"lead":"National rules:","text":"a TGA-listed medicine is listed, labelled and advertised under the same Commonwealth rules wherever the brand is based."},{"lead":"Queensland rules:","text":"if your product is a food rather than a medicine, most food businesses in Queensland need a licence from their local council under the Food Act 2006, including one that manufactures food."},{"lead":"Track record:","text":"190 projects since 2020; 32 days from design to production order on a complex herbal capsule; 5.8 months from signed brief to dispatch for EverLeanBody."}],"tables":[]},{"heading":"Working with us from Brisbane","anchor":"working-with-us-from-brisbane","markdown":"Product development is mostly decisions, documents and samples, so it runs the same way whether a brand is in Brisbane or on the Northern Beaches:\n\n1. **A 15-minute call** to see whether the product and the timing fit. Then a brief.\n2. **The five steps of Friday Launch Engine™**, run side by side: discover, design, de-risk, deliver and drive ([Friday Launch Engine™](/system)).\n3. **Samples and proofs** for your sign-off: formula samples, label proofs and packaging.\n4. **Manufacture through audited cGMP partners** matched to your format, volume and margin, then release testing, imports where needed and freight to your warehouse or 3PL ([managed manufacturing](/manufacturing)).\n\nDevelopment stages are fixed fees for a defined outcome, and manufacturing is priced per unit.","text":"Product development is mostly decisions, documents and samples, so it runs the same way whether a brand is in Brisbane or on the Northern Beaches: A 15-minute call to see whether the product and the timing fit. Then a brief. The five steps of Friday Launch Engine™, run side by side: discover, design, de-risk, deliver and drive (Friday Launch Engine™). Samples and proofs for your sign-off: formula samples, label proofs and packaging. Manufacture through audited cGMP partners matched to your format, volume and margin, then release testing, imports where needed and freight to your warehouse or 3PL (managed manufacturing). Development stages are fixed fees for a defined outcome, and manufacturing is priced per unit.","items":[{"lead":"A 15-minute call","text":"to see whether the product and the timing fit. Then a brief."},{"lead":"The five steps of Friday Launch Engine™","text":", run side by side: discover, design, de-risk, deliver and drive (Friday Launch Engine™)."},{"lead":"Samples and proofs","text":"for your sign-off: formula samples, label proofs and packaging."},{"lead":"Manufacture through audited cGMP partners","text":"matched to your format, volume and margin, then release testing, imports where needed and freight to your warehouse or 3PL (managed manufacturing)."}],"tables":[]},{"heading":"What's national, and what's Queensland's","anchor":"whats-national-and-whats-queenslands","markdown":"**National.** Most supplements in our records are TGA-listed medicines. The Therapeutic Goods Act is Commonwealth law: the listing on the ARTG, the permitted ingredients and indications, the label under TGO 116 and the Advertising Code are the same for a Brisbane brand as for a Sydney one ([TGA approval](/guides/tga-approval)). The company that lists the medicine is its sponsor: an Australian resident, or a company incorporated and doing business in Australia ([the TGA sponsor](/guides/tga-sponsor)).\n\n**Queensland.** A supplement sold as a food, such as many sports and protein powders, is covered by the Food Standards Code, which the states, territories and local councils enforce ([the food pathway](/pathways/foods)). In Queensland, the Food Act 2006 means most food businesses need a licence from their local council, including a business that \"manufactures food (making food by combining ingredients)\". Primary producers such as dairy and meat businesses are accredited by Safe Food Production Queensland instead. Licensed or not, a food business must comply with all food safety legislation. Your council confirms what your business needs.","text":"National. Most supplements in our records are TGA-listed medicines. The Therapeutic Goods Act is Commonwealth law: the listing on the ARTG, the permitted ingredients and indications, the label under TGO 116 and the Advertising Code are the same for a Brisbane brand as for a Sydney one (TGA approval). The company that lists the medicine is its sponsor: an Australian resident, or a company incorporated and doing business in Australia (the TGA sponsor). Queensland. A supplement sold as a food, such as many sports and protein powders, is covered by the Food Standards Code, which the states, territories and local councils enforce (the food pathway). In Queensland, the Food Act 2006 means most food businesses need a licence from their local council, including a business that \"manufactures food (making food by combining ingredients)\". Primary producers such as dairy and meat businesses are accredited by Safe Food Production Queensland instead. Licensed or not, a food business must comply with all food safety legislation. Your council confirms what your business needs.","items":[],"tables":[]},{"heading":"From our records","anchor":"from-our-records","markdown":"- [A complex herbal capsule](/work/ashwagandha-capsule-32-days) built around KSM-66® ashwagandha, with an evidence package covering more than 13 ingredients: 32 days from design to production order.\n- [The Belly Solution](/work/the-belly-solution-travel-gut-health-powder): a TGA-listed travel gut-health powder, about eight months from formulation to dispatch, then a national pharmacy distribution trial with more than 30 new stockists in the first week.\n- [ATP Science's core range](/work/sports-brand-core-range): four TGA-listed capsules reformulated from scratch and a food-pathway performance powder, with reorders on three within a year.\n- [EverLeanBody](/work/everleanbody-saffron-capsule): a TGA-listed capsule built around affron®, 5.8 months from signed brief to dispatch, delivered to the brand's third-party logistics partner.","text":"A complex herbal capsule built around KSM-66® ashwagandha, with an evidence package covering more than 13 ingredients: 32 days from design to production order. The Belly Solution: a TGA-listed travel gut-health powder, about eight months from formulation to dispatch, then a national pharmacy distribution trial with more than 30 new stockists in the first week. ATP Science's core range: four TGA-listed capsules reformulated from scratch and a food-pathway performance powder, with reorders on three within a year. EverLeanBody: a TGA-listed capsule built around affron®, 5.8 months from signed brief to dispatch, delivered to the brand's third-party logistics partner.","items":[],"tables":[]}],"faqs":[{"q":"Do you work with brands in Brisbane?","a":"Yes. We're based in Brookvale, Sydney, and work with brands across Australia and New Zealand. Development runs through calls, documents and samples, and we deliver the finished product to your warehouse or 3PL.","md":"Yes. We're based in Brookvale, Sydney, and work with brands across Australia and New Zealand. Development runs through calls, documents and samples, and we deliver the finished product to your warehouse or 3PL."},{"q":"Is Take Friday Off a supplement manufacturer?","a":"We're a product development company, not a factory. We develop the product and make it compliant, then manage its manufacture through audited cGMP partners and deliver it to you. See choosing a supplement manufacturer.","md":"We're a product development company, not a factory. We develop the product and make it compliant, then manage its manufacture through audited cGMP partners and deliver it to you. See [choosing a supplement manufacturer](/guides/choosing-a-supplement-manufacturer)."},{"q":"Are the TGA rules different in Queensland?","a":"No. A listed medicine follows the same Commonwealth rules in every state. What differs is the state law for foods: in Queensland, most food businesses, including food manufacturers, need a licence from their local council under the Food Act 2006.","md":"No. A listed medicine follows the same Commonwealth rules in every state. What differs is the state law for foods: in Queensland, most food businesses, including food manufacturers, need a licence from their local council under the Food Act 2006."},{"q":"What does it cost?","a":"Development stages are fixed fees for a defined outcome, and manufacturing is priced per unit. See what a supplement costs to develop.","md":"Development stages are fixed fees for a defined outcome, and manufacturing is priced per unit. See [what a supplement costs to develop](/guides/supplement-development-cost)."},{"q":"How do I start?","a":"Book a 15-minute call, or tell us what you're building on the contact page.","md":"Book a 15-minute call, or tell us what you're building on the [contact page](/contact)."}],"sources":{"note":"General information, checked against these sources on 3 November 2026. It isn't advice on a particular product. Our work is from Take Friday Off's records.","markdown":"General information, checked against these sources on 3 November 2026. It isn't advice on a particular product. Our work is from Take Friday Off's records.\n\n- [Do I need a food business licence?](https://www.qld.gov.au/health/staying-healthy/food-pantry/starting-a-food-business/food-business-licences/do-i-need-a-food-business-licence), Queensland Government, last updated 26 November 2025 (Food Act 2006 (Qld))\n- [Therapeutic Goods Act 1989](https://www.legislation.gov.au/C2004A03952/latest/text), Federal Register of Legislation\n- [Food and medicine regulation](https://www.tga.gov.au/community-qa/food-and-medicine-regulation), Therapeutic Goods Administration","items":[{"text":"Do I need a food business licence?, Queensland Government, last updated 26 November 2025 (Food Act 2006 (Qld))","links":[{"title":"Do I need a food business licence?","url":"https://www.qld.gov.au/health/staying-healthy/food-pantry/starting-a-food-business/food-business-licences/do-i-need-a-food-business-licence"}]},{"text":"Therapeutic Goods Act 1989, Federal Register of Legislation","links":[{"title":"Therapeutic Goods Act 1989","url":"https://www.legislation.gov.au/C2004A03952/latest/text"}]},{"text":"Food and medicine regulation, Therapeutic Goods Administration","links":[{"title":"Food and medicine regulation","url":"https://www.tga.gov.au/community-qa/food-and-medicine-regulation"}]}]}},{"slug":"skincare","kind":"service","url":"/skincare","title":"Skincare, sunscreen and cosmetic product development","name":"Skincare and cosmetics","description":"Creams, serums and sunscreens developed for Australian brands on the cosmetics or TGA pathway: formula, claims, compliance and managed cosmetic manufacturing.","eyebrow":"Skincare and cosmetics","lead":"We develop creams, serums and sunscreens on the cosmetics pathway or as TGA-listed medicines, settle which one the claims put them on, and manage their manufacture through cGMP partners through to your warehouse.","studies":["pain-relief-cream","vitable-hair-growth-range","skincare-brand-regulatory-partner","deeply-rooted-organic-oil"],"formats":["creams"],"order":30,"updated":"2026-10-19","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- In Australia a cream, serum or lotion is a cosmetic while its claims stay cosmetic: appearance, cleansing, odour, and protecting the skin or keeping it in good condition.\n- A therapeutic claim, a scheduled poison or the way it is used makes it a therapeutic good, regulated by the TGA.\n- A primary sunscreen is a therapeutic good; an SPF 4 to 15 moisturiser can stay a cosmetic if it meets every condition of the Excluded Goods Determination.\n- A business that imports cosmetics or their ingredients, or makes a chemical for sale, generally registers with AICIS each year it does.","text":"In Australia a cream, serum or lotion is a cosmetic while its claims stay cosmetic: appearance, cleansing, odour, and protecting the skin or keeping it in good condition. A therapeutic claim, a scheduled poison or the way it is used makes it a therapeutic good, regulated by the TGA. A primary sunscreen is a therapeutic good; an SPF 4 to 15 moisturiser can stay a cosmetic if it meets every condition of the Excluded Goods Determination. A business that imports cosmetics or their ingredients, or makes a chemical for sale, generally registers with AICIS each year it does.","items":[],"tables":[]},{"heading":"Cosmetic or medicine: the claim decides","anchor":"cosmetic-or-medicine-the-claim-decides","markdown":"A cream, serum or lotion is a cosmetic in Australia while it only changes how the skin looks, cleanses it, perfumes it, protects it or keeps it in good condition. It becomes a therapeutic good, regulated by the TGA, when its claims, its ingredients or the way it is used say it does more. The TGA's own examples:\n\n| A cosmetic claim | A therapeutic claim |\n| --- | --- |\n| \"Helps your skin look even and smooth\" | \"Reduces skin pigmentation and uneven skin tone\" |\n| \"Helps skin look firm\" | \"Improves skin's internal structure for firmer skin\" |\n| Contains collagen \"to smooth the appearance of fine lines\" | Stimulates \"collagen production to repair skin at the cellular level\" |\n\nImages and context count as well as words. Claims to treat acne, eczema, psoriasis, rosacea, scarring or burns, or to promote hair growth, will likely make a product a therapeutic good unless it is excluded, and so will an ingredient from Schedule 2, 3, 4 or 8 of the Poisons Standard. Anti-wrinkle and anti-ageing products without an SPF are generally cosmetics, as long as their claims stay cosmetic. A therapeutic cream can be a listed medicine (AUST L) only if every ingredient is in the TGA's Permissible Ingredients Determination and every indication is a permitted indication: that is how we built [a pain relief cream](/work/pain-relief-cream). The wider rules, including for products that are swallowed, are on [medicine, food or cosmetic?](/pathways)","text":"A cream, serum or lotion is a cosmetic in Australia while it only changes how the skin looks, cleanses it, perfumes it, protects it or keeps it in good condition. It becomes a therapeutic good, regulated by the TGA, when its claims, its ingredients or the way it is used say it does more. The TGA's own examples: A cosmetic claim: \"Helps your skin look even and smooth\"; A therapeutic claim: \"Reduces skin pigmentation and uneven skin tone\". A cosmetic claim: \"Helps skin look firm\"; A therapeutic claim: \"Improves skin's internal structure for firmer skin\". A cosmetic claim: Contains collagen \"to smooth the appearance of fine lines\"; A therapeutic claim: Stimulates \"collagen production to repair skin at the cellular level\". Images and context count as well as words. Claims to treat acne, eczema, psoriasis, rosacea, scarring or burns, or to promote hair growth, will likely make a product a therapeutic good unless it is excluded, and so will an ingredient from Schedule 2, 3, 4 or 8 of the Poisons Standard. Anti-wrinkle and anti-ageing products without an SPF are generally cosmetics, as long as their claims stay cosmetic. A therapeutic cream can be a listed medicine (AUST L) only if every ingredient is in the TGA's Permissible Ingredients Determination and every indication is a permitted indication: that is how we built a pain relief cream. The wider rules, including for products that are swallowed, are on medicine, food or cosmetic?","items":[],"tables":[{"header":["A cosmetic claim","A therapeutic claim"],"rows":[["\"Helps your skin look even and smooth\"","\"Reduces skin pigmentation and uneven skin tone\""],["\"Helps skin look firm\"","\"Improves skin's internal structure for firmer skin\""],["Contains collagen \"to smooth the appearance of fine lines\"","Stimulates \"collagen production to repair skin at the cellular level\""]]}]},{"heading":"Sunscreens: primary or secondary","anchor":"sunscreens-primary-or-secondary","markdown":"- **A primary sunscreen**, presented mainly to protect the skin from UV, is a therapeutic good. It must be on the Australian Register of Therapeutic Goods before it is sold, generally as a listed medicine with an AUST L number on the label.\n- **An SPF moisturiser stays a cosmetic** only if all of these hold: SPF 4 to 15, a pack of 300 mL or 300 g or less, not presented as water resistant, no therapeutic claims other than about premature ageing from the sun, no ingredient from Schedule 2, 3, 4 or 8 of the Poisons Standard, an expiry date if it isn't stable for at least 36 months, and the secondary sunscreen, labelling and broad-spectrum requirements of AS/NZS 2604:2021 are met. Above SPF 15, it is a therapeutic sunscreen. Lip products and tinted foundations with SPF 4 or more are excluded under their own conditions.\n- **Cosmetic sunscreens are still tested.** They must meet the testing and labelling requirements of the Australian sunscreen standard.\n- **Changes may be coming.** The TGA consulted on improving sunscreen regulation from March to May 2026, including cosmetic sunscreens with high SPF claims. As of 19 October 2026 it had announced no outcome.","text":"A primary sunscreen, presented mainly to protect the skin from UV, is a therapeutic good. It must be on the Australian Register of Therapeutic Goods before it is sold, generally as a listed medicine with an AUST L number on the label. An SPF moisturiser stays a cosmetic only if all of these hold: SPF 4 to 15, a pack of 300 mL or 300 g or less, not presented as water resistant, no therapeutic claims other than about premature ageing from the sun, no ingredient from Schedule 2, 3, 4 or 8 of the Poisons Standard, an expiry date if it isn't stable for at least 36 months, and the secondary sunscreen, labelling and broad-spectrum requirements of AS/NZS 2604:2021 are met. Above SPF 15, it is a therapeutic sunscreen. Lip products and tinted foundations with SPF 4 or more are excluded under their own conditions. Cosmetic sunscreens are still tested. They must meet the testing and labelling requirements of the Australian sunscreen standard. Changes may be coming. The TGA consulted on improving sunscreen regulation from March to May 2026, including cosmetic sunscreens with high SPF claims. As of 19 October 2026 it had announced no outcome.","items":[{"lead":"A primary sunscreen","text":", presented mainly to protect the skin from UV, is a therapeutic good. It must be on the Australian Register of Therapeutic Goods before it is sold, generally as a listed medicine with an AUST L number on the label."},{"lead":"An SPF moisturiser stays a cosmetic","text":"only if all of these hold: SPF 4 to 15, a pack of 300 mL or 300 g or less, not presented as water resistant, no therapeutic claims other than about premature ageing from the sun, no ingredient from Schedule 2, 3, 4 or 8 of the Poisons Standard, an expiry date if it isn't stable for at least 36 months, and the secondary sunscreen, labelling and broad-spectrum requirements of AS/NZS 2604:2021 are met. Above SPF 15, it is a therapeutic sunscreen. Lip products and tinted foundations with SPF 4 or more are excluded under their own conditions."},{"lead":"Cosmetic sunscreens are still tested.","text":"They must meet the testing and labelling requirements of the Australian sunscreen standard."},{"lead":"Changes may be coming.","text":"The TGA consulted on improving sunscreen regulation from March to May 2026, including cosmetic sunscreens with high SPF claims. As of 19 October 2026 it had announced no outcome."}],"tables":[]},{"heading":"Selling cosmetics: registration and labels","anchor":"selling-cosmetics-registration-and-labels","markdown":"- **Who registers.** A business must register with AICIS if it imports ready-made cosmetics, unless they are for personal use, or imports essential oils, carrier oils, fragrance or base ingredients. Buying ingredients from Australian suppliers to blend doesn't need registration for that. Making a chemical for sale generally does, such as soap from fats or oils and lye, though soap made in Australia from no more than 10 kg of each fat or oil a registration year can be excluded. AICIS registers the business, not its products or ingredients.\n- **When and what it costs.** The registration year runs from 1 September to 31 August, and you register before you introduce a chemical in that year. The cost is a flat fee plus a levy based on the value of the chemicals introduced in the previous financial year: for 2026–27 it ranges from $85 (under $50,000 introduced) to $3,585 ($15 million or more), after a one-off levy discount; AICIS says levies return to their 2025–26 levels, indexed, from 2027–28.\n- **What registration involves.** Each chemical introduction is put into a category (listed, exempted, reported or assessed, among others), records are kept, and a declaration goes in at the end of each registration year.\n- **The ingredient list.** Labels follow the Consumer Goods (Cosmetics) Information Standard 2020, which the ACCC administers: every ingredient listed on the container, in descending order by volume or mass (or with ingredients under 1% and colour additives after the rest, in any order). It doesn't apply to therapeutic goods, free samples or testers.","text":"Who registers. A business must register with AICIS if it imports ready-made cosmetics, unless they are for personal use, or imports essential oils, carrier oils, fragrance or base ingredients. Buying ingredients from Australian suppliers to blend doesn't need registration for that. Making a chemical for sale generally does, such as soap from fats or oils and lye, though soap made in Australia from no more than 10 kg of each fat or oil a registration year can be excluded. AICIS registers the business, not its products or ingredients. When and what it costs. The registration year runs from 1 September to 31 August, and you register before you introduce a chemical in that year. The cost is a flat fee plus a levy based on the value of the chemicals introduced in the previous financial year: for 2026–27 it ranges from $85 (under $50,000 introduced) to $3,585 ($15 million or more), after a one-off levy discount; AICIS says levies return to their 2025–26 levels, indexed, from 2027–28. What registration involves. Each chemical introduction is put into a category (listed, exempted, reported or assessed, among others), records are kept, and a declaration goes in at the end of each registration year. The ingredient list. Labels follow the Consumer Goods (Cosmetics) Information Standard 2020, which the ACCC administers: every ingredient listed on the container, in descending order by volume or mass (or with ingredients under 1% and colour additives after the rest, in any order). It doesn't apply to therapeutic goods, free samples or testers.","items":[{"lead":"Who registers.","text":"A business must register with AICIS if it imports ready-made cosmetics, unless they are for personal use, or imports essential oils, carrier oils, fragrance or base ingredients. Buying ingredients from Australian suppliers to blend doesn't need registration for that. Making a chemical for sale generally does, such as soap from fats or oils and lye, though soap made in Australia from no more than 10 kg of each fat or oil a registration year can be excluded. AICIS registers the business, not its products or ingredients."},{"lead":"When and what it costs.","text":"The registration year runs from 1 September to 31 August, and you register before you introduce a chemical in that year. The cost is a flat fee plus a levy based on the value of the chemicals introduced in the previous financial year: for 2026–27 it ranges from $85 (under $50,000 introduced) to $3,585 ($15 million or more), after a one-off levy discount; AICIS says levies return to their 2025–26 levels, indexed, from 2027–28."},{"lead":"What registration involves.","text":"Each chemical introduction is put into a category (listed, exempted, reported or assessed, among others), records are kept, and a declaration goes in at the end of each registration year."},{"lead":"The ingredient list.","text":"Labels follow the Consumer Goods (Cosmetics) Information Standard 2020, which the ACCC administers: every ingredient listed on the container, in descending order by volume or mass (or with ingredients under 1% and colour additives after the rest, in any order). It doesn't apply to therapeutic goods, free samples or testers."}],"tables":[]},{"heading":"What we build","anchor":"what-we-build","markdown":"Products your customers apply rather than swallow: creams, serums, balms, gels, lotions, ointments and body oils. They're popular for magnesium cream, vitamin C serum, hair serum, barrier balm, and hair and body oils. Choose a topical when you're building a cosmetic or a TGA-listed topical; we confirm the pathway at the brief.\n\nCreams and serums on the cosmetics pathway or the TGA pathway, and the regulatory work that keeps a range compliant. From our records:\n\n- [A pain relief cream](/work/pain-relief-cream), a TGA-listed medicine built to match the category's leading creams on formula and price, feel non-greasy, not stain, and come in a pack older users can open easily. We built the formula and R&D samples, the claims evidence, the TGA listing (updated after a preservative change), the stability program, the specification and the label, and we are managing manufacturing now, including the tube supply.\n- [Vitable](/work/vitable-hair-growth-range): a topical serum on the cosmetics pathway, matched to a TGA-listed capsule, with manufacturing of both managed through to delivery.\n- [An international skincare brand](/work/skincare-brand-regulatory-partner): formula and evidence work across two supplements and a sunscreen, with stability studies out to 36 months. Since 2024 we have run its regulatory work on a monthly retainer.\n- [Deeply Rooted](/work/deeply-rooted-organic-oil): an organic essential oil blend for children, made in New Zealand and sold in Australia, with the cross-border supply chain managed end to end.","text":"Products your customers apply rather than swallow: creams, serums, balms, gels, lotions, ointments and body oils. They're popular for magnesium cream, vitamin C serum, hair serum, barrier balm, and hair and body oils. Choose a topical when you're building a cosmetic or a TGA-listed topical; we confirm the pathway at the brief. Creams and serums on the cosmetics pathway or the TGA pathway, and the regulatory work that keeps a range compliant. From our records: A pain relief cream, a TGA-listed medicine built to match the category's leading creams on formula and price, feel non-greasy, not stain, and come in a pack older users can open easily. We built the formula and R&D samples, the claims evidence, the TGA listing (updated after a preservative change), the stability program, the specification and the label, and we are managing manufacturing now, including the tube supply. Vitable: a topical serum on the cosmetics pathway, matched to a TGA-listed capsule, with manufacturing of both managed through to delivery. An international skincare brand: formula and evidence work across two supplements and a sunscreen, with stability studies out to 36 months. Since 2024 we have run its regulatory work on a monthly retainer. Deeply Rooted: an organic essential oil blend for children, made in New Zealand and sold in Australia, with the cross-border supply chain managed end to end.","items":[],"tables":[]},{"heading":"Cosmetic manufacturing, managed","anchor":"cosmetic-manufacturing-managed","markdown":"The same model as everything we develop. We are not a cosmetic factory: we match the product to cGMP manufacturing partners by format, volume and margin, carry the specification, packaging and labelling, and manage release testing, imports and freight through to your warehouse or 3PL. See [managed manufacturing](/manufacturing).","text":"The same model as everything we develop. We are not a cosmetic factory: we match the product to cGMP manufacturing partners by format, volume and margin, carry the specification, packaging and labelling, and manage release testing, imports and freight through to your warehouse or 3PL. See managed manufacturing.","items":[],"tables":[]}],"faqs":[{"q":"Can a cream be a TGA-listed medicine?","a":"Yes. A pain relief cream we developed is a TGA-listed medicine: we built its claims evidence, secured the listing and updated it after a preservative change, and designed its stability program.","md":"Yes. A pain relief cream we developed is a TGA-listed medicine: we built its claims evidence, secured the listing and updated it after a preservative change, and designed its stability program."},{"q":"Do you work on sunscreens?","a":"Yes. For an international skincare brand we did the formula and evidence work on a sunscreen and two supplements, with stability studies out to 36 months.","md":"Yes. For an international skincare brand we did the formula and evidence work on a sunscreen and two supplements, with stability studies out to 36 months."},{"q":"Can one range have cosmetics and medicines in it?","a":"Yes. Vitable's hair range pairs a TGA-listed capsule with a serum on the cosmetics pathway, and we managed manufacturing for both. A supplement for skin, hair or nails is a medicine by law: more in our beauty supplements guide.","md":"Yes. Vitable's hair range pairs a TGA-listed capsule with a serum on the cosmetics pathway, and we managed manufacturing for both. A supplement for skin, hair or nails is a medicine by law: more in our [beauty supplements guide](/guides/beauty-supplements)."},{"q":"Do you handle regulatory work for a range that's already on the market?","a":"Yes. Since 2024 we have run an international skincare brand's Australian regulatory work on a monthly retainer, now in its third year.","md":"Yes. Since 2024 we have run an international skincare brand's Australian regulatory work on a monthly retainer, now in its third year."},{"q":"Do I need to register with AICIS?","a":"If your business imports cosmetics or cosmetic ingredients into Australia, or makes a chemical for sale, generally yes, for each registration year (1 September to 31 August) in which it does. AICIS registers the business, not each product. A business that buys all its ingredients from Australian suppliers to blend doesn't need to register for that. More in our AICIS registration guide.","md":"If your business imports cosmetics or cosmetic ingredients into Australia, or makes a chemical for sale, generally yes, for each registration year (1 September to 31 August) in which it does. AICIS registers the business, not each product. A business that buys all its ingredients from Australian suppliers to blend doesn't need to register for that. More in our [AICIS registration guide](/guides/aicis-registration)."},{"q":"When is an SPF moisturiser a cosmetic?","a":"Only if it meets every condition in the Excluded Goods Determination: SPF 4 to 15, a pack of 300 mL or 300 g or less, not water resistant, no therapeutic claims beyond premature ageing from the sun, no Schedule 2, 3, 4 or 8 poisons, an expiry date if it isn't stable for at least 36 months, and the AS/NZS 2604:2021 requirements. If it misses any of them it is a therapeutic sunscreen, which generally must be on the ARTG.","md":"Only if it meets every condition in the Excluded Goods Determination: SPF 4 to 15, a pack of 300 mL or 300 g or less, not water resistant, no therapeutic claims beyond premature ageing from the sun, no Schedule 2, 3, 4 or 8 poisons, an expiry date if it isn't stable for at least 36 months, and the AS/NZS 2604:2021 requirements. If it misses any of them it is a therapeutic sunscreen, which generally must be on the ARTG."},{"q":"Does a cosmetic need TGA approval?","a":"No. A product that is only a cosmetic isn't on the ARTG and has no TGA approval step. It must still meet consumer law, the ingredient labelling standard and, for the business, AICIS registration where that applies. If its claims or ingredients make it a therapeutic good, the TGA rules apply instead.","md":"No. A product that is only a cosmetic isn't on the ARTG and has no TGA approval step. It must still meet consumer law, the ingredient labelling standard and, for the business, AICIS registration where that applies. If its claims or ingredients make it a therapeutic good, the TGA rules apply instead."},{"q":"Can a skincare product claim to treat acne?","a":"Claims to treat acne will likely make it a therapeutic good. The Excluded Goods Determination keeps an acne product out of the medicines rules only if it is presented as controlling acne by cleansing, moisturising, exfoliating or drying the skin, with no Schedule 2, 3, 4 or 8 poisons. \"Helps skin look clearer\" is a cosmetic claim; \"treats acne\" is a therapeutic one.","md":"Claims to treat acne will likely make it a therapeutic good. The Excluded Goods Determination keeps an acne product out of the medicines rules only if it is presented as controlling acne by cleansing, moisturising, exfoliating or drying the skin, with no Schedule 2, 3, 4 or 8 poisons. \"Helps skin look clearer\" is a cosmetic claim; \"treats acne\" is a therapeutic one."}],"sources":{"note":"General information, checked against these sources on 19 October 2026. It isn't advice on a particular product.","markdown":"General information, checked against these sources on 19 October 2026. It isn't advice on a particular product.\n\n- [Cosmetics or therapeutic goods: guidance for advertisers and suppliers](https://www.tga.gov.au/sites/default/files/2024-06/cosmetics-therapeutic-goods-guidance-for-advertisers-suppliers.pdf), Therapeutic Goods Administration, June 2024\n- [Sunscreen regulation in Australia](https://www.tga.gov.au/products/medicines/therapeutic-sunscreens/overview/sunscreen-regulation-australia), Therapeutic Goods Administration\n- [Therapeutic Goods (Excluded Goods) Determination 2018](https://www.legislation.gov.au/F2018L01350/latest/text), Schedule 2 items 5 and 10, Federal Register of Legislation\n- [Improvements to the regulation of sunscreens in Australia](https://consultations.tga.gov.au/tga/improvements-to-regulation-of-sunscreens-in-aus/), TGA consultation, closed 23 May 2026\n- [Permissible ingredients determination](https://www.tga.gov.au/node/290205), Therapeutic Goods Administration\n- [Cosmetics and therapeutics](https://www.industrialchemicals.gov.au/cosmetics-and-soap/cosmetics-and-therapeutics) and [Is my product a cosmetic?](https://www.industrialchemicals.gov.au/cosmetics-and-soap/my-product-cosmetic), Australian Industrial Chemicals Introduction Scheme\n- [I make or import cosmetics: do I need to register?](https://www.industrialchemicals.gov.au/sites/default/files/2022-11/I%20make%20or%20import%20cosmetics%20-%20do%20I%20need%20to%20register.pdf), [Fees and charges for 2026–27](https://www.industrialchemicals.gov.au/node/188362) and [Before you start categorising your introduction](https://www.industrialchemicals.gov.au/node/144), Australian Industrial Chemicals Introduction Scheme\n- [Cosmetics ingredients labelling mandatory standard](https://www.productsafety.gov.au/business/search-mandatory-standards/cosmetics-ingredients-labelling-mandatory-standard), ACCC Product Safety Australia","items":[{"text":"Cosmetics or therapeutic goods: guidance for advertisers and suppliers, Therapeutic Goods Administration, June 2024","links":[{"title":"Cosmetics or therapeutic goods: guidance for advertisers and suppliers","url":"https://www.tga.gov.au/sites/default/files/2024-06/cosmetics-therapeutic-goods-guidance-for-advertisers-suppliers.pdf"}]},{"text":"Sunscreen regulation in Australia, Therapeutic Goods Administration","links":[{"title":"Sunscreen regulation in Australia","url":"https://www.tga.gov.au/products/medicines/therapeutic-sunscreens/overview/sunscreen-regulation-australia"}]},{"text":"Therapeutic Goods (Excluded Goods) Determination 2018, Schedule 2 items 5 and 10, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Excluded Goods) Determination 2018","url":"https://www.legislation.gov.au/F2018L01350/latest/text"}]},{"text":"Improvements to the regulation of sunscreens in Australia, TGA consultation, closed 23 May 2026","links":[{"title":"Improvements to the regulation of sunscreens in Australia","url":"https://consultations.tga.gov.au/tga/improvements-to-regulation-of-sunscreens-in-aus/"}]},{"text":"Permissible ingredients determination, Therapeutic Goods Administration","links":[{"title":"Permissible ingredients determination","url":"https://www.tga.gov.au/node/290205"}]},{"text":"Cosmetics and therapeutics and Is my product a cosmetic?, Australian Industrial Chemicals Introduction Scheme","links":[{"title":"Cosmetics and therapeutics","url":"https://www.industrialchemicals.gov.au/cosmetics-and-soap/cosmetics-and-therapeutics"},{"title":"Is my product a cosmetic?","url":"https://www.industrialchemicals.gov.au/cosmetics-and-soap/my-product-cosmetic"}]},{"text":"I make or import cosmetics: do I need to register?, Fees and charges for 2026–27 and Before you start categorising your introduction, Australian Industrial Chemicals Introduction Scheme","links":[{"title":"I make or import cosmetics: do I need to register?","url":"https://www.industrialchemicals.gov.au/sites/default/files/2022-11/I%20make%20or%20import%20cosmetics%20-%20do%20I%20need%20to%20register.pdf"},{"title":"Fees and charges for 2026–27","url":"https://www.industrialchemicals.gov.au/node/188362"},{"title":"Before you start categorising your introduction","url":"https://www.industrialchemicals.gov.au/node/144"}]},{"text":"Cosmetics ingredients labelling mandatory standard, ACCC Product Safety Australia","links":[{"title":"Cosmetics ingredients labelling mandatory standard","url":"https://www.productsafety.gov.au/business/search-mandatory-standards/cosmetics-ingredients-labelling-mandatory-standard"}]}]}},{"slug":"formats","kind":"hub","url":"/formats","title":"Product formats, from formula to delivery","name":"Formats","description":"The formats we develop and manage through cGMP partners: capsules, tablets and softgels, gummies, powders and sachets, liquids, and creams and serums.","eyebrow":"Formats","lead":"We develop products in the common wellness formats, capsules, tablets, chewables and softgels, gummies, powders, liquids and oils, creams and serums, and manage their manufacture through cGMP partners matched to the format, the volume and the margin, from the first formula to delivery at your warehouse. Each format page covers what we build in it, the pathway questions it raises and examples from our records.","lists":"format","studies":["everleanbody-saffron-capsule","eye-health-tablet-format-rescue","bwellness-practitioner-range","the-belly-solution-travel-gut-health-powder","deeply-rooted-organic-oil","pain-relief-cream"],"formats":[],"order":39,"updated":"2026-10-26","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- The format follows the formula, the dose and the customer: how much has to go into one serve, how it tastes, and how and where it will be taken.\n- A format doesn't decide the pathway. A capsule isn't always a medicine, and a powder can be a listed medicine or a food.\n- Trials prove the format before a production order does. Two of our projects changed format mid-project, after trials showed the first format wouldn't hold.","text":"The format follows the formula, the dose and the customer: how much has to go into one serve, how it tastes, and how and where it will be taken. A format doesn't decide the pathway. A capsule isn't always a medicine, and a powder can be a listed medicine or a food. Trials prove the format before a production order does. Two of our projects changed format mid-project, after trials showed the first format wouldn't hold.","items":[],"tables":[]},{"heading":"How the format is chosen","anchor":"how-the-format-is-chosen","markdown":"The format follows the formula, the dose and the customer, and sometimes the production line decides. A format doesn't settle the pathway, either: a capsule isn't always a medicine, and a powder can be a listed medicine or a food, so the pathway is settled at the brief, before the formula. Creams, serums and sunscreens are covered on [the skincare page](/skincare), on the cosmetics pathway or as TGA-listed medicines.","text":"The format follows the formula, the dose and the customer, and sometimes the production line decides. A format doesn't settle the pathway, either: a capsule isn't always a medicine, and a powder can be a listed medicine or a food, so the pathway is settled at the brief, before the formula. Creams, serums and sunscreens are covered on the skincare page, on the cosmetics pathway or as TGA-listed medicines.","items":[],"tables":[]},{"heading":"What each format page covers","anchor":"what-each-format-page-covers","markdown":"- **Capsules, tablets and softgels.** When a capsule, a tablet, a chewable or a softgel is the right call, from a single-ingredient formula to complex herbal blends of 13 or more ingredients, with the packs and the stability programs behind the shelf life on the label.\n- **Gummies.** Pectin, gelatin, sugar-free and centre-filled or coated gummies, and why a vitamin gummy is made as a listed medicine.\n- **Powders and sachets.** Probiotic, greens, protein, collagen and performance powders, the pack that suits each, and where the line between a listed medicine and a food falls for a powder.\n- **Liquids.** Drops, tinctures, shots, syrups and oral sprays, why vitamin D drops are usually listed medicines, and the preservative and packaging rules that weigh more on liquids.\n- **Creams and serums.** Topicals on the cosmetics pathway or as TGA-listed medicines, on [the skincare page](/skincare).","text":"Capsules, tablets and softgels. When a capsule, a tablet, a chewable or a softgel is the right call, from a single-ingredient formula to complex herbal blends of 13 or more ingredients, with the packs and the stability programs behind the shelf life on the label. Gummies. Pectin, gelatin, sugar-free and centre-filled or coated gummies, and why a vitamin gummy is made as a listed medicine. Powders and sachets. Probiotic, greens, protein, collagen and performance powders, the pack that suits each, and where the line between a listed medicine and a food falls for a powder. Liquids. Drops, tinctures, shots, syrups and oral sprays, why vitamin D drops are usually listed medicines, and the preservative and packaging rules that weigh more on liquids. Creams and serums. Topicals on the cosmetics pathway or as TGA-listed medicines, on the skincare page.","items":[{"lead":"Capsules, tablets and softgels.","text":"When a capsule, a tablet, a chewable or a softgel is the right call, from a single-ingredient formula to complex herbal blends of 13 or more ingredients, with the packs and the stability programs behind the shelf life on the label."},{"lead":"Gummies.","text":"Pectin, gelatin, sugar-free and centre-filled or coated gummies, and why a vitamin gummy is made as a listed medicine."},{"lead":"Powders and sachets.","text":"Probiotic, greens, protein, collagen and performance powders, the pack that suits each, and where the line between a listed medicine and a food falls for a powder."},{"lead":"Liquids.","text":"Drops, tinctures, shots, syrups and oral sprays, why vitamin D drops are usually listed medicines, and the preservative and packaging rules that weigh more on liquids."},{"lead":"Creams and serums.","text":"Topicals on the cosmetics pathway or as TGA-listed medicines, on the skincare page."}],"tables":[]},{"heading":"Formats at a glance","anchor":"formats-at-a-glance","markdown":"| Format | Suits | Watch for |\n| --- | --- | --- |\n| Capsules | Powders and extracts at moderate doses; quick to develop | How much fits in one capsule; under TGO 116, a capsule over 24.1 mm long or 9.5 mm wide needs a large dosage form warning on a listed medicine |\n| Tablets | Higher doses in one unit; coatings that mask taste | The blend has to compress; large tablet warnings apply above set sizes |\n| Softgels | Oils, such as fish oil and krill oil ([omega-3 guide](/guides/omega-3-supplement-development)) | Oxidation, which the stability program has to cover |\n| Chewables | Customers who won't swallow a capsule | Taste and texture over the whole shelf life |\n| Gummies | A daily format customers look forward to, when taste drives repeat purchase | Added vitamins or minerals make it a listed medicine: a general food can't carry them in confectionery. Taste and texture over the shelf life |\n| Powders in a tub or pouch | Large serves, such as probiotics, electrolytes and performance powders | Taste, how well it mixes, and moisture |\n| Sachets | Single serves, on the go, sampling and trial packs | More packaging per serve, and each sachet's label |\n| Liquids | Precise or adjustable doses: drops, tinctures, shots, syrups and oral sprays | Stability and taste are the hardest to hold in a liquid, and a water-based multidose liquid has to pass a preservative test |","text":"Format: Capsules; Suits: Powders and extracts at moderate doses; quick to develop; Watch for: How much fits in one capsule; under TGO 116, a capsule over 24.1 mm long or 9.5 mm wide needs a large dosage form warning on a listed medicine. Format: Tablets; Suits: Higher doses in one unit; coatings that mask taste; Watch for: The blend has to compress; large tablet warnings apply above set sizes. Format: Softgels; Suits: Oils, such as fish oil and krill oil (omega-3 guide); Watch for: Oxidation, which the stability program has to cover. Format: Chewables; Suits: Customers who won't swallow a capsule; Watch for: Taste and texture over the whole shelf life. Format: Gummies; Suits: A daily format customers look forward to, when taste drives repeat purchase; Watch for: Added vitamins or minerals make it a listed medicine: a general food can't carry them in confectionery. Taste and texture over the shelf life. Format: Powders in a tub or pouch; Suits: Large serves, such as probiotics, electrolytes and performance powders; Watch for: Taste, how well it mixes, and moisture. Format: Sachets; Suits: Single serves, on the go, sampling and trial packs; Watch for: More packaging per serve, and each sachet's label. Format: Liquids; Suits: Precise or adjustable doses: drops, tinctures, shots, syrups and oral sprays; Watch for: Stability and taste are the hardest to hold in a liquid, and a water-based multidose liquid has to pass a preservative test.","items":[],"tables":[{"header":["Format","Suits","Watch for"],"rows":[["Capsules","Powders and extracts at moderate doses; quick to develop","How much fits in one capsule; under TGO 116, a capsule over 24.1 mm long or 9.5 mm wide needs a large dosage form warning on a listed medicine"],["Tablets","Higher doses in one unit; coatings that mask taste","The blend has to compress; large tablet warnings apply above set sizes"],["Softgels","Oils, such as fish oil and krill oil (omega-3 guide)","Oxidation, which the stability program has to cover"],["Chewables","Customers who won't swallow a capsule","Taste and texture over the whole shelf life"],["Gummies","A daily format customers look forward to, when taste drives repeat purchase","Added vitamins or minerals make it a listed medicine: a general food can't carry them in confectionery. Taste and texture over the shelf life"],["Powders in a tub or pouch","Large serves, such as probiotics, electrolytes and performance powders","Taste, how well it mixes, and moisture"],["Sachets","Single serves, on the go, sampling and trial packs","More packaging per serve, and each sachet's label"],["Liquids","Precise or adjustable doses: drops, tinctures, shots, syrups and oral sprays","Stability and taste are the hardest to hold in a liquid, and a water-based multidose liquid has to pass a preservative test"]]}]},{"heading":"When the format changes mid-project","anchor":"when-the-format-changes-mid-project","markdown":"Trials decide. An eye-health formula kept failing in encapsulation because the ingredient mix was too wet, so it moved to a direct-compression tablet. A prenatal started as a liquid drop, wasn't stable and couldn't have its taste masked, so it became a two-a-day chewable. Finding that out in trials, not in production, is the point of the format stage.","text":"Trials decide. An eye-health formula kept failing in encapsulation because the ingredient mix was too wet, so it moved to a direct-compression tablet. A prenatal started as a liquid drop, wasn't stable and couldn't have its taste masked, so it became a two-a-day chewable. Finding that out in trials, not in production, is the point of the format stage.","items":[],"tables":[]},{"heading":"Manufacturing, managed","anchor":"manufacturing-managed","markdown":"Take Friday Off is not a contract manufacturer. We match the product to cGMP manufacturing partners by format, volume and margin, carry the specification, packaging and labelling, and manage release testing, imports and freight through to your warehouse or 3PL. For a listed medicine, every partner holds the TGA manufacturing licence or GMP clearance its step needs. See [managed manufacturing](/manufacturing).","text":"Take Friday Off is not a contract manufacturer. We match the product to cGMP manufacturing partners by format, volume and margin, carry the specification, packaging and labelling, and manage release testing, imports and freight through to your warehouse or 3PL. For a listed medicine, every partner holds the TGA manufacturing licence or GMP clearance its step needs. See managed manufacturing.","items":[],"tables":[]}],"faqs":[{"q":"Capsule or tablet: which is better?","a":"Neither in general. Capsules suit most powders and extracts and are quicker to develop. Tablets hold more in one unit and can be coated, but the blend has to compress. The dose decides most often: if a day's dose won't fit in two or three capsules, a tablet or a powder is usually the better call.","md":"Neither in general. Capsules suit most powders and extracts and are quicker to develop. Tablets hold more in one unit and can be coated, but the blend has to compress. The dose decides most often: if a day's dose won't fit in two or three capsules, a tablet or a powder is usually the better call."},{"q":"Can a powder be a listed medicine?","a":"Yes. The Belly Solution's travel gut-health powder is a TGA-listed medicine. A powder can also be a food, depending on its ingredients and its claims. See medicine, food or cosmetic?","md":"Yes. The Belly Solution's travel gut-health powder is a TGA-listed medicine. A powder can also be a food, depending on its ingredients and its claims. See [medicine, food or cosmetic?](/pathways)"},{"q":"What is the minimum order for a new format?","a":"3,000 finished retail packs per batch. Some packs also carry their own minimum from the packaging supplier: single-serve sachets, for example, typically need around 150,000 sachets. We set out both in the quote. See managed manufacturing.","md":"3,000 finished retail packs per batch. Some packs also carry their own minimum from the packaging supplier: single-serve sachets, for example, typically need around 150,000 sachets. We set out both in the quote. See [managed manufacturing](/manufacturing)."}],"sources":null},{"slug":"capsules-tablets-softgels","kind":"format","url":"/formats/capsules-tablets-softgels","title":"Capsule, tablet and softgel supplements, from formula to delivery","name":"Capsules, tablets and softgels","description":"Capsules, tablets, chewables and softgels developed and made for your brand: formula, evidence, TGA listing, stability and managed cGMP manufacturing.","eyebrow":"Format","lead":"We develop capsule, tablet, chewable and softgel products and manage their manufacture through cGMP partners matched to the format, the volume and the margin, from the first formula to delivery at your warehouse.","parent":"/manufacturing","studies":["everleanbody-saffron-capsule","eye-health-tablet-format-rescue","your-skin-scan-nicotinamide-tablet","ashwagandha-capsule-32-days","vitable-hair-growth-range","arxi-prenatal-chewable"],"formats":["capsules","tablets","softgels"],"order":40,"updated":"2026-10-26","author":"Take Friday Off","approved":true,"sections":[{"heading":"Capsule, tablet or softgel?","anchor":"capsule-tablet-or-softgel","markdown":"The format follows the formula, the dose and the customer, and sometimes the production line decides. A capsule isn't always a medicine, either: its pathway turns mostly on how it is presented, starting with its claims ([medicine, food or cosmetic?](/pathways)). From our records:\n\n- **A wet blend won't encapsulate.** An eye-health formula kept failing in encapsulation because the ingredient mix was too wet; hand-filling would have added one to two months. We moved it to a [direct-compression tablet](/work/eye-health-tablet-format-rescue) mid-project ([eye health supplements](/guides/eye-health-supplement-development)).\n- **Oils go in softgels.** Fish oil and krill oil are built as softgel capsules.\n- **Taste decides chewables.** B vitamins and selenium are bitter and smell strongly; a two-a-day [prenatal chewable](/work/arxi-prenatal-chewable) uses coated B vitamins to tame the taste.\n- **Ingredient count sets the size.** The range runs from a single-ingredient tablet to complex herbal capsules of 13 or more ingredients.","text":"The format follows the formula, the dose and the customer, and sometimes the production line decides. A capsule isn't always a medicine, either: its pathway turns mostly on how it is presented, starting with its claims (medicine, food or cosmetic?). From our records: A wet blend won't encapsulate. An eye-health formula kept failing in encapsulation because the ingredient mix was too wet; hand-filling would have added one to two months. We moved it to a direct-compression tablet mid-project (eye health supplements). Oils go in softgels. Fish oil and krill oil are built as softgel capsules. Taste decides chewables. B vitamins and selenium are bitter and smell strongly; a two-a-day prenatal chewable uses coated B vitamins to tame the taste. Ingredient count sets the size. The range runs from a single-ingredient tablet to complex herbal capsules of 13 or more ingredients.","items":[{"lead":"A wet blend won't encapsulate.","text":"An eye-health formula kept failing in encapsulation because the ingredient mix was too wet; hand-filling would have added one to two months. We moved it to a direct-compression tablet mid-project (eye health supplements)."},{"lead":"Oils go in softgels.","text":"Fish oil and krill oil are built as softgel capsules."},{"lead":"Taste decides chewables.","text":"B vitamins and selenium are bitter and smell strongly; a two-a-day prenatal chewable uses coated B vitamins to tame the taste."},{"lead":"Ingredient count sets the size.","text":"The range runs from a single-ingredient tablet to complex herbal capsules of 13 or more ingredients."}],"tables":[]},{"heading":"Capsules","anchor":"capsules","markdown":"Our most common format, and usually the quickest to develop. We make gelatin and vegan hard-shell capsules, delayed-release, acid-resistant and liquid-filled. They're popular for CoQ10, ashwagandha, curcumin, probiotics, magnesium glycinate, and sleep and stress blends. Choose a capsule when you have powders or extracts at moderate doses, from a single clinically studied extract to a complex herbal blend.\n\nFrom our records, from a four-ingredient formula to complex herbal blends of 13 or more ingredients:\n\n- [EverLeanBody](/work/everleanbody-saffron-capsule): a four-ingredient capsule built around affron®, a clinically studied saffron extract, with L-theanine, lemon balm and active-form B vitamins. 5.8 months from signed brief to dispatch.\n- A [complex herbal capsule](/work/ashwagandha-capsule-32-days) built around KSM-66® ashwagandha, with an evidence package covering more than 13 ingredients: design to production order in 32 days.\n- [Vitable](/work/vitable-hair-growth-range): a TGA-listed capsule with more than 13 ingredients, in a 100% recycled PET bottle.","text":"Our most common format, and usually the quickest to develop. We make gelatin and vegan hard-shell capsules, delayed-release, acid-resistant and liquid-filled. They're popular for CoQ10, ashwagandha, curcumin, probiotics, magnesium glycinate, and sleep and stress blends. Choose a capsule when you have powders or extracts at moderate doses, from a single clinically studied extract to a complex herbal blend. From our records, from a four-ingredient formula to complex herbal blends of 13 or more ingredients: EverLeanBody: a four-ingredient capsule built around affron®, a clinically studied saffron extract, with L-theanine, lemon balm and active-form B vitamins. 5.8 months from signed brief to dispatch. A complex herbal capsule built around KSM-66® ashwagandha, with an evidence package covering more than 13 ingredients: design to production order in 32 days. Vitable: a TGA-listed capsule with more than 13 ingredients, in a 100% recycled PET bottle.","items":[],"tables":[]},{"heading":"Tablets and chewables","anchor":"tablets-and-chewables","markdown":"More dose in one unit, and more control over how it releases. We make direct-compression, film-coated, chewable, effervescent, orally disintegrating, sublingual, bilayer and extended-release tablets. They're popular for magnesium, B-complex, iron, effervescent vitamin C and electrolytes, and chewable prenatals. Choose a tablet when the dose is high, the taste needs masking, or your customers won't swallow a capsule. For a softer chew, see [gummies](/formats/gummies).\n\nFrom our records, direct-compression tablets and two-a-day chewables:\n\n- [Your Skin Scan](/work/your-skin-scan-nicotinamide-tablet): a single-ingredient 500 mg nicotinamide tablet, 120 per bottle, as a TGA-listed medicine.\n- [BWellness](/work/bwellness-practitioner-range): a 60-tablet formula built on EnXtra®, with five production batches from 2021 to 2025.\n- An [Arxi prenatal](/work/arxi-prenatal-chewable) moved from a liquid drop to a two-a-day chewable, now in production.","text":"More dose in one unit, and more control over how it releases. We make direct-compression, film-coated, chewable, effervescent, orally disintegrating, sublingual, bilayer and extended-release tablets. They're popular for magnesium, B-complex, iron, effervescent vitamin C and electrolytes, and chewable prenatals. Choose a tablet when the dose is high, the taste needs masking, or your customers won't swallow a capsule. For a softer chew, see gummies. From our records, direct-compression tablets and two-a-day chewables: Your Skin Scan: a single-ingredient 500 mg nicotinamide tablet, 120 per bottle, as a TGA-listed medicine. BWellness: a 60-tablet formula built on EnXtra®, with five production batches from 2021 to 2025. An Arxi prenatal moved from a liquid drop to a two-a-day chewable, now in production.","items":[],"tables":[]},{"heading":"Softgels","anchor":"softgels","markdown":"Oils and oil-soluble nutrients, sealed in an easy-to-swallow shell. We make bovine and fish gelatin, vegan, chewable and enteric-coated softgels. They're popular for fish, krill and algal omega-3, vitamin D3, CoQ10 in oil, vitamin E and evening primrose oil. Choose a softgel when your actives are oils or dissolve in oil.\n\nFrom our records: a fish oil and a krill oil capsule for an established natural health company, taken from formula into production, with the fish oil since reordered. More in our [omega-3 and fish oil guide](/guides/omega-3-supplement-development).","text":"Oils and oil-soluble nutrients, sealed in an easy-to-swallow shell. We make bovine and fish gelatin, vegan, chewable and enteric-coated softgels. They're popular for fish, krill and algal omega-3, vitamin D3, CoQ10 in oil, vitamin E and evening primrose oil. Choose a softgel when your actives are oils or dissolve in oil. From our records: a fish oil and a krill oil capsule for an established natural health company, taken from formula into production, with the fish oil since reordered. More in our omega-3 and fish oil guide.","items":[],"tables":[]},{"heading":"Packs and stability","anchor":"packs-and-stability","markdown":"Packs we have delivered include 60-count packs, 120-count bottles, 100% recycled PET bottles ([sustainable packaging](/guides/sustainable-supplement-packaging)) and 7-day trial packs for sampling ([sample packs](/guides/supplement-sample-packs)). See [packaging and labelling](/packaging). A stability program supports the shelf life on the label: 24-month programs on recent capsules, and a protocol designed to support a three-year expiry on an eye-health tablet. What the TGA expects is in our [stability testing guide](/guides/stability-testing).","text":"Packs we have delivered include 60-count packs, 120-count bottles, 100% recycled PET bottles (sustainable packaging) and 7-day trial packs for sampling (sample packs). See packaging and labelling. A stability program supports the shelf life on the label: 24-month programs on recent capsules, and a protocol designed to support a three-year expiry on an eye-health tablet. What the TGA expects is in our stability testing guide.","items":[],"tables":[]}],"faqs":[{"q":"Can you move a product from capsules to tablets?","a":"Yes. When an eye-health formula kept failing in encapsulation, we moved it to a direct-compression tablet, got samples approved and designed the stability protocol for a three-year expiry. It shipped in 2024.","md":"Yes. When an eye-health formula kept failing in encapsulation, we moved it to a direct-compression tablet, got samples approved and designed the stability protocol for a three-year expiry. It shipped in 2024."},{"q":"Can you make vegan capsules and softgels?","a":"Yes. We make vegan hard-shell capsules and vegan softgels, as well as gelatin ones: bovine and fish gelatin for softgels.","md":"Yes. We make vegan hard-shell capsules and vegan softgels, as well as gelatin ones: bovine and fish gelatin for softgels."},{"q":"Which kinds of tablet can you make?","a":"Direct-compression, film-coated, chewable, effervescent, orally disintegrating, sublingual, bilayer and extended-release.","md":"Direct-compression, film-coated, chewable, effervescent, orally disintegrating, sublingual, bilayer and extended-release."},{"q":"Do you develop chewables?","a":"Yes. A two-a-day prenatal chewable with coated B vitamins is in production now, due for dispatch in late October 2026.","md":"Yes. A two-a-day prenatal chewable with coated B vitamins is in production now, due for dispatch in late October 2026."},{"q":"How long from design to a production order?","a":"From our records: 32 days for a complex herbal capsule, and under seven weeks for an eye-health formula with a 60-count pack and a trial pack.","md":"From our records: 32 days for a complex herbal capsule, and under seven weeks for an eye-health formula with a 60-count pack and a trial pack."},{"q":"Do you manage reorders?","a":"Yes. BWellness has had five production batches of its tablet since 2021 with a sixth in the pipeline, and Arxi's preconception capsule has had three production orders since 2024.","md":"Yes. BWellness has had five production batches of its tablet since 2021 with a sixth in the pipeline, and Arxi's preconception capsule has had three production orders since 2024."},{"q":"Who manufactures the product?","a":"cGMP manufacturing partners matched to your format, volume and margin. We manage the factory, so you don't have to: specification, packaging, labelling, release testing, imports and freight, through to your warehouse or 3PL. See managed manufacturing.","md":"cGMP manufacturing partners matched to your format, volume and margin. We manage the factory, so you don't have to: specification, packaging, labelling, release testing, imports and freight, through to your warehouse or 3PL. See [managed manufacturing](/manufacturing)."}],"sources":null},{"slug":"powders-sachets","kind":"format","url":"/formats/powders-sachets","title":"Powder and sachet supplements, from formula to delivery","name":"Powders and sachets","description":"Powder supplement manufacturing, managed: probiotic, greens, protein, collagen, creatine and electrolyte powders in tubs, pouches, stick packs and sachets.","eyebrow":"Format","lead":"We develop powders as listed medicines or foods and manage their manufacture through cGMP partners, from the first formula to delivery at your warehouse.","parent":"/manufacturing","studies":["the-belly-solution-travel-gut-health-powder","nivari-powder-supplement","sports-brand-core-range","ora-practitioner-natural-medicine","bwellness-practitioner-range"],"formats":["powders"],"order":41,"updated":"2026-10-19","author":"Take Friday Off","approved":true,"sections":[{"heading":"What we build in powders","anchor":"what-we-build-in-powders","markdown":"Large serves and flexible packs: tubs, pouches, stick packs and single-serve sachets. Popular for gut health and probiotic powders, greens, electrolytes, collagen, protein, creatine, and pre- and intra-workout. Choose a powder when the serve is too big for a capsule, or you want sampling and trial packs. From our records: a probiotic powder with a prebiotic and electrolytes, an immune powder and a performance powder, in packs including a 14-day pouch and a brand's own pouch.\n\nFor drops, tinctures, shots, syrups and oral sprays, see [liquids](/formats/liquids).","text":"Large serves and flexible packs: tubs, pouches, stick packs and single-serve sachets. Popular for gut health and probiotic powders, greens, electrolytes, collagen, protein, creatine, and pre- and intra-workout. Choose a powder when the serve is too big for a capsule, or you want sampling and trial packs. From our records: a probiotic powder with a prebiotic and electrolytes, an immune powder and a performance powder, in packs including a 14-day pouch and a brand's own pouch. For drops, tinctures, shots, syrups and oral sprays, see liquids.","items":[],"tables":[]},{"heading":"A tub, a pouch or sachets?","anchor":"a-tub-a-pouch-or-sachets","markdown":"Packaging has minimums of its own. Each pack format has a minimum from the packaging supplier, and single-serve sachets typically need around 150,000 sachets, so a tub or pouch is usually the better format to launch with. Stick packs and sachets come into their own for sampling and trial packs. More on what a first run costs in our [development cost guide](/guides/supplement-development-cost), and on packs in [packaging and labelling](/packaging).","text":"Packaging has minimums of its own. Each pack format has a minimum from the packaging supplier, and single-serve sachets typically need around 150,000 sachets, so a tub or pouch is usually the better format to launch with. Stick packs and sachets come into their own for sampling and trial packs. More on what a first run costs in our development cost guide, and on packs in packaging and labelling.","items":[],"tables":[]},{"heading":"Medicine or food?","anchor":"medicine-or-food","markdown":"A powder can be a listed medicine or a food, and the difference decides the ingredients, the claims and the label. The Belly Solution's travel gut-health powder is a TGA-listed medicine; a sports brand's performance powder went to market on the food pathway; Ora's range spans TGA-listed medicines and premium functional foods. We settle the pathway at the brief, before the formula. See [medicine, food or cosmetic?](/pathways).\n\nProtein and pre-workout powders made for sport are usually built as foods ([sports supplements](/guides/sports-supplement-development)). Sports powders have their own food standard, Standard 2.9.4 for formulated supplementary sports foods. It sets the label statements and, since 9 June 2026, caps caffeine at 200 mg in the amount for one day, as directed on the label, and below 5% of a powder, with a transition period to 9 June 2028. But a sports supplement presented for a therapeutic use, or likely to be taken as being for one, is declared a medicine if it contains, or is said to contain, a substance in the Poisons Standard, an added substance on the 2023 World Anti-Doping Prohibited List, added dendrobium or methylliberine, or something with the same pharmacological action, or if it is sold as a tablet, capsule or pill (since 30 November 2023, unless it contains only glucose). And whatever its presentation, a powder that contains, or is promoted to contain, isolated HMB or its salts is declared a medicine, as is a shark cartilage powder unless it is a wholesale product for use as a food ingredient. More on [the food pathway](/pathways/foods).","text":"A powder can be a listed medicine or a food, and the difference decides the ingredients, the claims and the label. The Belly Solution's travel gut-health powder is a TGA-listed medicine; a sports brand's performance powder went to market on the food pathway; Ora's range spans TGA-listed medicines and premium functional foods. We settle the pathway at the brief, before the formula. See medicine, food or cosmetic?. Protein and pre-workout powders made for sport are usually built as foods (sports supplements). Sports powders have their own food standard, Standard 2.9.4 for formulated supplementary sports foods. It sets the label statements and, since 9 June 2026, caps caffeine at 200 mg in the amount for one day, as directed on the label, and below 5% of a powder, with a transition period to 9 June 2028. But a sports supplement presented for a therapeutic use, or likely to be taken as being for one, is declared a medicine if it contains, or is said to contain, a substance in the Poisons Standard, an added substance on the 2023 World Anti-Doping Prohibited List, added dendrobium or methylliberine, or something with the same pharmacological action, or if it is sold as a tablet, capsule or pill (since 30 November 2023, unless it contains only glucose). And whatever its presentation, a powder that contains, or is promoted to contain, isolated HMB or its salts is declared a medicine, as is a shark cartilage powder unless it is a wholesale product for use as a food ingredient. More on the food pathway.","items":[],"tables":[]},{"heading":"Examples from our records","anchor":"examples-from-our-records","markdown":"- [The Belly Solution](/work/the-belly-solution-travel-gut-health-powder): a travel gut-health powder combining the clinically studied probiotic yeast *Saccharomyces boulardii*, a prebiotic and electrolytes, in a 14-day pouch. A TGA-listed medicine with a 36-month stability program, then a national pharmacy distribution trial with more than 30 new stockists in its first week. More in our [probiotics guide](/guides/probiotic-supplement-development).\n- [Nivari](/work/nivari-powder-supplement): a founder's first product, a powder supplement taken from idea to launch-ready and packed into the brand's own pouch for a mid-August 2026 launch.\n- [A sports brand's core range](/work/sports-brand-core-range): four capsules reformulated from scratch, plus a food-pathway performance powder.\n- [BWellness](/work/bwellness-practitioner-range): an immune powder built on Wellmune®, one of nine products for the same practitioner brand.","text":"The Belly Solution: a travel gut-health powder combining the clinically studied probiotic yeast Saccharomyces boulardii, a prebiotic and electrolytes, in a 14-day pouch. A TGA-listed medicine with a 36-month stability program, then a national pharmacy distribution trial with more than 30 new stockists in its first week. More in our probiotics guide. Nivari: a founder's first product, a powder supplement taken from idea to launch-ready and packed into the brand's own pouch for a mid-August 2026 launch. A sports brand's core range: four capsules reformulated from scratch, plus a food-pathway performance powder. BWellness: an immune powder built on Wellmune®, one of nine products for the same practitioner brand.","items":[],"tables":[]}],"faqs":[{"q":"Can you make a protein powder?","a":"Yes. Protein is one of the powders we make, with collagen, creatine, greens, electrolytes, and pre- and intra-workout. A protein powder made for sport is usually a food, and Standard 2.9.4 sets its label statements; we settle the pathway at the brief.","md":"Yes. Protein is one of the powders we make, with collagen, creatine, greens, electrolytes, and pre- and intra-workout. A protein powder made for sport is usually a food, and Standard 2.9.4 sets its label statements; we settle the pathway at the brief."},{"q":"Can you pack powders into our own pouch?","a":"Yes. Nivari's powder was packed into the brand's own pouch, and we have delivered The Belly Solution's powder in a 14-day pouch. More on packaging.","md":"Yes. Nivari's powder was packed into the brand's own pouch, and we have delivered The Belly Solution's powder in a 14-day pouch. More on [packaging](/packaging)."},{"q":"Can a powder be a TGA-listed medicine?","a":"Yes. The Belly Solution's travel gut-health powder is a TGA-listed medicine: we designed the formula, built the claims evidence, secured the TGA listing, drafted and reviewed the label, designed the stability protocol and set up a 36-month stability program.","md":"Yes. The Belly Solution's travel gut-health powder is a TGA-listed medicine: we designed the formula, built the claims evidence, secured the TGA listing, drafted and reviewed the label, designed the stability protocol and set up a 36-month stability program."},{"q":"Do you manage manufacturing across borders?","a":"Yes. For BWellness we manage every production run, including the imported ingredients, customs and freight.","md":"Yes. For BWellness we manage every production run, including the imported ingredients, customs and freight."},{"q":"How do I know which pathway my powder belongs on?","a":"It depends on the ingredients, the doses, the claims you want to make and how the product is presented. We settle it in the brief; medicine, food or cosmetic? sets out how the decision works.","md":"It depends on the ingredients, the doses, the claims you want to make and how the product is presented. We settle it in the brief; [medicine, food or cosmetic?](/pathways) sets out how the decision works."}],"sources":{"note":"General information, checked against these sources on 19 October 2026. It isn't advice on a particular product.","markdown":"General information, checked against these sources on 19 October 2026. It isn't advice on a particular product.\n\n- [Standard 2.9.4: Formulated supplementary sports foods](https://www.legislation.gov.au/F2015L00421/latest/text), Federal Register of Legislation\n- [Sports foods](https://www.foodstandards.gov.au/consumer/nutrition/sportfood), Food Standards Australia New Zealand\n- [Therapeutic Goods (Declared Goods) Order 2019](https://www.legislation.gov.au/F2019L01352/latest/text), Federal Register of Legislation","items":[{"text":"Standard 2.9.4: Formulated supplementary sports foods, Federal Register of Legislation","links":[{"title":"Standard 2.9.4: Formulated supplementary sports foods","url":"https://www.legislation.gov.au/F2015L00421/latest/text"}]},{"text":"Sports foods, Food Standards Australia New Zealand","links":[{"title":"Sports foods","url":"https://www.foodstandards.gov.au/consumer/nutrition/sportfood"}]},{"text":"Therapeutic Goods (Declared Goods) Order 2019, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Declared Goods) Order 2019","url":"https://www.legislation.gov.au/F2019L01352/latest/text"}]}]}},{"slug":"gummies","kind":"format","url":"/formats/gummies","title":"Gummy supplements, from formula to delivery","name":"Gummies","description":"Gummy supplement manufacturing, managed: pectin or gelatin, sugar-free, centre-filled or coated gummies, as TGA-listed medicines or foods.","eyebrow":"Format","lead":"We develop gummies as TGA-listed medicines or foods and manage their manufacture through cGMP partners, from the first formula to delivery at your warehouse, with taste and texture stability-tested across the shelf life.","parent":"/manufacturing","studies":[],"formats":["gummies"],"order":42,"updated":"2026-10-26","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- A daily format your customers look forward to. We make pectin (vegan), gelatin, sugar-free, and centre-filled or coated gummies.\n- In a general food, vitamins and minerals can only be added to the foods the Food Standards Code lists, and confectionery isn't one of them. So a vitamin gummy is made as a TGA-listed medicine, with an AUST L number on the label.\n- A gummy made as a medicine follows the same rules as a capsule: permitted ingredients and indications, a TGA-licensed or GMP-cleared manufacturer, and a TGO 116 label.\n- Choose a gummy when taste drives repeat purchase. We stability-test taste and texture across the shelf life, not just the actives.","text":"A daily format your customers look forward to. We make pectin (vegan), gelatin, sugar-free, and centre-filled or coated gummies. In a general food, vitamins and minerals can only be added to the foods the Food Standards Code lists, and confectionery isn't one of them. So a vitamin gummy is made as a TGA-listed medicine, with an AUST L number on the label. A gummy made as a medicine follows the same rules as a capsule: permitted ingredients and indications, a TGA-licensed or GMP-cleared manufacturer, and a TGO 116 label. Choose a gummy when taste drives repeat purchase. We stability-test taste and texture across the shelf life, not just the actives.","items":[],"tables":[]},{"heading":"What we make","anchor":"what-we-make","markdown":"- **Pectin gummies**, plant-based, for a vegan range.\n- **Gelatin gummies.**\n- **Sugar-free gummies.**\n- **Centre-filled or coated gummies**, for a second texture or a finish.\n\nGummies are popular for vitamin C, elderberry, apple cider vinegar, kids' multivitamins, and sleep and relaxation.","text":"Pectin gummies, plant-based, for a vegan range. Gelatin gummies. Sugar-free gummies. Centre-filled or coated gummies, for a second texture or a finish. Gummies are popular for vitamin C, elderberry, apple cider vinegar, kids' multivitamins, and sleep and relaxation.","items":[{"lead":"Pectin gummies","text":", plant-based, for a vegan range."},{"lead":"Gelatin gummies.","text":"- Sugar-free gummies."},{"lead":"Centre-filled or coated gummies","text":", for a second texture or a finish."}],"tables":[]},{"heading":"Medicine or food?","anchor":"medicine-or-food","markdown":"A gummy is a medicine or a food the same way a capsule is: by what it contains and how it's presented, starting with its claims ([medicine, food or cosmetic?](/pathways)). Two rules settle most gummies.\n\n- **Added vitamins and minerals.** In a general food, a vitamin or mineral can only be added to a food listed in Schedule 17 of the Food Standards Code (section S17-4): cereals and cereal products, dairy products, edible oils and spreads, extracts, juices and cordials, plant-based analogues, soups and formulated beverages. Confectionery isn't on the list. A vitamin gummy is made as a listed medicine instead, which is why Complementary Medicines Australia tells parents to buy only gummies with an AUST L number on the label.\n- **A claim about health.** A gummy that claims a therapeutic benefit is presented as a medicine. One with no added vitamins or minerals and no therapeutic claim can be a food, with its claims held to the food rules. More on [the food pathway](/pathways/foods).","text":"A gummy is a medicine or a food the same way a capsule is: by what it contains and how it's presented, starting with its claims (medicine, food or cosmetic?). Two rules settle most gummies. Added vitamins and minerals. In a general food, a vitamin or mineral can only be added to a food listed in Schedule 17 of the Food Standards Code (section S17-4): cereals and cereal products, dairy products, edible oils and spreads, extracts, juices and cordials, plant-based analogues, soups and formulated beverages. Confectionery isn't on the list. A vitamin gummy is made as a listed medicine instead, which is why Complementary Medicines Australia tells parents to buy only gummies with an AUST L number on the label. A claim about health. A gummy that claims a therapeutic benefit is presented as a medicine. One with no added vitamins or minerals and no therapeutic claim can be a food, with its claims held to the food rules. More on the food pathway.","items":[{"lead":"Added vitamins and minerals.","text":"In a general food, a vitamin or mineral can only be added to a food listed in Schedule 17 of the Food Standards Code (section S17-4): cereals and cereal products, dairy products, edible oils and spreads, extracts, juices and cordials, plant-based analogues, soups and formulated beverages. Confectionery isn't on the list. A vitamin gummy is made as a listed medicine instead, which is why Complementary Medicines Australia tells parents to buy only gummies with an AUST L number on the label."},{"lead":"A claim about health.","text":"A gummy that claims a therapeutic benefit is presented as a medicine. One with no added vitamins or minerals and no therapeutic claim can be a food, with its claims held to the food rules. More on the food pathway."}],"tables":[]},{"heading":"Making a gummy as a medicine","anchor":"making-a-gummy-as-a-medicine","markdown":"A gummy listed on the ARTG is held to the same rules as any other listed medicine. Every ingredient has to be in the Permissible Ingredients Determination, and every claim has to be a permitted indication backed by the sponsor's evidence ([permitted indications](/guides/permitted-indications)). It's made at a site licensed by the TGA, or one holding TGA GMP clearance if it's overseas ([choosing a supplement manufacturer](/guides/choosing-a-supplement-manufacturer)). The first run is at least 3,000 finished retail packs, as for any format ([what a supplement costs to develop](/guides/supplement-development-cost)).","text":"A gummy listed on the ARTG is held to the same rules as any other listed medicine. Every ingredient has to be in the Permissible Ingredients Determination, and every claim has to be a permitted indication backed by the sponsor's evidence (permitted indications). It's made at a site licensed by the TGA, or one holding TGA GMP clearance if it's overseas (choosing a supplement manufacturer). The first run is at least 3,000 finished retail packs, as for any format (what a supplement costs to develop).","items":[],"tables":[]},{"heading":"The label","anchor":"the-label","markdown":"The label follows TGO 116, like any listed medicine's. Two lines matter more for gummies than for most formats.\n\n- **Sugar alcohols.** An oral medicine whose sugar alcohols total more than 2 g in the maximum recommended daily dose must state that quantity and, unless the sugar alcohol is glycerol, carry \"Products containing [name of sugar alcohol] may have a laxative effect or cause diarrhoea\". That's worth checking on a sugar-free gummy.\n- **Iron and child-resistant packaging.** TGO 95 requires child-resistant packaging for listed medicines containing certain substances in set strengths or pack sizes. Iron is on the list: a pack with more than 250 mg of elemental iron in total, unless each dose unit has 5 mg or less and the iron is combined with other actives. That's worth checking on a kids' multivitamin gummy.\n\nMore in our [supplement labelling guide](/guides/supplement-labelling).","text":"The label follows TGO 116, like any listed medicine's. Two lines matter more for gummies than for most formats. Sugar alcohols. An oral medicine whose sugar alcohols total more than 2 g in the maximum recommended daily dose must state that quantity and, unless the sugar alcohol is glycerol, carry \"Products containing [name of sugar alcohol] may have a laxative effect or cause diarrhoea\". That's worth checking on a sugar-free gummy. Iron and child-resistant packaging. TGO 95 requires child-resistant packaging for listed medicines containing certain substances in set strengths or pack sizes. Iron is on the list: a pack with more than 250 mg of elemental iron in total, unless each dose unit has 5 mg or less and the iron is combined with other actives. That's worth checking on a kids' multivitamin gummy. More in our supplement labelling guide.","items":[{"lead":"Sugar alcohols.","text":"An oral medicine whose sugar alcohols total more than 2 g in the maximum recommended daily dose must state that quantity and, unless the sugar alcohol is glycerol, carry \"Products containing [name of sugar alcohol] may have a laxative effect or cause diarrhoea\". That's worth checking on a sugar-free gummy."},{"lead":"Iron and child-resistant packaging.","text":"TGO 95 requires child-resistant packaging for listed medicines containing certain substances in set strengths or pack sizes. Iron is on the list: a pack with more than 250 mg of elemental iron in total, unless each dose unit has 5 mg or less and the iron is combined with other actives. That's worth checking on a kids' multivitamin gummy."}],"tables":[]},{"heading":"Taste, texture and shelf life","anchor":"taste-texture-and-shelf-life","markdown":"Taste drives repeat purchase, so a gummy is tested for how it tastes and chews across its shelf life, as well as for its actives. The stability program supports the expiry on the label: what the TGA expects is in our [stability testing guide](/guides/stability-testing). When the dose is high, a tablet holds more in one unit ([capsules, tablets and softgels](/formats/capsules-tablets-softgels)), and a large serve suits a [powder](/formats/powders-sachets).","text":"Taste drives repeat purchase, so a gummy is tested for how it tastes and chews across its shelf life, as well as for its actives. The stability program supports the expiry on the label: what the TGA expects is in our stability testing guide. When the dose is high, a tablet holds more in one unit (capsules, tablets and softgels), and a large serve suits a powder.","items":[],"tables":[]}],"faqs":[{"q":"Can a gummy be a TGA-listed medicine?","a":"Yes. A gummy with added vitamins or minerals, or one that makes a therapeutic claim, is made as a listed medicine, with permitted ingredients and indications, a TGA-licensed or GMP-cleared manufacturer and a TGO 116 label. It carries an AUST L number like any other listed medicine.","md":"Yes. A gummy with added vitamins or minerals, or one that makes a therapeutic claim, is made as a listed medicine, with permitted ingredients and indications, a TGA-licensed or GMP-cleared manufacturer and a TGO 116 label. It carries an AUST L number like any other listed medicine."},{"q":"Can you make vegan gummies?","a":"Yes. Pectin gummies are plant-based, so they suit a vegan range. We also make gelatin gummies.","md":"Yes. Pectin gummies are plant-based, so they suit a vegan range. We also make gelatin gummies."},{"q":"Can you make sugar-free gummies?","a":"Yes. If a sugar-free gummy's sugar alcohols total more than 2 g in the maximum daily dose, a listed medicine's label must state the quantity and carry the laxative-effect statement, unless the sugar alcohol is glycerol.","md":"Yes. If a sugar-free gummy's sugar alcohols total more than 2 g in the maximum daily dose, a listed medicine's label must state the quantity and carry the laxative-effect statement, unless the sugar alcohol is glycerol."},{"q":"Do kids' gummies need child-resistant packaging?","a":"Only if they contain a substance TGO 95 lists, in the strength or pack size it sets, or if the label or pack says or implies it is child-resistant. Iron is on the list.","md":"Only if they contain a substance TGO 95 lists, in the strength or pack size it sets, or if the label or pack says or implies it is child-resistant. Iron is on the list."},{"q":"What's the minimum order?","a":"A first run is at least 3,000 finished retail packs per batch, made in one run, whatever the format.","md":"A first run is at least 3,000 finished retail packs per batch, made in one run, whatever the format."}],"sources":{"note":"General information, checked against these sources on 26 October 2026. It isn't advice on a particular product.","markdown":"General information, checked against these sources on 26 October 2026. It isn't advice on a particular product.\n\n- [Australia New Zealand Food Standards Code – Schedule 17 – Vitamins and minerals](https://www.legislation.gov.au/F2015L00449/latest), section S17-4, Federal Register of Legislation\n- [Vitamin gummies: what parents should know](https://cmaustralia.org.au/vitamin-gummies-what-parents-should-know/), Complementary Medicines Australia, 30 April 2026\n- [Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026](https://www.legislation.gov.au/F2026L01312/asmade/2026-09-28/text/original/pdf), Federal Register of Legislation\n- [Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017](https://legislation.gov.au/F2017L01577/asmade/2017-12-04/text/original/pdf), section 6 and Schedule 1, Federal Register of Legislation","items":[{"text":"Australia New Zealand Food Standards Code – Schedule 17 – Vitamins and minerals, section S17-4, Federal Register of Legislation","links":[{"title":"Australia New Zealand Food Standards Code – Schedule 17 – Vitamins and minerals","url":"https://www.legislation.gov.au/F2015L00449/latest"}]},{"text":"Vitamin gummies: what parents should know, Complementary Medicines Australia, 30 April 2026","links":[{"title":"Vitamin gummies: what parents should know","url":"https://cmaustralia.org.au/vitamin-gummies-what-parents-should-know/"}]},{"text":"Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026","url":"https://www.legislation.gov.au/F2026L01312/asmade/2026-09-28/text/original/pdf"}]},{"text":"Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017, section 6 and Schedule 1, Federal Register of Legislation","links":[{"title":"Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017","url":"https://legislation.gov.au/F2017L01577/asmade/2017-12-04/text/original/pdf"}]}]}},{"slug":"liquids","kind":"format","url":"/formats/liquids","title":"Liquid supplements, from formula to delivery","name":"Liquids","description":"Liquid supplement manufacturing, managed: vitamin drops, herbal tinctures, shots, syrups and oral sprays, as TGA-listed medicines or foods.","eyebrow":"Format","lead":"We develop drops, tinctures, shots, syrups and oral sprays as TGA-listed medicines or foods, and manage their manufacture through cGMP partners, from the first formula to delivery at your warehouse.","parent":"/manufacturing","studies":["deeply-rooted-organic-oil","arxi-prenatal-chewable"],"formats":["liquids"],"order":43,"updated":"2026-10-26","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- Doses your customers can measure, drop or spray. We make drops, tinctures, shots, syrups and oral sprays.\n- Popular for vitamin D drops, herbal tinctures, iron liquids and B12 sprays. Choose a liquid when you need precise or adjustable doses, or your customers prefer a liquid.\n- Vitamin D drops and B12 sprays are usually made as TGA-listed medicines. A shot can be a food, because formulated beverages and juices are among the foods the Food Standards Code lets vitamins and minerals be added to.\n- A water-based liquid in a multidose bottle has to pass a test of its preservative under TGO 100. An iron liquid with more than 250 mg of elemental iron in the pack needs child-resistant packaging under TGO 95.","text":"Doses your customers can measure, drop or spray. We make drops, tinctures, shots, syrups and oral sprays. Popular for vitamin D drops, herbal tinctures, iron liquids and B12 sprays. Choose a liquid when you need precise or adjustable doses, or your customers prefer a liquid. Vitamin D drops and B12 sprays are usually made as TGA-listed medicines. A shot can be a food, because formulated beverages and juices are among the foods the Food Standards Code lets vitamins and minerals be added to. A water-based liquid in a multidose bottle has to pass a test of its preservative under TGO 100. An iron liquid with more than 250 mg of elemental iron in the pack needs child-resistant packaging under TGO 95.","items":[],"tables":[]},{"heading":"What we make","anchor":"what-we-make","markdown":"- **Drops**, measured by the drop or the millilitre.\n- **Tinctures**, for herbal formulas.\n- **Shots**, a single serve in one small bottle.\n- **Syrups.**\n- **Oral sprays.**\n\nLiquids are popular for vitamin D drops, herbal tinctures, iron liquids and B12 sprays. Choose one when you need precise or adjustable doses, or your customers prefer a liquid. For a large serve, see [powders and sachets](/formats/powders-sachets).","text":"Drops, measured by the drop or the millilitre. Tinctures, for herbal formulas. Shots, a single serve in one small bottle. Syrups. Oral sprays. Liquids are popular for vitamin D drops, herbal tinctures, iron liquids and B12 sprays. Choose one when you need precise or adjustable doses, or your customers prefer a liquid. For a large serve, see powders and sachets.","items":[{"lead":"Drops","text":", measured by the drop or the millilitre."},{"lead":"Tinctures","text":", for herbal formulas."},{"lead":"Shots","text":", a single serve in one small bottle."},{"lead":"Syrups.","text":"- Oral sprays."}],"tables":[]},{"heading":"Medicine or food?","anchor":"medicine-or-food","markdown":"A liquid is a medicine or a food the same way any format is: by what it contains and how it's presented, starting with its claims ([medicine, food or cosmetic?](/pathways)).\n\n- **Drops and sprays.** In a general food, a vitamin or mineral can only be added to a food listed in Schedule 17 of the Food Standards Code (section S17-4), within its limits: cereals, dairy products, edible oils and spreads, juices, formulated beverages and a few others. Vitamin D drops and B12 sprays are usually made as listed medicines instead, with an AUST L number on the label, as a [vitamin gummy](/formats/gummies) is.\n- **Shots.** Formulated beverages are on the list, measured against a 600 mL serve, and so are fruit and vegetable juices. So a shot with added vitamins can be made as a food, if it meets the Code's rules for that kind of drink and stays within its limits. More on [the food pathway](/pathways/foods).\n- **Tinctures.** A herbal tincture presented for a therapeutic use is a medicine, usually a listed one. Then every herb has to be in the Permissible Ingredients Determination, and every claim has to be a permitted indication backed by the sponsor's evidence ([permitted indications](/guides/permitted-indications)).","text":"A liquid is a medicine or a food the same way any format is: by what it contains and how it's presented, starting with its claims (medicine, food or cosmetic?). Drops and sprays. In a general food, a vitamin or mineral can only be added to a food listed in Schedule 17 of the Food Standards Code (section S17-4), within its limits: cereals, dairy products, edible oils and spreads, juices, formulated beverages and a few others. Vitamin D drops and B12 sprays are usually made as listed medicines instead, with an AUST L number on the label, as a vitamin gummy is. Shots. Formulated beverages are on the list, measured against a 600 mL serve, and so are fruit and vegetable juices. So a shot with added vitamins can be made as a food, if it meets the Code's rules for that kind of drink and stays within its limits. More on the food pathway. Tinctures. A herbal tincture presented for a therapeutic use is a medicine, usually a listed one. Then every herb has to be in the Permissible Ingredients Determination, and every claim has to be a permitted indication backed by the sponsor's evidence (permitted indications).","items":[{"lead":"Drops and sprays.","text":"In a general food, a vitamin or mineral can only be added to a food listed in Schedule 17 of the Food Standards Code (section S17-4), within its limits: cereals, dairy products, edible oils and spreads, juices, formulated beverages and a few others. Vitamin D drops and B12 sprays are usually made as listed medicines instead, with an AUST L number on the label, as a vitamin gummy is."},{"lead":"Shots.","text":"Formulated beverages are on the list, measured against a 600 mL serve, and so are fruit and vegetable juices. So a shot with added vitamins can be made as a food, if it meets the Code's rules for that kind of drink and stays within its limits. More on the food pathway."},{"lead":"Tinctures.","text":"A herbal tincture presented for a therapeutic use is a medicine, usually a listed one. Then every herb has to be in the Permissible Ingredients Determination, and every claim has to be a permitted indication backed by the sponsor's evidence (permitted indications)."}],"tables":[]},{"heading":"Making a liquid as a medicine","anchor":"making-a-liquid-as-a-medicine","markdown":"A liquid listed on the ARTG is held to the same rules as any other listed medicine: permitted ingredients and indications, a site licensed by the TGA or holding TGA GMP clearance if it's overseas ([choosing a supplement manufacturer](/guides/choosing-a-supplement-manufacturer)), and a TGO 116 label. Two rules weigh more on liquids than on dry formats.\n\n- **Preservative testing.** Under TGO 100, a water-based medicine in a multidose container must pass the pharmacopoeial test of how well its preservative works, on top of the microbial limits every non-sterile medicine has to meet.\n- **Child-resistant packaging.** TGO 95 requires it for a listed medicine whose pack holds more than 250 mg of elemental iron in total. Its exception is for divided preparations, such as tablets, with 5 mg or less of iron per dosage unit alongside other actives, so for a liquid, check the total in the bottle. Some essential oils are on the list too: eucalyptus, clove and melaleuca oil need it unless the container is 15 mL or less with a restricted flow insert, or the oil is 25% or less of the product.\n\nThe first run is at least 3,000 finished retail packs, as for any format ([what a supplement costs to develop](/guides/supplement-development-cost)).","text":"A liquid listed on the ARTG is held to the same rules as any other listed medicine: permitted ingredients and indications, a site licensed by the TGA or holding TGA GMP clearance if it's overseas (choosing a supplement manufacturer), and a TGO 116 label. Two rules weigh more on liquids than on dry formats. Preservative testing. Under TGO 100, a water-based medicine in a multidose container must pass the pharmacopoeial test of how well its preservative works, on top of the microbial limits every non-sterile medicine has to meet. Child-resistant packaging. TGO 95 requires it for a listed medicine whose pack holds more than 250 mg of elemental iron in total. Its exception is for divided preparations, such as tablets, with 5 mg or less of iron per dosage unit alongside other actives, so for a liquid, check the total in the bottle. Some essential oils are on the list too: eucalyptus, clove and melaleuca oil need it unless the container is 15 mL or less with a restricted flow insert, or the oil is 25% or less of the product. The first run is at least 3,000 finished retail packs, as for any format (what a supplement costs to develop).","items":[{"lead":"Preservative testing.","text":"Under TGO 100, a water-based medicine in a multidose container must pass the pharmacopoeial test of how well its preservative works, on top of the microbial limits every non-sterile medicine has to meet."},{"lead":"Child-resistant packaging.","text":"TGO 95 requires it for a listed medicine whose pack holds more than 250 mg of elemental iron in total. Its exception is for divided preparations, such as tablets, with 5 mg or less of iron per dosage unit alongside other actives, so for a liquid, check the total in the bottle. Some essential oils are on the list too: eucalyptus, clove and melaleuca oil need it unless the container is 15 mL or less with a restricted flow insert, or the oil is 25% or less of the product."}],"tables":[]},{"heading":"The label","anchor":"the-label","markdown":"The label follows TGO 116, like any listed medicine's. Three lines matter more for liquids than for most formats.\n\n- **Alcohol.** It's one of the substances TGO 116 says to declare, with its percentage, for the routes and thresholds its Schedule 1 sets. That's a line on an alcohol-based tincture.\n- **Sugars and sugar alcohols.** Sugars are a declared substance too, which matters for a syrup. If sugar alcohols total more than 2 g in the maximum daily dose, the label must state the quantity and carry the laxative-effect statement, unless the sugar alcohol is glycerol.\n- **Small bottles.** A container of 25 mL or less inside a carton carries a short label of its own, in text at least 1.5 mm high: the medicine's name, each active and its quantity, the dosage form, the quantity, the batch number, the expiry date and the sponsor. A dropper bottle in a carton is often one.\n\nMore in our [supplement labelling guide](/guides/supplement-labelling).","text":"The label follows TGO 116, like any listed medicine's. Three lines matter more for liquids than for most formats. Alcohol. It's one of the substances TGO 116 says to declare, with its percentage, for the routes and thresholds its Schedule 1 sets. That's a line on an alcohol-based tincture. Sugars and sugar alcohols. Sugars are a declared substance too, which matters for a syrup. If sugar alcohols total more than 2 g in the maximum daily dose, the label must state the quantity and carry the laxative-effect statement, unless the sugar alcohol is glycerol. Small bottles. A container of 25 mL or less inside a carton carries a short label of its own, in text at least 1.5 mm high: the medicine's name, each active and its quantity, the dosage form, the quantity, the batch number, the expiry date and the sponsor. A dropper bottle in a carton is often one. More in our supplement labelling guide.","items":[{"lead":"Alcohol.","text":"It's one of the substances TGO 116 says to declare, with its percentage, for the routes and thresholds its Schedule 1 sets. That's a line on an alcohol-based tincture."},{"lead":"Sugars and sugar alcohols.","text":"Sugars are a declared substance too, which matters for a syrup. If sugar alcohols total more than 2 g in the maximum daily dose, the label must state the quantity and carry the laxative-effect statement, unless the sugar alcohol is glycerol."},{"lead":"Small bottles.","text":"A container of 25 mL or less inside a carton carries a short label of its own, in text at least 1.5 mm high: the medicine's name, each active and its quantity, the dosage form, the quantity, the batch number, the expiry date and the sponsor. A dropper bottle in a carton is often one."}],"tables":[]},{"heading":"When a liquid isn't the answer","anchor":"when-a-liquid-isnt-the-answer","markdown":"Liquids have their own limits. A prenatal for [Arxi](/work/arxi-prenatal-chewable) started as a liquid drop. Trials showed it wasn't stable and its taste couldn't be masked: vitamin C fizzes in liquid, and B vitamins and selenium are bitter and smell strongly. After testing a liposomal liquid, it moved to a two-a-day chewable. Finding that out in trials, not in production, is the point of the format stage. The stability program then supports the expiry on the label: what the TGA expects is in our [stability testing guide](/guides/stability-testing).","text":"Liquids have their own limits. A prenatal for Arxi started as a liquid drop. Trials showed it wasn't stable and its taste couldn't be masked: vitamin C fizzes in liquid, and B vitamins and selenium are bitter and smell strongly. After testing a liposomal liquid, it moved to a two-a-day chewable. Finding that out in trials, not in production, is the point of the format stage. The stability program then supports the expiry on the label: what the TGA expects is in our stability testing guide.","items":[],"tables":[]},{"heading":"From our records","anchor":"from-our-records","markdown":"- [Deeply Rooted](/work/deeply-rooted-organic-oil): an organic essential oil blend for children, made in New Zealand and sold in Australia. We handled product development and the whole cross-border supply chain, from the New Zealand maker to delivery in Australia, in 2025.\n- [Arxi](/work/arxi-prenatal-chewable): a prenatal that started as a liquid drop and moved to a chewable after trials.","text":"Deeply Rooted: an organic essential oil blend for children, made in New Zealand and sold in Australia. We handled product development and the whole cross-border supply chain, from the New Zealand maker to delivery in Australia, in 2025. Arxi: a prenatal that started as a liquid drop and moved to a chewable after trials.","items":[],"tables":[]}],"faqs":[{"q":"Can you make liquid supplements?","a":"Yes: drops, tinctures, shots, syrups and oral sprays, as TGA-listed medicines or foods. We settle the pathway at the brief, before the formula.","md":"Yes: drops, tinctures, shots, syrups and oral sprays, as TGA-listed medicines or foods. We settle the pathway at the brief, before the formula."},{"q":"Is a vitamin drop a medicine or a food?","a":"Usually a medicine. In a general food, vitamins and minerals can only be added to the foods Schedule 17 of the Food Standards Code lists, so vitamin D drops and B12 sprays are usually made as listed medicines. A shot can be a food, because formulated beverages and juices are on the list.","md":"Usually a medicine. In a general food, vitamins and minerals can only be added to the foods Schedule 17 of the Food Standards Code lists, so vitamin D drops and B12 sprays are usually made as listed medicines. A shot can be a food, because formulated beverages and juices are on the list."},{"q":"Why does a liquid need preservative testing?","a":"A water-based liquid in a multidose bottle is opened again and again. Under TGO 100, its preservative has to pass the pharmacopoeial efficacy test, as well as the microbial limits every non-sterile medicine meets.","md":"A water-based liquid in a multidose bottle is opened again and again. Under TGO 100, its preservative has to pass the pharmacopoeial efficacy test, as well as the microbial limits every non-sterile medicine meets."},{"q":"Do iron liquids need child-resistant packaging?","a":"Yes, if the pack holds more than 250 mg of elemental iron in total, under TGO 95. So does any pack whose label or packaging says or implies it's child-resistant.","md":"Yes, if the pack holds more than 250 mg of elemental iron in total, under TGO 95. So does any pack whose label or packaging says or implies it's child-resistant."},{"q":"Do you manage manufacturing across borders?","a":"Yes. For Deeply Rooted we managed the supply chain from the New Zealand maker through to delivery in Australia.","md":"Yes. For Deeply Rooted we managed the supply chain from the New Zealand maker through to delivery in Australia."},{"q":"What's the minimum order?","a":"A first run is at least 3,000 finished retail packs per batch, made in one run, whatever the format.","md":"A first run is at least 3,000 finished retail packs per batch, made in one run, whatever the format."}],"sources":{"note":"General information, checked against these sources on 26 October 2026. It isn't advice on a particular product.","markdown":"General information, checked against these sources on 26 October 2026. It isn't advice on a particular product.\n\n- [Australia New Zealand Food Standards Code – Schedule 17 – Vitamins and minerals](https://www.legislation.gov.au/F2015L00449/latest), section S17-4, Federal Register of Legislation\n- [Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018](https://www.legislation.gov.au/F2018L01685/latest/text), section 10, Federal Register of Legislation\n- [Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017](https://legislation.gov.au/F2017L01577/asmade/2017-12-04/text/original/pdf), section 6 and Schedule 1, Federal Register of Legislation\n- [Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026](https://www.legislation.gov.au/F2026L01312/asmade/2026-09-28/text/original/pdf), Federal Register of Legislation","items":[{"text":"Australia New Zealand Food Standards Code – Schedule 17 – Vitamins and minerals, section S17-4, Federal Register of Legislation","links":[{"title":"Australia New Zealand Food Standards Code – Schedule 17 – Vitamins and minerals","url":"https://www.legislation.gov.au/F2015L00449/latest"}]},{"text":"Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018, section 10, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018","url":"https://www.legislation.gov.au/F2018L01685/latest/text"}]},{"text":"Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017, section 6 and Schedule 1, Federal Register of Legislation","links":[{"title":"Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017","url":"https://legislation.gov.au/F2017L01577/asmade/2017-12-04/text/original/pdf"}]},{"text":"Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026","url":"https://www.legislation.gov.au/F2026L01312/asmade/2026-09-28/text/original/pdf"}]}]}},{"slug":"listed-medicines","kind":"pathway","url":"/pathways/listed-medicines","title":"Listed medicines: the TGA pathway most supplements take","name":"Listed medicines","description":"How a supplement becomes a TGA-listed medicine (AUST L): permitted ingredients and indications, the evidence, the listing, TGA fees, the label and stability.","eyebrow":"Pathway","lead":"Most vitamins, minerals, herbal medicines and other supplements sold as medicines in Australia are listed medicines, with an AUST L number on the pack. We design the formula inside the TGA's permitted ingredients and indications, build the evidence behind every claim, list it, write the label and run the stability program, then manage the manufacturing. Most of the products in our case studies are listed medicines.","parent":"/pathways","studies":["the-belly-solution-travel-gut-health-powder","everleanbody-saffron-capsule","pain-relief-cream","pump-haircare-hair-supplement","ashwagandha-capsule-32-days","skincare-brand-regulatory-partner"],"formats":[],"order":50,"updated":"2026-10-19","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- Most vitamins, minerals, herbal medicines and other supplements sold as medicines in Australia are listed medicines with an AUST L number: the TGA's lowest-risk tier of medicine.\n- A listed medicine can only use ingredients from the TGA's pre-approved list and low-level claims from its permitted indications, with evidence held for every claim.\n- The TGA doesn't evaluate it before sale: the Australian sponsor certifies that it meets the rules, and the TGA can review it at any time after.\n- From our records, design to production order has taken 32 days to 12 weeks. The listing itself is quick once the work behind it is done.\n- The TGA's fees from 1 July 2026: $1,063 to apply for a listing, then an annual charge of $1,566 for each listed medicine.","text":"Most vitamins, minerals, herbal medicines and other supplements sold as medicines in Australia are listed medicines with an AUST L number: the TGA's lowest-risk tier of medicine. A listed medicine can only use ingredients from the TGA's pre-approved list and low-level claims from its permitted indications, with evidence held for every claim. The TGA doesn't evaluate it before sale: the Australian sponsor certifies that it meets the rules, and the TGA can review it at any time after. From our records, design to production order has taken 32 days to 12 weeks. The listing itself is quick once the work behind it is done. The TGA's fees from 1 July 2026: $1,063 to apply for a listing, then an annual charge of $1,566 for each listed medicine.","items":[],"tables":[]},{"heading":"What a listed medicine is","anchor":"what-a-listed-medicine-is","markdown":"A listed medicine is the TGA's lowest-risk tier of non-prescription medicine. It can only use ingredients from the TGA's pre-approved list and make low-level health claims from its permitted indications. The TGA doesn't individually evaluate it before it is sold: the sponsor (an Australian resident, or a company doing business in Australia with a representative who lives here) certifies that it meets the rules and holds the evidence for its claims, and the TGA can review it at any time after. Medicines that need stronger claims go through assessed listing (AUST L(A)), where the TGA assesses efficacy before sale, or registration (AUST R), where it evaluates safety, quality and efficacy first. Our [TGA listing guide](/guides/tga-approval) sets out the differences, the steps and the fees.","text":"A listed medicine is the TGA's lowest-risk tier of non-prescription medicine. It can only use ingredients from the TGA's pre-approved list and make low-level health claims from its permitted indications. The TGA doesn't individually evaluate it before it is sold: the sponsor (an Australian resident, or a company doing business in Australia with a representative who lives here) certifies that it meets the rules and holds the evidence for its claims, and the TGA can review it at any time after. Medicines that need stronger claims go through assessed listing (AUST L(A)), where the TGA assesses efficacy before sale, or registration (AUST R), where it evaluates safety, quality and efficacy first. Our TGA listing guide sets out the differences, the steps and the fees.","items":[],"tables":[]},{"heading":"What we do on the listed pathway","anchor":"what-we-do-on-the-listed-pathway","markdown":"- **Ingredients and indications first.** Every ingredient must be in the Permissible Ingredients Determination, used only as it allows, and every indication must come from the Permissible Indications Determination. Both change: there have been three ingredient determinations in 2026 alone. We check every ingredient, its form and its dose at the brief, before the formula, so nothing has to be designed twice. What each indication allows, and the evidence behind it, is in our [claims and indications guide](/guides/permitted-indications).\n- **The evidence behind every claim.** The sponsor certifies at listing that it holds evidence for every indication and claim, and the TGA can ask to see it. Our evidence packages run from a single ingredient to formulas of 13 or more, including [a complex herbal capsule built around KSM-66® ashwagandha](/work/ashwagandha-capsule-32-days) and [a prenatal built on plant powders](/work/prenatal-multivitamin-capsule).\n- **The listing, and keeping it current.** We secure the listing and update it when the product changes: [a pain relief cream](/work/pain-relief-cream) after a preservative change, [a joint formula](/work/sports-nutrition-joint-formula) to keep it current, and [Pump Haircare's](/work/pump-haircare-hair-supplement) upgraded formula with a full new listing package.\n- **The label.** Since 30 September 2026, labels follow TGO 116, which replaced TGO 92 (TGO 92 labels remain an option for medicines released for supply before 1 October 2031). On [Arxi's prenatal](/work/arxi-prenatal-chewable), our label review caught two errors before print.\n- **Stability.** A program to support the expiry date on the label: 24 months on recent capsules, 36 months on [The Belly Solution's](/work/the-belly-solution-travel-gut-health-powder) powder, and a protocol designed to support a three-year expiry on [an eye-health tablet](/work/eye-health-tablet-format-rescue). What the TGA expects is in our [stability testing guide](/guides/stability-testing).\n- **Regulatory work on a retainer.** Since 2024 we have run [an international skincare brand's](/work/skincare-brand-regulatory-partner) Australian regulatory work, now in its third year.","text":"Ingredients and indications first. Every ingredient must be in the Permissible Ingredients Determination, used only as it allows, and every indication must come from the Permissible Indications Determination. Both change: there have been three ingredient determinations in 2026 alone. We check every ingredient, its form and its dose at the brief, before the formula, so nothing has to be designed twice. What each indication allows, and the evidence behind it, is in our claims and indications guide. The evidence behind every claim. The sponsor certifies at listing that it holds evidence for every indication and claim, and the TGA can ask to see it. Our evidence packages run from a single ingredient to formulas of 13 or more, including a complex herbal capsule built around KSM-66® ashwagandha and a prenatal built on plant powders. The listing, and keeping it current. We secure the listing and update it when the product changes: a pain relief cream after a preservative change, a joint formula to keep it current, and Pump Haircare's upgraded formula with a full new listing package. The label. Since 30 September 2026, labels follow TGO 116, which replaced TGO 92 (TGO 92 labels remain an option for medicines released for supply before 1 October 2031). On Arxi's prenatal, our label review caught two errors before print. Stability. A program to support the expiry date on the label: 24 months on recent capsules, 36 months on The Belly Solution's powder, and a protocol designed to support a three-year expiry on an eye-health tablet. What the TGA expects is in our stability testing guide. Regulatory work on a retainer. Since 2024 we have run an international skincare brand's Australian regulatory work, now in its third year.","items":[{"lead":"Ingredients and indications first.","text":"Every ingredient must be in the Permissible Ingredients Determination, used only as it allows, and every indication must come from the Permissible Indications Determination. Both change: there have been three ingredient determinations in 2026 alone. We check every ingredient, its form and its dose at the brief, before the formula, so nothing has to be designed twice. What each indication allows, and the evidence behind it, is in our claims and indications guide."},{"lead":"The evidence behind every claim.","text":"The sponsor certifies at listing that it holds evidence for every indication and claim, and the TGA can ask to see it. Our evidence packages run from a single ingredient to formulas of 13 or more, including a complex herbal capsule built around KSM-66® ashwagandha and a prenatal built on plant powders."},{"lead":"The listing, and keeping it current.","text":"We secure the listing and update it when the product changes: a pain relief cream after a preservative change, a joint formula to keep it current, and Pump Haircare's upgraded formula with a full new listing package."},{"lead":"The label.","text":"Since 30 September 2026, labels follow TGO 116, which replaced TGO 92 (TGO 92 labels remain an option for medicines released for supply before 1 October 2031). On Arxi's prenatal, our label review caught two errors before print."},{"lead":"Stability.","text":"A program to support the expiry date on the label: 24 months on recent capsules, 36 months on The Belly Solution's powder, and a protocol designed to support a three-year expiry on an eye-health tablet. What the TGA expects is in our stability testing guide."},{"lead":"Regulatory work on a retainer.","text":"Since 2024 we have run an international skincare brand's Australian regulatory work, now in its third year."}],"tables":[]},{"heading":"How long it takes","anchor":"how-long-it-takes","markdown":"The TGA's step is quick: once an application passes validation and its fee is paid, the medicine goes on the Australian Register of Therapeutic Goods with its AUST L number. The time is in the work before lodging. From our records, design to production order has taken 32 days for a complex herbal capsule, under seven weeks for [an eye-health formula](/work/areds2-eye-health-formula) and 12 weeks for [a two-a-day skin supplement](/work/probiotic-skin-supplement). [EverLeanBody's](/work/everleanbody-saffron-capsule) first capsule took 5.8 months from signed brief to dispatch to its 3PL. The full process, step by step with the TGA's fees, is in our guide to [TGA listing](/guides/tga-approval), and the stages that set the pace are in [how long it takes to develop a supplement](/guides/supplement-development-timeline).","text":"The TGA's step is quick: once an application passes validation and its fee is paid, the medicine goes on the Australian Register of Therapeutic Goods with its AUST L number. The time is in the work before lodging. From our records, design to production order has taken 32 days for a complex herbal capsule, under seven weeks for an eye-health formula and 12 weeks for a two-a-day skin supplement. EverLeanBody's first capsule took 5.8 months from signed brief to dispatch to its 3PL. The full process, step by step with the TGA's fees, is in our guide to TGA listing, and the stages that set the pace are in how long it takes to develop a supplement.","items":[],"tables":[]}],"faqs":[{"q":"Who can help my brand get a supplement TGA listed?","a":"The listing is the sponsor's: an Australian resident, or a company doing business here with a representative who lives in Australia, applies, certifies that the medicine meets the rules and holds the evidence for its claims: more in our TGA sponsor guide. We do the work behind it: the formula inside the permitted ingredients and indications, the evidence for every claim, the label, the stability program and the listing, then we manage the manufacturing. Most of the products in our case studies are listed medicines, among them EverLeanBody's saffron capsule and The Belly Solution's travel gut-health powder.","md":"The listing is the sponsor's: an Australian resident, or a company doing business here with a representative who lives in Australia, applies, certifies that the medicine meets the rules and holds the evidence for its claims: more in our [TGA sponsor guide](/guides/tga-sponsor). We do the work behind it: the formula inside the permitted ingredients and indications, the evidence for every claim, the label, the stability program and the listing, then we manage the manufacturing. Most of the products in our case studies are listed medicines, among them [EverLeanBody's saffron capsule](/work/everleanbody-saffron-capsule) and [The Belly Solution's travel gut-health powder](/work/the-belly-solution-travel-gut-health-powder)."},{"q":"Can you take over the regulatory work for products already on the market?","a":"Yes. Since 2024 we have run an international skincare brand's regulatory work on a monthly retainer, and we updated a sports nutrition brand's joint formula listing to keep it current.","md":"Yes. Since 2024 we have run an international skincare brand's regulatory work on a monthly retainer, and we updated a sports nutrition brand's joint formula listing to keep it current."},{"q":"Can a powder or a cream be a listed medicine?","a":"Yes. The Belly Solution's travel gut-health powder and a pain relief cream we developed are both TGA-listed medicines.","md":"Yes. The Belly Solution's travel gut-health powder and a pain relief cream we developed are both TGA-listed medicines."},{"q":"Do you work with branded clinical ingredients?","a":"Yes. Formulas we have developed are built on affron® saffron extract, KSM-66® ashwagandha, EnXtra®, Testofen® fenugreek extract, Eriomin® lemon flavonoids, AnaGain™ and Quatrefolic® active folate, among others.","md":"Yes. Formulas we have developed are built on affron® saffron extract, KSM-66® ashwagandha, EnXtra®, Testofen® fenugreek extract, Eriomin® lemon flavonoids, AnaGain™ and Quatrefolic® active folate, among others."},{"q":"How much does it cost to list a medicine with the TGA?","a":"The TGA's own fees, from 1 July 2026, are $1,063 to apply for a listing and an annual charge of $1,566 for each listed medicine. On top of that is the work behind the listing: the formula inside the permitted ingredients, the evidence for every claim, the label and the stability program. We quote each stage as a fixed fee before it begins.","md":"The TGA's own fees, from 1 July 2026, are $1,063 to apply for a listing and an annual charge of $1,566 for each listed medicine. On top of that is the work behind the listing: the formula inside the permitted ingredients, the evidence for every claim, the label and the stability program. We quote each stage as a fixed fee before it begins."},{"q":"What is an AUST L number?","a":"The number the TGA gives a listed medicine when it is entered on the Australian Register of Therapeutic Goods (ARTG). It must appear on the main label. AUST L(A) marks an assessed listed medicine and AUST R a registered one. More in our ARTG guide and our assessed listed medicines guide.","md":"The number the TGA gives a listed medicine when it is entered on the Australian Register of Therapeutic Goods (ARTG). It must appear on the main label. AUST L(A) marks an assessed listed medicine and AUST R a registered one. More in [our ARTG guide](/guides/artg) and our [assessed listed medicines guide](/guides/assessed-listed-medicines)."},{"q":"What evidence does a listed medicine need?","a":"Evidence for every indication and claim, held by the sponsor before the medicine is listed and supplied to the TGA if it asks. The evidence has to match the product: the ingredient, its form and its dose. Our evidence packages are built at the product's exact dose. See claims and indications.","md":"Evidence for every indication and claim, held by the sponsor before the medicine is listed and supplied to the TGA if it asks. The evidence has to match the product: the ingredient, its form and its dose. Our evidence packages are built at the product's exact dose. See [claims and indications](/guides/permitted-indications)."},{"q":"Can I advertise a listed medicine on social media?","a":"Yes, within the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021. Advertising, including a website, Instagram or TikTok, has to be consistent with the indications on the medicine's ARTG entry, and the TGA can act on advertising that isn't. We check the claims at the brief, so the label and the marketing say the same thing. More in our advertising guide.","md":"Yes, within the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021. Advertising, including a website, Instagram or TikTok, has to be consistent with the indications on the medicine's ARTG entry, and the TGA can act on advertising that isn't. We check the claims at the brief, so the label and the marketing say the same thing. More in our [advertising guide](/guides/tga-advertising)."},{"q":"How long is the shelf life of a listed medicine?","a":"As long as its stability data supports. Recent capsules we developed carry 24 months, and a powder carries 36. The stability program is designed for the expiry date the label will carry, and testing continues on the finished packed product. More in the stability testing guide.","md":"As long as its stability data supports. Recent capsules we developed carry 24 months, and a powder carries 36. The stability program is designed for the expiry date the label will carry, and testing continues on the finished packed product. More in [the stability testing guide](/guides/stability-testing)."},{"q":"Do I need a TGA regulatory consultant to list a supplement?","a":"It isn't required. The TGA puts the responsibility on the sponsor: the person or company that applies for the listing must meet every requirement and certify that it does. The risk is getting it wrong after launch. A listing that doesn't hold up, or advertising that goes beyond the indications, can mean relabelling, withdrawing stock or a TGA compliance letter. That is why most brands bring the work in: the formula inside the permitted ingredients, the evidence for every claim, the label and the listing, done before anything is certified.","md":"It isn't required. The TGA puts the responsibility on the sponsor: the person or company that applies for the listing must meet every requirement and certify that it does. The risk is getting it wrong after launch. A listing that doesn't hold up, or advertising that goes beyond the indications, can mean relabelling, withdrawing stock or a TGA compliance letter. That is why most brands bring the work in: the formula inside the permitted ingredients, the evidence for every claim, the label and the listing, done before anything is certified."}],"sources":{"note":"General information, checked against these sources on 19 October 2026. It isn't advice on a particular product.","markdown":"General information, checked against these sources on 19 October 2026. It isn't advice on a particular product.\n\n- [Listed medicines](https://www.tga.gov.au/node/520083) and [About listed medicines](https://www.tga.gov.au/node/546608), Therapeutic Goods Administration\n- [Listed, assessed listed and registered medicines](https://www.tga.gov.au/node/497532), Therapeutic Goods Administration\n- [General guidance for listed medicines](https://www.tga.gov.au/node/289506), Therapeutic Goods Administration\n- [Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026](https://www.legislation.gov.au/F2026L01382/asmade/versions) and [Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025](https://www.legislation.gov.au/F2025L00450/latest/versions), Federal Register of Legislation\n- [Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026](https://www.legislation.gov.au/F2026L01312/asmade), Federal Register of Legislation\n- [Fees and charges: summary, from 1 July 2026](https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf), Therapeutic Goods Administration\n- [Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021](https://www.legislation.gov.au/F2021L01661/latest/text), Federal Register of Legislation","items":[{"text":"Listed medicines and About listed medicines, Therapeutic Goods Administration","links":[{"title":"Listed medicines","url":"https://www.tga.gov.au/node/520083"},{"title":"About listed medicines","url":"https://www.tga.gov.au/node/546608"}]},{"text":"Listed, assessed listed and registered medicines, Therapeutic Goods Administration","links":[{"title":"Listed, assessed listed and registered medicines","url":"https://www.tga.gov.au/node/497532"}]},{"text":"General guidance for listed medicines, Therapeutic Goods Administration","links":[{"title":"General guidance for listed medicines","url":"https://www.tga.gov.au/node/289506"}]},{"text":"Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026 and Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026","url":"https://www.legislation.gov.au/F2026L01382/asmade/versions"},{"title":"Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025","url":"https://www.legislation.gov.au/F2025L00450/latest/versions"}]},{"text":"Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026","url":"https://www.legislation.gov.au/F2026L01312/asmade"}]},{"text":"Fees and charges: summary, from 1 July 2026, Therapeutic Goods Administration","links":[{"title":"Fees and charges: summary, from 1 July 2026","url":"https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf"}]},{"text":"Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021","url":"https://www.legislation.gov.au/F2021L01661/latest/text"}]}]}},{"slug":"foods","kind":"pathway","url":"/pathways/foods","title":"Supplements as foods: when the food pathway applies","name":"Foods","description":"When a powder, drink, bar or capsule can be sold as a food in Australia, not a listed medicine, and what the sports food, claims and label rules require.","eyebrow":"Pathway","lead":"A powder, drink, bar or capsule can be a food in Australia unless its presentation, or something else about it, makes it a medicine, or it is declared one. A product covered by a food standard, such as a sports food under Standard 2.9.4, is not a therapeutic good unless it is declared or determined to be one. As a food, it must meet the Food Standards Code, which sets what it can contain, what it can claim and what its label says. We settle the pathway at the brief, and develop products as foods as well as listed medicines.","parent":"/pathways","studies":["sports-brand-core-range","ora-practitioner-natural-medicine"],"formats":[],"order":51,"updated":"2026-10-20","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- A powder, drink, bar or capsule can be sold as a food in Australia unless its presentation, or something else about it, makes it a medicine, or it is declared one.\n- Beauty supplements are declared medicines, and so are sports supplements presented for a therapeutic use, such as gaining muscle, that come as a tablet, capsule or pill or contain certain substances.\n- Protein powders, nutrition bars and energy drinks made only of food ingredients stay foods. A food must meet the Food Standards Code, and no food may claim to prevent, cure or alleviate a disease.\n- Since 9 June 2026, a retail food can't contain caffeine unless the Code permits it, as it now does for sports foods: up to 200 mg a day.","text":"A powder, drink, bar or capsule can be sold as a food in Australia unless its presentation, or something else about it, makes it a medicine, or it is declared one. Beauty supplements are declared medicines, and so are sports supplements presented for a therapeutic use, such as gaining muscle, that come as a tablet, capsule or pill or contain certain substances. Protein powders, nutrition bars and energy drinks made only of food ingredients stay foods. A food must meet the Food Standards Code, and no food may claim to prevent, cure or alleviate a disease. Since 9 June 2026, a retail food can't contain caffeine unless the Code permits it, as it now does for sports foods: up to 200 mg a day.","items":[],"tables":[]},{"heading":"How a product ends up a food or a medicine","anchor":"how-a-product-ends-up-a-food-or-a-medicine","markdown":"The TGA says, \"Generally a product that is swallowed will be either one form of therapeutic good (a medicine) or a food.\" Under the Therapeutic Goods Act 1989, it is a therapeutic good if it is represented as, or likely to be taken to be, for therapeutic use.\n\nThe Act leaves out goods covered by a food standard, and goods with a tradition of use as food in Australia or New Zealand in the form presented. The exception is goods declared under section 7, or determined under section 7AAA, to be therapeutic goods.\n\n### Declared medicines\n\nOnce declared under section 7, a product \"cannot be a food\", the TGA says, even if a food standard covers it. The Therapeutic Goods (Declared Goods) Order 2019 declares them. Some are declared by form alone, whatever their presentation; others by how they are presented.\n\n**Sports supplements.** Products taken by mouth and represented as improving or maintaining performance in sport, exercise or recreational activity are declared when used, advertised or presented for a therapeutic use, such as gaining muscle, increasing focus or stamina, losing fat, or preparing for or recovering from a workout, or in a way likely to be taken as one, if they:\n\n- contain, or are said to contain, a Poisons Standard substance, an added substance on the 2023 World Anti-Doping Prohibited List, added dendrobium or methylliberine, or a substance with equivalent pharmacological action; or\n- since 30 November 2023, are supplied as a tablet, capsule or pill, unless they contain glucose only.\n\n**Beauty supplements.** Goods labelled or promoted for cosmetic purposes, such as improving the appearance of skin, hair and nails, are declared when used, advertised or presented for oral consumption. Our [beauty supplements guide](/guides/beauty-supplements) covers the claims and ingredients.\n\n**By form alone.** Goods containing fibre, made as a tablet, capsule or pill. Goods that contain, or are promoted to contain, isolated HMB or its salts, made as a tablet, capsule, pill or powder. Goods containing shark cartilage, made as a tablet, capsule or pill, or as a powder that isn't a wholesale product for use as an ingredient in food.\n\n### What stays a food\n\nThe TGA says sports supplements \"that only contain ingredients appropriate for food and are presented in a traditional food form\" are not affected, \"e.g. protein powders, nutrition bars and energy drinks\". Our [sports supplements guide](/guides/sports-supplement-development) covers building one on either pathway.","text":"The TGA says, \"Generally a product that is swallowed will be either one form of therapeutic good (a medicine) or a food.\" Under the Therapeutic Goods Act 1989, it is a therapeutic good if it is represented as, or likely to be taken to be, for therapeutic use. The Act leaves out goods covered by a food standard, and goods with a tradition of use as food in Australia or New Zealand in the form presented. The exception is goods declared under section 7, or determined under section 7AAA, to be therapeutic goods. Declared medicines Once declared under section 7, a product \"cannot be a food\", the TGA says, even if a food standard covers it. The Therapeutic Goods (Declared Goods) Order 2019 declares them. Some are declared by form alone, whatever their presentation; others by how they are presented. Sports supplements. Products taken by mouth and represented as improving or maintaining performance in sport, exercise or recreational activity are declared when used, advertised or presented for a therapeutic use, such as gaining muscle, increasing focus or stamina, losing fat, or preparing for or recovering from a workout, or in a way likely to be taken as one, if they: contain, or are said to contain, a Poisons Standard substance, an added substance on the 2023 World Anti-Doping Prohibited List, added dendrobium or methylliberine, or a substance with equivalent pharmacological action; or since 30 November 2023, are supplied as a tablet, capsule or pill, unless they contain glucose only. Beauty supplements. Goods labelled or promoted for cosmetic purposes, such as improving the appearance of skin, hair and nails, are declared when used, advertised or presented for oral consumption. Our beauty supplements guide covers the claims and ingredients. By form alone. Goods containing fibre, made as a tablet, capsule or pill. Goods that contain, or are promoted to contain, isolated HMB or its salts, made as a tablet, capsule, pill or powder. Goods containing shark cartilage, made as a tablet, capsule or pill, or as a powder that isn't a wholesale product for use as an ingredient in food. What stays a food The TGA says sports supplements \"that only contain ingredients appropriate for food and are presented in a traditional food form\" are not affected, \"e.g. protein powders, nutrition bars and energy drinks\". Our sports supplements guide covers building one on either pathway.","items":[],"tables":[]},{"heading":"The food standards that matter","anchor":"the-food-standards-that-matter","markdown":"Unless the Code expressly permits them, a food for sale must not contain added nutritive substances, such as vitamins and minerals. Nor, without such permission, can a retail food be or contain a novel food: our [novel foods guide](/guides/novel-foods) covers when an ingredient is novel and how FSANZ approves one.\n\nSince 9 June 2026, a retail food also can't contain caffeine from any source unless the Code expressly permits it, as Standard 2.9.4 now does for sports foods. Caffeine that comes naturally from added cocoa, chocolate, coffee or tea doesn't count, but caffeine from added guarana extract does, and caffeine itself and guarana extract can't be sold as a retail food. Until 9 June 2028, a product may follow the Code as it was or as amended.\n\n| Standard | Covers | What it allows or requires |\n| --- | --- | --- |\n| 2.9.4 Formulated supplementary sports foods | Products formulated to help sports people achieve nutritional or performance goals | Vitamins, minerals, amino acids and other substances listed in Schedule 29, within its limits; since 9 June 2026, up to 200 mg caffeine a day, below 5% of a powder or 1% of a liquid |\n| 2.9.3 Formulated meal replacements and formulated supplementary foods | Meal replacements, and foods formulated and sold as a supplement to a normal diet where energy and nutrient intakes may not be adequate | For a formulated supplementary food, at least 8 g protein, 550 kJ and 20% of the RDI of a listed vitamin or mineral in a serving (less for children aged 1 to 3) |\n| 1.3.2 Vitamins and minerals | Vitamins and minerals added to foods generally | Permitted forms, in the foods Schedule 17 lists, within its limits |\n| 1.5.1 Novel foods | Non-traditional foods that need a safety assessment | No retail sale unless listed in Schedule 25 and used within its conditions; listing follows a safety assessment by FSANZ |\n| 1.2.7 Nutrition, health and related claims | Nutrition content claims and health claims | Health claims from pre-approved relationships or, for general level claims, notified ones; no disease claims |","text":"Unless the Code expressly permits them, a food for sale must not contain added nutritive substances, such as vitamins and minerals. Nor, without such permission, can a retail food be or contain a novel food: our novel foods guide covers when an ingredient is novel and how FSANZ approves one. Since 9 June 2026, a retail food also can't contain caffeine from any source unless the Code expressly permits it, as Standard 2.9.4 now does for sports foods. Caffeine that comes naturally from added cocoa, chocolate, coffee or tea doesn't count, but caffeine from added guarana extract does, and caffeine itself and guarana extract can't be sold as a retail food. Until 9 June 2028, a product may follow the Code as it was or as amended. Standard: 2.9.4 Formulated supplementary sports foods; Covers: Products formulated to help sports people achieve nutritional or performance goals; What it allows or requires: Vitamins, minerals, amino acids and other substances listed in Schedule 29, within its limits; since 9 June 2026, up to 200 mg caffeine a day, below 5% of a powder or 1% of a liquid. Standard: 2.9.3 Formulated meal replacements and formulated supplementary foods; Covers: Meal replacements, and foods formulated and sold as a supplement to a normal diet where energy and nutrient intakes may not be adequate; What it allows or requires: For a formulated supplementary food, at least 8 g protein, 550 kJ and 20% of the RDI of a listed vitamin or mineral in a serving (less for children aged 1 to 3). Standard: 1.3.2 Vitamins and minerals; Covers: Vitamins and minerals added to foods generally; What it allows or requires: Permitted forms, in the foods Schedule 17 lists, within its limits. Standard: 1.5.1 Novel foods; Covers: Non-traditional foods that need a safety assessment; What it allows or requires: No retail sale unless listed in Schedule 25 and used within its conditions; listing follows a safety assessment by FSANZ. Standard: 1.2.7 Nutrition, health and related claims; Covers: Nutrition content claims and health claims; What it allows or requires: Health claims from pre-approved relationships or, for general level claims, notified ones; no disease claims.","items":[],"tables":[{"header":["Standard","Covers","What it allows or requires"],"rows":[["2.9.4 Formulated supplementary sports foods","Products formulated to help sports people achieve nutritional or performance goals","Vitamins, minerals, amino acids and other substances listed in Schedule 29, within its limits; since 9 June 2026, up to 200 mg caffeine a day, below 5% of a powder or 1% of a liquid"],["2.9.3 Formulated meal replacements and formulated supplementary foods","Meal replacements, and foods formulated and sold as a supplement to a normal diet where energy and nutrient intakes may not be adequate","For a formulated supplementary food, at least 8 g protein, 550 kJ and 20% of the RDI of a listed vitamin or mineral in a serving (less for children aged 1 to 3)"],["1.3.2 Vitamins and minerals","Vitamins and minerals added to foods generally","Permitted forms, in the foods Schedule 17 lists, within its limits"],["1.5.1 Novel foods","Non-traditional foods that need a safety assessment","No retail sale unless listed in Schedule 25 and used within its conditions; listing follows a safety assessment by FSANZ"],["1.2.7 Nutrition, health and related claims","Nutrition content claims and health claims","Health claims from pre-approved relationships or, for general level claims, notified ones; no disease claims"]]}]},{"heading":"What a food can and can't claim","anchor":"what-a-food-can-and-cant-claim","markdown":"Under Standard 1.2.7, no claim on a food may refer to \"the prevention, diagnosis, cure or alleviation of a disease, disorder or condition\". Health claims have two levels:\n\n- **High level claims** refer to a serious disease or a biomarker of one. They must rest on one of the 13 pre-approved relationships currently in Schedule 4.\n- **General level claims** are any other health claim, such as \"calcium for healthy bones and teeth\". They can rest on one of more than 200 pre-approved relationships, or on one established by systematic review and notified to FSANZ before use.\n\nFor a health claim, the food must also meet the Nutrient Profiling Scoring Criterion, unless it is a special purpose food, a group that includes formulated supplementary foods and sports foods.\n\nFSANZ doesn't consider the merits of a notified relationship. The business making the claim certifies that a systematic review established the relationship, and must provide records if an enforcement authority asks.\n\nUnless Division 3 of Standard 2.9.4 permits it, a sports food's label must not, expressly or by implication, relate the food \"to enhanced athletic performance or beneficial physiological effects\".","text":"Under Standard 1.2.7, no claim on a food may refer to \"the prevention, diagnosis, cure or alleviation of a disease, disorder or condition\". Health claims have two levels: High level claims refer to a serious disease or a biomarker of one. They must rest on one of the 13 pre-approved relationships currently in Schedule 4. General level claims are any other health claim, such as \"calcium for healthy bones and teeth\". They can rest on one of more than 200 pre-approved relationships, or on one established by systematic review and notified to FSANZ before use. For a health claim, the food must also meet the Nutrient Profiling Scoring Criterion, unless it is a special purpose food, a group that includes formulated supplementary foods and sports foods. FSANZ doesn't consider the merits of a notified relationship. The business making the claim certifies that a systematic review established the relationship, and must provide records if an enforcement authority asks. Unless Division 3 of Standard 2.9.4 permits it, a sports food's label must not, expressly or by implication, relate the food \"to enhanced athletic performance or beneficial physiological effects\".","items":[{"lead":"High level claims","text":"refer to a serious disease or a biomarker of one. They must rest on one of the 13 pre-approved relationships currently in Schedule 4."},{"lead":"General level claims","text":"are any other health claim, such as \"calcium for healthy bones and teeth\". They can rest on one of more than 200 pre-approved relationships, or on one established by systematic review and notified to FSANZ before use."}],"tables":[]},{"heading":"Labels","anchor":"labels","markdown":"Where a retail food needs a label, Standard 1.2.1 lists what it must show, from the name and ingredients to date marking and nutrition information. Most food sold in Australia must also be labelled with its country of origin, under the Country of Origin Food Labelling Information Standard 2016, and the ACCC can investigate breaches. Non-priority foods, such as sports drinks, need only a text statement about where the food was grown, produced, made or packed.\n\nA sports food's label must also carry the name \"formulated supplementary sports food\" and say it is not a sole source of nutrition. It must advise use with a nutritious diet and an appropriate training or exercise program. It must give directions, the recommended amount for one day and a nutrition information panel.\n\nIts warning says it is not suitable for children under 15 or pregnant women, and should only be used under medical or dietetic supervision. Since 9 June 2026, if a sports food has caffeine from anything other than cocoa, chocolate, or decaffeinated coffee or tea within set caffeine limits, the warning adds breastfeeding women. The label must then say it contains caffeine, and the panel must give the average caffeine per serving and per unit quantity. Until 9 June 2028, a product may follow the Code as it was or as amended.","text":"Where a retail food needs a label, Standard 1.2.1 lists what it must show, from the name and ingredients to date marking and nutrition information. Most food sold in Australia must also be labelled with its country of origin, under the Country of Origin Food Labelling Information Standard 2016, and the ACCC can investigate breaches. Non-priority foods, such as sports drinks, need only a text statement about where the food was grown, produced, made or packed. A sports food's label must also carry the name \"formulated supplementary sports food\" and say it is not a sole source of nutrition. It must advise use with a nutritious diet and an appropriate training or exercise program. It must give directions, the recommended amount for one day and a nutrition information panel. Its warning says it is not suitable for children under 15 or pregnant women, and should only be used under medical or dietetic supervision. Since 9 June 2026, if a sports food has caffeine from anything other than cocoa, chocolate, or decaffeinated coffee or tea within set caffeine limits, the warning adds breastfeeding women. The label must then say it contains caffeine, and the panel must give the average caffeine per serving and per unit quantity. Until 9 June 2028, a product may follow the Code as it was or as amended.","items":[],"tables":[]},{"heading":"Who enforces the Code","anchor":"who-enforces-the-code","markdown":"FSANZ develops and administers the Code but \"has no enforcement powers\". In Australia, state or territory agencies and local councils enforce and interpret it. The Department of Agriculture, Fisheries and Forestry enforces it at the border.\n\nThe department refers imported food for sale for inspection and testing under its Imported Food Inspection Scheme, at rates set by risk, and every consignment it inspects gets a label check. Failed food can't be released: the importer must relabel it if labelling was the problem, or destroy or re-export it under supervision. Since 30 November 2023, inspected sports supplements in tablets, capsules or pills that fall within the new rules are referred to the TGA.\n\nIn FSANZ's words, \"A food recall is action taken by a food business to remove unsafe food from distribution, sale and consumption.\" FSANZ coordinates recalls in Australia, and the states and territories can mandate one.","text":"FSANZ develops and administers the Code but \"has no enforcement powers\". In Australia, state or territory agencies and local councils enforce and interpret it. The Department of Agriculture, Fisheries and Forestry enforces it at the border. The department refers imported food for sale for inspection and testing under its Imported Food Inspection Scheme, at rates set by risk, and every consignment it inspects gets a label check. Failed food can't be released: the importer must relabel it if labelling was the problem, or destroy or re-export it under supervision. Since 30 November 2023, inspected sports supplements in tablets, capsules or pills that fall within the new rules are referred to the TGA. In FSANZ's words, \"A food recall is action taken by a food business to remove unsafe food from distribution, sale and consumption.\" FSANZ coordinates recalls in Australia, and the states and territories can mandate one.","items":[],"tables":[]},{"heading":"On the wrong side of the line","anchor":"on-the-wrong-side-of-the-line","markdown":"A product that is really a medicine must be on the [ARTG](/guides/artg) before it is imported, supplied or advertised, unless exempt, excluded or otherwise authorised. The sponsor of a declared sports supplement can't release it for further supply until it complies. As a medicine, it needs ARTG entry as a listed or registered medicine and must meet the applicable requirements; as a food, it needs \"different product claims, ingredients, and/or dosage forms\".\n\nA food making disease claims breaks Standard 1.2.7, which the states and territories enforce.","text":"A product that is really a medicine must be on the ARTG before it is imported, supplied or advertised, unless exempt, excluded or otherwise authorised. The sponsor of a declared sports supplement can't release it for further supply until it complies. As a medicine, it needs ARTG entry as a listed or registered medicine and must meet the applicable requirements; as a food, it needs \"different product claims, ingredients, and/or dosage forms\". A food making disease claims breaks Standard 1.2.7, which the states and territories enforce.","items":[],"tables":[]},{"heading":"Where we come in","anchor":"where-we-come-in","markdown":"We settle the pathway at the brief, before the formula, and develop products as foods as well as [listed medicines](/pathways/listed-medicines). A sports brand's [performance powder](/work/sports-brand-core-range) went to market as a food beside four TGA-listed capsules, and our founder's own brand, [Ora](/work/ora-practitioner-natural-medicine), spans TGA-listed medicines and premium functional foods. [Book a call](/contact), or see [how the pathway is decided](/pathways).","text":"We settle the pathway at the brief, before the formula, and develop products as foods as well as listed medicines. A sports brand's performance powder went to market as a food beside four TGA-listed capsules, and our founder's own brand, Ora, spans TGA-listed medicines and premium functional foods. Book a call, or see how the pathway is decided.","items":[],"tables":[]}],"faqs":[{"q":"Is a collagen powder a food or a medicine in Australia?","a":"Labelled or promoted for a cosmetic purpose, such as improving the appearance of skin, hair and nails, it is a declared therapeutic good. The TGA says such products \"cannot be regulated as foods or cosmetics\" and are usually listed medicines. Otherwise it is judged case by case, and may be a food. More in our beauty supplements guide.","md":"Labelled or promoted for a cosmetic purpose, such as improving the appearance of skin, hair and nails, it is a declared therapeutic good. The TGA says such products \"cannot be regulated as foods or cosmetics\" and are usually listed medicines. Otherwise it is judged case by case, and may be a food. More in our [beauty supplements guide](/guides/beauty-supplements)."},{"q":"What is the difference between a listed medicine and a food in Australia?","a":"A listed medicine is on the ARTG with an AUST L number and uses ingredients and indications from the TGA's lists. Its sponsor certifies it meets the requirements; the TGA doesn't individually evaluate it before supply. A food must meet the Food Standards Code, which the states and territories enforce, and can't claim to prevent, cure or alleviate a disease.","md":"A listed medicine is on the ARTG with an AUST L number and uses ingredients and indications from the TGA's lists. Its sponsor certifies it meets the requirements; the TGA doesn't individually evaluate it before supply. A food must meet the Food Standards Code, which the states and territories enforce, and can't claim to prevent, cure or alleviate a disease."},{"q":"Do sports supplements in capsules need to be TGA listed?","a":"Generally, yes. They need ARTG entry as a listed or registered medicine, unless exempt, excluded or otherwise authorised. Since 30 November 2023, a sports supplement supplied as a tablet, capsule or pill, other than one containing glucose only, is a declared therapeutic good when it is used, advertised or presented for a therapeutic use such as gaining muscle, or in a way likely to be taken as one.","md":"Generally, yes. They need ARTG entry as a listed or registered medicine, unless exempt, excluded or otherwise authorised. Since 30 November 2023, a sports supplement supplied as a tablet, capsule or pill, other than one containing glucose only, is a declared therapeutic good when it is used, advertised or presented for a therapeutic use such as gaining muscle, or in a way likely to be taken as one."},{"q":"What is a sports food?","a":"In the Food Standards Code, a formulated supplementary sports food is \"a product that is specifically formulated to assist sports people in achieving specific nutritional or performance goals\". Standard 2.9.4 allows substances restricted or not permitted in other foods, so FSANZ says sports foods are not suitable for children or pregnant women.","md":"In the Food Standards Code, a formulated supplementary sports food is \"a product that is specifically formulated to assist sports people in achieving specific nutritional or performance goals\". Standard 2.9.4 allows substances restricted or not permitted in other foods, so FSANZ says sports foods are not suitable for children or pregnant women."},{"q":"How much caffeine can a sports food contain?","a":"Under Standard 2.9.4 as amended from 9 June 2026 by Amendment No. 250, no more than 200 mg in total, from any source, in a day's amount as labelled. The concentration must be below 5% in a powder and 1% in a liquid. Until 9 June 2028, a product may follow the Code as it was or as amended.","md":"Under Standard 2.9.4 as amended from 9 June 2026 by Amendment No. 250, no more than 200 mg in total, from any source, in a day's amount as labelled. The concentration must be below 5% in a powder and 1% in a liquid. Until 9 June 2028, a product may follow the Code as it was or as amended."},{"q":"Does a food need approval before it is sold?","a":"Generally, no. There is no pre-market approval for most foods: the business must make sure the food meets the Food Standards Code. The exceptions are ingredients that need FSANZ to approve them before use, such as a novel food that isn't yet listed in Schedule 25.","md":"Generally, no. There is no pre-market approval for most foods: the business must make sure the food meets the Food Standards Code. The exceptions are ingredients that need FSANZ to approve them before use, such as a novel food that isn't yet listed in Schedule 25."},{"q":"Can a food supplement contain vitamins and minerals?","a":"Only where the Code permits them: in the foods listed in Standard 1.3.2, or as Standard 2.9.4 allows in a sports food or 2.9.3 in a formulated supplementary food, each within its limits and in permitted forms. A product that needs vitamin or mineral doses outside those rules is often better made as a listed medicine. Confectionery isn't one of the listed foods, which is why a vitamin gummy is made as a listed medicine (gummies).","md":"Only where the Code permits them: in the foods listed in Standard 1.3.2, or as Standard 2.9.4 allows in a sports food or 2.9.3 in a formulated supplementary food, each within its limits and in permitted forms. A product that needs vitamin or mineral doses outside those rules is often better made as a listed medicine. Confectionery isn't one of the listed foods, which is why a vitamin gummy is made as a listed medicine ([gummies](/formats/gummies))."}],"sources":{"note":"General information, checked against these sources on 20 October 2026. It isn't advice on a particular product.","markdown":"General information, checked against these sources on 20 October 2026. It isn't advice on a particular product.\n\n- [Food and medicine regulation](https://www.tga.gov.au/community-qa/food-and-medicine-regulation), Therapeutic Goods Administration\n- [Food-Medicine Interface Guidance Tool (FMIGT)](https://www.tga.gov.au/node/287500), Therapeutic Goods Administration\n- [Changes to the regulation of sports supplements in Australia](https://www.tga.gov.au/changes-regulation-sports-supplements-australia), Therapeutic Goods Administration\n- [Cosmetics or therapeutic goods: Guidance for advertisers and suppliers](https://www.tga.gov.au/sites/default/files/2024-06/cosmetics-therapeutic-goods-guidance-for-advertisers-suppliers.pdf), Therapeutic Goods Administration, June 2024\n- [About listed medicines](https://www.tga.gov.au/node/520077), Therapeutic Goods Administration\n- [Therapeutic Goods Act 1989](https://www.legislation.gov.au/C2004A03952/latest/text), section 3 (definitions), section 7 and section 7AAA, and the [Therapeutic Goods (Declared Goods) Order 2019](https://www.legislation.gov.au/F2019L01352/latest/text), Federal Register of Legislation\n- [Standard 2.9.4: Formulated supplementary sports foods](https://www.legislation.gov.au/F2015L00421/latest/text), [Standard 2.9.3: Formulated meal replacements and formulated supplementary foods](https://www.legislation.gov.au/F2015L00419/latest/text), [Standard 1.3.2: Vitamins and minerals](https://www.legislation.gov.au/F2015L00400/latest/text) and [Standard 1.5.1: Novel foods](https://www.legislation.gov.au/F2015L00403/latest/text), Federal Register of Legislation\n- [Standard 1.2.7: Nutrition, health and related claims](https://www.legislation.gov.au/F2015L00394/latest/text), [Standard 1.2.1: Requirements to have labels or otherwise provide information](https://www.legislation.gov.au/F2015L00386/latest/text), [Standard 1.1.1: Structure of the Code and general provisions](https://www.legislation.gov.au/F2015L00383/latest/text) and [Standard 1.1.2: Definitions used throughout the Code](https://www.legislation.gov.au/F2015L00385/latest/text), Federal Register of Legislation\n- [What we do](https://www.foodstandards.gov.au/about-us/whatwedo), [Food Standards Code](https://www.foodstandards.gov.au/food-standards-code) and [Sports foods](https://www.foodstandards.gov.au/consumer/nutrition/sportfood), Food Standards Australia New Zealand\n- [Nutrition content claims and health claims](https://www.foodstandards.gov.au/consumer/labelling/nutrition) and [Notifying a self-substantiated food-health relationship](https://www.foodstandards.gov.au/business/labelling/nutrition-health-and-related-claims/notifying-fhr), Food Standards Australia New Zealand\n- [Novel foods](https://www.foodstandards.gov.au/business/novel), [Amendment No. 250](https://www.foodstandards.gov.au/food-standards-code/gazette/amendment-no-250) and [About food recalls](https://www.foodstandards.gov.au/food-recalls/about-food-recalls), Food Standards Australia New Zealand\n- [The Code variation for Proposal P1056, the caffeine review](https://www.legislation.gov.au/F2026L00700/asmade/text), clause 4 (the transition to 9 June 2028), Federal Register of Legislation\n- [Country of origin food labelling](https://www.accc.gov.au/business/advertising-and-promotions/country-of-origin-food-labelling), Australian Competition and Consumer Commission\n- [Imported Food Inspection Scheme](https://www.agriculture.gov.au/biosecurity-trade/import/goods/food/inspection-compliance/inspection-scheme) and [Notification of changes to the regulation of sports supplements (IFN 16-23)](https://www.agriculture.gov.au/biosecurity-trade/import/goods/food/notices/ifn16-23), Department of Agriculture, Fisheries and Forestry","items":[{"text":"Food and medicine regulation, Therapeutic Goods Administration","links":[{"title":"Food and medicine regulation","url":"https://www.tga.gov.au/community-qa/food-and-medicine-regulation"}]},{"text":"Food-Medicine Interface Guidance Tool (FMIGT), Therapeutic Goods Administration","links":[{"title":"Food-Medicine Interface Guidance Tool (FMIGT)","url":"https://www.tga.gov.au/node/287500"}]},{"text":"Changes to the regulation of sports supplements in Australia, Therapeutic Goods Administration","links":[{"title":"Changes to the regulation of sports supplements in Australia","url":"https://www.tga.gov.au/changes-regulation-sports-supplements-australia"}]},{"text":"Cosmetics or therapeutic goods: Guidance for advertisers and suppliers, Therapeutic Goods Administration, June 2024","links":[{"title":"Cosmetics or therapeutic goods: Guidance for advertisers and suppliers","url":"https://www.tga.gov.au/sites/default/files/2024-06/cosmetics-therapeutic-goods-guidance-for-advertisers-suppliers.pdf"}]},{"text":"About listed medicines, Therapeutic Goods Administration","links":[{"title":"About listed medicines","url":"https://www.tga.gov.au/node/520077"}]},{"text":"Therapeutic Goods Act 1989, section 3 (definitions), section 7 and section 7AAA, and the Therapeutic Goods (Declared Goods) Order 2019, Federal Register of Legislation","links":[{"title":"Therapeutic Goods Act 1989","url":"https://www.legislation.gov.au/C2004A03952/latest/text"},{"title":"Therapeutic Goods (Declared Goods) Order 2019","url":"https://www.legislation.gov.au/F2019L01352/latest/text"}]},{"text":"Standard 2.9.4: Formulated supplementary sports foods, Standard 2.9.3: Formulated meal replacements and formulated supplementary foods, Standard 1.3.2: Vitamins and minerals and Standard 1.5.1: Novel foods, Federal Register of Legislation","links":[{"title":"Standard 2.9.4: Formulated supplementary sports foods","url":"https://www.legislation.gov.au/F2015L00421/latest/text"},{"title":"Standard 2.9.3: Formulated meal replacements and formulated supplementary foods","url":"https://www.legislation.gov.au/F2015L00419/latest/text"},{"title":"Standard 1.3.2: Vitamins and minerals","url":"https://www.legislation.gov.au/F2015L00400/latest/text"},{"title":"Standard 1.5.1: Novel foods","url":"https://www.legislation.gov.au/F2015L00403/latest/text"}]},{"text":"Standard 1.2.7: Nutrition, health and related claims, Standard 1.2.1: Requirements to have labels or otherwise provide information, Standard 1.1.1: Structure of the Code and general provisions and Standard 1.1.2: Definitions used throughout the Code, Federal Register of Legislation","links":[{"title":"Standard 1.2.7: Nutrition, health and related claims","url":"https://www.legislation.gov.au/F2015L00394/latest/text"},{"title":"Standard 1.2.1: Requirements to have labels or otherwise provide information","url":"https://www.legislation.gov.au/F2015L00386/latest/text"},{"title":"Standard 1.1.1: Structure of the Code and general provisions","url":"https://www.legislation.gov.au/F2015L00383/latest/text"},{"title":"Standard 1.1.2: Definitions used throughout the Code","url":"https://www.legislation.gov.au/F2015L00385/latest/text"}]},{"text":"What we do, Food Standards Code and Sports foods, Food Standards Australia New Zealand","links":[{"title":"What we do","url":"https://www.foodstandards.gov.au/about-us/whatwedo"},{"title":"Food Standards Code","url":"https://www.foodstandards.gov.au/food-standards-code"},{"title":"Sports foods","url":"https://www.foodstandards.gov.au/consumer/nutrition/sportfood"}]},{"text":"Nutrition content claims and health claims and Notifying a self-substantiated food-health relationship, Food Standards Australia New Zealand","links":[{"title":"Nutrition content claims and health claims","url":"https://www.foodstandards.gov.au/consumer/labelling/nutrition"},{"title":"Notifying a self-substantiated food-health relationship","url":"https://www.foodstandards.gov.au/business/labelling/nutrition-health-and-related-claims/notifying-fhr"}]},{"text":"Novel foods, Amendment No. 250 and About food recalls, Food Standards Australia New Zealand","links":[{"title":"Novel foods","url":"https://www.foodstandards.gov.au/business/novel"},{"title":"Amendment No. 250","url":"https://www.foodstandards.gov.au/food-standards-code/gazette/amendment-no-250"},{"title":"About food recalls","url":"https://www.foodstandards.gov.au/food-recalls/about-food-recalls"}]},{"text":"The Code variation for Proposal P1056, the caffeine review, clause 4 (the transition to 9 June 2028), Federal Register of Legislation","links":[{"title":"The Code variation for Proposal P1056, the caffeine review","url":"https://www.legislation.gov.au/F2026L00700/asmade/text"}]},{"text":"Country of origin food labelling, Australian Competition and Consumer Commission","links":[{"title":"Country of origin food labelling","url":"https://www.accc.gov.au/business/advertising-and-promotions/country-of-origin-food-labelling"}]},{"text":"Imported Food Inspection Scheme and Notification of changes to the regulation of sports supplements (IFN 16-23), Department of Agriculture, Fisheries and Forestry","links":[{"title":"Imported Food Inspection Scheme","url":"https://www.agriculture.gov.au/biosecurity-trade/import/goods/food/inspection-compliance/inspection-scheme"},{"title":"Notification of changes to the regulation of sports supplements (IFN 16-23)","url":"https://www.agriculture.gov.au/biosecurity-trade/import/goods/food/notices/ifn16-23"}]}]}},{"slug":"guides","kind":"hub","url":"/guides","title":"Guides to the rules a supplement, food or cosmetic meets in Australia","name":"Guides","description":"Guides to developing a supplement, food or cosmetic in Australia: TGA listing, the ARTG, claims, advertising, new ingredients, stability, AICIS, cost and time.","eyebrow":"Guides","lead":"Plain guides to the rules a wellness product meets in Australia, each checked against the regulator pages it cites: how an AUST L listing works and what it costs, what the ARTG is, what a listed medicine can claim and how it can be advertised, how a new ingredient gets permitted, in a medicine or a food, when a claim needs an assessed listing, the stability evidence the TGA expects, what a sponsor answers for, who registers with AICIS, how a supplement is exported, and what development costs and how long it takes.","lists":"guide","studies":[],"formats":[],"order":59,"updated":"2026-10-22","author":"Take Friday Off","approved":true,"sections":[{"heading":"","anchor":"","markdown":"Every guide sits under the pathway or service it belongs to, so its breadcrumbs lead back there: the TGA listing, ARTG, claims, advertising, new ingredients, stability, sponsor, assessed listing and export guides under listed medicines, the novel foods guide under foods, the AICIS and beauty supplements guides under skincare, the labelling guide under packaging, the timeline and the costs under formulation, the GMP clearance guide under manufacturing, and pet supplements under the pathways. This page lists them all in one place.","text":"Every guide sits under the pathway or service it belongs to, so its breadcrumbs lead back there: the TGA listing, ARTG, claims, advertising, new ingredients, stability, sponsor, assessed listing and export guides under listed medicines, the novel foods guide under foods, the AICIS and beauty supplements guides under skincare, the labelling guide under packaging, the timeline and the costs under formulation, the GMP clearance guide under manufacturing, and pet supplements under the pathways. This page lists them all in one place.","items":[],"tables":[]},{"heading":"How the guides are written","anchor":"how-the-guides-are-written","markdown":"Each guide opens with its answer in a few lines, then the detail, step by step, then the questions people ask us and the sources it was checked against, with the date. The facts come from the regulator's own pages and the legislation: the TGA, FSANZ, AICIS, the ACCC and the Federal Register of Legislation. Where a guide quotes a figure, such as a TGA fee or a caffeine limit, it was checked on the date the guide shows.\n\nThe guides are general information, not advice on a particular product. Timelines from our own records are marked as such.","text":"Each guide opens with its answer in a few lines, then the detail, step by step, then the questions people ask us and the sources it was checked against, with the date. The facts come from the regulator's own pages and the legislation: the TGA, FSANZ, AICIS, the ACCC and the Federal Register of Legislation. Where a guide quotes a figure, such as a TGA fee or a caffeine limit, it was checked on the date the guide shows. The guides are general information, not advice on a particular product. Timelines from our own records are marked as such.","items":[],"tables":[]},{"heading":"The guides","anchor":"the-guides","markdown":"- [Starting a supplement brand](/guides/start-a-supplement-brand): every step from the idea to the first batch on a shelf, in order, with the guide for each.\n- [TGA listing for a supplement](/guides/tga-approval): the AUST L pathway step by step, with the TGA's fees.\n- [The ARTG and AUST L numbers](/guides/artg): what the register is and what the number on the label means.\n- [Claims and permitted indications](/guides/permitted-indications): what a listed medicine can claim, and the evidence behind each claim.\n- [Stability testing](/guides/stability-testing): what the TGA expects, and how the shelf life on the label is supported.\n- [AICIS registration](/guides/aicis-registration): who registers to import or make cosmetics and their ingredients, and what it costs.\n- [How long it takes to develop a supplement](/guides/supplement-development-timeline): the stages, from our records, and what holds a launch up.\n- [What it costs to develop a supplement](/guides/supplement-development-cost): the development work, the TGA's fees, the minimum order and the cost of goods.\n- [Advertising a supplement](/guides/tga-advertising): the TGA's Advertising Code, influencers, social media and penalties.\n- [New ingredients](/guides/permissible-ingredients): how an ingredient that isn't permitted gets into the Permissible Ingredients Determination.\n- [Pet supplements](/guides/pet-supplements): when a product for animals needs APVMA registration, and when it is a pet food.\n- [GMP clearance](/guides/gmp-clearance): what a listed medicine made overseas needs from the TGA, and why supplement factories often need an inspection.\n- [Choosing a manufacturer](/guides/choosing-a-supplement-manufacturer): what a TGA licence covers and how to check it, the GMP agreement, release for supply and the standards each batch is tested to.\n- [The TGA sponsor](/guides/tga-sponsor): who is legally responsible for a listed medicine, what an overseas brand does, and the sponsor's duties.\n- [Assessed listed medicines](/guides/assessed-listed-medicines): the AUST L(A) pathway for claims stronger than the permitted list, with the TGA's fees and timeframes.\n- [Novel foods](/guides/novel-foods): when a new food ingredient needs FSANZ approval, what it costs and how long it takes.\n- [Exporting a supplement](/guides/exporting-supplements): export-only listings, the TGA's export certificates and what the importing country decides.\n- [Beauty supplements](/guides/beauty-supplements): why a skin, hair or nail supplement is a medicine, the claims it can make, collagen and the advertising rules.\n- [Labelling a supplement](/guides/supplement-labelling): what a listed medicine's label must show under TGO 116, from the main label to the warnings.","text":"Starting a supplement brand: every step from the idea to the first batch on a shelf, in order, with the guide for each. TGA listing for a supplement: the AUST L pathway step by step, with the TGA's fees. The ARTG and AUST L numbers: what the register is and what the number on the label means. Claims and permitted indications: what a listed medicine can claim, and the evidence behind each claim. Stability testing: what the TGA expects, and how the shelf life on the label is supported. AICIS registration: who registers to import or make cosmetics and their ingredients, and what it costs. How long it takes to develop a supplement: the stages, from our records, and what holds a launch up. What it costs to develop a supplement: the development work, the TGA's fees, the minimum order and the cost of goods. Advertising a supplement: the TGA's Advertising Code, influencers, social media and penalties. New ingredients: how an ingredient that isn't permitted gets into the Permissible Ingredients Determination. Pet supplements: when a product for animals needs APVMA registration, and when it is a pet food. GMP clearance: what a listed medicine made overseas needs from the TGA, and why supplement factories often need an inspection. Choosing a manufacturer: what a TGA licence covers and how to check it, the GMP agreement, release for supply and the standards each batch is tested to. The TGA sponsor: who is legally responsible for a listed medicine, what an overseas brand does, and the sponsor's duties. Assessed listed medicines: the AUST L(A) pathway for claims stronger than the permitted list, with the TGA's fees and timeframes. Novel foods: when a new food ingredient needs FSANZ approval, what it costs and how long it takes. Exporting a supplement: export-only listings, the TGA's export certificates and what the importing country decides. Beauty supplements: why a skin, hair or nail supplement is a medicine, the claims it can make, collagen and the advertising rules. Labelling a supplement: what a listed medicine's label must show under TGO 116, from the main label to the warnings.","items":[],"tables":[]},{"heading":"Where to start","anchor":"where-to-start","markdown":"- **A brand of your own, from the start.** The guide to starting a supplement brand takes the steps in order, from the pathway and the permitted ingredients to the sponsor, the manufacturer, the label, the listing and the launch, and points to the guide for each.\n- **A supplement you want to sell as a medicine.** Start with the TGA listing guide, which covers the AUST L listing step by step with the TGA's fees, then the claims and indications guide and the stability testing guide.\n- **A powder, drink or bar that could be a food.** The pathways page settles whether a product is a medicine, a food or a cosmetic, and the food pathway covers the sports food, claims and label rules.\n- **A cream, serum or sunscreen.** The skincare page settles the claim, and the AICIS guide covers who registers and what it costs.\n- **A supplement for skin, hair or nails.** The beauty supplements guide covers why it is a medicine, the claims it can make and the ingredients it can use.\n- **A launch date and a budget.** The development timeline guide sets out the stages, from our records, and what holds a launch up; the cost guide sets out what each part of the budget covers.\n- **An ingredient that isn't permitted yet.** The new ingredients guide covers the TGA's application levels, fees and timeframes, and the options meanwhile.\n- **The label.** The labelling guide covers what TGO 116 requires, from the main label to the warnings and the transition from TGO 92.\n- **The marketing.** The advertising guide covers what every ad must say, what influencers can and can't do, and what the TGA can do about an ad that breaks the rules.\n- **A product for animals.** The pet supplements guide covers where the APVMA draws the line, the products the law excludes or lists, and what registration costs.\n- **A manufacturer to choose.** The guide to choosing a supplement manufacturer covers what a TGA licence covers and how to check one, the five steps a listing names, the GMP agreement and the standards each batch is tested to, with the questions to ask before you sign.\n- **A factory overseas.** The GMP clearance guide covers the three routes to the TGA's clearance, the evidence and the fees.\n- **A brand based overseas.** The sponsor guide covers who can be the Australian sponsor, how to become one and what the role involves.\n- **A claim the permitted list doesn't cover.** The assessed listed medicines guide covers the AUST L(A) pathway, its evidence, fees and timeframes.\n- **A new ingredient in a food.** The novel foods guide covers when it needs FSANZ's approval, and what the application involves.\n- **Selling overseas.** The export guide covers exporting a listed medicine, export-only listings and the TGA's certificates.","text":"A brand of your own, from the start. The guide to starting a supplement brand takes the steps in order, from the pathway and the permitted ingredients to the sponsor, the manufacturer, the label, the listing and the launch, and points to the guide for each. A supplement you want to sell as a medicine. Start with the TGA listing guide, which covers the AUST L listing step by step with the TGA's fees, then the claims and indications guide and the stability testing guide. A powder, drink or bar that could be a food. The pathways page settles whether a product is a medicine, a food or a cosmetic, and the food pathway covers the sports food, claims and label rules. A cream, serum or sunscreen. The skincare page settles the claim, and the AICIS guide covers who registers and what it costs. A supplement for skin, hair or nails. The beauty supplements guide covers why it is a medicine, the claims it can make and the ingredients it can use. A launch date and a budget. The development timeline guide sets out the stages, from our records, and what holds a launch up; the cost guide sets out what each part of the budget covers. An ingredient that isn't permitted yet. The new ingredients guide covers the TGA's application levels, fees and timeframes, and the options meanwhile. The label. The labelling guide covers what TGO 116 requires, from the main label to the warnings and the transition from TGO 92. The marketing. The advertising guide covers what every ad must say, what influencers can and can't do, and what the TGA can do about an ad that breaks the rules. A product for animals. The pet supplements guide covers where the APVMA draws the line, the products the law excludes or lists, and what registration costs. A manufacturer to choose. The guide to choosing a supplement manufacturer covers what a TGA licence covers and how to check one, the five steps a listing names, the GMP agreement and the standards each batch is tested to, with the questions to ask before you sign. A factory overseas. The GMP clearance guide covers the three routes to the TGA's clearance, the evidence and the fees. A brand based overseas. The sponsor guide covers who can be the Australian sponsor, how to become one and what the role involves. A claim the permitted list doesn't cover. The assessed listed medicines guide covers the AUST L(A) pathway, its evidence, fees and timeframes. A new ingredient in a food. The novel foods guide covers when it needs FSANZ's approval, and what the application involves. Selling overseas. The export guide covers exporting a listed medicine, export-only listings and the TGA's certificates.","items":[{"lead":"A brand of your own, from the start.","text":"The guide to starting a supplement brand takes the steps in order, from the pathway and the permitted ingredients to the sponsor, the manufacturer, the label, the listing and the launch, and points to the guide for each."},{"lead":"A supplement you want to sell as a medicine.","text":"Start with the TGA listing guide, which covers the AUST L listing step by step with the TGA's fees, then the claims and indications guide and the stability testing guide."},{"lead":"A powder, drink or bar that could be a food.","text":"The pathways page settles whether a product is a medicine, a food or a cosmetic, and the food pathway covers the sports food, claims and label rules."},{"lead":"A cream, serum or sunscreen.","text":"The skincare page settles the claim, and the AICIS guide covers who registers and what it costs."},{"lead":"A supplement for skin, hair or nails.","text":"The beauty supplements guide covers why it is a medicine, the claims it can make and the ingredients it can use."},{"lead":"A launch date and a budget.","text":"The development timeline guide sets out the stages, from our records, and what holds a launch up; the cost guide sets out what each part of the budget covers."},{"lead":"An ingredient that isn't permitted yet.","text":"The new ingredients guide covers the TGA's application levels, fees and timeframes, and the options meanwhile."},{"lead":"The label.","text":"The labelling guide covers what TGO 116 requires, from the main label to the warnings and the transition from TGO 92."},{"lead":"The marketing.","text":"The advertising guide covers what every ad must say, what influencers can and can't do, and what the TGA can do about an ad that breaks the rules."},{"lead":"A product for animals.","text":"The pet supplements guide covers where the APVMA draws the line, the products the law excludes or lists, and what registration costs."},{"lead":"A manufacturer to choose.","text":"The guide to choosing a supplement manufacturer covers what a TGA licence covers and how to check one, the five steps a listing names, the GMP agreement and the standards each batch is tested to, with the questions to ask before you sign."},{"lead":"A factory overseas.","text":"The GMP clearance guide covers the three routes to the TGA's clearance, the evidence and the fees."},{"lead":"A brand based overseas.","text":"The sponsor guide covers who can be the Australian sponsor, how to become one and what the role involves."},{"lead":"A claim the permitted list doesn't cover.","text":"The assessed listed medicines guide covers the AUST L(A) pathway, its evidence, fees and timeframes."},{"lead":"A new ingredient in a food.","text":"The novel foods guide covers when it needs FSANZ's approval, and what the application involves."},{"lead":"Selling overseas.","text":"The export guide covers exporting a listed medicine, export-only listings and the TGA's certificates."}],"tables":[]},{"heading":"Where we come in","anchor":"where-we-come-in","markdown":"We take a product through what the guides describe: the pathway at the brief, the formula inside the permitted ingredients and indications, the evidence, the stability program, the label and the listing, then we manage the manufacture. See [Friday Launch Engine™](/system), or [book a call](/contact).","text":"We take a product through what the guides describe: the pathway at the brief, the formula inside the permitted ingredients and indications, the evidence, the stability program, the label and the listing, then we manage the manufacture. See Friday Launch Engine™, or book a call.","items":[],"tables":[]}],"faqs":[],"sources":null},{"slug":"faq","kind":"page","url":"/faq","title":"Bringing a product to market with Take Friday Off","name":"FAQ","description":"Brands' first-call questions, answered: how long it takes, medicine or food, the sample, minimum orders, who owns the formula, pricing, after launch.","eyebrow":"Questions","lead":"The questions brands ask us most, answered straight. We've been asked these on first calls since 2020, by first-time founders and by brands with a dozen products on shelf. These are the answers we give.","studies":[],"formats":[],"order":60,"updated":"2026-10-22","author":"Take Friday Off","approved":true,"sections":[{"heading":"The five we hear on every call","anchor":"the-five-we-hear-on-every-call","markdown":"### How long will it take?\nSix months is the best case, and we have done it. EverLeanBody: *\"Six months from our first meeting, my first product was on a shelf.\"* Bespoke packaging, extra rounds of changes and decisions that wait all add time, and we tell you upfront which of those apply to your product.\n\n### Will it be a TGA medicine or a food?\nYour ingredients, doses and claims decide that, not the format. We settle it in the first workshop, before anyone designs a formula.\n\n### Can I taste it before it goes into production?\nYes. You approve the formula on paper first, with every ingredient and dose. Then you taste and approve the sample. Nothing is manufactured until you sign it off.\n\n### What's the minimum order?\n3,000 finished retail packs per batch, for TGA-listed medicines and foods alike.\n\n### Who owns the formula?\nIf you stop at the end of the Design phase, the formulation is yours to take anywhere. If you go into production with us, we manage its manufacture for your first three production orders.","text":"How long will it take? Six months is the best case, and we have done it. EverLeanBody: \"Six months from our first meeting, my first product was on a shelf.\" Bespoke packaging, extra rounds of changes and decisions that wait all add time, and we tell you upfront which of those apply to your product. Will it be a TGA medicine or a food? Your ingredients, doses and claims decide that, not the format. We settle it in the first workshop, before anyone designs a formula. Can I taste it before it goes into production? Yes. You approve the formula on paper first, with every ingredient and dose. Then you taste and approve the sample. Nothing is manufactured until you sign it off. What's the minimum order? 3,000 finished retail packs per batch, for TGA-listed medicines and foods alike. Who owns the formula? If you stop at the end of the Design phase, the formulation is yours to take anywhere. If you go into production with us, we manage its manufacture for your first three production orders.","items":[],"tables":[]},{"heading":"Before you start","anchor":"before-you-start","markdown":"### Why work with Take Friday Off rather than go straight to a manufacturer?\nA manufacturer makes what it is given. It won't check whether your formula fits its pathway, whether your claims hold up or whether your label is right. That risk sits with you, and it surfaces after launch, when fixing it means relabelling or pulling stock.\n\nWe carry the whole job as one team: the brief, the formulation, the evidence behind every claim, the listing, the label, the packaging, and managing the manufacture and delivery to your warehouse. You deal with us; we deal with the factory.\n\n### Have you done this before?\nWe've run around 190 projects since 2020: capsules, tablets, chewables, powders, liquids and creams, as TGA-listed medicines, foods and cosmetics.\n\n- **BWellness:** nine products, and five production batches of its tablet since 2021.\n- **EverLeanBody:** a premium saffron capsule, 5.8 months from signed brief to dispatch.\n- **The Belly Solution:** a TGA-listed travel gut-health powder, now in its second batch.\n- **Pump Haircare, Arxi, Vitable, Mother Daily, Your Skin Scan and Nivari** are among the brands we've launched or relaunched.\n\nOur Google rating is 4.8.\n\n### Who will I be working with?\nGabriel Perera leads every project. He has spent 20 years building natural health brands, including senior roles at Blackmores and BioCeuticals and in raw materials and cGMP manufacturing at TSI Group. With our regulatory and technical specialists, the team brings more than 40 years of combined experience.\n\n### What do I need to bring?\nThe product idea, the customer it is for and the price it has to sell at. Brand assets help if you have them. We build everything else with you.\n\n### I'm new to this. Is that a problem?\nNo. Many of our clients are launching their first product. You make the commercial decisions; we handle the technical and regulatory ones and explain each as we go.","text":"Why work with Take Friday Off rather than go straight to a manufacturer? A manufacturer makes what it is given. It won't check whether your formula fits its pathway, whether your claims hold up or whether your label is right. That risk sits with you, and it surfaces after launch, when fixing it means relabelling or pulling stock. We carry the whole job as one team: the brief, the formulation, the evidence behind every claim, the listing, the label, the packaging, and managing the manufacture and delivery to your warehouse. You deal with us; we deal with the factory. Have you done this before? We've run around 190 projects since 2020: capsules, tablets, chewables, powders, liquids and creams, as TGA-listed medicines, foods and cosmetics. BWellness: nine products, and five production batches of its tablet since 2021. EverLeanBody: a premium saffron capsule, 5.8 months from signed brief to dispatch. The Belly Solution: a TGA-listed travel gut-health powder, now in its second batch. Pump Haircare, Arxi, Vitable, Mother Daily, Your Skin Scan and Nivari are among the brands we've launched or relaunched. Our Google rating is 4.8. Who will I be working with? Gabriel Perera leads every project. He has spent 20 years building natural health brands, including senior roles at Blackmores and BioCeuticals and in raw materials and cGMP manufacturing at TSI Group. With our regulatory and technical specialists, the team brings more than 40 years of combined experience. What do I need to bring? The product idea, the customer it is for and the price it has to sell at. Brand assets help if you have them. We build everything else with you. I'm new to this. Is that a problem? No. Many of our clients are launching their first product. You make the commercial decisions; we handle the technical and regulatory ones and explain each as we go.","items":[{"lead":"BWellness:","text":"nine products, and five production batches of its tablet since 2021."},{"lead":"EverLeanBody:","text":"a premium saffron capsule, 5.8 months from signed brief to dispatch."},{"lead":"The Belly Solution:","text":"a TGA-listed travel gut-health powder, now in its second batch."},{"lead":"Pump Haircare, Arxi, Vitable, Mother Daily, Your Skin Scan and Nivari","text":"are among the brands we've launched or relaunched."}],"tables":[]},{"heading":"Process and timing","anchor":"process-and-timing","markdown":"### How does the process work?\nTwo phases.\n\n- **Design (8 to 10 weeks).** We build your brief together in a workshop, then design the formulation, specify it and quote it. You approve the formula and the quote, and place your order.\n- **Build (20 to 24 weeks).** The R&D sample, the product specification, the evidence, the listing and the label, then 12 to 14 weeks in manufacture and delivery to your warehouse.\n\n### What happens in the workshop?\nWe send you the project brief a week before. In the workshop we work through it together: your customer and channels, your competitors, the format, the ingredients against your target cost, the packaging, the claims and the regulatory pathway. Everything that follows is built on that brief.\n\n### What sets the pace?\nFour things:\n- how quickly decisions are made: approving the formula, the sample and the label\n- whether a second round of changes is needed on the formula or the sample\n- bespoke packaging, which adds about three months\n- the January shutdown, when most Australian manufacturing closes, so an early-year launch starts the spring before.\n\n### Can you develop several products at once?\nYes, in parallel, with staggered starts.","text":"How does the process work? Two phases. Design (8 to 10 weeks). We build your brief together in a workshop, then design the formulation, specify it and quote it. You approve the formula and the quote, and place your order. Build (20 to 24 weeks). The R&D sample, the product specification, the evidence, the listing and the label, then 12 to 14 weeks in manufacture and delivery to your warehouse. What happens in the workshop? We send you the project brief a week before. In the workshop we work through it together: your customer and channels, your competitors, the format, the ingredients against your target cost, the packaging, the claims and the regulatory pathway. Everything that follows is built on that brief. What sets the pace? Four things: how quickly decisions are made: approving the formula, the sample and the label whether a second round of changes is needed on the formula or the sample bespoke packaging, which adds about three months the January shutdown, when most Australian manufacturing closes, so an early-year launch starts the spring before. Can you develop several products at once? Yes, in parallel, with staggered starts.","items":[{"lead":"Design (8 to 10 weeks).","text":"We build your brief together in a workshop, then design the formulation, specify it and quote it. You approve the formula and the quote, and place your order."},{"lead":"Build (20 to 24 weeks).","text":"The R&D sample, the product specification, the evidence, the listing and the label, then 12 to 14 weeks in manufacture and delivery to your warehouse."}],"tables":[]},{"heading":"The formula and the sample","anchor":"the-formula-and-the-sample","markdown":"### Who decides what goes into the formula?\nYou set the brief: the customer, the claim you want to make, the format and the price. We design the formulation to meet it, choosing every ingredient, its form and its dose against the evidence and the rules of your pathway. You approve it before anything is made.\n\n### Can I use an ingredient I've found, or my preferred supplier?\nUsually. It has to be permitted for your pathway and fit your cost target. If it does, we build it in.\n\n### I already have a formula. Can you just make it?\nIt goes through a full regulatory and technical review first. Existing formulas often need changes to doses, ingredient forms or claims before they can be listed and made.\n\n### When do I get to taste it?\nYou approve the formula on paper at the formulation presentation. The R&D sample is made once your order is placed, and nothing goes into production until you approve it. Each sample round takes about two weeks.\n\n### What if I don't like the sample?\nOne round of changes is included at the sample stage, and one at the formula stage before it. Building your flavour preferences into the brief, such as customer feedback, gives the best chance of getting it right first time.\n\n### Can the product be clean label, or preservative-free?\nOften, depending on the format. Capsules, tablets and powders rarely need preservatives. A water-based liquid does, for safety and a 24-month shelf life, though an oil base can work for some formulas.\n\n### Can one product work for adults and children?\nNo. Adults and children need different doses, claims and warnings, so they are separate products.","text":"Who decides what goes into the formula? You set the brief: the customer, the claim you want to make, the format and the price. We design the formulation to meet it, choosing every ingredient, its form and its dose against the evidence and the rules of your pathway. You approve it before anything is made. Can I use an ingredient I've found, or my preferred supplier? Usually. It has to be permitted for your pathway and fit your cost target. If it does, we build it in. I already have a formula. Can you just make it? It goes through a full regulatory and technical review first. Existing formulas often need changes to doses, ingredient forms or claims before they can be listed and made. When do I get to taste it? You approve the formula on paper at the formulation presentation. The R&D sample is made once your order is placed, and nothing goes into production until you approve it. Each sample round takes about two weeks. What if I don't like the sample? One round of changes is included at the sample stage, and one at the formula stage before it. Building your flavour preferences into the brief, such as customer feedback, gives the best chance of getting it right first time. Can the product be clean label, or preservative-free? Often, depending on the format. Capsules, tablets and powders rarely need preservatives. A water-based liquid does, for safety and a 24-month shelf life, though an oil base can work for some formulas. Can one product work for adults and children? No. Adults and children need different doses, claims and warnings, so they are separate products.","items":[],"tables":[]},{"heading":"Regulatory and claims","anchor":"regulatory-and-claims","markdown":"### TGA medicine or food: what's the difference for me?\n- **TGA-listed medicine:** therapeutic claims from the TGA's permitted indications, at therapeutic doses, backed by evidence you hold. It needs a listing and carries an annual TGA charge.\n- **Food:** food-level claims only, and every ingredient must be permitted in food, at food levels. No listing, but strict rules on claims and labels.\n\nA capsule isn't automatically a medicine, and a powder can be either. We settle it in the workshop.\n\n### Can I avoid the TGA?\nSometimes, by making the product a food, such as a powdered drink. You give up therapeutic claims, and some herbal ingredients may need swapping for food-permitted ones. Whether that trade is right depends on what your brand needs to say.\n\n### What claims can I make?\nClaims from the TGA's permitted indications that the evidence supports at your product's exact dose. We build a few strong claims rather than many weak ones, and map them in the workshop.\n\n### How long does TGA listing take?\nAbout two weeks, once the product, the evidence and the label are ready. Listed medicines aren't evaluated before they go on the register: the sponsor certifies that the product meets the rules.\n\n### Who is legally responsible for the product?\nFor a TGA-listed medicine, the sponsor, which is normally your company. Sign through your company, not as an individual. The TGA looks at your website, Instagram and TikTok as closely as your label, and your advertising must stay within your listed indications. Check every piece of copy against your evidence dossier before you publish it. More in our [advertising guide](/guides/tga-advertising) and our [TGA sponsor guide](/guides/tga-sponsor).\n\n### What if my ingredient isn't allowed yet?\nIt can't be an active in a listed medicine until the TGA adds it to the permitted list, and the supplier may hold exclusive rights for a period after that. We'll tell you what's realistic, or find the permitted alternative. More in our [new ingredients guide](/guides/permissible-ingredients).\n\n### Can I sell overseas later?\nYes. If export is in your plans, we design the formula for both markets from the start. More in our [export guide](/guides/exporting-supplements).\n\n### Do you work on pet products?\nYes. Pet products follow the APVMA, not the TGA. Therapeutic claims get closer scrutiny, and retailers may ask for an evidence dossier. More in our [pet supplements guide](/guides/pet-supplements).","text":"TGA medicine or food: what's the difference for me? TGA-listed medicine: therapeutic claims from the TGA's permitted indications, at therapeutic doses, backed by evidence you hold. It needs a listing and carries an annual TGA charge. Food: food-level claims only, and every ingredient must be permitted in food, at food levels. No listing, but strict rules on claims and labels. A capsule isn't automatically a medicine, and a powder can be either. We settle it in the workshop. Can I avoid the TGA? Sometimes, by making the product a food, such as a powdered drink. You give up therapeutic claims, and some herbal ingredients may need swapping for food-permitted ones. Whether that trade is right depends on what your brand needs to say. What claims can I make? Claims from the TGA's permitted indications that the evidence supports at your product's exact dose. We build a few strong claims rather than many weak ones, and map them in the workshop. How long does TGA listing take? About two weeks, once the product, the evidence and the label are ready. Listed medicines aren't evaluated before they go on the register: the sponsor certifies that the product meets the rules. Who is legally responsible for the product? For a TGA-listed medicine, the sponsor, which is normally your company. Sign through your company, not as an individual. The TGA looks at your website, Instagram and TikTok as closely as your label, and your advertising must stay within your listed indications. Check every piece of copy against your evidence dossier before you publish it. More in our advertising guide and our TGA sponsor guide. What if my ingredient isn't allowed yet? It can't be an active in a listed medicine until the TGA adds it to the permitted list, and the supplier may hold exclusive rights for a period after that. We'll tell you what's realistic, or find the permitted alternative. More in our new ingredients guide. Can I sell overseas later? Yes. If export is in your plans, we design the formula for both markets from the start. More in our export guide. Do you work on pet products? Yes. Pet products follow the APVMA, not the TGA. Therapeutic claims get closer scrutiny, and retailers may ask for an evidence dossier. More in our pet supplements guide.","items":[{"lead":"TGA-listed medicine:","text":"therapeutic claims from the TGA's permitted indications, at therapeutic doses, backed by evidence you hold. It needs a listing and carries an annual TGA charge."},{"lead":"Food:","text":"food-level claims only, and every ingredient must be permitted in food, at food levels. No listing, but strict rules on claims and labels."}],"tables":[]},{"heading":"Manufacturing, minimums and packaging","anchor":"manufacturing-minimums-and-packaging","markdown":"### What is the minimum order?\n3,000 finished retail packs per batch, made in one run. That is the minimum for a production run, whatever the format.\n\n### Can I split a batch across two formats?\nSometimes. We look at it for your product. Each pack format also has its own minimum from the packaging supplier, and single-serve sachets typically need around 150,000 sachets, so a tub or pouch is usually the better format to launch with.\n\n### Can I have custom packaging?\nYes. A bespoke pack adds about three months. Standard bottles, pouches and tubs are faster, and we can use your own pack if you have one.\n\n### What shelf life will I get?\n24 months is standard for a listed medicine, and 36 months is possible with the right stability program. Retailers usually want at least 12 months left when stock arrives.\n\n### Are your products tested?\nEvery TGA-listed batch is third-party tested before release, and every partner we use holds the TGA licence or GMP clearance its step requires.\n\n### What format should I choose?\nThe one that fits the dose, the customer and the moment it is taken. Capsules suit most powders and extracts. Tablets hold more per unit. Powders suit large serves. Sachets suit single serves on the go. Effervescent tablets need very large batches and don't suit herbal extracts. Liquids are the hardest format to keep stable and make taste good.","text":"What is the minimum order? 3,000 finished retail packs per batch, made in one run. That is the minimum for a production run, whatever the format. Can I split a batch across two formats? Sometimes. We look at it for your product. Each pack format also has its own minimum from the packaging supplier, and single-serve sachets typically need around 150,000 sachets, so a tub or pouch is usually the better format to launch with. Can I have custom packaging? Yes. A bespoke pack adds about three months. Standard bottles, pouches and tubs are faster, and we can use your own pack if you have one. What shelf life will I get? 24 months is standard for a listed medicine, and 36 months is possible with the right stability program. Retailers usually want at least 12 months left when stock arrives. Are your products tested? Every TGA-listed batch is third-party tested before release, and every partner we use holds the TGA licence or GMP clearance its step requires. What format should I choose? The one that fits the dose, the customer and the moment it is taken. Capsules suit most powders and extracts. Tablets hold more per unit. Powders suit large serves. Sachets suit single serves on the go. Effervescent tablets need very large batches and don't suit herbal extracts. Liquids are the hardest format to keep stable and make taste good.","items":[],"tables":[]},{"heading":"Commercials","anchor":"commercials","markdown":"### How is the work priced and paid?\nEach stage is a fixed fee for a defined outcome, paid before the stage begins. Manufacturing is priced per unit on a formal quote: half with your purchase order, half before dispatch. We take you through the investment on the strategy call.\n\n### How do I know the product will make money?\nWe design to your price. As a rule of thumb, divide your retail price by four or five to get the target cost of goods, including packaging. At that level, direct-to-consumer brands typically keep about 80% gross margin, and brands selling through pharmacy and health food stores about 60%. The formula is built to that target, and the quote confirms it before you order.\n\n### Am I locked in?\nNo. You can stop at the end of the Design phase with no obligation to have us manage the manufacture, and the formulation is yours. If you go into production with us, the agreement covers your first three production orders.","text":"How is the work priced and paid? Each stage is a fixed fee for a defined outcome, paid before the stage begins. Manufacturing is priced per unit on a formal quote: half with your purchase order, half before dispatch. We take you through the investment on the strategy call. How do I know the product will make money? We design to your price. As a rule of thumb, divide your retail price by four or five to get the target cost of goods, including packaging. At that level, direct-to-consumer brands typically keep about 80% gross margin, and brands selling through pharmacy and health food stores about 60%. The formula is built to that target, and the quote confirms it before you order. Am I locked in? No. You can stop at the end of the Design phase with no obligation to have us manage the manufacture, and the formulation is yours. If you go into production with us, the agreement covers your first three production orders.","items":[],"tables":[]},{"heading":"After launch","anchor":"after-launch","markdown":"### What happens after the first batch?\nWe manage your reorders, keep the stability program running for the shelf life on your label, and update the listing and label when the product changes. BWellness has reordered five times since 2021, and Arxi's preconception capsule has had three production orders since 2024.\n\n### Can you help with the next product?\nYes. Our longest partnerships are ranges, not single products. BWellness has nine.","text":"What happens after the first batch? We manage your reorders, keep the stability program running for the shelf life on your label, and update the listing and label when the product changes. BWellness has reordered five times since 2021, and Arxi's preconception capsule has had three production orders since 2024. Can you help with the next product? Yes. Our longest partnerships are ranges, not single products. BWellness has nine.","items":[],"tables":[]},{"heading":"Where to start","anchor":"where-to-start","markdown":"Book a 15-minute VIP Strategy Call with Gabriel: [calendly.com/gabriel_perera/tfo-vip-strategy-call](https://calendly.com/gabriel_perera/tfo-vip-strategy-call). Bring the idea, the customer and the price. You'll leave knowing the pathway, the realistic timeline and the next step.","text":"Book a 15-minute VIP Strategy Call with Gabriel: calendly.com/gabrielperera/tfo-vip-strategy-call. Bring the idea, the customer and the price. You'll leave knowing the pathway, the realistic timeline and the next step.","items":[],"tables":[]}],"faqs":[{"q":"How long will it take?","a":"Six months is the best case, and we have done it. EverLeanBody: \"Six months from our first meeting, my first product was on a shelf.\" Bespoke packaging, extra rounds of changes and decisions that wait all add time, and we tell you upfront which of those apply to your product.","md":"Six months is the best case, and we have done it. EverLeanBody: *\"Six months from our first meeting, my first product was on a shelf.\"* Bespoke packaging, extra rounds of changes and decisions that wait all add time, and we tell you upfront which of those apply to your product."},{"q":"Will it be a TGA medicine or a food?","a":"Your ingredients, doses and claims decide that, not the format. We settle it in the first workshop, before anyone designs a formula.","md":"Your ingredients, doses and claims decide that, not the format. We settle it in the first workshop, before anyone designs a formula."},{"q":"Can I taste it before it goes into production?","a":"Yes. You approve the formula on paper first, with every ingredient and dose. Then you taste and approve the sample. Nothing is manufactured until you sign it off.","md":"Yes. You approve the formula on paper first, with every ingredient and dose. Then you taste and approve the sample. Nothing is manufactured until you sign it off."},{"q":"What's the minimum order?","a":"3,000 finished retail packs per batch, for TGA-listed medicines and foods alike.","md":"3,000 finished retail packs per batch, for TGA-listed medicines and foods alike."},{"q":"Who owns the formula?","a":"If you stop at the end of the Design phase, the formulation is yours to take anywhere. If you go into production with us, we manage its manufacture for your first three production orders.","md":"If you stop at the end of the Design phase, the formulation is yours to take anywhere. If you go into production with us, we manage its manufacture for your first three production orders."},{"q":"Why work with Take Friday Off rather than go straight to a manufacturer?","a":"A manufacturer makes what it is given. It won't check whether your formula fits its pathway, whether your claims hold up or whether your label is right. That risk sits with you, and it surfaces after launch, when fixing it means relabelling or pulling stock. We carry the whole job as one team: the brief, the formulation, the evidence behind every claim, the listing, the label, the packaging, and managing the manufacture and delivery to your warehouse. You deal with us; we deal with the factory.","md":"A manufacturer makes what it is given. It won't check whether your formula fits its pathway, whether your claims hold up or whether your label is right. That risk sits with you, and it surfaces after launch, when fixing it means relabelling or pulling stock. We carry the whole job as one team: the brief, the formulation, the evidence behind every claim, the listing, the label, the packaging, and managing the manufacture and delivery to your warehouse. You deal with us; we deal with the factory."},{"q":"Have you done this before?","a":"We've run around 190 projects since 2020: capsules, tablets, chewables, powders, liquids and creams, as TGA-listed medicines, foods and cosmetics. - BWellness: nine products, and five production batches of its tablet since 2021. - EverLeanBody: a premium saffron capsule, 5.8 months from signed brief to dispatch. - The Belly Solution: a TGA-listed travel gut-health powder, now in its second batch. - Pump Haircare, Arxi, Vitable, Mother Daily, Your Skin Scan and Nivari are among the brands we've launched or relaunched. Our Google rating is 4.8.","md":"We've run around 190 projects since 2020: capsules, tablets, chewables, powders, liquids and creams, as TGA-listed medicines, foods and cosmetics. - **BWellness:** nine products, and five production batches of its tablet since 2021. - **EverLeanBody:** a premium saffron capsule, 5.8 months from signed brief to dispatch. - **The Belly Solution:** a TGA-listed travel gut-health powder, now in its second batch. - **Pump Haircare, Arxi, Vitable, Mother Daily, Your Skin Scan and Nivari** are among the brands we've launched or relaunched. Our Google rating is 4.8."},{"q":"Who will I be working with?","a":"Gabriel Perera leads every project. He has spent 20 years building natural health brands, including senior roles at Blackmores and BioCeuticals and in raw materials and cGMP manufacturing at TSI Group. With our regulatory and technical specialists, the team brings more than 40 years of combined experience.","md":"Gabriel Perera leads every project. He has spent 20 years building natural health brands, including senior roles at Blackmores and BioCeuticals and in raw materials and cGMP manufacturing at TSI Group. With our regulatory and technical specialists, the team brings more than 40 years of combined experience."},{"q":"What do I need to bring?","a":"The product idea, the customer it is for and the price it has to sell at. Brand assets help if you have them. We build everything else with you.","md":"The product idea, the customer it is for and the price it has to sell at. Brand assets help if you have them. We build everything else with you."},{"q":"I'm new to this. Is that a problem?","a":"No. Many of our clients are launching their first product. You make the commercial decisions; we handle the technical and regulatory ones and explain each as we go.","md":"No. Many of our clients are launching their first product. You make the commercial decisions; we handle the technical and regulatory ones and explain each as we go."},{"q":"How does the process work?","a":"Two phases. - Design (8 to 10 weeks). We build your brief together in a workshop, then design the formulation, specify it and quote it. You approve the formula and the quote, and place your order. - Build (20 to 24 weeks). The R&D sample, the product specification, the evidence, the listing and the label, then 12 to 14 weeks in manufacture and delivery to your warehouse.","md":"Two phases. - **Design (8 to 10 weeks).** We build your brief together in a workshop, then design the formulation, specify it and quote it. You approve the formula and the quote, and place your order. - **Build (20 to 24 weeks).** The R&D sample, the product specification, the evidence, the listing and the label, then 12 to 14 weeks in manufacture and delivery to your warehouse."},{"q":"What happens in the workshop?","a":"We send you the project brief a week before. In the workshop we work through it together: your customer and channels, your competitors, the format, the ingredients against your target cost, the packaging, the claims and the regulatory pathway. Everything that follows is built on that brief.","md":"We send you the project brief a week before. In the workshop we work through it together: your customer and channels, your competitors, the format, the ingredients against your target cost, the packaging, the claims and the regulatory pathway. Everything that follows is built on that brief."},{"q":"What sets the pace?","a":"Four things: - how quickly decisions are made: approving the formula, the sample and the label - whether a second round of changes is needed on the formula or the sample - bespoke packaging, which adds about three months - the January shutdown, when most Australian manufacturing closes, so an early-year launch starts the spring before.","md":"Four things: - how quickly decisions are made: approving the formula, the sample and the label - whether a second round of changes is needed on the formula or the sample - bespoke packaging, which adds about three months - the January shutdown, when most Australian manufacturing closes, so an early-year launch starts the spring before."},{"q":"Can you develop several products at once?","a":"Yes, in parallel, with staggered starts.","md":"Yes, in parallel, with staggered starts."},{"q":"Who decides what goes into the formula?","a":"You set the brief: the customer, the claim you want to make, the format and the price. We design the formulation to meet it, choosing every ingredient, its form and its dose against the evidence and the rules of your pathway. You approve it before anything is made.","md":"You set the brief: the customer, the claim you want to make, the format and the price. We design the formulation to meet it, choosing every ingredient, its form and its dose against the evidence and the rules of your pathway. You approve it before anything is made."},{"q":"Can I use an ingredient I've found, or my preferred supplier?","a":"Usually. It has to be permitted for your pathway and fit your cost target. If it does, we build it in.","md":"Usually. It has to be permitted for your pathway and fit your cost target. If it does, we build it in."},{"q":"I already have a formula. Can you just make it?","a":"It goes through a full regulatory and technical review first. Existing formulas often need changes to doses, ingredient forms or claims before they can be listed and made.","md":"It goes through a full regulatory and technical review first. Existing formulas often need changes to doses, ingredient forms or claims before they can be listed and made."},{"q":"When do I get to taste it?","a":"You approve the formula on paper at the formulation presentation. The R&D sample is made once your order is placed, and nothing goes into production until you approve it. Each sample round takes about two weeks.","md":"You approve the formula on paper at the formulation presentation. The R&D sample is made once your order is placed, and nothing goes into production until you approve it. Each sample round takes about two weeks."},{"q":"What if I don't like the sample?","a":"One round of changes is included at the sample stage, and one at the formula stage before it. Building your flavour preferences into the brief, such as customer feedback, gives the best chance of getting it right first time.","md":"One round of changes is included at the sample stage, and one at the formula stage before it. Building your flavour preferences into the brief, such as customer feedback, gives the best chance of getting it right first time."},{"q":"Can the product be clean label, or preservative-free?","a":"Often, depending on the format. Capsules, tablets and powders rarely need preservatives. A water-based liquid does, for safety and a 24-month shelf life, though an oil base can work for some formulas.","md":"Often, depending on the format. Capsules, tablets and powders rarely need preservatives. A water-based liquid does, for safety and a 24-month shelf life, though an oil base can work for some formulas."},{"q":"Can one product work for adults and children?","a":"No. Adults and children need different doses, claims and warnings, so they are separate products.","md":"No. Adults and children need different doses, claims and warnings, so they are separate products."},{"q":"TGA medicine or food: what's the difference for me?","a":"- TGA-listed medicine: therapeutic claims from the TGA's permitted indications, at therapeutic doses, backed by evidence you hold. It needs a listing and carries an annual TGA charge. - Food: food-level claims only, and every ingredient must be permitted in food, at food levels. No listing, but strict rules on claims and labels. A capsule isn't automatically a medicine, and a powder can be either. We settle it in the workshop.","md":"- **TGA-listed medicine:** therapeutic claims from the TGA's permitted indications, at therapeutic doses, backed by evidence you hold. It needs a listing and carries an annual TGA charge. - **Food:** food-level claims only, and every ingredient must be permitted in food, at food levels. No listing, but strict rules on claims and labels. A capsule isn't automatically a medicine, and a powder can be either. We settle it in the workshop."},{"q":"Can I avoid the TGA?","a":"Sometimes, by making the product a food, such as a powdered drink. You give up therapeutic claims, and some herbal ingredients may need swapping for food-permitted ones. Whether that trade is right depends on what your brand needs to say.","md":"Sometimes, by making the product a food, such as a powdered drink. You give up therapeutic claims, and some herbal ingredients may need swapping for food-permitted ones. Whether that trade is right depends on what your brand needs to say."},{"q":"What claims can I make?","a":"Claims from the TGA's permitted indications that the evidence supports at your product's exact dose. We build a few strong claims rather than many weak ones, and map them in the workshop.","md":"Claims from the TGA's permitted indications that the evidence supports at your product's exact dose. We build a few strong claims rather than many weak ones, and map them in the workshop."},{"q":"How long does TGA listing take?","a":"About two weeks, once the product, the evidence and the label are ready. Listed medicines aren't evaluated before they go on the register: the sponsor certifies that the product meets the rules.","md":"About two weeks, once the product, the evidence and the label are ready. Listed medicines aren't evaluated before they go on the register: the sponsor certifies that the product meets the rules."},{"q":"Who is legally responsible for the product?","a":"For a TGA-listed medicine, the sponsor, which is normally your company. Sign through your company, not as an individual. The TGA looks at your website, Instagram and TikTok as closely as your label, and your advertising must stay within your listed indications. Check every piece of copy against your evidence dossier before you publish it. More in our advertising guide and our TGA sponsor guide.","md":"For a TGA-listed medicine, the sponsor, which is normally your company. Sign through your company, not as an individual. The TGA looks at your website, Instagram and TikTok as closely as your label, and your advertising must stay within your listed indications. Check every piece of copy against your evidence dossier before you publish it. More in our [advertising guide](/guides/tga-advertising) and our [TGA sponsor guide](/guides/tga-sponsor)."},{"q":"What if my ingredient isn't allowed yet?","a":"It can't be an active in a listed medicine until the TGA adds it to the permitted list, and the supplier may hold exclusive rights for a period after that. We'll tell you what's realistic, or find the permitted alternative. More in our new ingredients guide.","md":"It can't be an active in a listed medicine until the TGA adds it to the permitted list, and the supplier may hold exclusive rights for a period after that. We'll tell you what's realistic, or find the permitted alternative. More in our [new ingredients guide](/guides/permissible-ingredients)."},{"q":"Can I sell overseas later?","a":"Yes. If export is in your plans, we design the formula for both markets from the start. More in our export guide.","md":"Yes. If export is in your plans, we design the formula for both markets from the start. More in our [export guide](/guides/exporting-supplements)."},{"q":"Do you work on pet products?","a":"Yes. Pet products follow the APVMA, not the TGA. Therapeutic claims get closer scrutiny, and retailers may ask for an evidence dossier. More in our pet supplements guide.","md":"Yes. Pet products follow the APVMA, not the TGA. Therapeutic claims get closer scrutiny, and retailers may ask for an evidence dossier. More in our [pet supplements guide](/guides/pet-supplements)."},{"q":"What is the minimum order?","a":"3,000 finished retail packs per batch, made in one run. That is the minimum for a production run, whatever the format.","md":"3,000 finished retail packs per batch, made in one run. That is the minimum for a production run, whatever the format."},{"q":"Can I split a batch across two formats?","a":"Sometimes. We look at it for your product. Each pack format also has its own minimum from the packaging supplier, and single-serve sachets typically need around 150,000 sachets, so a tub or pouch is usually the better format to launch with.","md":"Sometimes. We look at it for your product. Each pack format also has its own minimum from the packaging supplier, and single-serve sachets typically need around 150,000 sachets, so a tub or pouch is usually the better format to launch with."},{"q":"Can I have custom packaging?","a":"Yes. A bespoke pack adds about three months. Standard bottles, pouches and tubs are faster, and we can use your own pack if you have one.","md":"Yes. A bespoke pack adds about three months. Standard bottles, pouches and tubs are faster, and we can use your own pack if you have one."},{"q":"What shelf life will I get?","a":"24 months is standard for a listed medicine, and 36 months is possible with the right stability program. Retailers usually want at least 12 months left when stock arrives.","md":"24 months is standard for a listed medicine, and 36 months is possible with the right stability program. Retailers usually want at least 12 months left when stock arrives."},{"q":"Are your products tested?","a":"Every TGA-listed batch is third-party tested before release, and every partner we use holds the TGA licence or GMP clearance its step requires.","md":"Every TGA-listed batch is third-party tested before release, and every partner we use holds the TGA licence or GMP clearance its step requires."},{"q":"What format should I choose?","a":"The one that fits the dose, the customer and the moment it is taken. Capsules suit most powders and extracts. Tablets hold more per unit. Powders suit large serves. Sachets suit single serves on the go. Effervescent tablets need very large batches and don't suit herbal extracts. Liquids are the hardest format to keep stable and make taste good.","md":"The one that fits the dose, the customer and the moment it is taken. Capsules suit most powders and extracts. Tablets hold more per unit. Powders suit large serves. Sachets suit single serves on the go. Effervescent tablets need very large batches and don't suit herbal extracts. Liquids are the hardest format to keep stable and make taste good."},{"q":"How is the work priced and paid?","a":"Each stage is a fixed fee for a defined outcome, paid before the stage begins. Manufacturing is priced per unit on a formal quote: half with your purchase order, half before dispatch. We take you through the investment on the strategy call.","md":"Each stage is a fixed fee for a defined outcome, paid before the stage begins. Manufacturing is priced per unit on a formal quote: half with your purchase order, half before dispatch. We take you through the investment on the strategy call."},{"q":"How do I know the product will make money?","a":"We design to your price. As a rule of thumb, divide your retail price by four or five to get the target cost of goods, including packaging. At that level, direct-to-consumer brands typically keep about 80% gross margin, and brands selling through pharmacy and health food stores about 60%. The formula is built to that target, and the quote confirms it before you order.","md":"We design to your price. As a rule of thumb, divide your retail price by four or five to get the target cost of goods, including packaging. At that level, direct-to-consumer brands typically keep about 80% gross margin, and brands selling through pharmacy and health food stores about 60%. The formula is built to that target, and the quote confirms it before you order."},{"q":"Am I locked in?","a":"No. You can stop at the end of the Design phase with no obligation to have us manage the manufacture, and the formulation is yours. If you go into production with us, the agreement covers your first three production orders.","md":"No. You can stop at the end of the Design phase with no obligation to have us manage the manufacture, and the formulation is yours. If you go into production with us, the agreement covers your first three production orders."},{"q":"What happens after the first batch?","a":"We manage your reorders, keep the stability program running for the shelf life on your label, and update the listing and label when the product changes. BWellness has reordered five times since 2021, and Arxi's preconception capsule has had three production orders since 2024.","md":"We manage your reorders, keep the stability program running for the shelf life on your label, and update the listing and label when the product changes. BWellness has reordered five times since 2021, and Arxi's preconception capsule has had three production orders since 2024."},{"q":"Can you help with the next product?","a":"Yes. Our longest partnerships are ranges, not single products. BWellness has nine.","md":"Yes. Our longest partnerships are ranges, not single products. BWellness has nine."}],"sources":null},{"slug":"tga-approval","kind":"guide","url":"/guides/tga-approval","title":"TGA approval for supplements: how an AUST L listing works","name":"TGA listing guide","description":"TGA approval for a supplement usually means an AUST L listing on the ARTG. What AUST L means, the steps, the TGO 116 labels and the 2026–27 fees.","eyebrow":"Guide","lead":"Most supplements sold as medicines in Australia are listed, not individually evaluated by the TGA. The sponsor certifies that the product meets the rules, it goes on the Australian Register of Therapeutic Goods (ARTG) with an AUST L number, and the TGA can check it at any time after. This guide covers what that involves, step by step, with the TGA's 2026–27 fees and the label rules that replaced TGO 92 on 30 September 2026.","parent":"/pathways/listed-medicines","studies":["everleanbody-saffron-capsule","the-belly-solution-travel-gut-health-powder","your-skin-scan-nicotinamide-tablet","arxi-preconception-supplement","prenatal-multivitamin-capsule","probiotic-skin-supplement"],"formats":[],"order":60,"updated":"2026-10-19","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- For a supplement, \"TGA approval\" usually means an AUST L listing on the ARTG. The TGA doesn't evaluate a listed medicine before it is sold: its Australian sponsor certifies that it meets the rules.\n- Every ingredient must be in the Permissible Ingredients Determination and every indication in the Permissible Indications Determination, with evidence held for each claim.\n- For 2026–27 the TGA charges $1,063 to apply, then $1,566 a year once the medicine has had turnover.\n- Labels follow TGO 116 since 30 September 2026; a medicine released for supply before 1 October 2031 can still follow TGO 92.\n- Once the fee is paid, the medicine goes on the ARTG with its AUST L number, usually showing in TGA Business Services the next day. The time goes into the formula, the evidence, GMP manufacturing, stability data and the label before lodging.","text":"For a supplement, \"TGA approval\" usually means an AUST L listing on the ARTG. The TGA doesn't evaluate a listed medicine before it is sold: its Australian sponsor certifies that it meets the rules. Every ingredient must be in the Permissible Ingredients Determination and every indication in the Permissible Indications Determination, with evidence held for each claim. For 2026–27 the TGA charges $1,063 to apply, then $1,566 a year once the medicine has had turnover. Labels follow TGO 116 since 30 September 2026; a medicine released for supply before 1 October 2031 can still follow TGO 92. Once the fee is paid, the medicine goes on the ARTG with its AUST L number, usually showing in TGA Business Services the next day. The time goes into the formula, the evidence, GMP manufacturing, stability data and the label before lodging.","items":[],"tables":[]},{"heading":"Approval, listing or registration?","anchor":"approval-listing-or-registration","markdown":"The TGA sorts non-prescription medicines into three tiers by risk. Most complementary medicines are listed; few are registered.\n\n| Pathway | Listed | Assessed listed | Registered |\n| --- | --- | --- | --- |\n| On the label | AUST L | AUST L(A) | AUST R |\n| Before it is sold, the TGA | doesn't evaluate it: the sponsor certifies it meets the rules | assesses its indications for efficacy | fully evaluates it, including the indications on its label |\n| What it can claim | Low-level indications from the permitted list, such as \"relieves throat irritation\" | Intermediate indications, which may name a condition such as tinnitus | Claims evaluated as part of registration |\n\nVitamins, herbal medicines, Traditional Chinese Medicines and some sunscreens are typical listed medicines. Over-the-counter pain relief, antihistamines and higher dose iron supplements are registered. Listed and assessed listed medicines draw their ingredients from the same pre-approved list. An assessed listed medicine can say \"TGA assessed\" on its label, and so can a registered complementary medicine; a listed medicine can't. So for a supplement, \"TGA approval\" usually means an AUST L listing. Our [assessed listed medicines guide](/guides/assessed-listed-medicines) covers the middle tier.","text":"The TGA sorts non-prescription medicines into three tiers by risk. Most complementary medicines are listed; few are registered. Pathway: On the label; Listed: AUST L; Assessed listed: AUST L(A); Registered: AUST R. Pathway: Before it is sold, the TGA; Listed: doesn't evaluate it: the sponsor certifies it meets the rules; Assessed listed: assesses its indications for efficacy; Registered: fully evaluates it, including the indications on its label. Pathway: What it can claim; Listed: Low-level indications from the permitted list, such as \"relieves throat irritation\"; Assessed listed: Intermediate indications, which may name a condition such as tinnitus; Registered: Claims evaluated as part of registration. Vitamins, herbal medicines, Traditional Chinese Medicines and some sunscreens are typical listed medicines. Over-the-counter pain relief, antihistamines and higher dose iron supplements are registered. Listed and assessed listed medicines draw their ingredients from the same pre-approved list. An assessed listed medicine can say \"TGA assessed\" on its label, and so can a registered complementary medicine; a listed medicine can't. So for a supplement, \"TGA approval\" usually means an AUST L listing. Our assessed listed medicines guide covers the middle tier.","items":[],"tables":[{"header":["Pathway","Listed","Assessed listed","Registered"],"rows":[["On the label","AUST L","AUST L(A)","AUST R"],["Before it is sold, the TGA","doesn't evaluate it: the sponsor certifies it meets the rules","assesses its indications for efficacy","fully evaluates it, including the indications on its label"],["What it can claim","Low-level indications from the permitted list, such as \"relieves throat irritation\"","Intermediate indications, which may name a condition such as tinnitus","Claims evaluated as part of registration"]]}]},{"heading":"Who can list a medicine","anchor":"who-can-list-a-medicine","markdown":"A listing is applied for by the medicine's sponsor: the person or company that imports, exports or manufactures it, or arranges for someone else to. The sponsor must be an Australian resident, or a company incorporated and doing business in Australia with a representative who lives here, so an overseas brand needs an Australian sponsor. At listing, the sponsor signs a statutory declaration that the application meets every condition of listing, and it is responsible for the medicine meeting every requirement. More in our [TGA sponsor guide](/guides/tga-sponsor).","text":"A listing is applied for by the medicine's sponsor: the person or company that imports, exports or manufactures it, or arranges for someone else to. The sponsor must be an Australian resident, or a company incorporated and doing business in Australia with a representative who lives here, so an overseas brand needs an Australian sponsor. At listing, the sponsor signs a statutory declaration that the application meets every condition of listing, and it is responsible for the medicine meeting every requirement. More in our TGA sponsor guide.","items":[],"tables":[]},{"heading":"The steps to an AUST L listing","anchor":"the-steps-to-an-aust-l-listing","markdown":"1. **Confirm it is a medicine.** The same product could be a food or a cosmetic, depending on how it is presented. See [medicine, food or cosmetic?](/pathways)\n2. **Check every ingredient.** Each one must be in the Therapeutic Goods (Permissible Ingredients) Determination and be used only for the purposes and within the limits it sets. The list moves: the current determination, the third of 2026, commenced on 16 October 2026, and Andrographis paniculata was removed on 17 September 2026. An ingredient that isn't on the list needs [its own application and evaluation](/guides/permissible-ingredients) first.\n3. **Choose permitted indications.** Every indication must come from the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025, which sets for each one the type of evidence it allows (scientific or traditional) and any requirements for using it, such as a statement the label must carry. Our [claims and indications guide](/guides/permitted-indications) goes further.\n4. **Hold the evidence.** The sponsor certifies that it holds evidence for every indication and every other claim. The TGA's Listed medicines evidence guidelines (version 4.0, June 2022) set out what counts, and the TGA can ask to see the evidence at any time.\n5. **Make it under GMP.** Unless exempt, every manufacturing step needs a TGA manufacturing licence if it happens in Australia, including testing, packaging, labelling and release for supply, or a TGA [GMP clearance](/guides/gmp-clearance) or certification if it happens overseas.\n6. **Prove the shelf life.** The TGA says stability evidence should be held at or before listing, showing the product meets its specifications under the label's storage conditions until its expiry date. If full data aren't ready at listing, older TGA guidance allows an interim shelf life supported by evidence. Ongoing real-time stability testing is mandatory, and the TGA says at least one batch from each product group should go on the ongoing stability program each year. More in our [stability testing guide](/guides/stability-testing).\n7. **Write the label to TGO 116.** Below.\n8. **Lodge and pay.** A new sponsor first gets a Client ID through the TGA's organisation details form. The medicine is entered in TGA Business Services, where the Electronic Listing Facility validates it; the sponsor submits, certifies, and pays the application fee within 14 days. Once payment is finalised, the medicine is entered on the [ARTG](/guides/artg) with its AUST L number.","text":"Confirm it is a medicine. The same product could be a food or a cosmetic, depending on how it is presented. See medicine, food or cosmetic? Check every ingredient. Each one must be in the Therapeutic Goods (Permissible Ingredients) Determination and be used only for the purposes and within the limits it sets. The list moves: the current determination, the third of 2026, commenced on 16 October 2026, and Andrographis paniculata was removed on 17 September 2026. An ingredient that isn't on the list needs its own application and evaluation first. Choose permitted indications. Every indication must come from the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025, which sets for each one the type of evidence it allows (scientific or traditional) and any requirements for using it, such as a statement the label must carry. Our claims and indications guide goes further. Hold the evidence. The sponsor certifies that it holds evidence for every indication and every other claim. The TGA's Listed medicines evidence guidelines (version 4.0, June 2022) set out what counts, and the TGA can ask to see the evidence at any time. Make it under GMP. Unless exempt, every manufacturing step needs a TGA manufacturing licence if it happens in Australia, including testing, packaging, labelling and release for supply, or a TGA GMP clearance or certification if it happens overseas. Prove the shelf life. The TGA says stability evidence should be held at or before listing, showing the product meets its specifications under the label's storage conditions until its expiry date. If full data aren't ready at listing, older TGA guidance allows an interim shelf life supported by evidence. Ongoing real-time stability testing is mandatory, and the TGA says at least one batch from each product group should go on the ongoing stability program each year. More in our stability testing guide. Write the label to TGO 116. Below. Lodge and pay. A new sponsor first gets a Client ID through the TGA's organisation details form. The medicine is entered in TGA Business Services, where the Electronic Listing Facility validates it; the sponsor submits, certifies, and pays the application fee within 14 days. Once payment is finalised, the medicine is entered on the ARTG with its AUST L number.","items":[{"lead":"Confirm it is a medicine.","text":"The same product could be a food or a cosmetic, depending on how it is presented. See medicine, food or cosmetic?"},{"lead":"Check every ingredient.","text":"Each one must be in the Therapeutic Goods (Permissible Ingredients) Determination and be used only for the purposes and within the limits it sets. The list moves: the current determination, the third of 2026, commenced on 16 October 2026, and Andrographis paniculata was removed on 17 September 2026. An ingredient that isn't on the list needs its own application and evaluation first."},{"lead":"Choose permitted indications.","text":"Every indication must come from the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025, which sets for each one the type of evidence it allows (scientific or traditional) and any requirements for using it, such as a statement the label must carry. Our claims and indications guide goes further."},{"lead":"Hold the evidence.","text":"The sponsor certifies that it holds evidence for every indication and every other claim. The TGA's Listed medicines evidence guidelines (version 4.0, June 2022) set out what counts, and the TGA can ask to see the evidence at any time."},{"lead":"Make it under GMP.","text":"Unless exempt, every manufacturing step needs a TGA manufacturing licence if it happens in Australia, including testing, packaging, labelling and release for supply, or a TGA GMP clearance or certification if it happens overseas."},{"lead":"Prove the shelf life.","text":"The TGA says stability evidence should be held at or before listing, showing the product meets its specifications under the label's storage conditions until its expiry date. If full data aren't ready at listing, older TGA guidance allows an interim shelf life supported by evidence. Ongoing real-time stability testing is mandatory, and the TGA says at least one batch from each product group should go on the ongoing stability program each year. More in our stability testing guide."},{"lead":"Write the label to TGO 116.","text":"Below."},{"lead":"Lodge and pay.","text":"A new sponsor first gets a Client ID through the TGA's organisation details form. The medicine is entered in TGA Business Services, where the Electronic Listing Facility validates it; the sponsor submits, certifies, and pays the application fee within 14 days. Once payment is finalised, the medicine is entered on the ARTG with its AUST L number."}],"tables":[]},{"heading":"TGO 92 is now TGO 116","anchor":"tgo-92-is-now-tgo-116","markdown":"TGO 92, the labelling standard for non-prescription medicines, was repealed on 30 September 2026, the day before it would have expired. Its replacement is the Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026, and it covers listed medicines. What a label must show under it is in our [TGO 116 labelling guide](/guides/supplement-labelling). It is a disallowable instrument, so Parliament can still disallow it during a period that began when it was tabled on 12 October 2026.\n\n- **The transition runs to 2031.** A medicine released for supply before 1 October 2031 can still follow TGO 92, or a set mix of TGO 116 and TGO 92 provisions. From 1 October 2031 every one must comply with TGO 116 in full. Our [labelling guide](/guides/supplement-labelling) sets out what the label must show.\n- **QR codes are allowed but can't replace what the label must say.** The information a code links to must be controlled by the sponsor (or be the TGA's information about the medicine) and must not contradict the label.\n- **Small containers.** On a small container, a listed medicine's name can be as small as 1.5 mm.\n- **An active's name can be shorter.** A listed medicine's main label may drop the salt, hydrate or solvate from an active's name if the full name appears elsewhere on the label, the strength isn't based on it and it doesn't matter to safety or efficacy.\n- **Advertising follows the label.** The Therapeutic Goods Advertising Code now refers to TGO 116.\n\nA new product can still launch on a TGO 92 label, but designing to TGO 116 now saves a second round of artwork before 2031.","text":"TGO 92, the labelling standard for non-prescription medicines, was repealed on 30 September 2026, the day before it would have expired. Its replacement is the Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026, and it covers listed medicines. What a label must show under it is in our TGO 116 labelling guide. It is a disallowable instrument, so Parliament can still disallow it during a period that began when it was tabled on 12 October 2026. The transition runs to 2031. A medicine released for supply before 1 October 2031 can still follow TGO 92, or a set mix of TGO 116 and TGO 92 provisions. From 1 October 2031 every one must comply with TGO 116 in full. Our labelling guide sets out what the label must show. QR codes are allowed but can't replace what the label must say. The information a code links to must be controlled by the sponsor (or be the TGA's information about the medicine) and must not contradict the label. Small containers. On a small container, a listed medicine's name can be as small as 1.5 mm. An active's name can be shorter. A listed medicine's main label may drop the salt, hydrate or solvate from an active's name if the full name appears elsewhere on the label, the strength isn't based on it and it doesn't matter to safety or efficacy. Advertising follows the label. The Therapeutic Goods Advertising Code now refers to TGO 116. A new product can still launch on a TGO 92 label, but designing to TGO 116 now saves a second round of artwork before 2031.","items":[{"lead":"The transition runs to 2031.","text":"A medicine released for supply before 1 October 2031 can still follow TGO 92, or a set mix of TGO 116 and TGO 92 provisions. From 1 October 2031 every one must comply with TGO 116 in full. Our labelling guide sets out what the label must show."},{"lead":"QR codes are allowed but can't replace what the label must say.","text":"The information a code links to must be controlled by the sponsor (or be the TGA's information about the medicine) and must not contradict the label."},{"lead":"Small containers.","text":"On a small container, a listed medicine's name can be as small as 1.5 mm."},{"lead":"An active's name can be shorter.","text":"A listed medicine's main label may drop the salt, hydrate or solvate from an active's name if the full name appears elsewhere on the label, the strength isn't based on it and it doesn't matter to safety or efficacy."},{"lead":"Advertising follows the label.","text":"The Therapeutic Goods Advertising Code now refers to TGO 116."}],"tables":[]},{"heading":"What it costs: TGA fees for 2026–27","anchor":"what-it-costs-tga-fees-for-202627","markdown":"| Fee | Amount |\n| --- | --- |\n| Listing application | $1,063 |\n| Annual charge, each financial year once the product has had turnover | $1,566 |\n| Varying an existing listing | $537 |\n| Asking for a new permitted indication | $1,331 |\n| New ingredient, IN1 or IN2 (application, then evaluation) | $1,370 + $18,456 |\n| New ingredient, IN3 or IN4 (application, then evaluation) | $3,629 + $30,067 |\n| GMP clearance processing, per manufacturer, site and sponsor | $818 |\n\nThe annual charge applies to every listing on the ARTG at any time in the financial year, even one cancelled later that year. The exception is a listing that has never had turnover: it stays exempt until sales start, as long as the sponsor declares between 1 and 22 July each year that it had none in the year before. Once a product has had turnover, the charge applies every year, even in a later year with no sales. These are the TGA's fees only: the formula, the evidence, stability testing and manufacturing are separate costs, set out in our guide to [what a supplement costs to develop](/guides/supplement-development-cost).","text":"Fee: Listing application; Amount: $1,063. Fee: Annual charge, each financial year once the product has had turnover; Amount: $1,566. Fee: Varying an existing listing; Amount: $537. Fee: Asking for a new permitted indication; Amount: $1,331. Fee: New ingredient, IN1 or IN2 (application, then evaluation); Amount: $1,370 + $18,456. Fee: New ingredient, IN3 or IN4 (application, then evaluation); Amount: $3,629 + $30,067. Fee: GMP clearance processing, per manufacturer, site and sponsor; Amount: $818. The annual charge applies to every listing on the ARTG at any time in the financial year, even one cancelled later that year. The exception is a listing that has never had turnover: it stays exempt until sales start, as long as the sponsor declares between 1 and 22 July each year that it had none in the year before. Once a product has had turnover, the charge applies every year, even in a later year with no sales. These are the TGA's fees only: the formula, the evidence, stability testing and manufacturing are separate costs, set out in our guide to what a supplement costs to develop.","items":[],"tables":[{"header":["Fee","Amount"],"rows":[["Listing application","$1,063"],["Annual charge, each financial year once the product has had turnover","$1,566"],["Varying an existing listing","$537"],["Asking for a new permitted indication","$1,331"],["New ingredient, IN1 or IN2 (application, then evaluation)","$1,370 + $18,456"],["New ingredient, IN3 or IN4 (application, then evaluation)","$3,629 + $30,067"],["GMP clearance processing, per manufacturer, site and sponsor","$818"]]}]},{"heading":"How long it takes","anchor":"how-long-it-takes","markdown":"The TGA's own step is quick. Once the application passes validation and the fee is paid, the medicine is entered on the ARTG with its AUST L number, and it usually shows in TGA Business Services the next day. In 2024–25 the TGA added 2,143 new listed medicines.\n\nThe time goes into what must be in place before lodging: the formula, the evidence, GMP manufacturing, stability data and the label. The TGA gives no timeframes for these. From our records, design to production order has taken 32 days for a complex herbal capsule, under seven weeks for an eye-health formula and 12 weeks for a two-a-day skin supplement, and [EverLeanBody's](/work/everleanbody-saffron-capsule) first capsule took 5.8 months from signed brief to dispatch.","text":"The TGA's own step is quick. Once the application passes validation and the fee is paid, the medicine is entered on the ARTG with its AUST L number, and it usually shows in TGA Business Services the next day. In 2024–25 the TGA added 2,143 new listed medicines. The time goes into what must be in place before lodging: the formula, the evidence, GMP manufacturing, stability data and the label. The TGA gives no timeframes for these. From our records, design to production order has taken 32 days for a complex herbal capsule, under seven weeks for an eye-health formula and 12 weeks for a two-a-day skin supplement, and EverLeanBody's first capsule took 5.8 months from signed brief to dispatch.","items":[],"tables":[]},{"heading":"After the listing","anchor":"after-the-listing","markdown":"- **The TGA can review a listing at any time.** A compliance review can ask for information on the label, quality, safety or efficacy. A medicine that doesn't comply can have its listing suspended or cancelled, its label changed, or be recalled.\n- **What the TGA is looking for.** Its 2024–25 compliance priorities included advertising indications not on the ARTG, missing mandatory warnings, not meeting ingredient restrictions, quality problems, and not holding enough evidence of efficacy.\n- **Advertising has its own code.** Under the Therapeutic Goods Advertising Code, advertising must be accurate and balanced, substantiated before it is published, and not inconsistent with the indications on the ARTG. Most medicine advertising must carry \"ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE\" (short-form ads carry \"ALWAYS FOLLOW THE DIRECTIONS FOR USE\"), and, except in advertising directed only at health professionals, none can use endorsements from current or former health practitioners, health professionals or medical researchers. More in our [advertising guide](/guides/tga-advertising) and [claims and indications guide](/guides/permitted-indications).","text":"The TGA can review a listing at any time. A compliance review can ask for information on the label, quality, safety or efficacy. A medicine that doesn't comply can have its listing suspended or cancelled, its label changed, or be recalled. What the TGA is looking for. Its 2024–25 compliance priorities included advertising indications not on the ARTG, missing mandatory warnings, not meeting ingredient restrictions, quality problems, and not holding enough evidence of efficacy. Advertising has its own code. Under the Therapeutic Goods Advertising Code, advertising must be accurate and balanced, substantiated before it is published, and not inconsistent with the indications on the ARTG. Most medicine advertising must carry \"ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE\" (short-form ads carry \"ALWAYS FOLLOW THE DIRECTIONS FOR USE\"), and, except in advertising directed only at health professionals, none can use endorsements from current or former health practitioners, health professionals or medical researchers. More in our advertising guide and claims and indications guide.","items":[{"lead":"The TGA can review a listing at any time.","text":"A compliance review can ask for information on the label, quality, safety or efficacy. A medicine that doesn't comply can have its listing suspended or cancelled, its label changed, or be recalled."},{"lead":"What the TGA is looking for.","text":"Its 2024–25 compliance priorities included advertising indications not on the ARTG, missing mandatory warnings, not meeting ingredient restrictions, quality problems, and not holding enough evidence of efficacy."},{"lead":"Advertising has its own code.","text":"Under the Therapeutic Goods Advertising Code, advertising must be accurate and balanced, substantiated before it is published, and not inconsistent with the indications on the ARTG. Most medicine advertising must carry \"ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE\" (short-form ads carry \"ALWAYS FOLLOW THE DIRECTIONS FOR USE\"), and, except in advertising directed only at health professionals, none can use endorsements from current or former health practitioners, health professionals or medical researchers. More in our advertising guide and claims and indications guide."}],"tables":[]},{"heading":"Where we come in","anchor":"where-we-come-in","markdown":"We take a product through steps 2 to 8: a formula inside the permitted ingredients and indications, the evidence package, manufacturing partners with the licence or clearance the product needs, the stability program, the label and the listing, then we keep the listing current as the product changes. More on [the listed-medicines pathway](/pathways/listed-medicines), or [book a call](/contact).","text":"We take a product through steps 2 to 8: a formula inside the permitted ingredients and indications, the evidence package, manufacturing partners with the licence or clearance the product needs, the stability program, the label and the listing, then we keep the listing current as the product changes. More on the listed-medicines pathway, or book a call.","items":[],"tables":[]}],"faqs":[{"q":"How do I get a supplement listed with the TGA?","a":"Through its Australian sponsor. Confirm it is a medicine, check every ingredient and its dose against the Permissible Ingredients Determination, choose permitted indications and hold the evidence for every claim, arrange GMP manufacturing, prove its shelf life and write its label (to TGO 116, or TGO 92 for a medicine released for supply before 1 October 2031). The sponsor then enters it in TGA Business Services, where it is validated, certifies that it meets every condition of listing and pays the fee within 14 days of submitting. Once payment is finalised, the medicine goes on the ARTG with its AUST L number.","md":"Through its Australian sponsor. Confirm it is a medicine, check every ingredient and its dose against the Permissible Ingredients Determination, choose permitted indications and hold the evidence for every claim, arrange GMP manufacturing, prove its shelf life and write its label (to TGO 116, or TGO 92 for a medicine released for supply before 1 October 2031). The sponsor then enters it in TGA Business Services, where it is validated, certifies that it meets every condition of listing and pays the fee within 14 days of submitting. Once payment is finalised, the medicine goes on the ARTG with its AUST L number."},{"q":"Does the TGA approve supplements?","a":"In the TGA's words, a medicine with an AUST number \"has been approved (registered or listed) by the TGA for supply in Australia\". But most supplements sold as medicines are listed (AUST L), and listed medicines aren't individually evaluated before sale: the sponsor certifies that the product meets the rules and holds the evidence for its claims. Registered medicines (AUST R) are fully evaluated, including the indications on the label. Supplements sold as foods aren't approved by the TGA at all.","md":"In the TGA's words, a medicine with an AUST number \"has been approved (registered or listed) by the TGA for supply in Australia\". But most supplements sold as medicines are listed (AUST L), and listed medicines aren't individually evaluated before sale: the sponsor certifies that the product meets the rules and holds the evidence for its claims. Registered medicines (AUST R) are fully evaluated, including the indications on the label. Supplements sold as foods aren't approved by the TGA at all."},{"q":"What does AUST L mean?","a":"An AUST L number on the pack shows the product is a listed medicine on the Australian Register of Therapeutic Goods: the lowest-risk tier, using ingredients from the TGA's pre-approved list and low-level indications. AUST L(A) marks an assessed listed medicine, whose indications the TGA has assessed for efficacy.","md":"An AUST L number on the pack shows the product is a listed medicine on the Australian Register of Therapeutic Goods: the lowest-risk tier, using ingredients from the TGA's pre-approved list and low-level indications. AUST L(A) marks an assessed listed medicine, whose indications the TGA has assessed for efficacy."},{"q":"What is TGO 92?","a":"TGO 92 was the labelling standard for non-prescription medicines, including listed medicines, until TGO 116 replaced it on 30 September 2026. Medicines released for supply before 1 October 2031 can still use TGO 92 labels.","md":"TGO 92 was the labelling standard for non-prescription medicines, including listed medicines, until TGO 116 replaced it on 30 September 2026. Medicines released for supply before 1 October 2031 can still use TGO 92 labels."},{"q":"How much does a TGA listing cost?","a":"For 2026–27, the TGA charges $1,063 to apply, then $1,566 a year from the financial year the medicine starts selling. Developing the product, the evidence, stability testing and manufacturing cost extra.","md":"For 2026–27, the TGA charges $1,063 to apply, then $1,566 a year from the financial year the medicine starts selling. Developing the product, the evidence, stability testing and manufacturing cost extra."},{"q":"How long does a TGA listing take?","a":"Once the application passes validation and the fee is paid (within 14 days of submitting), the medicine goes on the ARTG with its AUST L number. The months go into the work before lodging: formula, evidence, manufacturing, stability and label.","md":"Once the application passes validation and the fee is paid (within 14 days of submitting), the medicine goes on the ARTG with its AUST L number. The months go into the work before lodging: formula, evidence, manufacturing, stability and label."},{"q":"Can an overseas brand list a supplement in Australia?","a":"Only through an Australian sponsor: an Australian resident, or a company incorporated and doing business here with a representative who lives in Australia.","md":"Only through an Australian sponsor: an Australian resident, or a company incorporated and doing business here with a representative who lives in Australia."},{"q":"Does passing validation mean the TGA has checked my product?","a":"No. The TGA says that although the Electronic Listing Facility validates listings, \"this does not mean that the TGA has confirmed that your medicine meets all regulatory requirements\". The sponsor stays responsible.","md":"No. The TGA says that although the Electronic Listing Facility validates listings, \"this does not mean that the TGA has confirmed that your medicine meets all regulatory requirements\". The sponsor stays responsible."}],"sources":{"note":"General information, checked against these sources on 19 October 2026. It isn't advice on a particular product.","markdown":"General information, checked against these sources on 19 October 2026. It isn't advice on a particular product.\n\n- [Listed medicines](https://www.tga.gov.au/node/520083), [About listed medicines](https://www.tga.gov.au/node/520077), [About listed medicines for sponsors](https://www.tga.gov.au/node/546608) and [Listed, assessed listed and registered medicines](https://www.tga.gov.au/node/497532), Therapeutic Goods Administration\n- [About assessed listed medicines](https://www.tga.gov.au/products/medicines/assessed-listed-medicines/overview/about-assessed-listed-medicines), Therapeutic Goods Administration\n- [AUST numbers on medicine labels](https://www.tga.gov.au/products/medicines/labelling-and-advertising/medicines-and-biologicals-labelling-and-packaging/aust-numbers-medicine-labels), Therapeutic Goods Administration\n- [The role of the sponsor](https://www.tga.gov.au/how-we-regulate/supply-therapeutic-good/overview-supplying-therapeutic-goods-australia/role-sponsor), Therapeutic Goods Administration\n- [General guidance for listed medicines](https://www.tga.gov.au/node/289506), Therapeutic Goods Administration\n- [Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026](https://www.legislation.gov.au/F2026L01382/asmade/versions) and the [Andrographis removal](https://www.legislation.gov.au/F2026L01211/asmade), Federal Register of Legislation\n- [Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025](https://www.legislation.gov.au/F2025L00450/latest/versions), Federal Register of Legislation\n- [Listed medicines evidence guidelines](https://www.tga.gov.au/resources/resource/guidance/evidence-guidelines), Therapeutic Goods Administration\n- [Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026](https://www.legislation.gov.au/F2026L01312/asmade), Federal Register of Legislation\n- [Manufacturing therapeutic goods](https://www.tga.gov.au/products/regulations-all-products/manufacturing), Therapeutic Goods Administration\n- [Stability requirements for listed medicines](https://www.tga.gov.au/stability-requirements-listed-medicines), [Performing ongoing stability testing](https://www.tga.gov.au/node/452227) and [Stability testing of listed complementary medicines](https://www.tga.gov.au/node/497429) (older guidance), Therapeutic Goods Administration\n- [Fees and charges: summary, from 1 July 2026](https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf), [Annual charges](https://www.tga.gov.au/products/regulations-all-products/fees-and-payments/annual-charges) and the [annual charge exemption scheme FAQ](https://www.tga.gov.au/products/regulations-all-products/fees-and-payments/annual-charge-exemption-scheme-therapeutic-goods/annual-charge-exemption-scheme-frequently-asked-questions), Therapeutic Goods Administration\n- [TGA Performance Report 2024–25](https://www.tga.gov.au/sites/default/files/2026-05/therapeutic-goods-administration-performance-report-2024-25.PDF), Therapeutic Goods Administration\n- [Understanding listed medicines compliance reviews](https://www.tga.gov.au/resources/guidance/understanding-listed-medicines-compliance-reviews) and the [Regulatory update from the Complementary & Over-the-Counter Medicines Branch](https://www.tga.gov.au/sites/default/files/2025-06/b22a-update-from-complementary-over-the-counter-medicines-branch-arcs-2025-presentation.pdf) (2025), Therapeutic Goods Administration\n- [Therapeutic Goods Advertising Code](https://www.legislation.gov.au/F2021L01661/latest/text), Federal Register of Legislation","items":[{"text":"Listed medicines, About listed medicines, About listed medicines for sponsors and Listed, assessed listed and registered medicines, Therapeutic Goods Administration","links":[{"title":"Listed medicines","url":"https://www.tga.gov.au/node/520083"},{"title":"About listed medicines","url":"https://www.tga.gov.au/node/520077"},{"title":"About listed medicines for sponsors","url":"https://www.tga.gov.au/node/546608"},{"title":"Listed, assessed listed and registered medicines","url":"https://www.tga.gov.au/node/497532"}]},{"text":"About assessed listed medicines, Therapeutic Goods Administration","links":[{"title":"About assessed listed medicines","url":"https://www.tga.gov.au/products/medicines/assessed-listed-medicines/overview/about-assessed-listed-medicines"}]},{"text":"AUST numbers on medicine labels, Therapeutic Goods Administration","links":[{"title":"AUST numbers on medicine labels","url":"https://www.tga.gov.au/products/medicines/labelling-and-advertising/medicines-and-biologicals-labelling-and-packaging/aust-numbers-medicine-labels"}]},{"text":"The role of the sponsor, Therapeutic Goods Administration","links":[{"title":"The role of the sponsor","url":"https://www.tga.gov.au/how-we-regulate/supply-therapeutic-good/overview-supplying-therapeutic-goods-australia/role-sponsor"}]},{"text":"General guidance for listed medicines, Therapeutic Goods Administration","links":[{"title":"General guidance for listed medicines","url":"https://www.tga.gov.au/node/289506"}]},{"text":"Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026 and the Andrographis removal, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026","url":"https://www.legislation.gov.au/F2026L01382/asmade/versions"},{"title":"Andrographis removal","url":"https://www.legislation.gov.au/F2026L01211/asmade"}]},{"text":"Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025","url":"https://www.legislation.gov.au/F2025L00450/latest/versions"}]},{"text":"Listed medicines evidence guidelines, Therapeutic Goods Administration","links":[{"title":"Listed medicines evidence guidelines","url":"https://www.tga.gov.au/resources/resource/guidance/evidence-guidelines"}]},{"text":"Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026","url":"https://www.legislation.gov.au/F2026L01312/asmade"}]},{"text":"Manufacturing therapeutic goods, Therapeutic Goods Administration","links":[{"title":"Manufacturing therapeutic goods","url":"https://www.tga.gov.au/products/regulations-all-products/manufacturing"}]},{"text":"Stability requirements for listed medicines, Performing ongoing stability testing and Stability testing of listed complementary medicines (older guidance), Therapeutic Goods Administration","links":[{"title":"Stability requirements for listed medicines","url":"https://www.tga.gov.au/stability-requirements-listed-medicines"},{"title":"Performing ongoing stability testing","url":"https://www.tga.gov.au/node/452227"},{"title":"Stability testing of listed complementary medicines","url":"https://www.tga.gov.au/node/497429"}]},{"text":"Fees and charges: summary, from 1 July 2026, Annual charges and the annual charge exemption scheme FAQ, Therapeutic Goods Administration","links":[{"title":"Fees and charges: summary, from 1 July 2026","url":"https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf"},{"title":"Annual charges","url":"https://www.tga.gov.au/products/regulations-all-products/fees-and-payments/annual-charges"},{"title":"annual charge exemption scheme FAQ","url":"https://www.tga.gov.au/products/regulations-all-products/fees-and-payments/annual-charge-exemption-scheme-therapeutic-goods/annual-charge-exemption-scheme-frequently-asked-questions"}]},{"text":"TGA Performance Report 2024–25, Therapeutic Goods Administration","links":[{"title":"TGA Performance Report 2024–25","url":"https://www.tga.gov.au/sites/default/files/2026-05/therapeutic-goods-administration-performance-report-2024-25.PDF"}]},{"text":"Understanding listed medicines compliance reviews and the Regulatory update from the Complementary & Over-the-Counter Medicines Branch (2025), Therapeutic Goods Administration","links":[{"title":"Understanding listed medicines compliance reviews","url":"https://www.tga.gov.au/resources/guidance/understanding-listed-medicines-compliance-reviews"},{"title":"Regulatory update from the Complementary & Over-the-Counter Medicines Branch","url":"https://www.tga.gov.au/sites/default/files/2025-06/b22a-update-from-complementary-over-the-counter-medicines-branch-arcs-2025-presentation.pdf"}]},{"text":"Therapeutic Goods Advertising Code, Federal Register of Legislation","links":[{"title":"Therapeutic Goods Advertising Code","url":"https://www.legislation.gov.au/F2021L01661/latest/text"}]}]}},{"slug":"artg","kind":"guide","url":"/guides/artg","title":"The ARTG: what it is and how to check a product","name":"ARTG guide","description":"ARTG search, step by step: look up an AUST L, AUST R or AUST L(A) number on the TGA's register, and see what an entry does and doesn't tell you.","eyebrow":"Guide","lead":"The Australian Register of Therapeutic Goods (ARTG) is the TGA's public database of therapeutic goods, such as medicines, medical devices and biologicals, that can be legally supplied in Australia. A medicine on it must carry its AUST R, AUST L or AUST L(A) number on the label. You can look that number up in the TGA's ARTG search. An entry tells you a product can be supplied (unless it is listed for export only), but not always that the TGA has evaluated it.","parent":"/pathways/listed-medicines","studies":["everleanbody-saffron-capsule","pump-haircare-hair-supplement","sports-nutrition-joint-formula"],"formats":[],"order":61,"updated":"2026-10-20","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- The ARTG, the Australian Register of Therapeutic Goods, is the TGA's public database of the therapeutic goods that can be legally supplied in Australia.\n- A medicine on it carries an AUST R, AUST L or AUST L(A) number on its label, which you can look up in the TGA's ARTG search, by number, name or sponsor.\n- An entry means a product can be legally supplied (unless it is listed for export only), not always that the TGA evaluated it: listed (AUST L) medicines aren't individually evaluated before sale.\n- Cancelled and suspended products no longer appear in the search.","text":"The ARTG, the Australian Register of Therapeutic Goods, is the TGA's public database of the therapeutic goods that can be legally supplied in Australia. A medicine on it carries an AUST R, AUST L or AUST L(A) number on its label, which you can look up in the TGA's ARTG search, by number, name or sponsor. An entry means a product can be legally supplied (unless it is listed for export only), not always that the TGA evaluated it: listed (AUST L) medicines aren't individually evaluated before sale. Cancelled and suspended products no longer appear in the search.","items":[],"tables":[]},{"heading":"What is the ARTG?","anchor":"what-is-the-artg","markdown":"The ARTG is the public database of therapeutic goods that can be legally supplied in Australia. It holds each product's name and formulation details, and the details of its sponsor and manufacturer.\n\nThe register exists under section 9A of the Therapeutic Goods Act 1989. Its purpose, in the Act's words, is \"compiling information in relation to, and providing for evaluation of, therapeutic goods for use in humans\". The TGA keeps it and enters goods on it.\n\nWith few exceptions, a therapeutic good that isn't on the ARTG can't be manufactured, imported, exported, supplied or advertised in Australia. Schedules 5 and 5A of the Therapeutic Goods Regulations 1990 exempt some goods from the Act's registration, listing and biologicals rules, some only under conditions. Some medical devices are exempt from inclusion too.\n\nGoods that aren't on the ARTG can also reach individual patients or groups under specific conditions. The TGA's access pathways for this include the Special Access Scheme, the Authorised Prescriber Scheme, clinical trial schemes and the Personal Importation Scheme. The TGA says these schemes \"cannot be used to facilitate the commercial supply of therapeutic goods\": they are not a route to market.","text":"The ARTG is the public database of therapeutic goods that can be legally supplied in Australia. It holds each product's name and formulation details, and the details of its sponsor and manufacturer. The register exists under section 9A of the Therapeutic Goods Act 1989. Its purpose, in the Act's words, is \"compiling information in relation to, and providing for evaluation of, therapeutic goods for use in humans\". The TGA keeps it and enters goods on it. With few exceptions, a therapeutic good that isn't on the ARTG can't be manufactured, imported, exported, supplied or advertised in Australia. Schedules 5 and 5A of the Therapeutic Goods Regulations 1990 exempt some goods from the Act's registration, listing and biologicals rules, some only under conditions. Some medical devices are exempt from inclusion too. Goods that aren't on the ARTG can also reach individual patients or groups under specific conditions. The TGA's access pathways for this include the Special Access Scheme, the Authorised Prescriber Scheme, clinical trial schemes and the Personal Importation Scheme. The TGA says these schemes \"cannot be used to facilitate the commercial supply of therapeutic goods\": they are not a route to market.","items":[],"tables":[]},{"heading":"What is on the ARTG?","anchor":"what-is-on-the-artg","markdown":"The Act divides the register into five parts: registered goods, provisionally registered goods, listed goods, biologicals and medical devices. Non-prescription medicines go on it as listed, assessed listed or registered medicines.\n\n| Kind of entry | Number | What it covers |\n| --- | --- | --- |\n| Registered medicine | AUST R | Higher-risk medicines: all prescription medicines, most over-the-counter ones such as pain relief and antihistamines, and higher dose iron supplements |\n| Listed medicine | AUST L | The lowest-risk non-prescription medicines, such as vitamins, herbal medicines, Traditional Chinese Medicines and some sunscreens |\n| Assessed listed medicine | AUST L(A) | Medicines like listed ones that can also make intermediate indications, whose efficacy the TGA assesses before sale |\n| Medical device | ARTG number | Class I devices such as bandages and splints; Class III devices such as pacemakers |\n\nA medicine on the ARTG must carry its AUST number on the label. The TGA says this number is also known as the ARTG ID, or the registration or listing number.\n\nWhether a product is a medicine at all, rather than a food or a cosmetic, is a separate question: see [medicine, food or cosmetic?](/pathways)","text":"The Act divides the register into five parts: registered goods, provisionally registered goods, listed goods, biologicals and medical devices. Non-prescription medicines go on it as listed, assessed listed or registered medicines. Kind of entry: Registered medicine; Number: AUST R; What it covers: Higher-risk medicines: all prescription medicines, most over-the-counter ones such as pain relief and antihistamines, and higher dose iron supplements. Kind of entry: Listed medicine; Number: AUST L; What it covers: The lowest-risk non-prescription medicines, such as vitamins, herbal medicines, Traditional Chinese Medicines and some sunscreens. Kind of entry: Assessed listed medicine; Number: AUST L(A); What it covers: Medicines like listed ones that can also make intermediate indications, whose efficacy the TGA assesses before sale. Kind of entry: Medical device; Number: ARTG number; What it covers: Class I devices such as bandages and splints; Class III devices such as pacemakers. A medicine on the ARTG must carry its AUST number on the label. The TGA says this number is also known as the ARTG ID, or the registration or listing number. Whether a product is a medicine at all, rather than a food or a cosmetic, is a separate question: see medicine, food or cosmetic?","items":[],"tables":[{"header":["Kind of entry","Number","What it covers"],"rows":[["Registered medicine","AUST R","Higher-risk medicines: all prescription medicines, most over-the-counter ones such as pain relief and antihistamines, and higher dose iron supplements"],["Listed medicine","AUST L","The lowest-risk non-prescription medicines, such as vitamins, herbal medicines, Traditional Chinese Medicines and some sunscreens"],["Assessed listed medicine","AUST L(A)","Medicines like listed ones that can also make intermediate indications, whose efficacy the TGA assesses before sale"],["Medical device","ARTG number","Class I devices such as bandages and splints; Class III devices such as pacemakers"]]}]},{"heading":"How to search the ARTG","anchor":"how-to-search-the-artg","markdown":"The TGA's [ARTG search](https://www.tga.gov.au/resources/artg) covers the medicines, medical devices and biologicals that can be supplied in Australia.\n\n1. **Find the number.** On a medicine, look for the AUST R, AUST L or AUST L(A) number on the label.\n2. **Search for it.** The search works by name, ID or sponsor, so enter the number, the product name or the sponsor.\n3. **Narrow the results.** Filter them by sponsor or by published date.\n4. **Check the entry.** Results include the product name and formulation details, the sponsor and manufacturer details, and Consumer Medicine Information (CMI) and Product Information (PI). Not all CMI and PI documents are available.\n5. **Read the public summary.** It gives details such as the sponsor and the product's intended purpose or indications.\n\nFor a more detailed search, the TGA has an ARTG visualisation tool, built for larger screens and the Chrome browser.\n\nA number from a pack that brings up nothing may belong to a product that has been cancelled or suspended. The TGA's 2021 search manual says the search shows only current entries. It suggests checking the number, and contacting the place of purchase if you have concerns.","text":"The TGA's ARTG search covers the medicines, medical devices and biologicals that can be supplied in Australia. Find the number. On a medicine, look for the AUST R, AUST L or AUST L(A) number on the label. Search for it. The search works by name, ID or sponsor, so enter the number, the product name or the sponsor. Narrow the results. Filter them by sponsor or by published date. Check the entry. Results include the product name and formulation details, the sponsor and manufacturer details, and Consumer Medicine Information (CMI) and Product Information (PI). Not all CMI and PI documents are available. Read the public summary. It gives details such as the sponsor and the product's intended purpose or indications. For a more detailed search, the TGA has an ARTG visualisation tool, built for larger screens and the Chrome browser. A number from a pack that brings up nothing may belong to a product that has been cancelled or suspended. The TGA's 2021 search manual says the search shows only current entries. It suggests checking the number, and contacting the place of purchase if you have concerns.","items":[{"lead":"Find the number.","text":"On a medicine, look for the AUST R, AUST L or AUST L(A) number on the label."},{"lead":"Search for it.","text":"The search works by name, ID or sponsor, so enter the number, the product name or the sponsor."},{"lead":"Narrow the results.","text":"Filter them by sponsor or by published date."},{"lead":"Check the entry.","text":"Results include the product name and formulation details, the sponsor and manufacturer details, and Consumer Medicine Information (CMI) and Product Information (PI). Not all CMI and PI documents are available."},{"lead":"Read the public summary.","text":"It gives details such as the sponsor and the product's intended purpose or indications."}],"tables":[]},{"heading":"What an ARTG entry tells you, and what it doesn't","anchor":"what-an-artg-entry-tells-you-and-what-it-doesnt","markdown":"An entry tells you the product can be legally supplied in Australia (unless it is listed for export only), who its sponsor is and what its formulation details are. For a medicine, the AUST number also tells you whether it is registered, listed or assessed listed.\n\nThat matters, because the TGA checks each tier differently. Medicines with AUST R and AUST L(A) numbers are assessed for efficacy; those with AUST L are not. Listed medicines are not individually evaluated by the TGA for quality, safety and efficacy before they are supplied, and most complementary medicines are [listed](/pathways/listed-medicines).\n\nThe TGA's own 2024–25 performance report makes the point. Some lower-risk goods are entered \"on the basis of certifications made by the sponsor of the goods, rather than comprehensive pre-market evaluation\". So being on the ARTG is not the same as being evaluated by the TGA.\n\nNor is the register advice: the TGA says it \"is not intended to provide guidance, advice or recommendations\" on the goods. And a public summary is not an ARTG certificate, which only the sponsor can view or print.","text":"An entry tells you the product can be legally supplied in Australia (unless it is listed for export only), who its sponsor is and what its formulation details are. For a medicine, the AUST number also tells you whether it is registered, listed or assessed listed. That matters, because the TGA checks each tier differently. Medicines with AUST R and AUST L(A) numbers are assessed for efficacy; those with AUST L are not. Listed medicines are not individually evaluated by the TGA for quality, safety and efficacy before they are supplied, and most complementary medicines are listed. The TGA's own 2024–25 performance report makes the point. Some lower-risk goods are entered \"on the basis of certifications made by the sponsor of the goods, rather than comprehensive pre-market evaluation\". So being on the ARTG is not the same as being evaluated by the TGA. Nor is the register advice: the TGA says it \"is not intended to provide guidance, advice or recommendations\" on the goods. And a public summary is not an ARTG certificate, which only the sponsor can view or print.","items":[],"tables":[]},{"heading":"How a product gets on the ARTG","anchor":"how-a-product-gets-on-the-artg","markdown":"The sponsor, the individual or company intending to supply a product, is responsible for meeting the regulatory requirements. The TGA enters higher-risk goods once it has assessed them as meeting the requirements for quality, safety and, where appropriate, efficacy or performance. Lower-risk medicines, biologicals and medical devices go on once their applications have been validated (for a listed medicine, once the fee is paid too). More on the sponsor's role in our [TGA sponsor guide](/guides/tga-sponsor).\n\nFor a listed medicine, our [TGA listing guide](/guides/tga-approval) sets out what must be in place before lodging, the steps and the fees. In 2024–25 the TGA added 2,143 new listed medicines.","text":"The sponsor, the individual or company intending to supply a product, is responsible for meeting the regulatory requirements. The TGA enters higher-risk goods once it has assessed them as meeting the requirements for quality, safety and, where appropriate, efficacy or performance. Lower-risk medicines, biologicals and medical devices go on once their applications have been validated (for a listed medicine, once the fee is paid too). More on the sponsor's role in our TGA sponsor guide. For a listed medicine, our TGA listing guide sets out what must be in place before lodging, the steps and the fees. In 2024–25 the TGA added 2,143 new listed medicines.","items":[],"tables":[]},{"heading":"ARTG cancellations and suspensions","anchor":"artg-cancellations-and-suspensions","markdown":"Under the Act, a registration or listing can be suspended (section 29D) or cancelled (section 30). Suspended and cancelled products no longer appear in the ARTG; the TGA lists them in separate databases, and its cancellations and suspensions database gives the grounds for each cancellation.\n\nComplementary medicines can be cancelled after a TGA review. If a compliance review finds a listed medicine doesn't comply, the TGA acts according to the risk. It can require the sponsor to change the label, remove the medicine from the ARTG so it can no longer be lawfully supplied, or recall it. Carrying out a recall is the sponsor's job.\n\nThe TGA also publishes sponsor-requested cancellations, and products cancelled for failure to pay annual charges.","text":"Under the Act, a registration or listing can be suspended (section 29D) or cancelled (section 30). Suspended and cancelled products no longer appear in the ARTG; the TGA lists them in separate databases, and its cancellations and suspensions database gives the grounds for each cancellation. Complementary medicines can be cancelled after a TGA review. If a compliance review finds a listed medicine doesn't comply, the TGA acts according to the risk. It can require the sponsor to change the label, remove the medicine from the ARTG so it can no longer be lawfully supplied, or recall it. Carrying out a recall is the sponsor's job. The TGA also publishes sponsor-requested cancellations, and products cancelled for failure to pay annual charges.","items":[],"tables":[]},{"heading":"Where we come in","anchor":"where-we-come-in","markdown":"We take listed medicines through to an ARTG listing for brands, then keep the listing current as the product changes. The listing comes once the formula, the evidence, stability data and the label are ready, and a licensed or GMP-cleared manufacturer is lined up. Our [TGA listing guide](/guides/tga-approval) covers each one, or [book a call](/contact).","text":"We take listed medicines through to an ARTG listing for brands, then keep the listing current as the product changes. The listing comes once the formula, the evidence, stability data and the label are ready, and a licensed or GMP-cleared manufacturer is lined up. Our TGA listing guide covers each one, or book a call.","items":[],"tables":[]}],"faqs":[{"q":"What does ARTG stand for?","a":"Australian Register of Therapeutic Goods. It is the public database of therapeutic goods that can be legally supplied in Australia. Section 9A of the Therapeutic Goods Act 1989 requires it, and the TGA keeps it.","md":"Australian Register of Therapeutic Goods. It is the public database of therapeutic goods that can be legally supplied in Australia. Section 9A of the Therapeutic Goods Act 1989 requires it, and the TGA keeps it."},{"q":"How do I check if a supplement is on the ARTG?","a":"Find the AUST L, AUST L(A) or AUST R number on the label and enter it in the TGA's ARTG search. You can also search by product name or sponsor. If nothing comes up, check the number: cancelled and suspended products no longer appear in the ARTG.","md":"Find the AUST L, AUST L(A) or AUST R number on the label and enter it in the TGA's ARTG search. You can also search by product name or sponsor. If nothing comes up, check the number: cancelled and suspended products no longer appear in the ARTG."},{"q":"Does being on the ARTG mean the TGA approved it?","a":"In the TGA's words, yes: it says an AUST number gives \"confidence that the medicine has been approved (registered or listed) by the TGA for supply in Australia\". That doesn't always mean the TGA evaluated it. Registered medicines are fully assessed for safety, quality and efficacy before they go on sale. Listed medicines (AUST L), which include most complementary medicines, are not individually evaluated before they are supplied.","md":"In the TGA's words, yes: it says an AUST number gives \"confidence that the medicine has been approved (registered or listed) by the TGA for supply in Australia\". That doesn't always mean the TGA evaluated it. Registered medicines are fully assessed for safety, quality and efficacy before they go on sale. Listed medicines (AUST L), which include most complementary medicines, are not individually evaluated before they are supplied."},{"q":"What is an ARTG ID?","a":"The number that identifies a product on the ARTG. For a medicine it is the AUST R, AUST L or AUST L(A) number on the label, also called the registration or listing number. A medical device gets an ARTG number when its entry is created.","md":"The number that identifies a product on the ARTG. For a medicine it is the AUST R, AUST L or AUST L(A) number on the label, also called the registration or listing number. A medical device gets an ARTG number when its entry is created."},{"q":"Do foods or cosmetics go on the ARTG?","a":"Not as foods or cosmetics: the ARTG is a register of therapeutic goods. Foods are mostly regulated by state and territory food regulators, and the ACCC is the primary regulator for cosmetics. Some sunscreens, though, are listed medicines.","md":"Not as foods or cosmetics: the ARTG is a register of therapeutic goods. Foods are mostly regulated by state and territory food regulators, and the ACCC is the primary regulator for cosmetics. Some sunscreens, though, are listed medicines."},{"q":"Can a therapeutic good be sold without being on the ARTG?","a":"Only in limited cases. A therapeutic good must generally be on the ARTG, or exempt, before it can be supplied. Individual patients can sometimes get one through an access pathway such as the Special Access Scheme, which is not a route to market.","md":"Only in limited cases. A therapeutic good must generally be on the ARTG, or exempt, before it can be supplied. Individual patients can sometimes get one through an access pathway such as the Special Access Scheme, which is not a route to market."}],"sources":{"note":"General information, checked against these sources on 20 October 2026. It isn't advice on a particular product.","markdown":"General information, checked against these sources on 20 October 2026. It isn't advice on a particular product.\n\n- [About the Australian Register of Therapeutic Goods (ARTG)](https://www.tga.gov.au/products/regulations-all-products/about-australian-register-therapeutic-goods-artg), Therapeutic Goods Administration\n- [Australian Register of Therapeutic Goods (ARTG)](https://www.tga.gov.au/resources/artg), Therapeutic Goods Administration\n- [ARTG Search (Public) User Manual](https://www.tga.gov.au/sites/default/files/2023-06/artgsearchguidance.pdf), Therapeutic Goods Administration\n- [Therapeutic Goods Act 1989](https://www.legislation.gov.au/C2004A03952/latest/text), Federal Register of Legislation\n- [Therapeutic Goods Regulations 1990](https://www.legislation.gov.au/F1996B00406/latest/text), Federal Register of Legislation\n- [Cosmetics or therapeutic goods: guidance for advertisers and suppliers](https://www.tga.gov.au/sites/default/files/2024-06/cosmetics-therapeutic-goods-guidance-for-advertisers-suppliers.pdf), Therapeutic Goods Administration\n- [Overview of supplying therapeutic goods in Australia](https://www.tga.gov.au/overview-supplying-therapeutic-goods-australia), Therapeutic Goods Administration\n- [Access pathways for unapproved therapeutic goods](https://www.tga.gov.au/products/unapproved-therapeutic-goods/access-pathways), Therapeutic Goods Administration\n- [Medicines and TGA classifications](https://www.tga.gov.au/products/medicines/overview/medicines-and-tga-classifications), Therapeutic Goods Administration\n- [Listed medicines](https://www.tga.gov.au/node/520083), Therapeutic Goods Administration\n- [About listed medicines](https://www.tga.gov.au/node/520077), Therapeutic Goods Administration\n- [Listed, assessed listed and registered medicines](https://www.tga.gov.au/node/497532), Therapeutic Goods Administration\n- [About assessed listed medicines](https://www.tga.gov.au/products/medicines/assessed-listed-medicines/overview/about-assessed-listed-medicines), Therapeutic Goods Administration\n- [AUST numbers on medicine labels](https://www.tga.gov.au/products/medicines/labelling-and-advertising/medicines-and-biologicals-labelling-and-packaging/aust-numbers-medicine-labels), Therapeutic Goods Administration\n- [Regulatory basics on medical devices for health practitioners](https://www.tga.gov.au/sites/default/files/2024-04/regulatory-basics-medical-devices-health-practitioners.pdf), Therapeutic Goods Administration\n- [Print the ARTG certificate of inclusion for your medical device](https://www.tga.gov.au/products/medical-devices/application-and-market-authorisation/supply-medical-device/medical-device-inclusion-process/print-artg-certificate-inclusion-your-medical-device), Therapeutic Goods Administration\n- [Publicly available information about therapeutic goods](https://www.tga.gov.au/community-qa/publicly-available-information-about-therapeutic-goods), Therapeutic Goods Administration\n- [Printing your ARTG certificate](https://www.tga.gov.au/printing-your-artg-certificate), Therapeutic Goods Administration\n- [TGA Performance Report 2024–25](https://www.tga.gov.au/sites/default/files/2026-05/therapeutic-goods-administration-performance-report-2024-25.PDF), Therapeutic Goods Administration\n- [Cancellations and suspensions from the Australian Register of Therapeutic Goods](https://www.tga.gov.au/resources/artg-cancellations-and-suspensions), Therapeutic Goods Administration\n- [Cancellations and suspensions](https://www.tga.gov.au/resources/cancellations-suspensions), Therapeutic Goods Administration\n- [Understanding listed medicines compliance reviews](https://www.tga.gov.au/resources/guidance/understanding-listed-medicines-compliance-reviews) and [Manage a recall](https://www.tga.gov.au/node/285921), Therapeutic Goods Administration\n- [Export Only medicines](https://www.tga.gov.au/node/288014), Therapeutic Goods Administration\n- [Food and medicine regulation](https://www.tga.gov.au/community-qa/food-and-medicine-regulation), Therapeutic Goods Administration","items":[{"text":"About the Australian Register of Therapeutic Goods (ARTG), Therapeutic Goods Administration","links":[{"title":"About the Australian Register of Therapeutic Goods (ARTG)","url":"https://www.tga.gov.au/products/regulations-all-products/about-australian-register-therapeutic-goods-artg"}]},{"text":"Australian Register of Therapeutic Goods (ARTG), Therapeutic Goods Administration","links":[{"title":"Australian Register of Therapeutic Goods (ARTG)","url":"https://www.tga.gov.au/resources/artg"}]},{"text":"ARTG Search (Public) User Manual, Therapeutic Goods Administration","links":[{"title":"ARTG Search (Public) User Manual","url":"https://www.tga.gov.au/sites/default/files/2023-06/artgsearchguidance.pdf"}]},{"text":"Therapeutic Goods Act 1989, Federal Register of Legislation","links":[{"title":"Therapeutic Goods Act 1989","url":"https://www.legislation.gov.au/C2004A03952/latest/text"}]},{"text":"Therapeutic Goods Regulations 1990, Federal Register of Legislation","links":[{"title":"Therapeutic Goods Regulations 1990","url":"https://www.legislation.gov.au/F1996B00406/latest/text"}]},{"text":"Cosmetics or therapeutic goods: guidance for advertisers and suppliers, Therapeutic Goods Administration","links":[{"title":"Cosmetics or therapeutic goods: guidance for advertisers and suppliers","url":"https://www.tga.gov.au/sites/default/files/2024-06/cosmetics-therapeutic-goods-guidance-for-advertisers-suppliers.pdf"}]},{"text":"Overview of supplying therapeutic goods in Australia, Therapeutic Goods Administration","links":[{"title":"Overview of supplying therapeutic goods in Australia","url":"https://www.tga.gov.au/overview-supplying-therapeutic-goods-australia"}]},{"text":"Access pathways for unapproved therapeutic goods, Therapeutic Goods Administration","links":[{"title":"Access pathways for unapproved therapeutic goods","url":"https://www.tga.gov.au/products/unapproved-therapeutic-goods/access-pathways"}]},{"text":"Medicines and TGA classifications, Therapeutic Goods Administration","links":[{"title":"Medicines and TGA classifications","url":"https://www.tga.gov.au/products/medicines/overview/medicines-and-tga-classifications"}]},{"text":"Listed medicines, Therapeutic Goods Administration","links":[{"title":"Listed medicines","url":"https://www.tga.gov.au/node/520083"}]},{"text":"About listed medicines, Therapeutic Goods Administration","links":[{"title":"About listed medicines","url":"https://www.tga.gov.au/node/520077"}]},{"text":"Listed, assessed listed and registered medicines, Therapeutic Goods Administration","links":[{"title":"Listed, assessed listed and registered medicines","url":"https://www.tga.gov.au/node/497532"}]},{"text":"About assessed listed medicines, Therapeutic Goods Administration","links":[{"title":"About assessed listed medicines","url":"https://www.tga.gov.au/products/medicines/assessed-listed-medicines/overview/about-assessed-listed-medicines"}]},{"text":"AUST numbers on medicine labels, Therapeutic Goods Administration","links":[{"title":"AUST numbers on medicine labels","url":"https://www.tga.gov.au/products/medicines/labelling-and-advertising/medicines-and-biologicals-labelling-and-packaging/aust-numbers-medicine-labels"}]},{"text":"Regulatory basics on medical devices for health practitioners, Therapeutic Goods Administration","links":[{"title":"Regulatory basics on medical devices for health practitioners","url":"https://www.tga.gov.au/sites/default/files/2024-04/regulatory-basics-medical-devices-health-practitioners.pdf"}]},{"text":"Print the ARTG certificate of inclusion for your medical device, Therapeutic Goods Administration","links":[{"title":"Print the ARTG certificate of inclusion for your medical device","url":"https://www.tga.gov.au/products/medical-devices/application-and-market-authorisation/supply-medical-device/medical-device-inclusion-process/print-artg-certificate-inclusion-your-medical-device"}]},{"text":"Publicly available information about therapeutic goods, Therapeutic Goods Administration","links":[{"title":"Publicly available information about therapeutic goods","url":"https://www.tga.gov.au/community-qa/publicly-available-information-about-therapeutic-goods"}]},{"text":"Printing your ARTG certificate, Therapeutic Goods Administration","links":[{"title":"Printing your ARTG certificate","url":"https://www.tga.gov.au/printing-your-artg-certificate"}]},{"text":"TGA Performance Report 2024–25, Therapeutic Goods Administration","links":[{"title":"TGA Performance Report 2024–25","url":"https://www.tga.gov.au/sites/default/files/2026-05/therapeutic-goods-administration-performance-report-2024-25.PDF"}]},{"text":"Cancellations and suspensions from the Australian Register of Therapeutic Goods, Therapeutic Goods Administration","links":[{"title":"Cancellations and suspensions from the Australian Register of Therapeutic Goods","url":"https://www.tga.gov.au/resources/artg-cancellations-and-suspensions"}]},{"text":"Cancellations and suspensions, Therapeutic Goods Administration","links":[{"title":"Cancellations and suspensions","url":"https://www.tga.gov.au/resources/cancellations-suspensions"}]},{"text":"Understanding listed medicines compliance reviews and Manage a recall, Therapeutic Goods Administration","links":[{"title":"Understanding listed medicines compliance reviews","url":"https://www.tga.gov.au/resources/guidance/understanding-listed-medicines-compliance-reviews"},{"title":"Manage a recall","url":"https://www.tga.gov.au/node/285921"}]},{"text":"Export Only medicines, Therapeutic Goods Administration","links":[{"title":"Export Only medicines","url":"https://www.tga.gov.au/node/288014"}]},{"text":"Food and medicine regulation, Therapeutic Goods Administration","links":[{"title":"Food and medicine regulation","url":"https://www.tga.gov.au/community-qa/food-and-medicine-regulation"}]}]}},{"slug":"aicis-registration","kind":"guide","url":"/guides/aicis-registration","title":"AICIS registration for cosmetics brands: who needs it and what it costs","name":"AICIS guide","description":"Cosmetic product registration in Australia: AICIS registers businesses, not products. Who must register, the 2026–27 costs, and where the TGA comes in.","eyebrow":"Guide","lead":"A business that imports cosmetics or their ingredients, or manufactures industrial chemicals, must first register with the Australian Industrial Chemicals Introduction Scheme (AICIS), and renew for each year it keeps introducing them. For the 2026–27 registration year, 1 September 2026 to 31 August 2027, registration costs $85 to $3,585, depending on the value of chemicals introduced in the previous financial year. A brand that buys all its products and ingredients from Australian suppliers, and only re-sells or blends them, doesn't need to register. This guide covers who registers, the costs, what comes after, and when a cream or sunscreen is regulated by the TGA instead.","parent":"/skincare","studies":["vitable-hair-growth-range","skincare-brand-regulatory-partner"],"formats":[],"order":62,"updated":"2026-10-20","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- A business that imports cosmetics or their ingredients, or manufactures industrial chemicals, must register with AICIS before it does, and renew for each year it keeps introducing them.\n- For the 2026–27 registration year (1 September 2026 to 31 August 2027), registration costs $85 to $3,585, set by the value of chemicals introduced in the previous financial year.\n- A brand that buys all its products and ingredients from Australian suppliers, and only re-sells or blends them, doesn't need to register.\n- AICIS registers businesses, not products. The ACCC is the primary regulator of cosmetic products, and a product claiming to treat a condition such as acne or eczema is likely a therapeutic good, regulated by the TGA, unless excluded.","text":"A business that imports cosmetics or their ingredients, or manufactures industrial chemicals, must register with AICIS before it does, and renew for each year it keeps introducing them. For the 2026–27 registration year (1 September 2026 to 31 August 2027), registration costs $85 to $3,585, set by the value of chemicals introduced in the previous financial year. A brand that buys all its products and ingredients from Australian suppliers, and only re-sells or blends them, doesn't need to register. AICIS registers businesses, not products. The ACCC is the primary regulator of cosmetic products, and a product claiming to treat a condition such as acne or eczema is likely a therapeutic good, regulated by the TGA, unless excluded.","items":[],"tables":[]},{"heading":"What is AICIS?","anchor":"what-is-aicis","markdown":"AICIS, the Australian Industrial Chemicals Introduction Scheme, regulates the import and manufacture of industrial chemicals in Australia. The Industrial Chemicals Act 2019 establishes it, and it replaced the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) on 1 July 2020.\n\nCosmetic ingredients, even those described as natural, are regulated as industrial chemicals. AICIS registers the businesses that introduce them, not products. The Australian Competition and Consumer Commission (ACCC), not AICIS, is the primary regulator for cosmetic products, including their safety, ingredient labelling and claims. Some ingredients are also restricted by the Poisons Standard, which state and territory laws put into effect.","text":"AICIS, the Australian Industrial Chemicals Introduction Scheme, regulates the import and manufacture of industrial chemicals in Australia. The Industrial Chemicals Act 2019 establishes it, and it replaced the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) on 1 July 2020. Cosmetic ingredients, even those described as natural, are regulated as industrial chemicals. AICIS registers the businesses that introduce them, not products. The Australian Competition and Consumer Commission (ACCC), not AICIS, is the primary regulator for cosmetic products, including their safety, ingredient labelling and claims. Some ingredients are also restricted by the Poisons Standard, which state and territory laws put into effect.","items":[],"tables":[]},{"heading":"Who needs to register with AICIS?","anchor":"who-needs-to-register-with-aicis","markdown":"You must register your business before you import or manufacture (\"introduce\") industrial chemicals for a commercial purpose. That includes importing finished products such as labelled soap, shampoo or lotion. For a cosmetics brand, it turns on where products and ingredients come from:\n\n- **You import finished cosmetics.** Register, unless they are for your own personal use. As the importer, you are the introducer.\n- **You import ingredients.** Importing essential oils, carrier oils, fragrance or base ingredients to blend into cosmetics needs registration.\n- **You buy in Australia.** Introducing doesn't include mixing, blending or re-selling chemicals you bought in Australia. But buy any ingredient from overseas and you must register.\n- **You make a chemical.** A reaction that creates more industrial chemicals, such as making soap from fats or oils and lye, is manufacturing, which needs registration. Soap made in Australia with lye can be excluded if every fat or oil is on the Inventory and you use no more than 10 kg of each a registration year. Any ingredient you import still needs registration.\n- **You sell from overseas.** If you use an Australian agent or distributor, it is the introducer and registers. If you sell directly to Australian customers, you may be the introducer, and must then register before you ship. That needs an ARBN; without one, you need an Australian agent or distributor.","text":"You must register your business before you import or manufacture (\"introduce\") industrial chemicals for a commercial purpose. That includes importing finished products such as labelled soap, shampoo or lotion. For a cosmetics brand, it turns on where products and ingredients come from: You import finished cosmetics. Register, unless they are for your own personal use. As the importer, you are the introducer. You import ingredients. Importing essential oils, carrier oils, fragrance or base ingredients to blend into cosmetics needs registration. You buy in Australia. Introducing doesn't include mixing, blending or re-selling chemicals you bought in Australia. But buy any ingredient from overseas and you must register. You make a chemical. A reaction that creates more industrial chemicals, such as making soap from fats or oils and lye, is manufacturing, which needs registration. Soap made in Australia with lye can be excluded if every fat or oil is on the Inventory and you use no more than 10 kg of each a registration year. Any ingredient you import still needs registration. You sell from overseas. If you use an Australian agent or distributor, it is the introducer and registers. If you sell directly to Australian customers, you may be the introducer, and must then register before you ship. That needs an ARBN; without one, you need an Australian agent or distributor.","items":[{"lead":"You import finished cosmetics.","text":"Register, unless they are for your own personal use. As the importer, you are the introducer."},{"lead":"You import ingredients.","text":"Importing essential oils, carrier oils, fragrance or base ingredients to blend into cosmetics needs registration."},{"lead":"You buy in Australia.","text":"Introducing doesn't include mixing, blending or re-selling chemicals you bought in Australia. But buy any ingredient from overseas and you must register."},{"lead":"You make a chemical.","text":"A reaction that creates more industrial chemicals, such as making soap from fats or oils and lye, is manufacturing, which needs registration. Soap made in Australia with lye can be excluded if every fat or oil is on the Inventory and you use no more than 10 kg of each a registration year. Any ingredient you import still needs registration."},{"lead":"You sell from overseas.","text":"If you use an Australian agent or distributor, it is the introducer and registers. If you sell directly to Australian customers, you may be the introducer, and must then register before you ship. That needs an ARBN; without one, you need an Australian agent or distributor."}],"tables":[]},{"heading":"When to register and renew","anchor":"when-to-register-and-renew","markdown":"The registration year runs from 1 September to 31 August. Register before you introduce a chemical in a registration year, then renew by 31 August every year to keep introducing, or penalties may apply. Both are done online, through AICIS Business Services.","text":"The registration year runs from 1 September to 31 August. Register before you introduce a chemical in a registration year, then renew by 31 August every year to keep introducing, or penalties may apply. Both are done online, through AICIS Business Services.","items":[],"tables":[]},{"heading":"What AICIS registration costs in 2026–27","anchor":"what-aicis-registration-costs-in-202627","markdown":"Registration is a flat fee plus a levy set by your registration level. For the 2026–27 registration year, the fee is $85.\n\nYour level depends on the value of industrial chemicals you imported and manufactured in the previous financial year, not on sales or profit. A first-time registrant that introduced nothing that year is level 1.\n\n| Level | Value introduced, previous financial year | 2026–27 levy | 2026–27 total |\n| --- | --- | --- | --- |\n| 1 | $0 to $49,999 | Nil | $85 |\n| 2 | $50,000 to $99,999 | $10 | $95 |\n| 3 | $100,000 to $249,999 | $20 | $105 |\n| 4 | $250,000 to $499,999 | $35 | $120 |\n| 5 | $500,000 to $2,999,999 | $210 | $295 |\n| 6 | $3,000,000 to $4,999,999 | $375 | $460 |\n| 7 | $5,000,000 to $14,999,999 | $2,450 | $2,535 |\n| 8 | $15,000,000 or higher | $3,500 | $3,585 |\n\nThese levies carry a one-off discount for levels 2 to 8. AICIS says levies return to their 2025–26 levels, with indexation, from 2027–28. In 2025–26, level 5 cost $2,180 and level 8 $35,080.\n\nKeep records of the value of chemicals you introduce for 5 years, to prove your level. An assessed introduction also needs an assessment certificate, and in 2026–27 applying for one costs from $14,530.","text":"Registration is a flat fee plus a levy set by your registration level. For the 2026–27 registration year, the fee is $85. Your level depends on the value of industrial chemicals you imported and manufactured in the previous financial year, not on sales or profit. A first-time registrant that introduced nothing that year is level 1. Level: 1; Value introduced, previous financial year: $0 to $49,999; 2026–27 levy: Nil; 2026–27 total: $85. Level: 2; Value introduced, previous financial year: $50,000 to $99,999; 2026–27 levy: $10; 2026–27 total: $95. Level: 3; Value introduced, previous financial year: $100,000 to $249,999; 2026–27 levy: $20; 2026–27 total: $105. Level: 4; Value introduced, previous financial year: $250,000 to $499,999; 2026–27 levy: $35; 2026–27 total: $120. Level: 5; Value introduced, previous financial year: $500,000 to $2,999,999; 2026–27 levy: $210; 2026–27 total: $295. Level: 6; Value introduced, previous financial year: $3,000,000 to $4,999,999; 2026–27 levy: $375; 2026–27 total: $460. Level: 7; Value introduced, previous financial year: $5,000,000 to $14,999,999; 2026–27 levy: $2,450; 2026–27 total: $2,535. Level: 8; Value introduced, previous financial year: $15,000,000 or higher; 2026–27 levy: $3,500; 2026–27 total: $3,585. These levies carry a one-off discount for levels 2 to 8. AICIS says levies return to their 2025–26 levels, with indexation, from 2027–28. In 2025–26, level 5 cost $2,180 and level 8 $35,080. Keep records of the value of chemicals you introduce for 5 years, to prove your level. An assessed introduction also needs an assessment certificate, and in 2026–27 applying for one costs from $14,530.","items":[],"tables":[{"header":["Level","Value introduced, previous financial year","2026–27 levy","2026–27 total"],"rows":[["1","$0 to $49,999","Nil","$85"],["2","$50,000 to $99,999","$10","$95"],["3","$100,000 to $249,999","$20","$105"],["4","$250,000 to $499,999","$35","$120"],["5","$500,000 to $2,999,999","$210","$295"],["6","$3,000,000 to $4,999,999","$375","$460"],["7","$5,000,000 to $14,999,999","$2,450","$2,535"],["8","$15,000,000 or higher","$3,500","$3,585"]]}]},{"heading":"After you register: categorise every chemical","anchor":"after-you-register-categorise-every-chemical","markdown":"Check that each ingredient is on the Australian Inventory of Industrial Chemicals, and categorise each chemical introduction. The category sets your obligations:\n\n- **Listed:** on the Inventory. You must meet any terms of its listing, but needn't tell AICIS beforehand.\n- **Exempted:** very low risk, under very strict criteria. Some need a once-off post-introduction declaration.\n- **Reported:** low risk. You submit a once-off pre-introduction report before you start.\n- **Assessed:** medium to high risk. AICIS must issue an assessment certificate before you introduce it.\n- **Authorisations:** a commercial evaluation authorisation, an alternative to the exempted, reported or assessed category, or a Minister's authorisation in exceptional circumstances.\n\nRegistered introducers keep records and submit an annual declaration, due by 30 November after each registration year. For 2025–26, that is 30 November 2026. A registered business that introduced nothing can select \"Did not introduce\".\n\nAICIS also bans using new animal test data for chemicals used only in cosmetics, and restricts it for chemicals with cosmetic and other end uses. New data come from tests on a live vertebrate (not a human) or a cephalopod from 1 July 2020. Older data can still be used, and there are limited exceptions.","text":"Check that each ingredient is on the Australian Inventory of Industrial Chemicals, and categorise each chemical introduction. The category sets your obligations: Listed: on the Inventory. You must meet any terms of its listing, but needn't tell AICIS beforehand. Exempted: very low risk, under very strict criteria. Some need a once-off post-introduction declaration. Reported: low risk. You submit a once-off pre-introduction report before you start. Assessed: medium to high risk. AICIS must issue an assessment certificate before you introduce it. Authorisations: a commercial evaluation authorisation, an alternative to the exempted, reported or assessed category, or a Minister's authorisation in exceptional circumstances. Registered introducers keep records and submit an annual declaration, due by 30 November after each registration year. For 2025–26, that is 30 November 2026. A registered business that introduced nothing can select \"Did not introduce\". AICIS also bans using new animal test data for chemicals used only in cosmetics, and restricts it for chemicals with cosmetic and other end uses. New data come from tests on a live vertebrate (not a human) or a cephalopod from 1 July 2020. Older data can still be used, and there are limited exceptions.","items":[{"lead":"Listed:","text":"on the Inventory. You must meet any terms of its listing, but needn't tell AICIS beforehand."},{"lead":"Exempted:","text":"very low risk, under very strict criteria. Some need a once-off post-introduction declaration."},{"lead":"Reported:","text":"low risk. You submit a once-off pre-introduction report before you start."},{"lead":"Assessed:","text":"medium to high risk. AICIS must issue an assessment certificate before you introduce it."},{"lead":"Authorisations:","text":"a commercial evaluation authorisation, an alternative to the exempted, reported or assessed category, or a Minister's authorisation in exceptional circumstances."}],"tables":[]},{"heading":"Cosmetic or therapeutic good?","anchor":"cosmetic-or-therapeutic-good","markdown":"AICIS doesn't regulate therapeutic goods; the Therapeutic Goods Administration (TGA) does. A cosmetic is used on an external part of the body, or in the mouth, to change its odour or appearance, cleanse it, keep it in good condition or protect it. A therapeutic product is used to prevent, diagnose or treat a disease or its symptoms, or to affect the body's structure or functions.\n\nBusinesses must decide which their product is, from its claims, its ingredients, how it is used and whether it is an excluded good. Products that claim to treat acne, eczema or psoriasis, or to promote hair growth, would likely be therapeutic goods unless excluded. So would one with an ingredient in Schedule 2, 3, 4 or 8 of the Poisons Standard.\n\nA therapeutic good must be on the Australian Register of Therapeutic Goods (ARTG) before it is imported, supplied or advertised, unless exempt.\n\nA primary sunscreen, presented mainly to protect the skin from UV, is a therapeutic good, generally listed with an AUST L number. Most secondary sunscreens are cosmetics, such as an SPF 4 to 15 moisturiser that meets the TGA's conditions. These must still meet the Australian sunscreen standard's testing and labelling requirements.\n\n[Our skincare page](/skincare) lists the conditions; see also [medicine, food or cosmetic?](/pathways) and [our TGA listing guide](/guides/tga-approval).","text":"AICIS doesn't regulate therapeutic goods; the Therapeutic Goods Administration (TGA) does. A cosmetic is used on an external part of the body, or in the mouth, to change its odour or appearance, cleanse it, keep it in good condition or protect it. A therapeutic product is used to prevent, diagnose or treat a disease or its symptoms, or to affect the body's structure or functions. Businesses must decide which their product is, from its claims, its ingredients, how it is used and whether it is an excluded good. Products that claim to treat acne, eczema or psoriasis, or to promote hair growth, would likely be therapeutic goods unless excluded. So would one with an ingredient in Schedule 2, 3, 4 or 8 of the Poisons Standard. A therapeutic good must be on the Australian Register of Therapeutic Goods (ARTG) before it is imported, supplied or advertised, unless exempt. A primary sunscreen, presented mainly to protect the skin from UV, is a therapeutic good, generally listed with an AUST L number. Most secondary sunscreens are cosmetics, such as an SPF 4 to 15 moisturiser that meets the TGA's conditions. These must still meet the Australian sunscreen standard's testing and labelling requirements. Our skincare page lists the conditions; see also medicine, food or cosmetic? and our TGA listing guide.","items":[],"tables":[]},{"heading":"The ingredient label","anchor":"the-ingredient-label","markdown":"AICIS doesn't set or enforce labelling rules for cosmetics. The ingredient list must meet the Consumer Goods (Cosmetics) Information Standard 2020, a mandatory standard the ACCC is responsible for, and a cosmetic must also meet any Poisons Standard requirements that apply to it.\n\n- **Where:** on the container, or on the product if it isn't packed in a container. If its size, shape or nature prevents that, the list must be shown another way that ensures the consumer can be informed of the ingredients.\n- **Order:** descending by volume or mass. Or: ingredients at 1% or more in descending order, then those under 1% in any order, then colour additives in any order.\n- **Names:** English names or International Nomenclature Cosmetic Ingredient (INCI) names, prominently shown and clearly legible.\n- **Exceptions:** therapeutic goods, hand sanitisers excluded from the therapeutic goods rules, cosmetics made in Australia for export, free samples and testers.\n\nFines and penalties may apply for not complying.","text":"AICIS doesn't set or enforce labelling rules for cosmetics. The ingredient list must meet the Consumer Goods (Cosmetics) Information Standard 2020, a mandatory standard the ACCC is responsible for, and a cosmetic must also meet any Poisons Standard requirements that apply to it. Where: on the container, or on the product if it isn't packed in a container. If its size, shape or nature prevents that, the list must be shown another way that ensures the consumer can be informed of the ingredients. Order: descending by volume or mass. Or: ingredients at 1% or more in descending order, then those under 1% in any order, then colour additives in any order. Names: English names or International Nomenclature Cosmetic Ingredient (INCI) names, prominently shown and clearly legible. Exceptions: therapeutic goods, hand sanitisers excluded from the therapeutic goods rules, cosmetics made in Australia for export, free samples and testers. Fines and penalties may apply for not complying.","items":[{"lead":"Where:","text":"on the container, or on the product if it isn't packed in a container. If its size, shape or nature prevents that, the list must be shown another way that ensures the consumer can be informed of the ingredients."},{"lead":"Order:","text":"descending by volume or mass. Or: ingredients at 1% or more in descending order, then those under 1% in any order, then colour additives in any order."},{"lead":"Names:","text":"English names or International Nomenclature Cosmetic Ingredient (INCI) names, prominently shown and clearly legible."},{"lead":"Exceptions:","text":"therapeutic goods, hand sanitisers excluded from the therapeutic goods rules, cosmetics made in Australia for export, free samples and testers."}],"tables":[]},{"heading":"Where we come in","anchor":"where-we-come-in","markdown":"At the brief, before the formula, we settle whether the claims for a cream, serum or sunscreen make it a cosmetic or a TGA-listed medicine. Then we develop it on that pathway and manage its manufacture through cGMP partners, as with Vitable's range: a TGA-listed capsule and a cosmetic serum. If a new skincare active needs its own AICIS introduction, we manage that too ([new ingredient applications](/new-ingredients)). More on [skincare and cosmetics](/skincare), or [book a call](/contact).","text":"At the brief, before the formula, we settle whether the claims for a cream, serum or sunscreen make it a cosmetic or a TGA-listed medicine. Then we develop it on that pathway and manage its manufacture through cGMP partners, as with Vitable's range: a TGA-listed capsule and a cosmetic serum. If a new skincare active needs its own AICIS introduction, we manage that too (new ingredient applications). More on skincare and cosmetics, or book a call.","items":[],"tables":[]}],"faqs":[{"q":"What is AICIS?","a":"The Australian Industrial Chemicals Introduction Scheme (AICIS) regulates the import and manufacture of industrial chemicals in Australia, including cosmetic ingredients. It runs under the Industrial Chemicals Act 2019 and replaced NICNAS on 1 July 2020.","md":"The Australian Industrial Chemicals Introduction Scheme (AICIS) regulates the import and manufacture of industrial chemicals in Australia, including cosmetic ingredients. It runs under the Industrial Chemicals Act 2019 and replaced NICNAS on 1 July 2020."},{"q":"Do I need to register with AICIS to sell cosmetics?","a":"Yes, if your business imports cosmetics or their ingredients for a commercial purpose, or manufactures industrial chemicals. Re-selling products, or blending ingredients without a chemical reaction, doesn't need registration if you bought them all from Australian suppliers. AICIS registers the business, not each product.","md":"Yes, if your business imports cosmetics or their ingredients for a commercial purpose, or manufactures industrial chemicals. Re-selling products, or blending ingredients without a chemical reaction, doesn't need registration if you bought them all from Australian suppliers. AICIS registers the business, not each product."},{"q":"How much does AICIS registration cost?","a":"It costs $85 to $3,585 for the 2026–27 registration year, depending on the value of chemicals you introduced in the previous financial year. That includes a one-off levy discount: AICIS says levies return to their 2025–26 levels, with indexation, from 2027–28.","md":"It costs $85 to $3,585 for the 2026–27 registration year, depending on the value of chemicals you introduced in the previous financial year. That includes a one-off levy discount: AICIS says levies return to their 2025–26 levels, with indexation, from 2027–28."},{"q":"When do I renew AICIS registration?","a":"By 31 August every year, to keep introducing chemicals in the registration year that starts on 1 September. The annual declaration for the year just ended is due by 30 November.","md":"By 31 August every year, to keep introducing chemicals in the registration year that starts on 1 September. The annual declaration for the year just ended is due by 30 November."},{"q":"What replaced NICNAS?","a":"AICIS, the Australian Industrial Chemicals Introduction Scheme, replaced the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) on 1 July 2020.","md":"AICIS, the Australian Industrial Chemicals Introduction Scheme, replaced the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) on 1 July 2020."},{"q":"Is a sunscreen a cosmetic in Australia?","a":"Some are. A primary sunscreen, presented mainly to protect the skin from UV, is a therapeutic good, generally on the ARTG. Most secondary sunscreens, such as an SPF 4 to 15 moisturiser meeting the TGA's conditions, are cosmetics.","md":"Some are. A primary sunscreen, presented mainly to protect the skin from UV, is a therapeutic good, generally on the ARTG. Most secondary sunscreens, such as an SPF 4 to 15 moisturiser meeting the TGA's conditions, are cosmetics."}],"sources":{"note":"General information, checked against these sources on 20 October 2026. It isn't advice on a particular product.","markdown":"General information, checked against these sources on 20 October 2026. It isn't advice on a particular product.\n\n- [Who we are and what we do](https://www.industrialchemicals.gov.au/about-us/who-we-are-and-what-we-do), Australian Industrial Chemicals Introduction Scheme\n- [What is registration and who must register?](https://www.industrialchemicals.gov.au/business/getting-started-registration-importing-and-manufacturing/what-registration-and-who-must-register), Australian Industrial Chemicals Introduction Scheme\n- [What is registration?](https://www.industrialchemicals.gov.au/sites/default/files/2022-11/What%20is%20registration.pdf), Australian Industrial Chemicals Introduction Scheme\n- [What is an introduction?](https://www.industrialchemicals.gov.au/business/getting-started-registration-importing-and-manufacturing/what-introduction), Australian Industrial Chemicals Introduction Scheme\n- [I make or import cosmetics. Do I need to register with AICIS?](https://www.industrialchemicals.gov.au/sites/default/files/2022-11/I%20make%20or%20import%20cosmetics%20-%20do%20I%20need%20to%20register.pdf), Australian Industrial Chemicals Introduction Scheme\n- [Introductions that don't require categorisation and registration](https://www.industrialchemicals.gov.au/business/getting-started-registration-importing-and-manufacturing/introductions-dont-require-categorisation-and-registration), Australian Industrial Chemicals Introduction Scheme\n- [Difference between blending and manufacturing chemicals](https://www.industrialchemicals.gov.au/business/getting-started-registration-importing-and-manufacturing/difference-between-blending-and-manufacturing-chemicals), Australian Industrial Chemicals Introduction Scheme\n- [Foreign companies and chemical data providers](https://www.industrialchemicals.gov.au/business/foreign-companies-and-chemical-data-providers), Australian Industrial Chemicals Introduction Scheme\n- [Fees and charges for 2026–27](https://www.industrialchemicals.gov.au/node/188362), Australian Industrial Chemicals Introduction Scheme\n- [How much is my registration cost?](https://www.industrialchemicals.gov.au/business/registration-hub/how-much-my-registration-cost), Australian Industrial Chemicals Introduction Scheme\n- [Records to prove that you are registered at the correct level](https://www.industrialchemicals.gov.au/business/reporting-and-record-keeping-obligations/records-prove-you-are-registered-correct-level), Australian Industrial Chemicals Introduction Scheme\n- [Before you start categorising your introduction](https://www.industrialchemicals.gov.au/node/144), Australian Industrial Chemicals Introduction Scheme\n- [What is the Inventory?](https://www.industrialchemicals.gov.au/sites/default/files/2021-04/What%20is%20the%20inventory%20%5B1.2MB%5D_1.pdf), Australian Industrial Chemicals Introduction Scheme\n- [Annual declaration for all introducers](https://www.industrialchemicals.gov.au/business/reporting-and-record-keeping-obligations/annual-declaration-all-introducers), Australian Industrial Chemicals Introduction Scheme\n- [Use of animal test data](https://www.industrialchemicals.gov.au/business/use-animal-test-data), Australian Industrial Chemicals Introduction Scheme\n- [Animal test data: when it can and can't be used and when you need pre-approval](https://www.industrialchemicals.gov.au/business/use-animal-test-data/animal-test-data-when-it-can-and-cant-be-used-and-when-you-need-pre-approval), Australian Industrial Chemicals Introduction Scheme\n- [Cosmetics and therapeutics](https://www.industrialchemicals.gov.au/cosmetics-and-soap/cosmetics-and-therapeutics), Australian Industrial Chemicals Introduction Scheme\n- [Is my product a cosmetic?](https://www.industrialchemicals.gov.au/cosmetics-and-soap/my-product-cosmetic), Australian Industrial Chemicals Introduction Scheme\n- [Cosmetics with sunscreen](https://www.industrialchemicals.gov.au/cosmetics-and-soap/cosmetics-sunscreen), Australian Industrial Chemicals Introduction Scheme\n- [Labelling, SDS and packaging](https://www.industrialchemicals.gov.au/node/218), Australian Industrial Chemicals Introduction Scheme\n- [Soap making and importing](https://www.industrialchemicals.gov.au/node/257), Australian Industrial Chemicals Introduction Scheme\n- [Cosmetics](https://www.tga.gov.au/resources/explore-topic/cosmetics), Therapeutic Goods Administration\n- [Determining if your product is a cosmetic or therapeutic good](https://www.tga.gov.au/resources/guidance/determining-if-your-product-cosmetic-or-therapeutic-good), Therapeutic Goods Administration\n- [Cosmetics or therapeutic goods: guidance for advertisers and suppliers](https://www.tga.gov.au/sites/default/files/2024-06/cosmetics-therapeutic-goods-guidance-for-advertisers-suppliers.pdf), Therapeutic Goods Administration, June 2024\n- [Sunscreen regulation in Australia](https://www.tga.gov.au/products/medicines/therapeutic-sunscreens/overview/sunscreen-regulation-australia), Therapeutic Goods Administration\n- [Cosmetics ingredients labelling mandatory standard](https://www.productsafety.gov.au/business/search-mandatory-standards/cosmetics-ingredients-labelling-mandatory-standard), ACCC Product Safety Australia\n- [Consumer Goods (Cosmetics) Information Standard 2020](https://www.legislation.gov.au/F2020L01469/asmade/2020-11-24/text/original/epub/OEBPS/document_1/document_1.html), Federal Register of Legislation","items":[{"text":"Who we are and what we do, Australian Industrial Chemicals Introduction Scheme","links":[{"title":"Who we are and what we do","url":"https://www.industrialchemicals.gov.au/about-us/who-we-are-and-what-we-do"}]},{"text":"What is registration and who must register?, Australian Industrial Chemicals Introduction Scheme","links":[{"title":"What is registration and who must register?","url":"https://www.industrialchemicals.gov.au/business/getting-started-registration-importing-and-manufacturing/what-registration-and-who-must-register"}]},{"text":"What is registration?, Australian Industrial Chemicals Introduction Scheme","links":[{"title":"What is registration?","url":"https://www.industrialchemicals.gov.au/sites/default/files/2022-11/What%20is%20registration.pdf"}]},{"text":"What is an introduction?, Australian Industrial Chemicals Introduction Scheme","links":[{"title":"What is an introduction?","url":"https://www.industrialchemicals.gov.au/business/getting-started-registration-importing-and-manufacturing/what-introduction"}]},{"text":"I make or import cosmetics. Do I need to register with AICIS?, Australian Industrial Chemicals Introduction Scheme","links":[{"title":"I make or import cosmetics. Do I need to register with AICIS?","url":"https://www.industrialchemicals.gov.au/sites/default/files/2022-11/I%20make%20or%20import%20cosmetics%20-%20do%20I%20need%20to%20register.pdf"}]},{"text":"Introductions that don't require categorisation and registration, Australian Industrial Chemicals Introduction Scheme","links":[{"title":"Introductions that don't require categorisation and registration","url":"https://www.industrialchemicals.gov.au/business/getting-started-registration-importing-and-manufacturing/introductions-dont-require-categorisation-and-registration"}]},{"text":"Difference between blending and manufacturing chemicals, Australian Industrial Chemicals Introduction Scheme","links":[{"title":"Difference between blending and manufacturing chemicals","url":"https://www.industrialchemicals.gov.au/business/getting-started-registration-importing-and-manufacturing/difference-between-blending-and-manufacturing-chemicals"}]},{"text":"Foreign companies and chemical data providers, Australian Industrial Chemicals Introduction Scheme","links":[{"title":"Foreign companies and chemical data providers","url":"https://www.industrialchemicals.gov.au/business/foreign-companies-and-chemical-data-providers"}]},{"text":"Fees and charges for 2026–27, Australian Industrial Chemicals Introduction Scheme","links":[{"title":"Fees and charges for 2026–27","url":"https://www.industrialchemicals.gov.au/node/188362"}]},{"text":"How much is my registration cost?, Australian Industrial Chemicals Introduction Scheme","links":[{"title":"How much is my registration cost?","url":"https://www.industrialchemicals.gov.au/business/registration-hub/how-much-my-registration-cost"}]},{"text":"Records to prove that you are registered at the correct level, Australian Industrial Chemicals Introduction Scheme","links":[{"title":"Records to prove that you are registered at the correct level","url":"https://www.industrialchemicals.gov.au/business/reporting-and-record-keeping-obligations/records-prove-you-are-registered-correct-level"}]},{"text":"Before you start categorising your introduction, Australian Industrial Chemicals Introduction Scheme","links":[{"title":"Before you start categorising your introduction","url":"https://www.industrialchemicals.gov.au/node/144"}]},{"text":"What is the Inventory?, Australian Industrial Chemicals Introduction Scheme","links":[{"title":"What is the Inventory?","url":"https://www.industrialchemicals.gov.au/sites/default/files/2021-04/What%20is%20the%20inventory%20%5B1.2MB%5D_1.pdf"}]},{"text":"Annual declaration for all introducers, Australian Industrial Chemicals Introduction Scheme","links":[{"title":"Annual declaration for all introducers","url":"https://www.industrialchemicals.gov.au/business/reporting-and-record-keeping-obligations/annual-declaration-all-introducers"}]},{"text":"Use of animal test data, Australian Industrial Chemicals Introduction Scheme","links":[{"title":"Use of animal test data","url":"https://www.industrialchemicals.gov.au/business/use-animal-test-data"}]},{"text":"Animal test data: when it can and can't be used and when you need pre-approval, Australian Industrial Chemicals Introduction Scheme","links":[{"title":"Animal test data: when it can and can't be used and when you need pre-approval","url":"https://www.industrialchemicals.gov.au/business/use-animal-test-data/animal-test-data-when-it-can-and-cant-be-used-and-when-you-need-pre-approval"}]},{"text":"Cosmetics and therapeutics, Australian Industrial Chemicals Introduction Scheme","links":[{"title":"Cosmetics and therapeutics","url":"https://www.industrialchemicals.gov.au/cosmetics-and-soap/cosmetics-and-therapeutics"}]},{"text":"Is my product a cosmetic?, Australian Industrial Chemicals Introduction Scheme","links":[{"title":"Is my product a cosmetic?","url":"https://www.industrialchemicals.gov.au/cosmetics-and-soap/my-product-cosmetic"}]},{"text":"Cosmetics with sunscreen, Australian Industrial Chemicals Introduction Scheme","links":[{"title":"Cosmetics with sunscreen","url":"https://www.industrialchemicals.gov.au/cosmetics-and-soap/cosmetics-sunscreen"}]},{"text":"Labelling, SDS and packaging, Australian Industrial Chemicals Introduction Scheme","links":[{"title":"Labelling, SDS and packaging","url":"https://www.industrialchemicals.gov.au/node/218"}]},{"text":"Soap making and importing, Australian Industrial Chemicals Introduction Scheme","links":[{"title":"Soap making and importing","url":"https://www.industrialchemicals.gov.au/node/257"}]},{"text":"Cosmetics, Therapeutic Goods Administration","links":[{"title":"Cosmetics","url":"https://www.tga.gov.au/resources/explore-topic/cosmetics"}]},{"text":"Determining if your product is a cosmetic or therapeutic good, Therapeutic Goods Administration","links":[{"title":"Determining if your product is a cosmetic or therapeutic good","url":"https://www.tga.gov.au/resources/guidance/determining-if-your-product-cosmetic-or-therapeutic-good"}]},{"text":"Cosmetics or therapeutic goods: guidance for advertisers and suppliers, Therapeutic Goods Administration, June 2024","links":[{"title":"Cosmetics or therapeutic goods: guidance for advertisers and suppliers","url":"https://www.tga.gov.au/sites/default/files/2024-06/cosmetics-therapeutic-goods-guidance-for-advertisers-suppliers.pdf"}]},{"text":"Sunscreen regulation in Australia, Therapeutic Goods Administration","links":[{"title":"Sunscreen regulation in Australia","url":"https://www.tga.gov.au/products/medicines/therapeutic-sunscreens/overview/sunscreen-regulation-australia"}]},{"text":"Cosmetics ingredients labelling mandatory standard, ACCC Product Safety Australia","links":[{"title":"Cosmetics ingredients labelling mandatory standard","url":"https://www.productsafety.gov.au/business/search-mandatory-standards/cosmetics-ingredients-labelling-mandatory-standard"}]},{"text":"Consumer Goods (Cosmetics) Information Standard 2020, Federal Register of Legislation","links":[{"title":"Consumer Goods (Cosmetics) Information Standard 2020","url":"https://www.legislation.gov.au/F2020L01469/asmade/2020-11-24/text/original/epub/OEBPS/document_1/document_1.html"}]}]}},{"slug":"supplement-development-timeline","kind":"guide","url":"/guides/supplement-development-timeline","title":"How long does it take to develop a supplement?","name":"Development timeline","description":"How long it takes to develop a supplement, from our records: 32 days from design to production order at the fastest, the stages, and what holds a launch up.","eyebrow":"Guide","lead":"How long a supplement takes depends on where the clock starts and what the formula needs. From our records, a complex herbal capsule went from design to production order in 32 days, and EverLeanBody's first capsule took 5.8 months from signed brief to dispatch. This guide sets out the stages, the TGA's part and what holds a launch up.","parent":"/product-development","studies":["ashwagandha-capsule-32-days","everleanbody-saffron-capsule","eye-health-tablet-format-rescue"],"formats":[],"order":63,"updated":"2026-10-20","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- From our records, listed medicines have taken 32 days to 12 weeks from design to production order, and 5.8 to about eight months from brief or formulation to dispatch.\n- The stages are the brief and the pathway, the formula, the evidence, stability, the label and the listing, then manufacturing and delivery. Most of them can overlap.\n- The TGA's listing step is short. What holds a launch up is a formula that won't run, an ingredient that isn't on the TGA's list, or a pathway settled late.\n- A new ingredient needs its own TGA evaluation first: the law allows 40 working days for a preliminary assessment, then 70 to 180 working days for the evaluation.","text":"From our records, listed medicines have taken 32 days to 12 weeks from design to production order, and 5.8 to about eight months from brief or formulation to dispatch. The stages are the brief and the pathway, the formula, the evidence, stability, the label and the listing, then manufacturing and delivery. Most of them can overlap. The TGA's listing step is short. What holds a launch up is a formula that won't run, an ingredient that isn't on the TGA's list, or a pathway settled late. A new ingredient needs its own TGA evaluation first: the law allows 40 working days for a preliminary assessment, then 70 to 180 working days for the evaluation.","items":[],"tables":[]},{"heading":"From our records","anchor":"from-our-records","markdown":"How long a product takes depends on where the clock starts. \"Design to production order\" runs from the start of design to the first production order. \"Brief to dispatch\" runs from the signed brief to the first batch leaving for the brand's 3PL, so it takes in manufacturing. One record starts at formulation instead.\n\n| Product | Pathway | Time | Measured from and to |\n| --- | --- | --- | --- |\n| [A complex herbal capsule](/work/ashwagandha-capsule-32-days) built around KSM-66® ashwagandha, with an evidence package covering more than 13 ingredients | Listed medicine | 32 days | Design to production order |\n| [An eye-health formula](/work/areds2-eye-health-formula) in a 60-count pack and a trial pack | Listed medicine | Under seven weeks | Design to production order |\n| [A two-a-day probiotic skin supplement](/work/probiotic-skin-supplement), the second version of its formula | Listed medicine | 12 weeks | Design to production order |\n| [EverLeanBody's saffron capsule](/work/everleanbody-saffron-capsule), built around affron® | Listed medicine | 5.8 months | Signed brief to dispatch to the brand's 3PL |\n| [The Belly Solution's travel gut-health powder](/work/the-belly-solution-travel-gut-health-powder), in a 14-day pouch | Listed medicine | About eight months | Formulation to dispatch |","text":"How long a product takes depends on where the clock starts. \"Design to production order\" runs from the start of design to the first production order. \"Brief to dispatch\" runs from the signed brief to the first batch leaving for the brand's 3PL, so it takes in manufacturing. One record starts at formulation instead. Product: A complex herbal capsule built around KSM-66® ashwagandha, with an evidence package covering more than 13 ingredients; Pathway: Listed medicine; Time: 32 days; Measured from and to: Design to production order. Product: An eye-health formula in a 60-count pack and a trial pack; Pathway: Listed medicine; Time: Under seven weeks; Measured from and to: Design to production order. Product: A two-a-day probiotic skin supplement, the second version of its formula; Pathway: Listed medicine; Time: 12 weeks; Measured from and to: Design to production order. Product: EverLeanBody's saffron capsule, built around affron®; Pathway: Listed medicine; Time: 5.8 months; Measured from and to: Signed brief to dispatch to the brand's 3PL. Product: The Belly Solution's travel gut-health powder, in a 14-day pouch; Pathway: Listed medicine; Time: About eight months; Measured from and to: Formulation to dispatch.","items":[],"tables":[{"header":["Product","Pathway","Time","Measured from and to"],"rows":[["A complex herbal capsule built around KSM-66® ashwagandha, with an evidence package covering more than 13 ingredients","Listed medicine","32 days","Design to production order"],["An eye-health formula in a 60-count pack and a trial pack","Listed medicine","Under seven weeks","Design to production order"],["A two-a-day probiotic skin supplement, the second version of its formula","Listed medicine","12 weeks","Design to production order"],["EverLeanBody's saffron capsule, built around affron®","Listed medicine","5.8 months","Signed brief to dispatch to the brand's 3PL"],["The Belly Solution's travel gut-health powder, in a 14-day pouch","Listed medicine","About eight months","Formulation to dispatch"]]}]},{"heading":"Where the time goes","anchor":"where-the-time-goes","markdown":"These are the stages a listed medicine is built in. Most of them can overlap: we run formulation, regulatory work and sourcing in parallel rather than in sequence.\n\n1. **The brief and the pathway.** The customer, the claim, the format and the retail price come first, then the pathway: [medicine, food or cosmetic](/pathways). The pathway decides the ingredients you can use, the claims you can make, the label and who regulates you, so it is settled before the formula.\n2. **The formula.** Every ingredient, its form and its dose, chosen for the claim and the price the product has to sell at, then samples and a specification a manufacturer can quote. For a listed medicine, every ingredient must already be in the TGA's Permissible Ingredients Determination, and be used within the limits it sets.\n3. **The evidence.** Every indication must come from the TGA's permitted list, and the sponsor must hold evidence for each one. The herbal capsule above needed an evidence package covering more than 13 ingredients. More in our [claims and indications guide](/guides/permitted-indications).\n4. **Stability.** The TGA says stability evidence should be held at or before listing. If full data aren't ready, older TGA guidance allows an interim shelf life supported by evidence, and real-time testing continues after launch. Our recent stability programs run for 24 or 36 months. More in our [stability testing guide](/guides/stability-testing).\n5. **The label and the listing.** The label is written to the TGA's labelling rules, now [TGO 116](/guides/tga-approval#tgo-92-is-now-tgo-116). The listing is lodged and validated in TGA Business Services, the fee is paid within 14 days of submitting, and the medicine is then entered on the ARTG with its AUST L number.\n6. **Manufacturing and delivery.** A cGMP partner matched to the format, the volume and the margin makes the first batch. It is release-tested, imported if it was made overseas, and delivered to the brand's warehouse or 3PL. Unless a step is exempt, every manufacturing step in Australia needs a TGA manufacturing licence, and an overseas site needs a TGA GMP clearance or certification.","text":"These are the stages a listed medicine is built in. Most of them can overlap: we run formulation, regulatory work and sourcing in parallel rather than in sequence. The brief and the pathway. The customer, the claim, the format and the retail price come first, then the pathway: medicine, food or cosmetic. The pathway decides the ingredients you can use, the claims you can make, the label and who regulates you, so it is settled before the formula. The formula. Every ingredient, its form and its dose, chosen for the claim and the price the product has to sell at, then samples and a specification a manufacturer can quote. For a listed medicine, every ingredient must already be in the TGA's Permissible Ingredients Determination, and be used within the limits it sets. The evidence. Every indication must come from the TGA's permitted list, and the sponsor must hold evidence for each one. The herbal capsule above needed an evidence package covering more than 13 ingredients. More in our claims and indications guide. Stability. The TGA says stability evidence should be held at or before listing. If full data aren't ready, older TGA guidance allows an interim shelf life supported by evidence, and real-time testing continues after launch. Our recent stability programs run for 24 or 36 months. More in our stability testing guide. The label and the listing. The label is written to the TGA's labelling rules, now TGO 116. The listing is lodged and validated in TGA Business Services, the fee is paid within 14 days of submitting, and the medicine is then entered on the ARTG with its AUST L number. Manufacturing and delivery. A cGMP partner matched to the format, the volume and the margin makes the first batch. It is release-tested, imported if it was made overseas, and delivered to the brand's warehouse or 3PL. Unless a step is exempt, every manufacturing step in Australia needs a TGA manufacturing licence, and an overseas site needs a TGA GMP clearance or certification.","items":[{"lead":"The brief and the pathway.","text":"The customer, the claim, the format and the retail price come first, then the pathway: medicine, food or cosmetic. The pathway decides the ingredients you can use, the claims you can make, the label and who regulates you, so it is settled before the formula."},{"lead":"The formula.","text":"Every ingredient, its form and its dose, chosen for the claim and the price the product has to sell at, then samples and a specification a manufacturer can quote. For a listed medicine, every ingredient must already be in the TGA's Permissible Ingredients Determination, and be used within the limits it sets."},{"lead":"The evidence.","text":"Every indication must come from the TGA's permitted list, and the sponsor must hold evidence for each one. The herbal capsule above needed an evidence package covering more than 13 ingredients. More in our claims and indications guide."},{"lead":"Stability.","text":"The TGA says stability evidence should be held at or before listing. If full data aren't ready, older TGA guidance allows an interim shelf life supported by evidence, and real-time testing continues after launch. Our recent stability programs run for 24 or 36 months. More in our stability testing guide."},{"lead":"The label and the listing.","text":"The label is written to the TGA's labelling rules, now TGO 116. The listing is lodged and validated in TGA Business Services, the fee is paid within 14 days of submitting, and the medicine is then entered on the ARTG with its AUST L number."},{"lead":"Manufacturing and delivery.","text":"A cGMP partner matched to the format, the volume and the margin makes the first batch. It is release-tested, imported if it was made overseas, and delivered to the brand's warehouse or 3PL. Unless a step is exempt, every manufacturing step in Australia needs a TGA manufacturing licence, and an overseas site needs a TGA GMP clearance or certification."}],"tables":[]},{"heading":"What holds a launch up","anchor":"what-holds-a-launch-up","markdown":"- **A formula that won't run.** Another eye-health formula, for a different brand, kept failing in encapsulation because the ingredient mix was too wet, and hand-filling would have added one to two more months. We [moved it to a direct-compression tablet](/work/eye-health-tablet-format-rescue), and it shipped in 2024.\n- **An ingredient that isn't on the list.** A new ingredient needs its own TGA application and evaluation before any product using it can be listed. The law allows the TGA 40 working days for a preliminary assessment, then 70 to 180 working days for the evaluation, depending on the application's level (IN1 to IN4). For 2026–27 the TGA charges $1,370 to apply and $18,456 to evaluate an IN1 or IN2 application, and $3,629 and $30,067 for IN3 or IN4. More in our [new ingredients guide](/guides/permissible-ingredients).\n- **A pathway settled late.** A product's pathway turns mostly on how it is presented: its claims, its name, its form, its dose. A claim added after the formula is set can move a product from food to medicine, and with it the ingredients, the label and the regulator.\n- **A factory without the right clearance.** A listed medicine made overseas needs a TGA GMP clearance for the site, which the Australian sponsor applies for. A partner whose site already has the GMP evidence the TGA accepts makes that step shorter; it doesn't remove it. More in our [GMP clearance guide](/guides/gmp-clearance).","text":"A formula that won't run. Another eye-health formula, for a different brand, kept failing in encapsulation because the ingredient mix was too wet, and hand-filling would have added one to two more months. We moved it to a direct-compression tablet, and it shipped in 2024. An ingredient that isn't on the list. A new ingredient needs its own TGA application and evaluation before any product using it can be listed. The law allows the TGA 40 working days for a preliminary assessment, then 70 to 180 working days for the evaluation, depending on the application's level (IN1 to IN4). For 2026–27 the TGA charges $1,370 to apply and $18,456 to evaluate an IN1 or IN2 application, and $3,629 and $30,067 for IN3 or IN4. More in our new ingredients guide. A pathway settled late. A product's pathway turns mostly on how it is presented: its claims, its name, its form, its dose. A claim added after the formula is set can move a product from food to medicine, and with it the ingredients, the label and the regulator. A factory without the right clearance. A listed medicine made overseas needs a TGA GMP clearance for the site, which the Australian sponsor applies for. A partner whose site already has the GMP evidence the TGA accepts makes that step shorter; it doesn't remove it. More in our GMP clearance guide.","items":[{"lead":"A formula that won't run.","text":"Another eye-health formula, for a different brand, kept failing in encapsulation because the ingredient mix was too wet, and hand-filling would have added one to two more months. We moved it to a direct-compression tablet, and it shipped in 2024."},{"lead":"An ingredient that isn't on the list.","text":"A new ingredient needs its own TGA application and evaluation before any product using it can be listed. The law allows the TGA 40 working days for a preliminary assessment, then 70 to 180 working days for the evaluation, depending on the application's level (IN1 to IN4). For 2026–27 the TGA charges $1,370 to apply and $18,456 to evaluate an IN1 or IN2 application, and $3,629 and $30,067 for IN3 or IN4. More in our new ingredients guide."},{"lead":"A pathway settled late.","text":"A product's pathway turns mostly on how it is presented: its claims, its name, its form, its dose. A claim added after the formula is set can move a product from food to medicine, and with it the ingredients, the label and the regulator."},{"lead":"A factory without the right clearance.","text":"A listed medicine made overseas needs a TGA GMP clearance for the site, which the Australian sponsor applies for. A partner whose site already has the GMP evidence the TGA accepts makes that step shorter; it doesn't remove it. More in our GMP clearance guide."}],"tables":[]},{"heading":"The TGA's listing step is short","anchor":"the-tgas-listing-step-is-short","markdown":"The TGA doesn't individually evaluate a listed medicine before it goes on the ARTG: the sponsor certifies that it meets the rules. Once the application passes validation and the fee is paid, the medicine is entered on the ARTG with its AUST L number, and it usually shows in TGA Business Services the next day.\n\nSo the listing itself rarely sets the pace; the work before it does. The TGA sets no timeframe for the sponsor's own work, only for evaluating a new ingredient where one is needed. More on [the ARTG](/guides/artg) and [the listing steps](/guides/tga-approval).","text":"The TGA doesn't individually evaluate a listed medicine before it goes on the ARTG: the sponsor certifies that it meets the rules. Once the application passes validation and the fee is paid, the medicine is entered on the ARTG with its AUST L number, and it usually shows in TGA Business Services the next day. So the listing itself rarely sets the pace; the work before it does. The TGA sets no timeframe for the sponsor's own work, only for evaluating a new ingredient where one is needed. More on the ARTG and the listing steps.","items":[],"tables":[]},{"heading":"Foods and cosmetics","anchor":"foods-and-cosmetics","markdown":"A product on the food pathway isn't entered on the ARTG: it must comply with the Food Standards Code. A cosmetic needs no TGA entry either, but the business that imports it or its ingredients, or makes the chemicals in it, registers with AICIS for each year it does. More on [AICIS registration](/guides/aicis-registration).\n\nA food with a novel ingredient has its own step: novel foods must be listed in the Code before they are used. Neither pathway skips the brief, the formula, the label or manufacturing, so the stages above still set most of the timeline.","text":"A product on the food pathway isn't entered on the ARTG: it must comply with the Food Standards Code. A cosmetic needs no TGA entry either, but the business that imports it or its ingredients, or makes the chemicals in it, registers with AICIS for each year it does. More on AICIS registration. A food with a novel ingredient has its own step: novel foods must be listed in the Code before they are used. Neither pathway skips the brief, the formula, the label or manufacturing, so the stages above still set most of the timeline.","items":[],"tables":[]},{"heading":"Where we come in","anchor":"where-we-come-in","markdown":"We run formulation, regulatory work and sourcing side by side, with manufacturing partners already in place, so most stages don't wait for the one before. That is how we take a product from concept to shelf in as little as six months. What each stage costs is in our guide to [what a supplement costs to develop](/guides/supplement-development-cost). See [Friday Launch Engine™](/system) and [the journeys we run](/product-development), [check the fit](/partner) or [brief a project](/contact).","text":"We run formulation, regulatory work and sourcing side by side, with manufacturing partners already in place, so most stages don't wait for the one before. That is how we take a product from concept to shelf in as little as six months. What each stage costs is in our guide to what a supplement costs to develop. See Friday Launch Engine™ and the journeys we run, check the fit or brief a project.","items":[],"tables":[]}],"faqs":[{"q":"How do I launch a new supplement in Australia, from formula to shelf?","a":"For a listed medicine, in six stages, most of which can overlap: settle the brief and the pathway, design the formula, build the evidence for its claims, hold stability evidence for its shelf life, write the label and lodge the listing, then make, release-test and deliver the first batch. A food or a cosmetic has no TGA listing, but still goes through the brief, the formula, the label and manufacturing. The pathway comes first, because it decides the ingredients you can use, the claims you can make, the label and who regulates you. Every step, in order, is in our guide to starting a supplement brand.","md":"For a listed medicine, in six stages, most of which can overlap: settle the brief and the pathway, design the formula, build the evidence for its claims, hold stability evidence for its shelf life, write the label and lodge the listing, then make, release-test and deliver the first batch. A food or a cosmetic has no TGA listing, but still goes through the brief, the formula, the label and manufacturing. The pathway comes first, because it decides the ingredients you can use, the claims you can make, the label and who regulates you. Every step, in order, is in our [guide to starting a supplement brand](/guides/start-a-supplement-brand)."},{"q":"How long does it take to develop a supplement?","a":"From our records, between 32 days and 12 weeks from design to production order for listed medicines, and between 5.8 and about eight months from brief or formulation to dispatch. The pathway, the formula and the evidence set the pace more than the TGA does, unless a new ingredient has to be evaluated first.","md":"From our records, between 32 days and 12 weeks from design to production order for listed medicines, and between 5.8 and about eight months from brief or formulation to dispatch. The pathway, the formula and the evidence set the pace more than the TGA does, unless a new ingredient has to be evaluated first."},{"q":"Can a supplement go on sale before its stability study is finished?","a":"Yes, with a shelf life the evidence supports. The TGA says stability evidence should be held at or before listing, older TGA guidance allows an interim shelf life when full data aren't ready, and real-time testing continues after launch.","md":"Yes, with a shelf life the evidence supports. The TGA says stability evidence should be held at or before listing, older TGA guidance allows an interim shelf life when full data aren't ready, and real-time testing continues after launch."},{"q":"What slows supplement development down?","a":"A formula that won't run on the machine, an ingredient that isn't in the Permissible Ingredients Determination and needs its own application and evaluation first, and a claim added after the pathway is set. Settling the pathway at the brief avoids the last one.","md":"A formula that won't run on the machine, an ingredient that isn't in the Permissible Ingredients Determination and needs its own application and evaluation first, and a claim added after the pathway is set. Settling the pathway at the brief avoids the last one."},{"q":"Is a food or a cosmetic faster than a listed medicine?","a":"There's no TGA listing step, but the formula, the label and manufacturing still take their time, and the rules differ: the Food Standards Code for foods; for cosmetics, AICIS registration for the business that introduces the chemicals and the ACCC's ingredient labelling standard. Which pathway a product takes depends mostly on how it is presented, starting with its claims.","md":"There's no TGA listing step, but the formula, the label and manufacturing still take their time, and the rules differ: the Food Standards Code for foods; for cosmetics, AICIS registration for the business that introduces the chemicals and the ACCC's ingredient labelling standard. Which pathway a product takes depends mostly on how it is presented, starting with its claims."}],"sources":{"note":"General information, checked against these sources on 20 October 2026. It isn't advice on a particular product. Timelines are from Take Friday Off's project records.","markdown":"General information, checked against these sources on 20 October 2026. It isn't advice on a particular product. Timelines are from Take Friday Off's project records.\n\n- [Listed medicines](https://www.tga.gov.au/node/520083) and [About listed medicines for sponsors](https://www.tga.gov.au/node/546608), Therapeutic Goods Administration\n- [General guidance for listed medicines](https://www.tga.gov.au/node/289506), Therapeutic Goods Administration\n- [Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026](https://www.legislation.gov.au/F2026L01382/asmade/versions), Federal Register of Legislation\n- [Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025](https://www.legislation.gov.au/F2025L00450/latest/versions), Federal Register of Legislation\n- [Listed medicines evidence guidelines](https://www.tga.gov.au/resources/resource/guidance/evidence-guidelines), Therapeutic Goods Administration\n- [Application requirements for new substances in listed medicines](https://www.tga.gov.au/resources/resource/guidance/application-requirements-new-substances-listed-medicines), Therapeutic Goods Administration\n- [Stability requirements for listed medicines](https://www.tga.gov.au/stability-requirements-listed-medicines), [Performing ongoing stability testing](https://www.tga.gov.au/node/452227) and [Stability testing of listed complementary medicines](https://www.tga.gov.au/node/497429) (older guidance), Therapeutic Goods Administration\n- [Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026](https://www.legislation.gov.au/F2026L01312/asmade), Federal Register of Legislation\n- [Manufacturing therapeutic goods](https://www.tga.gov.au/products/regulations-all-products/manufacturing), Therapeutic Goods Administration\n- [Fees and charges: summary, from 1 July 2026](https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf), Therapeutic Goods Administration\n- [Food Standards Code](https://www.foodstandards.gov.au/food-standards-code), Food Standards Australia New Zealand\n- [What is registration and who must register?](https://www.industrialchemicals.gov.au/business/getting-started-registration-importing-and-manufacturing/what-registration-and-who-must-register), Australian Industrial Chemicals Introduction Scheme","items":[{"text":"Listed medicines and About listed medicines for sponsors, Therapeutic Goods Administration","links":[{"title":"Listed medicines","url":"https://www.tga.gov.au/node/520083"},{"title":"About listed medicines for sponsors","url":"https://www.tga.gov.au/node/546608"}]},{"text":"General guidance for listed medicines, Therapeutic Goods Administration","links":[{"title":"General guidance for listed medicines","url":"https://www.tga.gov.au/node/289506"}]},{"text":"Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026","url":"https://www.legislation.gov.au/F2026L01382/asmade/versions"}]},{"text":"Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025","url":"https://www.legislation.gov.au/F2025L00450/latest/versions"}]},{"text":"Listed medicines evidence guidelines, Therapeutic Goods Administration","links":[{"title":"Listed medicines evidence guidelines","url":"https://www.tga.gov.au/resources/resource/guidance/evidence-guidelines"}]},{"text":"Application requirements for new substances in listed medicines, Therapeutic Goods Administration","links":[{"title":"Application requirements for new substances in listed medicines","url":"https://www.tga.gov.au/resources/resource/guidance/application-requirements-new-substances-listed-medicines"}]},{"text":"Stability requirements for listed medicines, Performing ongoing stability testing and Stability testing of listed complementary medicines (older guidance), Therapeutic Goods Administration","links":[{"title":"Stability requirements for listed medicines","url":"https://www.tga.gov.au/stability-requirements-listed-medicines"},{"title":"Performing ongoing stability testing","url":"https://www.tga.gov.au/node/452227"},{"title":"Stability testing of listed complementary medicines","url":"https://www.tga.gov.au/node/497429"}]},{"text":"Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026","url":"https://www.legislation.gov.au/F2026L01312/asmade"}]},{"text":"Manufacturing therapeutic goods, Therapeutic Goods Administration","links":[{"title":"Manufacturing therapeutic goods","url":"https://www.tga.gov.au/products/regulations-all-products/manufacturing"}]},{"text":"Fees and charges: summary, from 1 July 2026, Therapeutic Goods Administration","links":[{"title":"Fees and charges: summary, from 1 July 2026","url":"https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf"}]},{"text":"Food Standards Code, Food Standards Australia New Zealand","links":[{"title":"Food Standards Code","url":"https://www.foodstandards.gov.au/food-standards-code"}]},{"text":"What is registration and who must register?, Australian Industrial Chemicals Introduction Scheme","links":[{"title":"What is registration and who must register?","url":"https://www.industrialchemicals.gov.au/business/getting-started-registration-importing-and-manufacturing/what-registration-and-who-must-register"}]}]}},{"slug":"stability-testing","kind":"guide","url":"/guides/stability-testing","title":"Stability testing and shelf life for supplements: what the TGA expects","name":"Stability testing guide","description":"Shelf life testing for listed medicines: the stability evidence the TGA expects, real-time and accelerated studies, ongoing testing and failed results.","eyebrow":"Guide","lead":"TGA guidance says a listed medicine's sponsor should hold, at or before listing, evidence that the product will meet its specifications, stored as its label says, until its expiry date. That evidence comes from stability studies. Stability testing is mandatory, and the ongoing program runs in real time at the label's storage conditions: at least one batch from each product group should go on the ongoing program each year. This guide covers what the TGA expects, real-time and accelerated studies, what is tested and how long it takes.","parent":"/pathways/listed-medicines","studies":["the-belly-solution-travel-gut-health-powder","everleanbody-saffron-capsule","eye-health-tablet-format-rescue"],"formats":[],"order":64,"updated":"2026-10-20","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- TGA guidance says a listed medicine's sponsor should hold stability evidence at or before listing, showing the product meets its specifications, stored as its label says, until its expiry date.\n- If full data aren't ready, older TGA guidance allows an interim shelf life supported by evidence. Testing only at expiry isn't acceptable.\n- Ongoing stability testing is mandatory and runs in real time: at least one batch from each product group should go on the program each year.\n- A program lasts at least as long as the shelf life it supports. Our recent programs run for 24 or 36 months.","text":"TGA guidance says a listed medicine's sponsor should hold stability evidence at or before listing, showing the product meets its specifications, stored as its label says, until its expiry date. If full data aren't ready, older TGA guidance allows an interim shelf life supported by evidence. Testing only at expiry isn't acceptable. Ongoing stability testing is mandatory and runs in real time: at least one batch from each product group should go on the program each year. A program lasts at least as long as the shelf life it supports. Our recent programs run for 24 or 36 months.","items":[],"tables":[]},{"heading":"What the TGA expects","anchor":"what-the-tga-expects","markdown":"A listed medicine is not individually evaluated by the TGA before it is supplied. Instead, the sponsor certifies at listing that it holds the records needed to meet quality requirements, such as stability information (the whole process is in our [TGA listing guide](/guides/tga-approval)).\n\nTGA guidance says those records, held at or before listing, should show that the medicine's specifications \"will be maintained under the conditions set out on the medicine's label until the medicine's expiry date\".\n\nWhere a standard applies, the medicine must conform to it. For tablets and capsules, that includes TGO 101, which TGA guidance says medicines must comply with \"throughout their shelf-lives\". Unless it follows a pharmacopoeial monograph, a listed tablet or capsule must assay at 90.0 to 120.0% of the amount on the label for most active ingredients. Vitamins, minerals, enzymes and probiotics have their own limits.\n\nA listed medicine may be reviewed at any time while it is on the ARTG. \"Initial stability reviews\" were among the TGA's 2024–25 compliance focus topics.","text":"A listed medicine is not individually evaluated by the TGA before it is supplied. Instead, the sponsor certifies at listing that it holds the records needed to meet quality requirements, such as stability information (the whole process is in our TGA listing guide). TGA guidance says those records, held at or before listing, should show that the medicine's specifications \"will be maintained under the conditions set out on the medicine's label until the medicine's expiry date\". Where a standard applies, the medicine must conform to it. For tablets and capsules, that includes TGO 101, which TGA guidance says medicines must comply with \"throughout their shelf-lives\". Unless it follows a pharmacopoeial monograph, a listed tablet or capsule must assay at 90.0 to 120.0% of the amount on the label for most active ingredients. Vitamins, minerals, enzymes and probiotics have their own limits. A listed medicine may be reviewed at any time while it is on the ARTG. \"Initial stability reviews\" were among the TGA's 2024–25 compliance focus topics.","items":[],"tables":[]},{"heading":"Selling before the study finishes","anchor":"selling-before-the-study-finishes","markdown":"If complete stability data aren't available at listing, older TGA guidance says the sponsor \"may make a judgement on an interim or abbreviated shelf life\". The judgement must be supported by evidence, and may be used until the stability results are available. Testing only at expiry, for example on a retention sample, is not acceptable.","text":"If complete stability data aren't available at listing, older TGA guidance says the sponsor \"may make a judgement on an interim or abbreviated shelf life\". The judgement must be supported by evidence, and may be used until the stability results are available. Testing only at expiry, for example on a retention sample, is not acceptable.","items":[],"tables":[]},{"heading":"Real-time and accelerated studies","anchor":"real-time-and-accelerated-studies","markdown":"Real-time studies store the product at its label's storage conditions, to at least the end of its shelf life. Accelerated studies store it above the label's maximum temperature, to predict a shelf life from short-term results.\n\n| Study | How it is run | What it can support |\n| --- | --- | --- |\n| Real-time | At the storage conditions on the label | The full shelf life |\n| Accelerated | Above the label's maximum temperature, for a shorter time | A predicted shelf life; full-term data should still be collected |\n| Similar product | Existing studies on a similar product | Under older TGA guidance, a shelf life for a complex multi-ingredient product, if the sponsor holds evidence the data apply; the product's own data in its market pack should still be collected |\n| Ongoing | In real time, on at least one batch per product group a year | Confirmation that the product remains stable over its shelf life |\n\nFor listed therapeutic sunscreens, the TGA's 2025 guidance puts numbers on it. Six months at 10°C above the labelled storage temperature can predict a two-year shelf life, and nine months a three-year one. Where the shelf life at listing rests on pilot-scale batches and accelerated studies, the sponsor will need to confirm it. That takes real-time studies across the whole shelf life, on at least two production batches.","text":"Real-time studies store the product at its label's storage conditions, to at least the end of its shelf life. Accelerated studies store it above the label's maximum temperature, to predict a shelf life from short-term results. Study: Real-time; How it is run: At the storage conditions on the label; What it can support: The full shelf life. Study: Accelerated; How it is run: Above the label's maximum temperature, for a shorter time; What it can support: A predicted shelf life; full-term data should still be collected. Study: Similar product; How it is run: Existing studies on a similar product; What it can support: Under older TGA guidance, a shelf life for a complex multi-ingredient product, if the sponsor holds evidence the data apply; the product's own data in its market pack should still be collected. Study: Ongoing; How it is run: In real time, on at least one batch per product group a year; What it can support: Confirmation that the product remains stable over its shelf life. For listed therapeutic sunscreens, the TGA's 2025 guidance puts numbers on it. Six months at 10°C above the labelled storage temperature can predict a two-year shelf life, and nine months a three-year one. Where the shelf life at listing rests on pilot-scale batches and accelerated studies, the sponsor will need to confirm it. That takes real-time studies across the whole shelf life, on at least two production batches.","items":[],"tables":[{"header":["Study","How it is run","What it can support"],"rows":[["Real-time","At the storage conditions on the label","The full shelf life"],["Accelerated","Above the label's maximum temperature, for a shorter time","A predicted shelf life; full-term data should still be collected"],["Similar product","Existing studies on a similar product","Under older TGA guidance, a shelf life for a complex multi-ingredient product, if the sponsor holds evidence the data apply; the product's own data in its market pack should still be collected"],["Ongoing","In real time, on at least one batch per product group a year","Confirmation that the product remains stable over its shelf life"]]}]},{"heading":"The ongoing program","anchor":"the-ongoing-program","markdown":"Stability testing for listed and complementary medicines is mandatory. The sponsor must make sure there is stability data to support the shelf life, and have access to the laboratory results. The testing can be contracted out, with responsibilities defined in a GMP agreement.\n\n- **Batches.** Older TGA guidance asks for at least two production batches, or pilot-scale batches in the interim. Then at least one batch from each product group should go on the ongoing program each year.\n- **Groups.** Grouping needs a documented justification: similarly constructed formulations and the same dosage form, method of manufacture and primary packaging. Different dose forms or packs may need separate studies.\n- **Time points.** The initial study's protocol should be \"in line with the ICH Guideline time points for stability testing\". Once the initial studies are confirmed as acceptable, ongoing studies may use different time points. They should still run to at least the end of the shelf life.\n- **Conditions.** For example, a label that says \"store below 30°C\" means studies at 30 ± 2°C and 65 ± 5% relative humidity; \"store below 25°C\", 25 ± 2°C and 60 ± 5%; \"store below 8°C (refrigerate)\", 5 ± 2°C. The study must also meet the requirements of each country the product is sold into.\n- **Tests.** Physical tests, including pack integrity; each active ingredient claimed on the label, tested quantitatively throughout the study by validated stability-indicating methods; and microbiological tests at least at the start and end. Reduced ongoing testing may be acceptable with a documented risk assessment, where full data already support the shelf life. Organic-form minerals are tested at least at the start and end, and chromatographic profiling should be considered for herbal ingredients with no standardised component claimed.\n- **Changes.** A product change calls for a risk assessment of whether a new stability study is needed.","text":"Stability testing for listed and complementary medicines is mandatory. The sponsor must make sure there is stability data to support the shelf life, and have access to the laboratory results. The testing can be contracted out, with responsibilities defined in a GMP agreement. Batches. Older TGA guidance asks for at least two production batches, or pilot-scale batches in the interim. Then at least one batch from each product group should go on the ongoing program each year. Groups. Grouping needs a documented justification: similarly constructed formulations and the same dosage form, method of manufacture and primary packaging. Different dose forms or packs may need separate studies. Time points. The initial study's protocol should be \"in line with the ICH Guideline time points for stability testing\". Once the initial studies are confirmed as acceptable, ongoing studies may use different time points. They should still run to at least the end of the shelf life. Conditions. For example, a label that says \"store below 30°C\" means studies at 30 ± 2°C and 65 ± 5% relative humidity; \"store below 25°C\", 25 ± 2°C and 60 ± 5%; \"store below 8°C (refrigerate)\", 5 ± 2°C. The study must also meet the requirements of each country the product is sold into. Tests. Physical tests, including pack integrity; each active ingredient claimed on the label, tested quantitatively throughout the study by validated stability-indicating methods; and microbiological tests at least at the start and end. Reduced ongoing testing may be acceptable with a documented risk assessment, where full data already support the shelf life. Organic-form minerals are tested at least at the start and end, and chromatographic profiling should be considered for herbal ingredients with no standardised component claimed. Changes. A product change calls for a risk assessment of whether a new stability study is needed.","items":[{"lead":"Batches.","text":"Older TGA guidance asks for at least two production batches, or pilot-scale batches in the interim. Then at least one batch from each product group should go on the ongoing program each year."},{"lead":"Groups.","text":"Grouping needs a documented justification: similarly constructed formulations and the same dosage form, method of manufacture and primary packaging. Different dose forms or packs may need separate studies."},{"lead":"Time points.","text":"The initial study's protocol should be \"in line with the ICH Guideline time points for stability testing\". Once the initial studies are confirmed as acceptable, ongoing studies may use different time points. They should still run to at least the end of the shelf life."},{"lead":"Conditions.","text":"For example, a label that says \"store below 30°C\" means studies at 30 ± 2°C and 65 ± 5% relative humidity; \"store below 25°C\", 25 ± 2°C and 60 ± 5%; \"store below 8°C (refrigerate)\", 5 ± 2°C. The study must also meet the requirements of each country the product is sold into."},{"lead":"Tests.","text":"Physical tests, including pack integrity; each active ingredient claimed on the label, tested quantitatively throughout the study by validated stability-indicating methods; and microbiological tests at least at the start and end. Reduced ongoing testing may be acceptable with a documented risk assessment, where full data already support the shelf life. Organic-form minerals are tested at least at the start and end, and chromatographic profiling should be considered for herbal ingredients with no standardised component claimed."},{"lead":"Changes.","text":"A product change calls for a risk assessment of whether a new stability study is needed."}],"tables":[]},{"heading":"When a result fails","anchor":"when-a-result-fails","markdown":"Results are reviewed at each time point. TGA guidance says an out-of-specification result or an atypical trend needs a formal investigation, and a risk assessment where the shelf life could be compromised. Where the shelf life can't be met, later production batches are to carry a reduced shelf life that reflects what is achievable. Reports should be available to the person who releases batches for supply, the sponsor, and the TGA on request.\n\nThe TGA doesn't only hear on request. Its 2020 guidance on the GMP code, written for an earlier edition of the code, says the TGA must be told of all statistically significant departures from established stability profiles, and that the GMP agreement between sponsor and manufacturer should say who reviews stability data and reports issues.\n\nIn its desktop stability reviews, the TGA said a sponsor would be given a chance to address deficiencies, and that enforcement action, such as cancellation from the ARTG, may also be taken. When a medicine doesn't comply, the TGA acts on the risk: it may require the sponsor to update its label, remove it from the ARTG or recall it.","text":"Results are reviewed at each time point. TGA guidance says an out-of-specification result or an atypical trend needs a formal investigation, and a risk assessment where the shelf life could be compromised. Where the shelf life can't be met, later production batches are to carry a reduced shelf life that reflects what is achievable. Reports should be available to the person who releases batches for supply, the sponsor, and the TGA on request. The TGA doesn't only hear on request. Its 2020 guidance on the GMP code, written for an earlier edition of the code, says the TGA must be told of all statistically significant departures from established stability profiles, and that the GMP agreement between sponsor and manufacturer should say who reviews stability data and reports issues. In its desktop stability reviews, the TGA said a sponsor would be given a chance to address deficiencies, and that enforcement action, such as cancellation from the ARTG, may also be taken. When a medicine doesn't comply, the TGA acts on the risk: it may require the sponsor to update its label, remove it from the ARTG or recall it.","items":[],"tables":[]},{"heading":"How long it takes","anchor":"how-long-it-takes","markdown":"Since the ongoing protocol should extend to at least the end of the shelf-life period, a program lasts at least as long as the shelf life it supports. From our records:\n\n- 24-month stability programs on [EverLeanBody's saffron capsule](/work/everleanbody-saffron-capsule) and [an eye-health formula](/work/areds2-eye-health-formula)\n- a 36-month stability program on [The Belly Solution's travel gut-health powder](/work/the-belly-solution-travel-gut-health-powder) (what a probiotic's stability data has to show is in our [probiotics guide](/guides/probiotic-supplement-development))\n- formula and evidence work on two supplements and a sunscreen for [an international skincare brand](/work/skincare-brand-regulatory-partner), with stability studies out to 36 months\n- the stability protocol needed to support a three-year expiry on [an eye-health tablet](/work/eye-health-tablet-format-rescue)\n- a long-term stability program on [a complex herbal capsule](/work/ashwagandha-capsule-32-days)","text":"Since the ongoing protocol should extend to at least the end of the shelf-life period, a program lasts at least as long as the shelf life it supports. From our records: 24-month stability programs on EverLeanBody's saffron capsule and an eye-health formula a 36-month stability program on The Belly Solution's travel gut-health powder (what a probiotic's stability data has to show is in our probiotics guide) formula and evidence work on two supplements and a sunscreen for an international skincare brand, with stability studies out to 36 months the stability protocol needed to support a three-year expiry on an eye-health tablet a long-term stability program on a complex herbal capsule","items":[],"tables":[]},{"heading":"Foods and cosmetics","anchor":"foods-and-cosmetics","markdown":"The TGA's ongoing-stability guidance applies only to listed and complementary medicines. Foods are date marked under Standard 1.2.5 of the Food Standards Code instead, and the food supplier is responsible for the date. Most foods have a best-before date; a use-by date is for foods that must be eaten by a certain time for health or safety reasons. Except for infant formula, no date mark is needed if the best-before date is two years or more after it is determined. More on [the food pathway](/pathways/foods).\n\nAn SPF moisturiser stays a cosmetic only if, among other conditions, it carries an expiry date when it isn't stable for at least 36 months. More on [skincare](/skincare).","text":"The TGA's ongoing-stability guidance applies only to listed and complementary medicines. Foods are date marked under Standard 1.2.5 of the Food Standards Code instead, and the food supplier is responsible for the date. Most foods have a best-before date; a use-by date is for foods that must be eaten by a certain time for health or safety reasons. Except for infant formula, no date mark is needed if the best-before date is two years or more after it is determined. More on the food pathway. An SPF moisturiser stays a cosmetic only if, among other conditions, it carries an expiry date when it isn't stable for at least 36 months. More on skincare.","items":[],"tables":[]},{"heading":"Where we come in","anchor":"where-we-come-in","markdown":"We design the stability protocol for the shelf life the label will carry, and manage the program. We also design the formula, build the claims evidence, secure the listing and draft the label. More on [the listed-medicines pathway](/pathways/listed-medicines), or [book a call](/contact).","text":"We design the stability protocol for the shelf life the label will carry, and manage the program. We also design the formula, build the claims evidence, secure the listing and draft the label. More on the listed-medicines pathway, or book a call.","items":[],"tables":[]}],"faqs":[{"q":"How long does stability testing take?","a":"At least as long as the shelf life it supports: the TGA says the ongoing protocol should extend to at least the end of the shelf-life period. Our records include 24-month and 36-month programs.","md":"At least as long as the shelf life it supports: the TGA says the ongoing protocol should extend to at least the end of the shelf-life period. Our records include 24-month and 36-month programs."},{"q":"Can I sell before the stability study finishes?","a":"Yes, with a shelf life backed by evidence held at listing. Older TGA guidance says the sponsor may set an interim or abbreviated shelf life, supported by evidence, until the stability results are available.","md":"Yes, with a shelf life backed by evidence held at listing. Older TGA guidance says the sponsor may set an interim or abbreviated shelf life, supported by evidence, until the stability results are available."},{"q":"What is accelerated stability testing?","a":"Testing above the label's maximum temperature, to predict a shelf life from short-term results. Older TGA guidance for listed complementary medicines calls it acceptable, but says full-term data at the nominated storage temperature should be collected.","md":"Testing above the label's maximum temperature, to predict a shelf life from short-term results. Older TGA guidance for listed complementary medicines calls it acceptable, but says full-term data at the nominated storage temperature should be collected."},{"q":"How many batches need stability testing?","a":"Older TGA guidance says \"a minimum of two production batches should be used\", with pilot-scale batches as an interim measure. Then at least one batch from each product group should go on the ongoing program each year.","md":"Older TGA guidance says \"a minimum of two production batches should be used\", with pilot-scale batches as an interim measure. Then at least one batch from each product group should go on the ongoing program each year."},{"q":"What happens if a stability result fails?","a":"TGA guidance calls for a formal investigation, a risk assessment where the shelf life could be compromised, and, where the shelf life can't be met, a reduced shelf life on later batches. Significant departures from the product's stability profile should be reported to the TGA, and if a medicine doesn't comply, the TGA may require the sponsor to update its label, remove it from the ARTG or recall it.","md":"TGA guidance calls for a formal investigation, a risk assessment where the shelf life could be compromised, and, where the shelf life can't be met, a reduced shelf life on later batches. Significant departures from the product's stability profile should be reported to the TGA, and if a medicine doesn't comply, the TGA may require the sponsor to update its label, remove it from the ARTG or recall it."},{"q":"Do foods need stability testing?","a":"Not under the TGA's guidance, and the Food Standards Code sets no stability protocol. But a best-before date is the date up to which the food stays fully marketable and keeps any qualities claimed for it, so the supplier, who is responsible for the date, needs a basis for it.","md":"Not under the TGA's guidance, and the Food Standards Code sets no stability protocol. But a best-before date is the date up to which the food stays fully marketable and keeps any qualities claimed for it, so the supplier, who is responsible for the date, needs a basis for it."}],"sources":{"note":"General information, checked against these sources on 20 October 2026. It isn't advice on a particular product.","markdown":"General information, checked against these sources on 20 October 2026. It isn't advice on a particular product.\n\n- [Stability requirements for listed medicines](https://www.tga.gov.au/stability-requirements-listed-medicines), Therapeutic Goods Administration\n- [Performing ongoing stability testing for listed and complementary medicines](https://www.tga.gov.au/node/452227), Therapeutic Goods Administration\n- [Stability testing of listed complementary medicines](https://www.tga.gov.au/node/497429), Therapeutic Goods Administration, undated older guidance\n- [About listed medicines](https://www.tga.gov.au/node/520077) and [Understanding listed medicines compliance reviews](https://www.tga.gov.au/resources/guidance/understanding-listed-medicines-compliance-reviews), Therapeutic Goods Administration\n- [Regulatory update from the Complementary & Over-the-Counter Medicines Branch](https://www.tga.gov.au/sites/default/files/2025-06/b22a-update-from-complementary-over-the-counter-medicines-branch-arcs-2025-presentation.pdf), Therapeutic Goods Administration, 2025\n- [Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019](https://www.legislation.gov.au/F2019L00369/latest/text), Federal Register of Legislation\n- [Complying with quality standards for tablets, capsules and pills](https://www.tga.gov.au/sites/default/files/2025-05/complying-with-quality-standards-for-tablets-capsules-and-pills.pdf), Therapeutic Goods Administration, May 2025, and the earlier [Guidance for TGO 101](https://www.tga.gov.au/sites/default/files/guidance-tgo-101.pdf), March 2019\n- [PE009, the PIC/S guide to GMP for medicinal products: TGA interpretation and expectations for demonstrating compliance](https://www.tga.gov.au/sites/default/files/pe009-pics-guide-gmp-medicinal-products.docx), Therapeutic Goods Administration, version 2.1, September 2020\n- [Understanding the regulation of therapeutic sunscreens](https://www.tga.gov.au/sites/default/files/2025-08/understanding-regulation-therapeutic-sunscreens.pdf), Therapeutic Goods Administration, version 4.0, August 2025\n- [Standard 1.2.5: Information requirements, date marking of food for sale](https://www.legislation.gov.au/F2015L00401/latest/text), Federal Register of Legislation\n- [Use-by and best-before dates](https://www.foodstandards.gov.au/consumer/labelling/dates), Food Standards Australia New Zealand\n- [Therapeutic Goods (Excluded Goods) Determination 2018](https://www.legislation.gov.au/F2018L01350/latest/text), Schedule 2 items 5 and 10, Federal Register of Legislation","items":[{"text":"Stability requirements for listed medicines, Therapeutic Goods Administration","links":[{"title":"Stability requirements for listed medicines","url":"https://www.tga.gov.au/stability-requirements-listed-medicines"}]},{"text":"Performing ongoing stability testing for listed and complementary medicines, Therapeutic Goods Administration","links":[{"title":"Performing ongoing stability testing for listed and complementary medicines","url":"https://www.tga.gov.au/node/452227"}]},{"text":"Stability testing of listed complementary medicines, Therapeutic Goods Administration, undated older guidance","links":[{"title":"Stability testing of listed complementary medicines","url":"https://www.tga.gov.au/node/497429"}]},{"text":"About listed medicines and Understanding listed medicines compliance reviews, Therapeutic Goods Administration","links":[{"title":"About listed medicines","url":"https://www.tga.gov.au/node/520077"},{"title":"Understanding listed medicines compliance reviews","url":"https://www.tga.gov.au/resources/guidance/understanding-listed-medicines-compliance-reviews"}]},{"text":"Regulatory update from the Complementary & Over-the-Counter Medicines Branch, Therapeutic Goods Administration, 2025","links":[{"title":"Regulatory update from the Complementary & Over-the-Counter Medicines Branch","url":"https://www.tga.gov.au/sites/default/files/2025-06/b22a-update-from-complementary-over-the-counter-medicines-branch-arcs-2025-presentation.pdf"}]},{"text":"Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019","url":"https://www.legislation.gov.au/F2019L00369/latest/text"}]},{"text":"Complying with quality standards for tablets, capsules and pills, Therapeutic Goods Administration, May 2025, and the earlier Guidance for TGO 101, March 2019","links":[{"title":"Complying with quality standards for tablets, capsules and pills","url":"https://www.tga.gov.au/sites/default/files/2025-05/complying-with-quality-standards-for-tablets-capsules-and-pills.pdf"},{"title":"Guidance for TGO 101","url":"https://www.tga.gov.au/sites/default/files/guidance-tgo-101.pdf"}]},{"text":"PE009, the PIC/S guide to GMP for medicinal products: TGA interpretation and expectations for demonstrating compliance, Therapeutic Goods Administration, version 2.1, September 2020","links":[{"title":"PE009, the PIC/S guide to GMP for medicinal products: TGA interpretation and expectations for demonstrating compliance","url":"https://www.tga.gov.au/sites/default/files/pe009-pics-guide-gmp-medicinal-products.docx"}]},{"text":"Understanding the regulation of therapeutic sunscreens, Therapeutic Goods Administration, version 4.0, August 2025","links":[{"title":"Understanding the regulation of therapeutic sunscreens","url":"https://www.tga.gov.au/sites/default/files/2025-08/understanding-regulation-therapeutic-sunscreens.pdf"}]},{"text":"Standard 1.2.5: Information requirements, date marking of food for sale, Federal Register of Legislation","links":[{"title":"Standard 1.2.5: Information requirements, date marking of food for sale","url":"https://www.legislation.gov.au/F2015L00401/latest/text"}]},{"text":"Use-by and best-before dates, Food Standards Australia New Zealand","links":[{"title":"Use-by and best-before dates","url":"https://www.foodstandards.gov.au/consumer/labelling/dates"}]},{"text":"Therapeutic Goods (Excluded Goods) Determination 2018, Schedule 2 items 5 and 10, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Excluded Goods) Determination 2018","url":"https://www.legislation.gov.au/F2018L01350/latest/text"}]}]}},{"slug":"permitted-indications","kind":"guide","url":"/guides/permitted-indications","title":"Permitted indications: what a listed medicine can claim, and the evidence behind it","name":"Claims and indications guide","description":"What a TGA-listed medicine can claim: the permitted indications, the evidence the sponsor must hold, the label statements and the advertising rules.","eyebrow":"Guide","lead":"A listed medicine (AUST L) can only make therapeutic claims from the TGA's list of permitted indications, set out in the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025. Each indication comes with the type of evidence the sponsor must hold, scientific or traditional, and any requirements for using it, such as a label statement. The TGA doesn't evaluate a listed medicine's evidence before it goes on the market, but it can ask for it at any time. Advertising, which includes the label, must not be inconsistent with the indications on the Australian Register of Therapeutic Goods (ARTG).","parent":"/pathways/listed-medicines","studies":["ashwagandha-capsule-32-days","everleanbody-saffron-capsule","the-belly-solution-travel-gut-health-powder"],"formats":[],"order":65,"updated":"2026-10-20","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- A listed (AUST L) medicine can only make therapeutic claims from the TGA's permitted indications, set out in the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025.\n- Each indication sets the evidence the sponsor must hold, scientific or traditional, and any requirements for using it, such as a label statement. The TGA can ask for the evidence at any time.\n- Listed medicines make low-level claims only: \"relieves throat irritation\", not \"reduces high blood pressure\".\n- Advertising, which includes the label, must not be inconsistent with the indications on the ARTG, and advertising to the public can't use endorsements from health practitioners, health professionals or medical researchers.","text":"A listed (AUST L) medicine can only make therapeutic claims from the TGA's permitted indications, set out in the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025. Each indication sets the evidence the sponsor must hold, scientific or traditional, and any requirements for using it, such as a label statement. The TGA can ask for the evidence at any time. Listed medicines make low-level claims only: \"relieves throat irritation\", not \"reduces high blood pressure\". Advertising, which includes the label, must not be inconsistent with the indications on the ARTG, and advertising to the public can't use endorsements from health practitioners, health professionals or medical researchers.","items":[],"tables":[]},{"heading":"What an indication is","anchor":"what-an-indication-is","markdown":"In the TGA's words, indications \"are statements that describe the specific therapeutic use for a medicine\", such as \"relieves coughs\".\n\nA label can carry other claims, but one that implies a therapeutic use needs a permitted indication of similar intent in the medicine's [ARTG](/guides/artg) entry, supported by evidence.","text":"In the TGA's words, indications \"are statements that describe the specific therapeutic use for a medicine\", such as \"relieves coughs\". A label can carry other claims, but one that implies a therapeutic use needs a permitted indication of similar intent in the medicine's ARTG entry, supported by evidence.","items":[],"tables":[]},{"heading":"How the Permissible Indications Determination works","anchor":"how-the-permissible-indications-determination-works","markdown":"The legal list is the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025, in force since 3 April 2025. Its 17 Parts group indications mostly by body system, with separate Parts for traditional Chinese medicine (TCM), traditional Ayurvedic medicine, sunscreens and pregnancy. Each entry gives the wording, the type of evidence needed and any requirements:\n\n- \"Maintain/support energy levels\": scientific or traditional evidence, and \"Product presentation must not imply or refer to chronic fatigue syndrome.\"\n- \"Aid/assist in the healing of minor body tissue injuries\": scientific or traditional, with the label statement \"If symptoms persist, talk to your health professional.\"\n- \"Aid/assist/helps connective tissue production/formation\": scientific evidence only.\n\nThe Determination also limits how the wording can change:\n\n- **Rewording.** A label can vary the wording, or where appropriate combine indications into simple sentences, without changing the meaning or intent. It must not imply that the medicine treats a serious form of a disease, ailment, defect or injury, or that it prevents or cures any disease, ailment, defect or injury. In a TGA example, \"Maintain/support gastrointestinal system health\" can read \"Maintains healthy gut\", but not \"Maintain healthy intestinal flora\".\n- **Qualifiers.** Only qualifiers from the TGA's code tables can modify an indication, and each must be on the label. Traditional evidence needs a traditional context qualifier; population, time of use and (for TCM evidence) TCM pattern qualifiers are optional. The TGA says the label and the ARTG entry must carry the same qualifiers.\n- **Pregnancy.** Pregnancy indications have their own Part, and can't be combined in a sentence with other indications. Building a prenatal? See [prenatal and postnatal supplements](/guides/prenatal-supplement-development).\n\nA sponsor can apply to have a new indication considered for the list; the 2026–27 fee is $1,331.","text":"The legal list is the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025, in force since 3 April 2025. Its 17 Parts group indications mostly by body system, with separate Parts for traditional Chinese medicine (TCM), traditional Ayurvedic medicine, sunscreens and pregnancy. Each entry gives the wording, the type of evidence needed and any requirements: \"Maintain/support energy levels\": scientific or traditional evidence, and \"Product presentation must not imply or refer to chronic fatigue syndrome.\" \"Aid/assist in the healing of minor body tissue injuries\": scientific or traditional, with the label statement \"If symptoms persist, talk to your health professional.\" \"Aid/assist/helps connective tissue production/formation\": scientific evidence only. The Determination also limits how the wording can change: Rewording. A label can vary the wording, or where appropriate combine indications into simple sentences, without changing the meaning or intent. It must not imply that the medicine treats a serious form of a disease, ailment, defect or injury, or that it prevents or cures any disease, ailment, defect or injury. In a TGA example, \"Maintain/support gastrointestinal system health\" can read \"Maintains healthy gut\", but not \"Maintain healthy intestinal flora\". Qualifiers. Only qualifiers from the TGA's code tables can modify an indication, and each must be on the label. Traditional evidence needs a traditional context qualifier; population, time of use and (for TCM evidence) TCM pattern qualifiers are optional. The TGA says the label and the ARTG entry must carry the same qualifiers. Pregnancy. Pregnancy indications have their own Part, and can't be combined in a sentence with other indications. Building a prenatal? See prenatal and postnatal supplements. A sponsor can apply to have a new indication considered for the list; the 2026–27 fee is $1,331.","items":[{"lead":"Rewording.","text":"A label can vary the wording, or where appropriate combine indications into simple sentences, without changing the meaning or intent. It must not imply that the medicine treats a serious form of a disease, ailment, defect or injury, or that it prevents or cures any disease, ailment, defect or injury. In a TGA example, \"Maintain/support gastrointestinal system health\" can read \"Maintains healthy gut\", but not \"Maintain healthy intestinal flora\"."},{"lead":"Qualifiers.","text":"Only qualifiers from the TGA's code tables can modify an indication, and each must be on the label. Traditional evidence needs a traditional context qualifier; population, time of use and (for TCM evidence) TCM pattern qualifiers are optional. The TGA says the label and the ARTG entry must carry the same qualifiers."},{"lead":"Pregnancy.","text":"Pregnancy indications have their own Part, and can't be combined in a sentence with other indications. Building a prenatal? See prenatal and postnatal supplements."}],"tables":[]},{"heading":"Listed, assessed listed or registered","anchor":"listed-assessed-listed-or-registered","markdown":"The TGA only allows listed medicines \"low level health claims\": a listed medicine may claim it \"relieves throat irritation\", but not \"reduces high blood pressure\" or \"cures rheumatoid arthritis\". An assessed listed medicine, which the TGA assesses for efficacy before sale, might be able to reference a condition like tinnitus. A registered medicine (AUST R) is fully assessed for safety, quality and efficacy before it goes on sale. Our [TGA listing guide](/guides/tga-approval) compares the three tiers, and our [assessed listed medicines guide](/guides/assessed-listed-medicines) covers what an intermediate indication takes.","text":"The TGA only allows listed medicines \"low level health claims\": a listed medicine may claim it \"relieves throat irritation\", but not \"reduces high blood pressure\" or \"cures rheumatoid arthritis\". An assessed listed medicine, which the TGA assesses for efficacy before sale, might be able to reference a condition like tinnitus. A registered medicine (AUST R) is fully assessed for safety, quality and efficacy before it goes on sale. Our TGA listing guide compares the three tiers, and our assessed listed medicines guide covers what an intermediate indication takes.","items":[],"tables":[]},{"heading":"TGA evidence requirements: what the sponsor must hold","anchor":"tga-evidence-requirements-what-the-sponsor-must-hold","markdown":"Listed medicines are not individually evaluated by the TGA for quality, safety and efficacy before they are supplied. Instead, the sponsor certifies, when applying to list, that the indications are covered by the Determination and meet its requirements. It also certifies that it holds evidence for every indication and claim.\n\nThe sponsor must hold that evidence \"at all times while the medicine remains listed\", and provide it to the TGA on request.\n\nThe TGA's Listed medicines evidence guidelines (version 4.0, June 2022) set out what counts. They aren't mandatory, but show what a TGA delegate considers in a compliance review. Non-specific scientific indications are about general health and wellbeing; specific ones go further.\n\n| Basis of the indication | Scientific | Traditional |\n| --- | --- | --- |\n| What it is | Evidence \"based on scientific research and quantifiable data\", usually including clinical trials in humans | Traditional use \"in a recognised paradigm outside modern conventional medicine\", for over three generations (75 years) |\n| The guidelines' minimum | Non-specific: two Category B or C sources, such as observational studies or non-systematic reviews. Specific: one Category A source, such as a double-blind randomised controlled trial, or one B and two C | Two sources of evidence of the tradition of use |\n| Not enough, or not allowed | Abstracts alone, or non-clinical studies on their own | Implying efficacy based on scientific evidence, such as \"clinically tested\" |\n\nThe guidelines call these minimums \"the lowest threshold below which the efficacy of the medicine cannot be reasonably assessed\", and say they may not suit every medicine. They also expect a critical appraisal of the evidence, which should weigh whether the benefit is clinically significant: for a listed medicine, \"a degree of health benefit that is meaningful to the consumer\". For a product built on a branded extract, see [branded ingredients](/guides/branded-ingredients).","text":"Listed medicines are not individually evaluated by the TGA for quality, safety and efficacy before they are supplied. Instead, the sponsor certifies, when applying to list, that the indications are covered by the Determination and meet its requirements. It also certifies that it holds evidence for every indication and claim. The sponsor must hold that evidence \"at all times while the medicine remains listed\", and provide it to the TGA on request. The TGA's Listed medicines evidence guidelines (version 4.0, June 2022) set out what counts. They aren't mandatory, but show what a TGA delegate considers in a compliance review. Non-specific scientific indications are about general health and wellbeing; specific ones go further. Basis of the indication: What it is; Scientific: Evidence \"based on scientific research and quantifiable data\", usually including clinical trials in humans; Traditional: Traditional use \"in a recognised paradigm outside modern conventional medicine\", for over three generations (75 years). Basis of the indication: The guidelines' minimum; Scientific: Non-specific: two Category B or C sources, such as observational studies or non-systematic reviews. Specific: one Category A source, such as a double-blind randomised controlled trial, or one B and two C; Traditional: Two sources of evidence of the tradition of use. Basis of the indication: Not enough, or not allowed; Scientific: Abstracts alone, or non-clinical studies on their own; Traditional: Implying efficacy based on scientific evidence, such as \"clinically tested\". The guidelines call these minimums \"the lowest threshold below which the efficacy of the medicine cannot be reasonably assessed\", and say they may not suit every medicine. They also expect a critical appraisal of the evidence, which should weigh whether the benefit is clinically significant: for a listed medicine, \"a degree of health benefit that is meaningful to the consumer\". For a product built on a branded extract, see branded ingredients.","items":[],"tables":[{"header":["Basis of the indication","Scientific","Traditional"],"rows":[["What it is","Evidence \"based on scientific research and quantifiable data\", usually including clinical trials in humans","Traditional use \"in a recognised paradigm outside modern conventional medicine\", for over three generations (75 years)"],["The guidelines' minimum","Non-specific: two Category B or C sources, such as observational studies or non-systematic reviews. Specific: one Category A source, such as a double-blind randomised controlled trial, or one B and two C","Two sources of evidence of the tradition of use"],["Not enough, or not allowed","Abstracts alone, or non-clinical studies on their own","Implying efficacy based on scientific evidence, such as \"clinically tested\""]]}]},{"heading":"Advertising: the Therapeutic Goods Advertising Code","anchor":"advertising-the-therapeutic-goods-advertising-code","markdown":"As the Act defines it, advertising includes any statement intended to promote the use or supply of the goods, including on the label. The rules below come from the Act, its Regulations and the Therapeutic Goods Advertising Code, which doesn't apply to advertising directed only at health professionals and the others named in section 42AA of the Act:\n\n- **Consistent with the ARTG.** Advertising must not be inconsistent with any indication accepted for the medicine's ARTG entry. It must be accurate, balanced, not misleading and substantiated before publication.\n- **Required statements.** Most medicine ads must include the medicine's name, one or more accepted indications and \"ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE\". Short-form ads carry \"ALWAYS FOLLOW THE DIRECTIONS FOR USE\" instead. Neither applies to the label itself.\n- **Online stores.** Where an ad lets people buy without inspecting the product, it must also give the dosage form, quantity and each active ingredient, plus any health warnings or a link to them.\n- **Endorsements and testimonials.** An endorsement must not be given by \"a current or former health practitioner, health professional or medical researcher\". Testimonials can't come from people engaged in producing, marketing or supplying the goods, which the Code says includes influencers and others who receive valuable consideration for them. The advertiser must verify each one.\n- **Restricted representations.** These refer to a serious form of a disease, condition, ailment or defect, one that requires \"a health professional to diagnose, follow-up or treat\". They need the TGA's prior approval or permission, unless part of a required health warning.\n- **Prohibited representations.** Listed in the Therapeutic Goods Regulations 1990, these include claims about treating or preventing cancer or mental illness, and can't be applied for. The TGA can permit them in specific ads if necessary for public health or the appropriate use of the goods.\n\nInfluencers, social media, the statements an ad must carry and the penalties are in our [advertising guide](/guides/tga-advertising).","text":"As the Act defines it, advertising includes any statement intended to promote the use or supply of the goods, including on the label. The rules below come from the Act, its Regulations and the Therapeutic Goods Advertising Code, which doesn't apply to advertising directed only at health professionals and the others named in section 42AA of the Act: Consistent with the ARTG. Advertising must not be inconsistent with any indication accepted for the medicine's ARTG entry. It must be accurate, balanced, not misleading and substantiated before publication. Required statements. Most medicine ads must include the medicine's name, one or more accepted indications and \"ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE\". Short-form ads carry \"ALWAYS FOLLOW THE DIRECTIONS FOR USE\" instead. Neither applies to the label itself. Online stores. Where an ad lets people buy without inspecting the product, it must also give the dosage form, quantity and each active ingredient, plus any health warnings or a link to them. Endorsements and testimonials. An endorsement must not be given by \"a current or former health practitioner, health professional or medical researcher\". Testimonials can't come from people engaged in producing, marketing or supplying the goods, which the Code says includes influencers and others who receive valuable consideration for them. The advertiser must verify each one. Restricted representations. These refer to a serious form of a disease, condition, ailment or defect, one that requires \"a health professional to diagnose, follow-up or treat\". They need the TGA's prior approval or permission, unless part of a required health warning. Prohibited representations. Listed in the Therapeutic Goods Regulations 1990, these include claims about treating or preventing cancer or mental illness, and can't be applied for. The TGA can permit them in specific ads if necessary for public health or the appropriate use of the goods. Influencers, social media, the statements an ad must carry and the penalties are in our advertising guide.","items":[{"lead":"Consistent with the ARTG.","text":"Advertising must not be inconsistent with any indication accepted for the medicine's ARTG entry. It must be accurate, balanced, not misleading and substantiated before publication."},{"lead":"Required statements.","text":"Most medicine ads must include the medicine's name, one or more accepted indications and \"ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE\". Short-form ads carry \"ALWAYS FOLLOW THE DIRECTIONS FOR USE\" instead. Neither applies to the label itself."},{"lead":"Online stores.","text":"Where an ad lets people buy without inspecting the product, it must also give the dosage form, quantity and each active ingredient, plus any health warnings or a link to them."},{"lead":"Endorsements and testimonials.","text":"An endorsement must not be given by \"a current or former health practitioner, health professional or medical researcher\". Testimonials can't come from people engaged in producing, marketing or supplying the goods, which the Code says includes influencers and others who receive valuable consideration for them. The advertiser must verify each one."},{"lead":"Restricted representations.","text":"These refer to a serious form of a disease, condition, ailment or defect, one that requires \"a health professional to diagnose, follow-up or treat\". They need the TGA's prior approval or permission, unless part of a required health warning."},{"lead":"Prohibited representations.","text":"Listed in the Therapeutic Goods Regulations 1990, these include claims about treating or preventing cancer or mental illness, and can't be applied for. The TGA can permit them in specific ads if necessary for public health or the appropriate use of the goods."}],"tables":[]},{"heading":"What the TGA checks, and what can follow","anchor":"what-the-tga-checks-and-what-can-follow","markdown":"- **Reviews.** The TGA runs random and targeted compliance reviews of listed medicines. Its 2024–25 priorities included advertising indications not on the ARTG and not meeting the Determination, especially restricted or prohibited representations. Another was not holding sufficient evidence to support efficacy.\n- **Outcomes.** If a medicine doesn't comply, the TGA acts according to the risk. It may, for example, require the sponsor to update the label, remove the medicine from the ARTG so it can no longer be lawfully supplied, or recall it.\n- **Cancellation.** Among other grounds, the TGA can cancel a listing if the sponsor's evidence certifications are incorrect, or the medicine's efficacy appears unacceptable. Criminal and civil penalty provisions may apply to a false or misleading statement in a certification.","text":"Reviews. The TGA runs random and targeted compliance reviews of listed medicines. Its 2024–25 priorities included advertising indications not on the ARTG and not meeting the Determination, especially restricted or prohibited representations. Another was not holding sufficient evidence to support efficacy. Outcomes. If a medicine doesn't comply, the TGA acts according to the risk. It may, for example, require the sponsor to update the label, remove the medicine from the ARTG so it can no longer be lawfully supplied, or recall it. Cancellation. Among other grounds, the TGA can cancel a listing if the sponsor's evidence certifications are incorrect, or the medicine's efficacy appears unacceptable. Criminal and civil penalty provisions may apply to a false or misleading statement in a certification.","items":[{"lead":"Reviews.","text":"The TGA runs random and targeted compliance reviews of listed medicines. Its 2024–25 priorities included advertising indications not on the ARTG and not meeting the Determination, especially restricted or prohibited representations. Another was not holding sufficient evidence to support efficacy."},{"lead":"Outcomes.","text":"If a medicine doesn't comply, the TGA acts according to the risk. It may, for example, require the sponsor to update the label, remove the medicine from the ARTG so it can no longer be lawfully supplied, or recall it."},{"lead":"Cancellation.","text":"Among other grounds, the TGA can cancel a listing if the sponsor's evidence certifications are incorrect, or the medicine's efficacy appears unacceptable. Criminal and civil penalty provisions may apply to a false or misleading statement in a certification."}],"tables":[]},{"heading":"Food and cosmetic claims work differently","anchor":"food-and-cosmetic-claims-work-differently","markdown":"On a food, Standard 1.2.7 of the Food Standards Code says a claim must not refer to the prevention, diagnosis, cure or alleviation of a disease, disorder or condition. In the TGA's example, \"Helps skin look firm\" is a cosmetic claim, about appearance, while \"Improves skin's internal structure for firmer skin\" is therapeutic. More on [medicine, food or cosmetic?](/pathways) and [skincare](/skincare).","text":"On a food, Standard 1.2.7 of the Food Standards Code says a claim must not refer to the prevention, diagnosis, cure or alleviation of a disease, disorder or condition. In the TGA's example, \"Helps skin look firm\" is a cosmetic claim, about appearance, while \"Improves skin's internal structure for firmer skin\" is therapeutic. More on medicine, food or cosmetic? and skincare.","items":[],"tables":[]},{"heading":"Where we come in","anchor":"where-we-come-in","markdown":"We design the formula inside the TGA's permitted ingredients and indications, with every ingredient, its form and its dose chosen for the claim you want to make. The claims evidence is built alongside the formula, not after it. For [a complex herbal capsule](/work/ashwagandha-capsule-32-days), the evidence package covered more than 13 ingredients. More on [formulation](/formulation), or [book a call](/contact).","text":"We design the formula inside the TGA's permitted ingredients and indications, with every ingredient, its form and its dose chosen for the claim you want to make. The claims evidence is built alongside the formula, not after it. For a complex herbal capsule, the evidence package covered more than 13 ingredients. More on formulation, or book a call.","items":[],"tables":[]}],"faqs":[{"q":"What are permitted indications?","a":"They are the therapeutic claims a listed medicine is allowed to make, set out in the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025. Each comes with the type of evidence it needs and any requirements, such as a label statement.","md":"They are the therapeutic claims a listed medicine is allowed to make, set out in the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025. Each comes with the type of evidence it needs and any requirements, such as a label statement."},{"q":"Can a listed medicine say it treats a disease?","a":"Its therapeutic claims must come from the permitted indications. Reworded or combined, they must not imply that it treats a serious form of a disease, ailment, defect or injury, or that it prevents or cures any. A listed medicine may claim it \"relieves throat irritation\", but not \"cures rheumatoid arthritis\".","md":"Its therapeutic claims must come from the permitted indications. Reworded or combined, they must not imply that it treats a serious form of a disease, ailment, defect or injury, or that it prevents or cures any. A listed medicine may claim it \"relieves throat irritation\", but not \"cures rheumatoid arthritis\"."},{"q":"What evidence do I need for a listed medicine?","a":"Evidence for every indication, of the type the Determination allows for it (scientific or traditional), and evidence for every other claim. The sponsor must hold it while the medicine is listed, and provide it if the TGA asks.","md":"Evidence for every indication, of the type the Determination allows for it (scientific or traditional), and evidence for every other claim. The sponsor must hold it while the medicine is listed, and provide it if the TGA asks."},{"q":"Can I use traditional evidence?","a":"Yes, for indications the Determination allows with traditional evidence. The label must carry a traditional context qualifier, and the TGA's guidelines expect more than three generations (75 years) of use.","md":"Yes, for indications the Determination allows with traditional evidence. The label must carry a traditional context qualifier, and the TGA's guidelines expect more than three generations (75 years) of use."},{"q":"Can a supplement ad use a doctor's endorsement?","a":"Not in advertising to the public. The Advertising Code says an endorsement must not be given by \"a current or former health practitioner, health professional or medical researcher\". The Code doesn't apply to advertising directed only at health professionals.","md":"Not in advertising to the public. The Advertising Code says an endorsement must not be given by \"a current or former health practitioner, health professional or medical researcher\". The Code doesn't apply to advertising directed only at health professionals."},{"q":"What happens if my claims aren't compliant?","a":"The TGA acts according to the risk. It may, for example, require the sponsor to update the label, remove the medicine from the ARTG, or recall it. It can also cancel a listing if the sponsor's certifications are incorrect.","md":"The TGA acts according to the risk. It may, for example, require the sponsor to update the label, remove the medicine from the ARTG, or recall it. It can also cancel a listing if the sponsor's certifications are incorrect."}],"sources":{"note":"General information, checked against these sources on 20 October 2026. It isn't advice on a particular product.","markdown":"General information, checked against these sources on 20 October 2026. It isn't advice on a particular product.\n\n- [Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025](https://www.legislation.gov.au/F2025L00450/latest/versions) and its [explanatory statement](https://www.legislation.gov.au/F2025L00450/asmade/2025-04-02/es/original/pdf), Federal Register of Legislation\n- [Permitted indications for listed medicines](https://www.tga.gov.au/products/medicines/listed-medicines/application-and-market-authorisation/permitted-indications-listed-medicines) and [Using permitted indications](https://tga.gov.au/node/286257), Therapeutic Goods Administration\n- [Listed medicines evidence guidelines: how to demonstrate the efficacy of listed medicines is acceptable](https://www.tga.gov.au/sites/default/files/evidence-guidelines.pdf), version 4.0, June 2022, and its web version, [Supporting claims and indications for listed medicines](https://www.tga.gov.au/resources/guidance/supporting-claims-and-indications-listed-medicines), Therapeutic Goods Administration\n- [About listed medicines](https://www.tga.gov.au/node/520077) and [Listed, assessed listed and registered medicines](https://www.tga.gov.au/node/497532), Therapeutic Goods Administration\n- [Fees and charges: summary, from 1 July 2026](https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf), Therapeutic Goods Administration\n- [Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021](https://www.legislation.gov.au/F2021L01661/latest/versions), Federal Register of Legislation\n- [Restricted and prohibited representations in advertising](https://www.tga.gov.au/node/288050), Therapeutic Goods Administration\n- [Understanding listed medicines compliance reviews](https://www.tga.gov.au/resources/guidance/understanding-listed-medicines-compliance-reviews) and [Regulatory update from the Complementary & Over-the-Counter Medicines Branch](https://www.tga.gov.au/sites/default/files/2025-06/b22a-update-from-complementary-over-the-counter-medicines-branch-arcs-2025-presentation.pdf), Therapeutic Goods Administration\n- [Standard 1.2.7: Nutrition, health and related claims](https://www.legislation.gov.au/F2015L00394/latest/text), Federal Register of Legislation\n- [Cosmetics or therapeutic goods: guidance for advertisers and suppliers](https://www.tga.gov.au/sites/default/files/2024-06/cosmetics-therapeutic-goods-guidance-for-advertisers-suppliers.pdf), Therapeutic Goods Administration, June 2024","items":[{"text":"Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025 and its explanatory statement, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025","url":"https://www.legislation.gov.au/F2025L00450/latest/versions"},{"title":"explanatory statement","url":"https://www.legislation.gov.au/F2025L00450/asmade/2025-04-02/es/original/pdf"}]},{"text":"Permitted indications for listed medicines and Using permitted indications, Therapeutic Goods Administration","links":[{"title":"Permitted indications for listed medicines","url":"https://www.tga.gov.au/products/medicines/listed-medicines/application-and-market-authorisation/permitted-indications-listed-medicines"},{"title":"Using permitted indications","url":"https://tga.gov.au/node/286257"}]},{"text":"Listed medicines evidence guidelines: how to demonstrate the efficacy of listed medicines is acceptable, version 4.0, June 2022, and its web version, Supporting claims and indications for listed medicines, Therapeutic Goods Administration","links":[{"title":"Listed medicines evidence guidelines: how to demonstrate the efficacy of listed medicines is acceptable","url":"https://www.tga.gov.au/sites/default/files/evidence-guidelines.pdf"},{"title":"Supporting claims and indications for listed medicines","url":"https://www.tga.gov.au/resources/guidance/supporting-claims-and-indications-listed-medicines"}]},{"text":"About listed medicines and Listed, assessed listed and registered medicines, Therapeutic Goods Administration","links":[{"title":"About listed medicines","url":"https://www.tga.gov.au/node/520077"},{"title":"Listed, assessed listed and registered medicines","url":"https://www.tga.gov.au/node/497532"}]},{"text":"Fees and charges: summary, from 1 July 2026, Therapeutic Goods Administration","links":[{"title":"Fees and charges: summary, from 1 July 2026","url":"https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf"}]},{"text":"Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021","url":"https://www.legislation.gov.au/F2021L01661/latest/versions"}]},{"text":"Restricted and prohibited representations in advertising, Therapeutic Goods Administration","links":[{"title":"Restricted and prohibited representations in advertising","url":"https://www.tga.gov.au/node/288050"}]},{"text":"Understanding listed medicines compliance reviews and Regulatory update from the Complementary & Over-the-Counter Medicines Branch, Therapeutic Goods Administration","links":[{"title":"Understanding listed medicines compliance reviews","url":"https://www.tga.gov.au/resources/guidance/understanding-listed-medicines-compliance-reviews"},{"title":"Regulatory update from the Complementary & Over-the-Counter Medicines Branch","url":"https://www.tga.gov.au/sites/default/files/2025-06/b22a-update-from-complementary-over-the-counter-medicines-branch-arcs-2025-presentation.pdf"}]},{"text":"Standard 1.2.7: Nutrition, health and related claims, Federal Register of Legislation","links":[{"title":"Standard 1.2.7: Nutrition, health and related claims","url":"https://www.legislation.gov.au/F2015L00394/latest/text"}]},{"text":"Cosmetics or therapeutic goods: guidance for advertisers and suppliers, Therapeutic Goods Administration, June 2024","links":[{"title":"Cosmetics or therapeutic goods: guidance for advertisers and suppliers","url":"https://www.tga.gov.au/sites/default/files/2024-06/cosmetics-therapeutic-goods-guidance-for-advertisers-suppliers.pdf"}]}]}},{"slug":"supplement-development-cost","kind":"guide","url":"/guides/supplement-development-cost","title":"How much does it cost to develop a supplement in Australia?","name":"Development costs","description":"What a supplement costs to develop in Australia: the development stages, the TGA's 2026–27 fees, minimum orders, cost of goods and what adds to the bill.","eyebrow":"Guide","lead":"What a supplement costs to develop depends on the formula, the format and the pathway, but the costs always fall into the same four parts: the development work, the TGA's fees, the first production run, and the costs that continue after launch. This guide sets out each one, with the TGA's 2026–27 fees, the minimum order, how to set a target cost of goods, and what adds time and money.","parent":"/product-development","studies":["everleanbody-saffron-capsule","the-belly-solution-travel-gut-health-powder","bwellness-practitioner-range"],"formats":[],"order":66,"updated":"2026-10-23","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- The costs fall into four parts: the development work, the TGA's fees, the first production run, and what continues after launch (the annual TGA charge, stability testing and reorders).\n- For a listed medicine in 2026–27, the TGA charges $1,063 to list it, then $1,566 a year once it has had turnover. A new ingredient that isn't yet permitted costs $19,826 to $33,696 in TGA fees to evaluate first.\n- A first production run is at least 3,000 finished retail packs, priced per unit on a formal quote.\n- Design to the price: divide the retail price by four or five to get the target cost of goods, packaging included.","text":"The costs fall into four parts: the development work, the TGA's fees, the first production run, and what continues after launch (the annual TGA charge, stability testing and reorders). For a listed medicine in 2026–27, the TGA charges $1,063 to list it, then $1,566 a year once it has had turnover. A new ingredient that isn't yet permitted costs $19,826 to $33,696 in TGA fees to evaluate first. A first production run is at least 3,000 finished retail packs, priced per unit on a formal quote. Design to the price: divide the retail price by four or five to get the target cost of goods, packaging included.","items":[],"tables":[]},{"heading":"Where the money goes","anchor":"where-the-money-goes","markdown":"| Cost | What it covers | What sets it |\n| --- | --- | --- |\n| Development: the Design phase | The brief workshop, the formulation, its specification and a quote for making it | A fixed fee for a defined outcome |\n| Development: the Build phase | The R&D sample, the product specification, the evidence, the TGA listing and the label | Fixed fees for each stage |\n| The TGA's fees | Listing the medicine, then the annual charge, plus any variation or new ingredient | The TGA's schedule, set each financial year |\n| The first production run | Manufacturing, release testing and delivery to your warehouse or 3PL | A per-unit price on a formal quote, at least 3,000 packs |\n| Packaging | The bottle, tub, pouch or sachet, the label and the carton | The format, and whether the pack is standard or bespoke |\n| After launch | The annual TGA charge, the stability program and reorders | The shelf life on the label and how the product sells |\n\nThe development work comes first. In our process it runs in two phases: Design, about 8 to 10 weeks, which ends with a formula, its specification and a quote you can approve; and Build, about 20 to 24 weeks, which takes the product through the sample, the evidence, the listing and the label to 12 to 14 weeks in manufacture. See [Friday Launch Engine™](/system) for the steps, and [formulation](/formulation) for what the design stage delivers.","text":"Cost: Development: the Design phase; What it covers: The brief workshop, the formulation, its specification and a quote for making it; What sets it: A fixed fee for a defined outcome. Cost: Development: the Build phase; What it covers: The R&D sample, the product specification, the evidence, the TGA listing and the label; What sets it: Fixed fees for each stage. Cost: The TGA's fees; What it covers: Listing the medicine, then the annual charge, plus any variation or new ingredient; What sets it: The TGA's schedule, set each financial year. Cost: The first production run; What it covers: Manufacturing, release testing and delivery to your warehouse or 3PL; What sets it: A per-unit price on a formal quote, at least 3,000 packs. Cost: Packaging; What it covers: The bottle, tub, pouch or sachet, the label and the carton; What sets it: The format, and whether the pack is standard or bespoke. Cost: After launch; What it covers: The annual TGA charge, the stability program and reorders; What sets it: The shelf life on the label and how the product sells. The development work comes first. In our process it runs in two phases: Design, about 8 to 10 weeks, which ends with a formula, its specification and a quote you can approve; and Build, about 20 to 24 weeks, which takes the product through the sample, the evidence, the listing and the label to 12 to 14 weeks in manufacture. See Friday Launch Engine™ for the steps, and formulation for what the design stage delivers.","items":[],"tables":[{"header":["Cost","What it covers","What sets it"],"rows":[["Development: the Design phase","The brief workshop, the formulation, its specification and a quote for making it","A fixed fee for a defined outcome"],["Development: the Build phase","The R&D sample, the product specification, the evidence, the TGA listing and the label","Fixed fees for each stage"],["The TGA's fees","Listing the medicine, then the annual charge, plus any variation or new ingredient","The TGA's schedule, set each financial year"],["The first production run","Manufacturing, release testing and delivery to your warehouse or 3PL","A per-unit price on a formal quote, at least 3,000 packs"],["Packaging","The bottle, tub, pouch or sachet, the label and the carton","The format, and whether the pack is standard or bespoke"],["After launch","The annual TGA charge, the stability program and reorders","The shelf life on the label and how the product sells"]]}]},{"heading":"The TGA's fees","anchor":"the-tgas-fees","markdown":"Every [listed medicine](/pathways/listed-medicines) pays two: the listing application, $1,063 in 2026–27, paid within 14 days of submitting, and then the annual charge, $1,566 for each financial year once the product has had turnover. A listing that has never had turnover is exempt from the annual charge until sales start, as long as the sponsor declares each July that it had none in the year before; once the product has sold, the charge applies every year, even in a later year with no sales.\n\nTwo more apply only in particular cases: a new ingredient that isn't yet in the TGA's Permissible Ingredients Determination, which costs $19,826 to $33,696 in TGA fees for its application and evaluation, and a GMP clearance for a factory overseas, $818 per manufacturer, site and sponsor. The full schedule, with variations and new indications, and the steps around each fee are in our [TGA approval guide](/guides/tga-approval#what-it-costs-tga-fees-for-202627).","text":"Every listed medicine pays two: the listing application, $1,063 in 2026–27, paid within 14 days of submitting, and then the annual charge, $1,566 for each financial year once the product has had turnover. A listing that has never had turnover is exempt from the annual charge until sales start, as long as the sponsor declares each July that it had none in the year before; once the product has sold, the charge applies every year, even in a later year with no sales. Two more apply only in particular cases: a new ingredient that isn't yet in the TGA's Permissible Ingredients Determination, which costs $19,826 to $33,696 in TGA fees for its application and evaluation, and a GMP clearance for a factory overseas, $818 per manufacturer, site and sponsor. The full schedule, with variations and new indications, and the steps around each fee are in our TGA approval guide.","items":[],"tables":[]},{"heading":"What our work costs","anchor":"what-our-work-costs","markdown":"Each stage is a fixed fee for a defined outcome, paid before the stage begins. Manufacturing is priced per unit on a formal quote: half with your purchase order, half before dispatch. We take you through the investment on the strategy call, for your product.\n\nYou can stop at the end of the Design phase with no obligation to have us manage the manufacture, and the formulation is yours to take anywhere. If you go into production with us, the agreement covers your first three production orders.","text":"Each stage is a fixed fee for a defined outcome, paid before the stage begins. Manufacturing is priced per unit on a formal quote: half with your purchase order, half before dispatch. We take you through the investment on the strategy call, for your product. You can stop at the end of the Design phase with no obligation to have us manage the manufacture, and the formulation is yours to take anywhere. If you go into production with us, the agreement covers your first three production orders.","items":[],"tables":[]},{"heading":"The minimum order","anchor":"the-minimum-order","markdown":"The minimum is 3,000 finished retail packs per batch, made in one run, whatever the format, for TGA-listed medicines and foods alike. So the first run's manufacturing cost is the unit price on the quote multiplied by at least 3,000.\n\nPackaging has minimums of its own. Each pack format has a minimum from the packaging supplier, and single-serve sachets typically need around 150,000 sachets, so a tub or pouch is usually the better format to launch with. Splitting one batch across two formats is sometimes possible, and we look at it for each product.","text":"The minimum is 3,000 finished retail packs per batch, made in one run, whatever the format, for TGA-listed medicines and foods alike. So the first run's manufacturing cost is the unit price on the quote multiplied by at least 3,000. Packaging has minimums of its own. Each pack format has a minimum from the packaging supplier, and single-serve sachets typically need around 150,000 sachets, so a tub or pouch is usually the better format to launch with. Splitting one batch across two formats is sometimes possible, and we look at it for each product.","items":[],"tables":[]},{"heading":"Design to the price: the cost of goods","anchor":"design-to-the-price-the-cost-of-goods","markdown":"The formula is built to the price the product has to sell at, not costed after it. As a rule of thumb, divide the retail price by four or five to get the target cost of goods, packaging included. At a retail price of $60, for example, that is $12 to $15 a unit.\n\nAt that level, direct-to-consumer brands typically keep about 80% gross margin, and brands selling through pharmacies and health food stores about 60%. The quote confirms the cost of goods before you order, so the margin is known before anything is made.","text":"The formula is built to the price the product has to sell at, not costed after it. As a rule of thumb, divide the retail price by four or five to get the target cost of goods, packaging included. At a retail price of $60, for example, that is $12 to $15 a unit. At that level, direct-to-consumer brands typically keep about 80% gross margin, and brands selling through pharmacies and health food stores about 60%. The quote confirms the cost of goods before you order, so the margin is known before anything is made.","items":[],"tables":[]},{"heading":"What adds to the cost","anchor":"what-adds-to-the-cost","markdown":"- **Bespoke packaging.** A custom pack adds about three months. Standard bottles, pouches and tubs are faster, and we can use your own pack if you have one. See [packaging](/packaging).\n- **A format with high minimums.** Single-serve sachets typically need around 150,000 sachets, and effervescent tablets need very large batches. More in [formats](/formats).\n- **Another round of changes.** A second round on the formula or the sample adds time to the stage it happens in.\n- **A new ingredient.** One that isn't yet permitted needs the TGA's own evaluation first: $19,826 to $33,696 in TGA fees, and 40 working days for a preliminary assessment, then 70 to 180 working days for the evaluation. See [new ingredients](/guides/permissible-ingredients) and [how long it takes](/guides/supplement-development-timeline).\n- **A longer shelf life.** 24 months is standard for a listed medicine; 36 months is possible with the right stability program, which runs for the length of the shelf life on the label. See [stability testing](/guides/stability-testing).\n- **A factory overseas.** A listed medicine made overseas needs a TGA GMP clearance for the site, applied for by the Australian sponsor; the processing fee is $818, and compliance verification or a TGA inspection can add to it. See [GMP clearance](/guides/gmp-clearance).","text":"Bespoke packaging. A custom pack adds about three months. Standard bottles, pouches and tubs are faster, and we can use your own pack if you have one. See packaging. A format with high minimums. Single-serve sachets typically need around 150,000 sachets, and effervescent tablets need very large batches. More in formats. Another round of changes. A second round on the formula or the sample adds time to the stage it happens in. A new ingredient. One that isn't yet permitted needs the TGA's own evaluation first: $19,826 to $33,696 in TGA fees, and 40 working days for a preliminary assessment, then 70 to 180 working days for the evaluation. See new ingredients and how long it takes. A longer shelf life. 24 months is standard for a listed medicine; 36 months is possible with the right stability program, which runs for the length of the shelf life on the label. See stability testing. A factory overseas. A listed medicine made overseas needs a TGA GMP clearance for the site, applied for by the Australian sponsor; the processing fee is $818, and compliance verification or a TGA inspection can add to it. See GMP clearance.","items":[{"lead":"Bespoke packaging.","text":"A custom pack adds about three months. Standard bottles, pouches and tubs are faster, and we can use your own pack if you have one. See packaging."},{"lead":"A format with high minimums.","text":"Single-serve sachets typically need around 150,000 sachets, and effervescent tablets need very large batches. More in formats."},{"lead":"Another round of changes.","text":"A second round on the formula or the sample adds time to the stage it happens in."},{"lead":"A new ingredient.","text":"One that isn't yet permitted needs the TGA's own evaluation first: $19,826 to $33,696 in TGA fees, and 40 working days for a preliminary assessment, then 70 to 180 working days for the evaluation. See new ingredients and how long it takes."},{"lead":"A longer shelf life.","text":"24 months is standard for a listed medicine; 36 months is possible with the right stability program, which runs for the length of the shelf life on the label. See stability testing."},{"lead":"A factory overseas.","text":"A listed medicine made overseas needs a TGA GMP clearance for the site, applied for by the Australian sponsor; the processing fee is $818, and compliance verification or a TGA inspection can add to it. See GMP clearance."}],"tables":[]},{"heading":"Foods and cosmetics","anchor":"foods-and-cosmetics","markdown":"A product on the food pathway pays no TGA listing fee or annual charge, because it isn't entered on the ARTG: it must comply with the Food Standards Code instead, and give up therapeutic claims. See [supplements as foods](/pathways/foods).\n\nA cosmetic needs no TGA entry either. The business that imports cosmetics or their ingredients, or makes the chemicals in them, registers with AICIS for each year it does: $85 to $3,585 for the 2026–27 registration year, depending on the value of chemicals introduced the year before. See [AICIS registration](/guides/aicis-registration).\n\nWhich pathway a product takes depends mostly on how it is presented, starting with its claims, and it changes the costs above. See [medicine, food or cosmetic?](/pathways)","text":"A product on the food pathway pays no TGA listing fee or annual charge, because it isn't entered on the ARTG: it must comply with the Food Standards Code instead, and give up therapeutic claims. See supplements as foods. A cosmetic needs no TGA entry either. The business that imports cosmetics or their ingredients, or makes the chemicals in them, registers with AICIS for each year it does: $85 to $3,585 for the 2026–27 registration year, depending on the value of chemicals introduced the year before. See AICIS registration. Which pathway a product takes depends mostly on how it is presented, starting with its claims, and it changes the costs above. See medicine, food or cosmetic?","items":[],"tables":[]},{"heading":"After launch","anchor":"after-launch","markdown":"The annual TGA charge continues each financial year, the stability program keeps running for the shelf life on the label, and every TGA-listed batch is third-party tested before release. We manage reorders and update the listing and the label when the product changes ([reformulating a supplement](/guides/reformulating-a-supplement)). Long partnerships tend to be ranges: [BWellness](/work/bwellness-practitioner-range) has had five production batches since 2021 and nine products developed with us. More in [extending a supplement range](/guides/extending-a-supplement-range).","text":"The annual TGA charge continues each financial year, the stability program keeps running for the shelf life on the label, and every TGA-listed batch is third-party tested before release. We manage reorders and update the listing and the label when the product changes (reformulating a supplement). Long partnerships tend to be ranges: BWellness has had five production batches since 2021 and nine products developed with us. More in extending a supplement range.","items":[],"tables":[]}],"faqs":[{"q":"How much does it cost to develop a supplement in Australia?","a":"It depends on the formula, the format and the pathway, but the costs fall into four parts: the development work (fixed fees for each stage), the TGA's fees (for a listed medicine in 2026–27, $1,063 to list it, then $1,566 a year once it has had turnover), the first production run (priced per unit, at least 3,000 packs) and what continues after launch: the annual charge, stability testing and reorders.","md":"It depends on the formula, the format and the pathway, but the costs fall into four parts: the development work (fixed fees for each stage), the TGA's fees (for a listed medicine in 2026–27, $1,063 to list it, then $1,566 a year once it has had turnover), the first production run (priced per unit, at least 3,000 packs) and what continues after launch: the annual charge, stability testing and reorders."},{"q":"Is a food cheaper to launch than a listed medicine?","a":"A food pays no TGA listing fee or annual charge, because it isn't entered on the ARTG, but it gives up therapeutic claims and every ingredient must be permitted in food, at food levels. The development work, the label and manufacturing remain, and with us the minimum order is the same: 3,000 finished retail packs per batch.","md":"A food pays no TGA listing fee or annual charge, because it isn't entered on the ARTG, but it gives up therapeutic claims and every ingredient must be permitted in food, at food levels. The development work, the label and manufacturing remain, and with us the minimum order is the same: 3,000 finished retail packs per batch."},{"q":"What is the minimum order for a supplement?","a":"With us, 3,000 finished retail packs per batch, made in one run, whatever the format. Packaging has its own minimums: single-serve sachets typically need around 150,000 sachets, so a tub or pouch is usually the better format to launch with.","md":"With us, 3,000 finished retail packs per batch, made in one run, whatever the format. Packaging has its own minimums: single-serve sachets typically need around 150,000 sachets, so a tub or pouch is usually the better format to launch with."},{"q":"How do I work out a target cost of goods?","a":"Divide the retail price by four or five, packaging included. Direct-to-consumer brands at that level typically keep about 80% gross margin, and brands selling through pharmacies and health food stores about 60%. The formula is designed to that target, and the quote confirms it before you order.","md":"Divide the retail price by four or five, packaging included. Direct-to-consumer brands at that level typically keep about 80% gross margin, and brands selling through pharmacies and health food stores about 60%. The formula is designed to that target, and the quote confirms it before you order."},{"q":"How is product development paid for?","a":"With us, each stage is a fixed fee for a defined outcome, paid before the stage begins, and manufacturing is priced per unit on a formal quote, half with the purchase order and half before dispatch.","md":"With us, each stage is a fixed fee for a defined outcome, paid before the stage begins, and manufacturing is priced per unit on a formal quote, half with the purchase order and half before dispatch."},{"q":"What costs continue after launch?","a":"The TGA's annual charge for a listed medicine, the stability program for the shelf life on the label, testing of each batch before release, and reorders. Changing the product later can mean varying the listing ($537 in 2026–27) and updating the label.","md":"The TGA's annual charge for a listed medicine, the stability program for the shelf life on the label, testing of each batch before release, and reorders. Changing the product later can mean varying the listing ($537 in 2026–27) and updating the label."}],"sources":{"note":"General information, checked against these sources on 22 and 23 October 2026. It isn't advice on a particular product. Minimums, payment terms, timings and the cost-of-goods rule of thumb are from Take Friday Off's records.","markdown":"General information, checked against these sources on 22 and 23 October 2026. It isn't advice on a particular product. Minimums, payment terms, timings and the cost-of-goods rule of thumb are from Take Friday Off's records.\n\n- [Fees and charges: summary, from 1 July 2026](https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf), Therapeutic Goods Administration\n- [General guidance for listed medicines](https://www.tga.gov.au/sites/default/files/general_guidance_for_listed_medicines_formerly_argcm_part_b.pdf), version 1.0, May 2020 (when the application fee is due), Therapeutic Goods Administration\n- [Annual charges](https://www.tga.gov.au/products/regulations-all-products/fees-and-payments/annual-charges) and the [annual charge exemption scheme FAQ](https://www.tga.gov.au/products/regulations-all-products/fees-and-payments/annual-charge-exemption-scheme-therapeutic-goods/annual-charge-exemption-scheme-frequently-asked-questions), Therapeutic Goods Administration\n- [Application requirements for new substances in listed medicines](https://www.tga.gov.au/resources/resource/guidance/application-requirements-new-substances-listed-medicines), Therapeutic Goods Administration\n- [Manufacturing therapeutic goods](https://www.tga.gov.au/products/regulations-all-products/manufacturing), Therapeutic Goods Administration\n- [Food Standards Code](https://www.foodstandards.gov.au/food-standards-code), Food Standards Australia New Zealand\n- [How much is my registration cost?](https://www.industrialchemicals.gov.au/business/registration-hub/how-much-my-registration-cost), Australian Industrial Chemicals Introduction Scheme","items":[{"text":"Fees and charges: summary, from 1 July 2026, Therapeutic Goods Administration","links":[{"title":"Fees and charges: summary, from 1 July 2026","url":"https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf"}]},{"text":"General guidance for listed medicines, version 1.0, May 2020 (when the application fee is due), Therapeutic Goods Administration","links":[{"title":"General guidance for listed medicines","url":"https://www.tga.gov.au/sites/default/files/general_guidance_for_listed_medicines_formerly_argcm_part_b.pdf"}]},{"text":"Annual charges and the annual charge exemption scheme FAQ, Therapeutic Goods Administration","links":[{"title":"Annual charges","url":"https://www.tga.gov.au/products/regulations-all-products/fees-and-payments/annual-charges"},{"title":"annual charge exemption scheme FAQ","url":"https://www.tga.gov.au/products/regulations-all-products/fees-and-payments/annual-charge-exemption-scheme-therapeutic-goods/annual-charge-exemption-scheme-frequently-asked-questions"}]},{"text":"Application requirements for new substances in listed medicines, Therapeutic Goods Administration","links":[{"title":"Application requirements for new substances in listed medicines","url":"https://www.tga.gov.au/resources/resource/guidance/application-requirements-new-substances-listed-medicines"}]},{"text":"Manufacturing therapeutic goods, Therapeutic Goods Administration","links":[{"title":"Manufacturing therapeutic goods","url":"https://www.tga.gov.au/products/regulations-all-products/manufacturing"}]},{"text":"Food Standards Code, Food Standards Australia New Zealand","links":[{"title":"Food Standards Code","url":"https://www.foodstandards.gov.au/food-standards-code"}]},{"text":"How much is my registration cost?, Australian Industrial Chemicals Introduction Scheme","links":[{"title":"How much is my registration cost?","url":"https://www.industrialchemicals.gov.au/business/registration-hub/how-much-my-registration-cost"}]}]}},{"slug":"permissible-ingredients","kind":"guide","url":"/guides/permissible-ingredients","title":"Permissible ingredients: getting a new ingredient approved for listed medicines","name":"New ingredients guide","description":"How a new ingredient gets into the TGA's Permissible Ingredients Determination: IN1 to IN4 applications, the data, 2026–27 fees, timeframes and exclusivity.","eyebrow":"Guide","lead":"A listed medicine can only contain ingredients in the Therapeutic Goods (Permissible Ingredients) Determination, used for the purposes and within the limits it sets. An ingredient that isn't in it, or one wanted at a higher level, by another route or in a new role, needs an application to the TGA first. This guide covers what needs one, the four application levels (IN1 to IN4), the data the TGA expects, the 2026–27 fees, the legislated timeframes and the two years of exclusive use a successful applicant can opt into.","parent":"/pathways/listed-medicines","studies":["everleanbody-saffron-capsule","vitable-hair-growth-range","prenatal-multivitamin-capsule"],"formats":[],"order":67,"updated":"2026-10-22","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- A listed medicine, AUST L or AUST L(A), can only contain ingredients in the Permissible Ingredients Determination. The current one, the third of 2026, commenced on 16 October 2026, and the TGA updates the list at least quarterly.\n- A new substance needs an application to the TGA, and so does a new role or a change to an ingredient's requirements, such as a higher permitted level or a new route of administration.\n- There are four application levels, IN1 to IN4. The more of the safety and quality case that rests on an evaluation by a comparable overseas regulator, or on a published monograph, the less the TGA evaluates itself and the shorter the timeframe.\n- In 2026–27 the TGA's fees are $19,826 for an IN1 or IN2 application and $33,696 for IN3 or IN4. The law allows 40 working days for a preliminary assessment, then 70 to 180 working days for the evaluation, not counting time the clock is stopped.\n- A successful applicant for a new ingredient can opt in, when it applies, to two years of exclusive use.","text":"A listed medicine, AUST L or AUST L(A), can only contain ingredients in the Permissible Ingredients Determination. The current one, the third of 2026, commenced on 16 October 2026, and the TGA updates the list at least quarterly. A new substance needs an application to the TGA, and so does a new role or a change to an ingredient's requirements, such as a higher permitted level or a new route of administration. There are four application levels, IN1 to IN4. The more of the safety and quality case that rests on an evaluation by a comparable overseas regulator, or on a published monograph, the less the TGA evaluates itself and the shorter the timeframe. In 2026–27 the TGA's fees are $19,826 for an IN1 or IN2 application and $33,696 for IN3 or IN4. The law allows 40 working days for a preliminary assessment, then 70 to 180 working days for the evaluation, not counting time the clock is stopped. A successful applicant for a new ingredient can opt in, when it applies, to two years of exclusive use.","items":[],"tables":[]},{"heading":"What needs an application","anchor":"what-needs-an-application","markdown":"In the TGA's words, all listed medicines, \"AUST L listed medicines, and AUST L(A) assessed listed medicines\", may only contain ingredients included in the Therapeutic Goods (Permissible Ingredients) Determination. Its requirements apply too: each ingredient can only be used for the purposes and within the limits the Determination sets.\n\nSo an application is needed for:\n\n- **A new substance,** one not in the Determination at all.\n- **A new role for a permitted ingredient,** such as an ingredient permitted as an excipient that you want to use as an active.\n- **A change to its requirements,** such as a higher permitted level of use or a new route of administration.\n\nGenerally, a substance can only be evaluated if it isn't a prohibited import and isn't, nor are its components, in a Schedule to the Poisons Standard.\n\nThe Determination changes often: the current one is the third of 2026, and the TGA says updates to listed medicine ingredients \"occur quarterly at minimum\". Checking every ingredient, its form and its dose against the current Determination is step 2 of [an AUST L listing](/guides/tga-approval#the-steps-to-an-aust-l-listing).","text":"In the TGA's words, all listed medicines, \"AUST L listed medicines, and AUST L(A) assessed listed medicines\", may only contain ingredients included in the Therapeutic Goods (Permissible Ingredients) Determination. Its requirements apply too: each ingredient can only be used for the purposes and within the limits the Determination sets. So an application is needed for: A new substance, one not in the Determination at all. A new role for a permitted ingredient, such as an ingredient permitted as an excipient that you want to use as an active. A change to its requirements, such as a higher permitted level of use or a new route of administration. Generally, a substance can only be evaluated if it isn't a prohibited import and isn't, nor are its components, in a Schedule to the Poisons Standard. The Determination changes often: the current one is the third of 2026, and the TGA says updates to listed medicine ingredients \"occur quarterly at minimum\". Checking every ingredient, its form and its dose against the current Determination is step 2 of an AUST L listing.","items":[{"lead":"A new substance,","text":"one not in the Determination at all."},{"lead":"A new role for a permitted ingredient,","text":"such as an ingredient permitted as an excipient that you want to use as an active."},{"lead":"A change to its requirements,","text":"such as a higher permitted level of use or a new route of administration."}],"tables":[]},{"heading":"The four application levels","anchor":"the-four-application-levels","markdown":"The level depends on whose evaluation the safety and quality case rests on. Where an applicant can provide an unredacted evaluation report from a comparable overseas body (a regulator on the TGA's list), or the ingredient's quality is set by a monograph in a default standard, the TGA asks for less supporting information and the timeframe is shorter.\n\n| Level | Safety | Quality |\n| --- | --- | --- |\n| IN1 | From a comparable overseas body's evaluation report | From a comparable overseas body's evaluation report, or a monograph in a default standard |\n| IN2 | From a comparable overseas body's evaluation report | Evaluated by the TGA |\n| IN3 | Evaluated by the TGA | From a comparable overseas body's evaluation report, or a monograph in a default standard |\n| IN4 | Evaluated by the TGA | Evaluated by the TGA |\n\nThe applicant selects the level, and the TGA confirms it during the preliminary assessment. The ingredient should be equivalent to the one the overseas body evaluated: the TGA's guidance on using those reports says any differences \"must be clearly justified\".","text":"The level depends on whose evaluation the safety and quality case rests on. Where an applicant can provide an unredacted evaluation report from a comparable overseas body (a regulator on the TGA's list), or the ingredient's quality is set by a monograph in a default standard, the TGA asks for less supporting information and the timeframe is shorter. Level: IN1; Safety: From a comparable overseas body's evaluation report; Quality: From a comparable overseas body's evaluation report, or a monograph in a default standard. Level: IN2; Safety: From a comparable overseas body's evaluation report; Quality: Evaluated by the TGA. Level: IN3; Safety: Evaluated by the TGA; Quality: From a comparable overseas body's evaluation report, or a monograph in a default standard. Level: IN4; Safety: Evaluated by the TGA; Quality: Evaluated by the TGA. The applicant selects the level, and the TGA confirms it during the preliminary assessment. The ingredient should be equivalent to the one the overseas body evaluated: the TGA's guidance on using those reports says any differences \"must be clearly justified\".","items":[],"tables":[{"header":["Level","Safety","Quality"],"rows":[["IN1","From a comparable overseas body's evaluation report","From a comparable overseas body's evaluation report, or a monograph in a default standard"],["IN2","From a comparable overseas body's evaluation report","Evaluated by the TGA"],["IN3","Evaluated by the TGA","From a comparable overseas body's evaluation report, or a monograph in a default standard"],["IN4","Evaluated by the TGA","Evaluated by the TGA"]]}]},{"heading":"The steps","anchor":"the-steps","markdown":"1. **A name first, if it needs one.** If the substance has no approved name that can be selected from the TGA's approved names list, a proposal for a new name comes before the application.\n2. **A pre-submission meeting, if you want one.** It is optional and has no fee, and the TGA may answer the questions in writing instead.\n3. **Lodge the whole dossier.** The application form goes in through TGA Business Services with the dossier for the chosen level and the application fee. The TGA asks for all the data at lodgement: leaving relevant data out can stop the application being accepted, and it doesn't accept unsolicited data later.\n4. **Preliminary assessment.** Within 40 working days the TGA identifies any critical deficiencies, confirms the level and says in writing whether the application goes to evaluation. If it does, an invoice for the evaluation fee follows, and the application lapses if it isn't paid within two months.\n5. **Evaluation.** It starts once the evaluation fee is paid. The TGA can ask for more information, and the clock stops while the applicant answers.\n6. **Recommendation and decision.** The TGA recommends whether the substance should be added, and a delegate of the Minister decides whether to vary the Determination. Once it is varied, the ingredient can be used in listed medicines. A refusal to recommend can be appealed under section 60 of the Act.\n\nAnyone can apply: the TGA describes the applicant as someone \"who may or may not be a medicine sponsor\", so an ingredient supplier can apply as well as a brand.","text":"A name first, if it needs one. If the substance has no approved name that can be selected from the TGA's approved names list, a proposal for a new name comes before the application. A pre-submission meeting, if you want one. It is optional and has no fee, and the TGA may answer the questions in writing instead. Lodge the whole dossier. The application form goes in through TGA Business Services with the dossier for the chosen level and the application fee. The TGA asks for all the data at lodgement: leaving relevant data out can stop the application being accepted, and it doesn't accept unsolicited data later. Preliminary assessment. Within 40 working days the TGA identifies any critical deficiencies, confirms the level and says in writing whether the application goes to evaluation. If it does, an invoice for the evaluation fee follows, and the application lapses if it isn't paid within two months. Evaluation. It starts once the evaluation fee is paid. The TGA can ask for more information, and the clock stops while the applicant answers. Recommendation and decision. The TGA recommends whether the substance should be added, and a delegate of the Minister decides whether to vary the Determination. Once it is varied, the ingredient can be used in listed medicines. A refusal to recommend can be appealed under section 60 of the Act. Anyone can apply: the TGA describes the applicant as someone \"who may or may not be a medicine sponsor\", so an ingredient supplier can apply as well as a brand.","items":[{"lead":"A name first, if it needs one.","text":"If the substance has no approved name that can be selected from the TGA's approved names list, a proposal for a new name comes before the application."},{"lead":"A pre-submission meeting, if you want one.","text":"It is optional and has no fee, and the TGA may answer the questions in writing instead."},{"lead":"Lodge the whole dossier.","text":"The application form goes in through TGA Business Services with the dossier for the chosen level and the application fee. The TGA asks for all the data at lodgement: leaving relevant data out can stop the application being accepted, and it doesn't accept unsolicited data later."},{"lead":"Preliminary assessment.","text":"Within 40 working days the TGA identifies any critical deficiencies, confirms the level and says in writing whether the application goes to evaluation. If it does, an invoice for the evaluation fee follows, and the application lapses if it isn't paid within two months."},{"lead":"Evaluation.","text":"It starts once the evaluation fee is paid. The TGA can ask for more information, and the clock stops while the applicant answers."},{"lead":"Recommendation and decision.","text":"The TGA recommends whether the substance should be added, and a delegate of the Minister decides whether to vary the Determination. Once it is varied, the ingredient can be used in listed medicines. A refusal to recommend can be appealed under section 60 of the Act."}],"tables":[]},{"heading":"What the dossier needs","anchor":"what-the-dossier-needs","markdown":"**Quality.** Unless a monograph in a default standard covers the ingredient, its specifications are set out in a compositional guideline, and the TGA publishes compositional guidelines on its website. The TGA asks for batch analyses of at least two commercial-scale batches of an active ingredient, specifications that cover all known or likely impurities and incidental constituents, and real-time and accelerated stability data for two commercial-scale batches.\n\n**Safety.** The dossier needs a systematic literature search, with its search strategy, and a history of use that establishes how much of the substance people are already exposed to. Safety data sheets alone aren't acceptable. Well-established use in food can support safety, with any reference in the Food Standards Code, but the TGA notes that food regulation generally has no pre-market evaluation or system for reporting adverse reactions.\n\n**Efficacy.** Not part of an ingredient application. Evidence for the claims comes later: when a medicine using the ingredient is listed, its sponsor certifies that it holds evidence for every indication. More in our [claims and indications guide](/guides/permitted-indications).","text":"Quality. Unless a monograph in a default standard covers the ingredient, its specifications are set out in a compositional guideline, and the TGA publishes compositional guidelines on its website. The TGA asks for batch analyses of at least two commercial-scale batches of an active ingredient, specifications that cover all known or likely impurities and incidental constituents, and real-time and accelerated stability data for two commercial-scale batches. Safety. The dossier needs a systematic literature search, with its search strategy, and a history of use that establishes how much of the substance people are already exposed to. Safety data sheets alone aren't acceptable. Well-established use in food can support safety, with any reference in the Food Standards Code, but the TGA notes that food regulation generally has no pre-market evaluation or system for reporting adverse reactions. Efficacy. Not part of an ingredient application. Evidence for the claims comes later: when a medicine using the ingredient is listed, its sponsor certifies that it holds evidence for every indication. More in our claims and indications guide.","items":[],"tables":[]},{"heading":"Fees and timeframes for 2026–27","anchor":"fees-and-timeframes-for-202627","markdown":"| Level | Application fee | Evaluation fee | Preliminary assessment | Evaluation |\n| --- | --- | --- | --- | --- |\n| IN1 | $1,370 | $18,456 | 40 working days | 70 working days |\n| IN2 | $1,370 | $18,456 | 40 working days | 120 working days |\n| IN3 | $3,629 | $30,067 | 40 working days | 150 working days |\n| IN4 | $3,629 | $30,067 | 40 working days | 180 working days |\n\n- **Working days only.** The timeframes exclude weekends and public holidays, and the time the clock is stopped: while the applicant answers a formal request for information, or when the applicant and the TGA agree to stop it.\n- **The two phases run one after the other.** Added together, the legislated maximums come to 110 working days for IN1 and 220 for IN4 (22 to 44 weeks), before any clock stops, the two months to pay the evaluation invoice, a name proposal or the time it takes to prepare the dossier.\n- **Refunds.** The application fee isn't refunded if the application isn't accepted for evaluation, and the evaluation fee isn't refunded if the application is withdrawn during evaluation. If the TGA doesn't make its recommendation within the evaluation timeframe, it must refund 25% of the evaluation fee.\n\nThese are the TGA's fees only. Our [TGA listing guide](/guides/tga-approval#what-it-costs-tga-fees-for-202627) adds them up with the listing and the annual charge for a whole plan, and [what a supplement costs to develop](/guides/supplement-development-cost) covers the rest of the budget.","text":"Level: IN1; Application fee: $1,370; Evaluation fee: $18,456; Preliminary assessment: 40 working days; Evaluation: 70 working days. Level: IN2; Application fee: $1,370; Evaluation fee: $18,456; Preliminary assessment: 40 working days; Evaluation: 120 working days. Level: IN3; Application fee: $3,629; Evaluation fee: $30,067; Preliminary assessment: 40 working days; Evaluation: 150 working days. Level: IN4; Application fee: $3,629; Evaluation fee: $30,067; Preliminary assessment: 40 working days; Evaluation: 180 working days. Working days only. The timeframes exclude weekends and public holidays, and the time the clock is stopped: while the applicant answers a formal request for information, or when the applicant and the TGA agree to stop it. The two phases run one after the other. Added together, the legislated maximums come to 110 working days for IN1 and 220 for IN4 (22 to 44 weeks), before any clock stops, the two months to pay the evaluation invoice, a name proposal or the time it takes to prepare the dossier. Refunds. The application fee isn't refunded if the application isn't accepted for evaluation, and the evaluation fee isn't refunded if the application is withdrawn during evaluation. If the TGA doesn't make its recommendation within the evaluation timeframe, it must refund 25% of the evaluation fee. These are the TGA's fees only. Our TGA listing guide adds them up with the listing and the annual charge for a whole plan, and what a supplement costs to develop covers the rest of the budget.","items":[{"lead":"Working days only.","text":"The timeframes exclude weekends and public holidays, and the time the clock is stopped: while the applicant answers a formal request for information, or when the applicant and the TGA agree to stop it."},{"lead":"The two phases run one after the other.","text":"Added together, the legislated maximums come to 110 working days for IN1 and 220 for IN4 (22 to 44 weeks), before any clock stops, the two months to pay the evaluation invoice, a name proposal or the time it takes to prepare the dossier."},{"lead":"Refunds.","text":"The application fee isn't refunded if the application isn't accepted for evaluation, and the evaluation fee isn't refunded if the application is withdrawn during evaluation. If the TGA doesn't make its recommendation within the evaluation timeframe, it must refund 25% of the evaluation fee."}],"tables":[{"header":["Level","Application fee","Evaluation fee","Preliminary assessment","Evaluation"],"rows":[["IN1","$1,370","$18,456","40 working days","70 working days"],["IN2","$1,370","$18,456","40 working days","120 working days"],["IN3","$3,629","$30,067","40 working days","150 working days"],["IN4","$3,629","$30,067","40 working days","180 working days"]]}]},{"heading":"Two years of exclusive use","anchor":"two-years-of-exclusive-use","markdown":"A successful applicant for a new ingredient can ask for exclusive use of it. In the TGA's words, the Act \"allows the Minister to permit the successful applicant to have exclusive use of that ingredient for a 2 year period (the protected ingredient)\".\n\n- **It is optional, and you opt in when you apply.** The TGA puts it on the applicant to opt in at the time of the application.\n- **It runs for two calendar years** from the date the ingredient is included in the Determination. After that, any sponsor can use it.\n- **New ingredients only.** It doesn't apply to an application for a new role or a change to an ingredient's requirements, or to an ingredient evaluated as part of an application for a registered complementary medicine.\n- **The owner can authorise others.** The ingredient's owner and the sponsors it authorises are named in the Determination, by name and TGA client ID. The TGA won't step into disagreements between sponsors, manufacturers or suppliers.\n\nSo if an ingredient you want was added recently, check the Determination: its supplier may hold exclusive rights for a while yet.","text":"A successful applicant for a new ingredient can ask for exclusive use of it. In the TGA's words, the Act \"allows the Minister to permit the successful applicant to have exclusive use of that ingredient for a 2 year period (the protected ingredient)\". It is optional, and you opt in when you apply. The TGA puts it on the applicant to opt in at the time of the application. It runs for two calendar years from the date the ingredient is included in the Determination. After that, any sponsor can use it. New ingredients only. It doesn't apply to an application for a new role or a change to an ingredient's requirements, or to an ingredient evaluated as part of an application for a registered complementary medicine. The owner can authorise others. The ingredient's owner and the sponsors it authorises are named in the Determination, by name and TGA client ID. The TGA won't step into disagreements between sponsors, manufacturers or suppliers. So if an ingredient you want was added recently, check the Determination: its supplier may hold exclusive rights for a while yet.","items":[{"lead":"It is optional, and you opt in when you apply.","text":"The TGA puts it on the applicant to opt in at the time of the application."},{"lead":"It runs for two calendar years","text":"from the date the ingredient is included in the Determination. After that, any sponsor can use it."},{"lead":"New ingredients only.","text":"It doesn't apply to an application for a new role or a change to an ingredient's requirements, or to an ingredient evaluated as part of an application for a registered complementary medicine."},{"lead":"The owner can authorise others.","text":"The ingredient's owner and the sponsors it authorises are named in the Determination, by name and TGA client ID. The TGA won't step into disagreements between sponsors, manufacturers or suppliers."}],"tables":[]},{"heading":"If the ingredient isn't permitted yet","anchor":"if-the-ingredient-isnt-permitted-yet","markdown":"- **A permitted alternative.** Often the fastest route: another form of the ingredient, another ingredient for the same purpose, or a dose within the current limits.\n- **Apply, and plan the launch around it.** The evaluation sets the earliest date a listed medicine using the ingredient can go on the market, so the formula, the evidence and the label are prepared alongside it. See [how long it takes](/guides/supplement-development-timeline).\n- **Assessed listing is not a way round it.** The Determination lists the ingredients for listed and assessed listed medicines alike.\n- **Registration is a far bigger application.** For a registered medicine (AUST R), a new ingredient is typically evaluated as part of the application to enter the medicine on the ARTG.\n- **A food is a different question.** Whether a product can be a food depends on how it is presented, and its ingredients must then be permitted in food under the Food Standards Code. See [supplements as foods](/pathways/foods), and our [novel foods guide](/guides/novel-foods) for a food ingredient that is new.","text":"A permitted alternative. Often the fastest route: another form of the ingredient, another ingredient for the same purpose, or a dose within the current limits. Apply, and plan the launch around it. The evaluation sets the earliest date a listed medicine using the ingredient can go on the market, so the formula, the evidence and the label are prepared alongside it. See how long it takes. Assessed listing is not a way round it. The Determination lists the ingredients for listed and assessed listed medicines alike. Registration is a far bigger application. For a registered medicine (AUST R), a new ingredient is typically evaluated as part of the application to enter the medicine on the ARTG. A food is a different question. Whether a product can be a food depends on how it is presented, and its ingredients must then be permitted in food under the Food Standards Code. See supplements as foods, and our novel foods guide for a food ingredient that is new.","items":[{"lead":"A permitted alternative.","text":"Often the fastest route: another form of the ingredient, another ingredient for the same purpose, or a dose within the current limits."},{"lead":"Apply, and plan the launch around it.","text":"The evaluation sets the earliest date a listed medicine using the ingredient can go on the market, so the formula, the evidence and the label are prepared alongside it. See how long it takes."},{"lead":"Assessed listing is not a way round it.","text":"The Determination lists the ingredients for listed and assessed listed medicines alike."},{"lead":"Registration is a far bigger application.","text":"For a registered medicine (AUST R), a new ingredient is typically evaluated as part of the application to enter the medicine on the ARTG."},{"lead":"A food is a different question.","text":"Whether a product can be a food depends on how it is presented, and its ingredients must then be permitted in food under the Food Standards Code. See supplements as foods, and our novel foods guide for a food ingredient that is new."}],"tables":[]},{"heading":"Where we come in","anchor":"where-we-come-in","markdown":"We design the formula inside the permitted ingredients, with every ingredient, its form and its dose checked against the current Determination before anything is quoted. If the ingredient you want isn't allowed yet, we'll tell you what's realistic, then manage the application ([new ingredient applications](/new-ingredients)) or find the permitted alternative. Our formulation comes with early access to new ingredients through our global ingredient network, and our formulas are built on clinically studied ones: affron® saffron for [EverLeanBody](/work/everleanbody-saffron-capsule), and AnaGain™ under licence for [Vitable](/work/vitable-hair-growth-range). More on [formulation](/formulation), or [book a call](/contact).","text":"We design the formula inside the permitted ingredients, with every ingredient, its form and its dose checked against the current Determination before anything is quoted. If the ingredient you want isn't allowed yet, we'll tell you what's realistic, then manage the application (new ingredient applications) or find the permitted alternative. Our formulation comes with early access to new ingredients through our global ingredient network, and our formulas are built on clinically studied ones: affron® saffron for EverLeanBody, and AnaGain™ under licence for Vitable. More on formulation, or book a call.","items":[],"tables":[]}],"faqs":[{"q":"Can I use an ingredient that isn't in the Permissible Ingredients Determination?","a":"Not in a listed medicine. Every ingredient in an AUST L or AUST L(A) medicine must be in the Determination and used within its requirements. An ingredient that isn't there needs an application to the TGA first, and so does a new role for a permitted one or a change to its requirements, such as a higher level of use.","md":"Not in a listed medicine. Every ingredient in an AUST L or AUST L(A) medicine must be in the Determination and used within its requirements. An ingredient that isn't there needs an application to the TGA first, and so does a new role for a permitted one or a change to its requirements, such as a higher level of use."},{"q":"How much does a new ingredient application cost?","a":"In 2026–27 the TGA charges an application fee and an evaluation fee: $1,370 and $18,456 for IN1 or IN2, so $19,826 in all, and $3,629 and $30,067 for IN3 or IN4, so $33,696. The application fee isn't refunded if the application isn't accepted for evaluation.","md":"In 2026–27 the TGA charges an application fee and an evaluation fee: $1,370 and $18,456 for IN1 or IN2, so $19,826 in all, and $3,629 and $30,067 for IN3 or IN4, so $33,696. The application fee isn't refunded if the application isn't accepted for evaluation."},{"q":"How long does it take to get a new ingredient approved?","a":"The law allows the TGA 40 working days for a preliminary assessment, then 70 working days to evaluate an IN1 application, 120 for IN2, 150 for IN3 and 180 for IN4. The timeframes exclude weekends, public holidays and the time the clock is stopped, such as while the applicant answers a request for information.","md":"The law allows the TGA 40 working days for a preliminary assessment, then 70 working days to evaluate an IN1 application, 120 for IN2, 150 for IN3 and 180 for IN4. The timeframes exclude weekends, public holidays and the time the clock is stopped, such as while the applicant answers a request for information."},{"q":"What is the difference between IN1, IN2, IN3 and IN4?","a":"Who evaluates the safety and quality case. IN1 rests on an evaluation by a comparable overseas body for both, with quality also possible from a published monograph; IN2 on an overseas evaluation of safety, with the TGA evaluating quality; IN3 on the TGA's own evaluation of safety; and IN4 on the TGA's own evaluation of both.","md":"Who evaluates the safety and quality case. IN1 rests on an evaluation by a comparable overseas body for both, with quality also possible from a published monograph; IN2 on an overseas evaluation of safety, with the TGA evaluating quality; IN3 on the TGA's own evaluation of safety; and IN4 on the TGA's own evaluation of both."},{"q":"Who can apply to add a new ingredient?","a":"Any person. The TGA describes the applicant as someone \"who may or may not be a medicine sponsor\", so an ingredient supplier or manufacturer can apply as well as a brand.","md":"Any person. The TGA describes the applicant as someone \"who may or may not be a medicine sponsor\", so an ingredient supplier or manufacturer can apply as well as a brand."},{"q":"Can I get exclusive use of a new ingredient?","a":"Yes, for two years, if you opt in when you apply and the ingredient is new. The two years start when the ingredient is included in the Determination, and the owner can authorise other sponsors to use it in that time.","md":"Yes, for two years, if you opt in when you apply and the ingredient is new. The two years start when the ingredient is included in the Determination, and the owner can authorise other sponsors to use it in that time."},{"q":"Does approval overseas, or use in food, help?","a":"It can. An evaluation report from a comparable overseas body can make an application eligible for IN1, IN2 or IN3, with less supporting information and a shorter timeframe, if the ingredient is equivalent to the one it evaluated, or any differences are justified. Well-established use in food can support the safety case, but doesn't replace it.","md":"It can. An evaluation report from a comparable overseas body can make an application eligible for IN1, IN2 or IN3, with less supporting information and a shorter timeframe, if the ingredient is equivalent to the one it evaluated, or any differences are justified. Well-established use in food can support the safety case, but doesn't replace it."}],"sources":{"note":"General information, checked against these sources on 22 October 2026. It isn't advice on a particular product. Our approach to ingredients is from Take Friday Off's records.","markdown":"General information, checked against these sources on 22 October 2026. It isn't advice on a particular product. Our approach to ingredients is from Take Friday Off's records.\n\n- [Application requirements for new substances in listed medicines](https://www.tga.gov.au/resources/resource/guidance/application-requirements-new-substances-listed-medicines), Therapeutic Goods Administration\n- [Guidance on using evaluation reports from comparable overseas bodies](https://www.tga.gov.au/sites/default/files/2022-11/guidance-using-evaluation-reports-comparable-overseas-bodies.pdf), Therapeutic Goods Administration\n- [Mandatory requirements for an application to vary the Permissible Ingredients Determination](https://www.tga.gov.au/sites/default/files/2023-01/mandatory-requirements-for-an-application-to-vary-the-permissible-ingredients-determination.pdf), Therapeutic Goods Administration, February 2023\n- [Fees and charges: summary, from 1 July 2026](https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf), Therapeutic Goods Administration\n- [Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026](https://www.legislation.gov.au/F2026L01382/asmade/versions), Federal Register of Legislation\n- [About the Permissible Ingredients Determination](https://tga.gov.au/node/290205) and [Updates to listed medicine ingredients](https://www.tga.gov.au/products/medicines/listed-medicines/overview/updates-listed-medicine-ingredients), Therapeutic Goods Administration\n- [Therapeutic Goods Regulations 1990](https://www.legislation.gov.au/F1996B00406/latest/text), regulation 2 (the application levels), and the [explanatory statement](https://www.legislation.gov.au/F2023L00054/asmade/2023-01-24/es/original/pdf) to the 2023 amendment, Federal Register of Legislation\n- [Therapeutic Goods Amendment (2017 Measures No. 1) Act 2018](https://legislation.gov.au/C2018A00007/asmade/2018-03-05/text/original/pdf), Federal Register of Legislation, and [MMDR complementary medicine regulatory reforms](https://www.tga.gov.au/news/news-articles/mmdr-complementary-medicine-regulatory-reforms), Therapeutic Goods Administration\n- [Ingredients](https://www.tga.gov.au/node/414479), Therapeutic Goods Administration","items":[{"text":"Application requirements for new substances in listed medicines, Therapeutic Goods Administration","links":[{"title":"Application requirements for new substances in listed medicines","url":"https://www.tga.gov.au/resources/resource/guidance/application-requirements-new-substances-listed-medicines"}]},{"text":"Guidance on using evaluation reports from comparable overseas bodies, Therapeutic Goods Administration","links":[{"title":"Guidance on using evaluation reports from comparable overseas bodies","url":"https://www.tga.gov.au/sites/default/files/2022-11/guidance-using-evaluation-reports-comparable-overseas-bodies.pdf"}]},{"text":"Mandatory requirements for an application to vary the Permissible Ingredients Determination, Therapeutic Goods Administration, February 2023","links":[{"title":"Mandatory requirements for an application to vary the Permissible Ingredients Determination","url":"https://www.tga.gov.au/sites/default/files/2023-01/mandatory-requirements-for-an-application-to-vary-the-permissible-ingredients-determination.pdf"}]},{"text":"Fees and charges: summary, from 1 July 2026, Therapeutic Goods Administration","links":[{"title":"Fees and charges: summary, from 1 July 2026","url":"https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf"}]},{"text":"Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026","url":"https://www.legislation.gov.au/F2026L01382/asmade/versions"}]},{"text":"About the Permissible Ingredients Determination and Updates to listed medicine ingredients, Therapeutic Goods Administration","links":[{"title":"About the Permissible Ingredients Determination","url":"https://tga.gov.au/node/290205"},{"title":"Updates to listed medicine ingredients","url":"https://www.tga.gov.au/products/medicines/listed-medicines/overview/updates-listed-medicine-ingredients"}]},{"text":"Therapeutic Goods Regulations 1990, regulation 2 (the application levels), and the explanatory statement to the 2023 amendment, Federal Register of Legislation","links":[{"title":"Therapeutic Goods Regulations 1990","url":"https://www.legislation.gov.au/F1996B00406/latest/text"},{"title":"explanatory statement","url":"https://www.legislation.gov.au/F2023L00054/asmade/2023-01-24/es/original/pdf"}]},{"text":"Therapeutic Goods Amendment (2017 Measures No. 1) Act 2018, Federal Register of Legislation, and MMDR complementary medicine regulatory reforms, Therapeutic Goods Administration","links":[{"title":"Therapeutic Goods Amendment (2017 Measures No. 1) Act 2018","url":"https://legislation.gov.au/C2018A00007/asmade/2018-03-05/text/original/pdf"},{"title":"MMDR complementary medicine regulatory reforms","url":"https://www.tga.gov.au/news/news-articles/mmdr-complementary-medicine-regulatory-reforms"}]},{"text":"Ingredients, Therapeutic Goods Administration","links":[{"title":"Ingredients","url":"https://www.tga.gov.au/node/414479"}]}]}},{"slug":"tga-advertising","kind":"guide","url":"/guides/tga-advertising","title":"TGA advertising rules for supplements: the Code, influencers and penalties","name":"Advertising guide","description":"How the TGA's Advertising Code applies to a supplement: what counts as advertising, required statements, testimonials, influencers, social media and penalties.","eyebrow":"Guide","lead":"A supplement sold as a listed medicine is advertised under the Therapeutic Goods Act 1989 and the Therapeutic Goods Advertising Code, and in the Act the label counts as advertising. The rules bind anyone who advertises the product, not only its sponsor: the brand, a retailer, an agency, an influencer. This guide covers what counts as advertising, the Code's core rules, the statements an ad must carry, testimonials, endorsements and influencers, social media, and what the TGA can do when an ad breaks the rules.","parent":"/pathways/listed-medicines","studies":["everleanbody-saffron-capsule","your-skin-scan-nicotinamide-tablet","arxi-prenatal-chewable"],"formats":[],"order":68,"updated":"2026-10-22","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- Advertising is any statement, picture or design intended to promote the use or supply of the goods, including on the label and the pack. The rules apply to any person who advertises a therapeutic good, or causes it to be advertised.\n- An ad must be accurate, balanced and not misleading, substantiated before it is published, and not inconsistent with the indications on the ARTG. It can't call the product safe, a guaranteed cure or miraculous, or say \"TGA approved\".\n- Most ads must carry the medicine's name, at least one accepted indication and \"ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE\". An online store must also give the dosage form, the quantity, each active ingredient and the health warnings.\n- A paid influencer can't give a testimonial, but can endorse a product if the payment is disclosed and they aren't in a group the Code excludes, such as health practitioners. A testimonial or endorsement on, or linked to, a brand's own pages becomes part of its advertising.\n- Ads haven't needed the TGA's approval since 1 July 2020. Instead the TGA enforces after the fact: it gave over 75 infringement notices in the second half of 2025, mostly for alleged unlawful advertising.","text":"Advertising is any statement, picture or design intended to promote the use or supply of the goods, including on the label and the pack. The rules apply to any person who advertises a therapeutic good, or causes it to be advertised. An ad must be accurate, balanced and not misleading, substantiated before it is published, and not inconsistent with the indications on the ARTG. It can't call the product safe, a guaranteed cure or miraculous, or say \"TGA approved\". Most ads must carry the medicine's name, at least one accepted indication and \"ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE\". An online store must also give the dosage form, the quantity, each active ingredient and the health warnings. A paid influencer can't give a testimonial, but can endorse a product if the payment is disclosed and they aren't in a group the Code excludes, such as health practitioners. A testimonial or endorsement on, or linked to, a brand's own pages becomes part of its advertising. Ads haven't needed the TGA's approval since 1 July 2020. Instead the TGA enforces after the fact: it gave over 75 infringement notices in the second half of 2025, mostly for alleged unlawful advertising.","items":[],"tables":[]},{"heading":"What counts as advertising, and who the rules bind","anchor":"what-counts-as-advertising-and-who-the-rules-bind","markdown":"The Act's definition is wide. To advertise a therapeutic good includes making \"any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods\", including on the label, on the package and on any material included with it. So a website, an online store, a post on Instagram or TikTok and the pack itself can all be advertising.\n\nThe Code binds every advertiser: \"a person who: (a) advertises, by any means, therapeutic goods; or (b) causes the advertising, by any means, of therapeutic goods.\" On social media, in the TGA's words, \"the same rules apply to: a business' posts on its own social media accounts; social media posts that a business pays for; advertising by any other person on social media platforms.\"\n\nTwo limits on the Code's reach:\n\n- **Advertising directed only at health professionals,** and the others named in section 42AA of the Act, is outside the Code. What that means for [a practitioner-only range](/practitioner-ranges).\n- **The label has its own rules.** It is advertising under the Act, but some of the Code's requirements, including the statements an ad must carry and the rule on citing research, don't apply to the label itself, which follows TGO 116. See [the label rules](/guides/tga-approval#tgo-92-is-now-tgo-116).","text":"The Act's definition is wide. To advertise a therapeutic good includes making \"any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods\", including on the label, on the package and on any material included with it. So a website, an online store, a post on Instagram or TikTok and the pack itself can all be advertising. The Code binds every advertiser: \"a person who: (a) advertises, by any means, therapeutic goods; or (b) causes the advertising, by any means, of therapeutic goods.\" On social media, in the TGA's words, \"the same rules apply to: a business' posts on its own social media accounts; social media posts that a business pays for; advertising by any other person on social media platforms.\" Two limits on the Code's reach: Advertising directed only at health professionals, and the others named in section 42AA of the Act, is outside the Code. What that means for a practitioner-only range. The label has its own rules. It is advertising under the Act, but some of the Code's requirements, including the statements an ad must carry and the rule on citing research, don't apply to the label itself, which follows TGO 116. See the label rules.","items":[{"lead":"Advertising directed only at health professionals,","text":"and the others named in section 42AA of the Act, is outside the Code. What that means for a practitioner-only range."},{"lead":"The label has its own rules.","text":"It is advertising under the Act, but some of the Code's requirements, including the statements an ad must carry and the rule on citing research, don't apply to the label itself, which follows TGO 116. See the label rules."}],"tables":[]},{"heading":"The Code's core rules","anchor":"the-codes-core-rules","markdown":"The Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 sets the rules. The main ones for a supplement:\n\n- **Accurate, balanced and substantiated.** An ad must \"be accurate, balanced and not misleading or likely to be misleading\" and \"only contain information that is substantiated by the advertiser prior to publication or dissemination\" (section 8).\n- **Consistent with the ARTG.** It \"must not be inconsistent with any indication or intended purpose accepted in relation to the inclusion of the goods in the Register\" (section 8). For a listed medicine, that means its permitted indications: see [what a listed medicine can claim](/guides/permitted-indications).\n- **Not safe, guaranteed or miraculous.** An ad can't represent the goods as \"safe, or without harm or side-effects\", \"effective in all cases, or a guaranteed cure\", or \"infallible, unfailing, magical or miraculous\" (section 9).\n- **No fear, no exaggeration.** It can't cause \"undue alarm, fear or distress\", or exaggerate \"the efficacy or performance of the goods\" (section 9).\n- **Fair comparisons.** It can't compare the goods with other therapeutic goods or services in a way that suggests those are \"harmful or ineffectual\" (section 9).\n- **Science, cited properly.** A scientific or clinical claim must \"be consistent with the body of scientific or clinical evidence applicable to the goods\". An ad that refers to research must identify the researcher, the research's financial sponsor where the advertiser knows or ought to know it, and the research itself, by a citation good enough for consumers to find it (section 11). What that means for a product built on [branded, clinically studied ingredients](/guides/branded-ingredients).\n- **Never \"TGA approved\".** The TGA says advertisers \"must not use terms such as 'TGA approved' or 'TGA registered' in therapeutic goods advertising, including on labels or packaging\", nor the TGA's logo or the Commonwealth Coat of Arms. An assessed listed medicine can carry \"TGA assessed\" on its label, and an ad can show it only on the label in a pack shot; a listed medicine can't use it at all. See [the \"TGA assessed\" claim](/guides/assessed-listed-medicines#the-tga-assessed-claim).\n- **Samples and incentives.** An ad can't contain or offer a free sample, except in the cases the Code allows (goods named in its Annexure 2), and can't offer a pharmacy assistant, or a retail salesperson who isn't a health professional, a personal incentive or commission for recommending or supplying the goods (sections 25 and 26).","text":"The Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 sets the rules. The main ones for a supplement: Accurate, balanced and substantiated. An ad must \"be accurate, balanced and not misleading or likely to be misleading\" and \"only contain information that is substantiated by the advertiser prior to publication or dissemination\" (section 8). Consistent with the ARTG. It \"must not be inconsistent with any indication or intended purpose accepted in relation to the inclusion of the goods in the Register\" (section 8). For a listed medicine, that means its permitted indications: see what a listed medicine can claim. Not safe, guaranteed or miraculous. An ad can't represent the goods as \"safe, or without harm or side-effects\", \"effective in all cases, or a guaranteed cure\", or \"infallible, unfailing, magical or miraculous\" (section 9). No fear, no exaggeration. It can't cause \"undue alarm, fear or distress\", or exaggerate \"the efficacy or performance of the goods\" (section 9). Fair comparisons. It can't compare the goods with other therapeutic goods or services in a way that suggests those are \"harmful or ineffectual\" (section 9). Science, cited properly. A scientific or clinical claim must \"be consistent with the body of scientific or clinical evidence applicable to the goods\". An ad that refers to research must identify the researcher, the research's financial sponsor where the advertiser knows or ought to know it, and the research itself, by a citation good enough for consumers to find it (section 11). What that means for a product built on branded, clinically studied ingredients. Never \"TGA approved\". The TGA says advertisers \"must not use terms such as 'TGA approved' or 'TGA registered' in therapeutic goods advertising, including on labels or packaging\", nor the TGA's logo or the Commonwealth Coat of Arms. An assessed listed medicine can carry \"TGA assessed\" on its label, and an ad can show it only on the label in a pack shot; a listed medicine can't use it at all. See the \"TGA assessed\" claim. Samples and incentives. An ad can't contain or offer a free sample, except in the cases the Code allows (goods named in its Annexure 2), and can't offer a pharmacy assistant, or a retail salesperson who isn't a health professional, a personal incentive or commission for recommending or supplying the goods (sections 25 and 26).","items":[{"lead":"Accurate, balanced and substantiated.","text":"An ad must \"be accurate, balanced and not misleading or likely to be misleading\" and \"only contain information that is substantiated by the advertiser prior to publication or dissemination\" (section 8)."},{"lead":"Consistent with the ARTG.","text":"It \"must not be inconsistent with any indication or intended purpose accepted in relation to the inclusion of the goods in the Register\" (section 8). For a listed medicine, that means its permitted indications: see what a listed medicine can claim."},{"lead":"Not safe, guaranteed or miraculous.","text":"An ad can't represent the goods as \"safe, or without harm or side-effects\", \"effective in all cases, or a guaranteed cure\", or \"infallible, unfailing, magical or miraculous\" (section 9)."},{"lead":"No fear, no exaggeration.","text":"It can't cause \"undue alarm, fear or distress\", or exaggerate \"the efficacy or performance of the goods\" (section 9)."},{"lead":"Fair comparisons.","text":"It can't compare the goods with other therapeutic goods or services in a way that suggests those are \"harmful or ineffectual\" (section 9)."},{"lead":"Science, cited properly.","text":"A scientific or clinical claim must \"be consistent with the body of scientific or clinical evidence applicable to the goods\". An ad that refers to research must identify the researcher, the research's financial sponsor where the advertiser knows or ought to know it, and the research itself, by a citation good enough for consumers to find it (section 11). What that means for a product built on branded, clinically studied ingredients."},{"lead":"Never \"TGA approved\".","text":"The TGA says advertisers \"must not use terms such as 'TGA approved' or 'TGA registered' in therapeutic goods advertising, including on labels or packaging\", nor the TGA's logo or the Commonwealth Coat of Arms. An assessed listed medicine can carry \"TGA assessed\" on its label, and an ad can show it only on the label in a pack shot; a listed medicine can't use it at all. See the \"TGA assessed\" claim."},{"lead":"Samples and incentives.","text":"An ad can't contain or offer a free sample, except in the cases the Code allows (goods named in its Annexure 2), and can't offer a pharmacy assistant, or a retail salesperson who isn't a health professional, a personal incentive or commission for recommending or supplying the goods (sections 25 and 26)."}],"tables":[]},{"heading":"What an ad must say","anchor":"what-an-ad-must-say","markdown":"Most advertising for a medicine must contain, under section 19:\n\n1. **The medicine's name,** as TGO 116 defines it (TGO 92 until the Code was amended on 30 September 2026).\n2. **One or more of its accepted indications.**\n3. **\"ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE\",** prominently displayed or communicated. A short-form ad carries \"ALWAYS FOLLOW THE DIRECTIONS FOR USE\" instead (section 17).\n\nAn online store, or any ad that lets someone buy a medicine they can't inspect first, must also give the dosage form, the quantity, each active ingredient and, where the medicine has health warnings, the warnings or a link that goes straight to them. A health warning here is a warning, contra-indication, precaution or restriction that the medicine's label must carry and that is \"reasonably necessary to inform a decision of a consumer to purchase the medicine\".","text":"Most advertising for a medicine must contain, under section 19: The medicine's name, as TGO 116 defines it (TGO 92 until the Code was amended on 30 September 2026). One or more of its accepted indications. \"ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE\", prominently displayed or communicated. A short-form ad carries \"ALWAYS FOLLOW THE DIRECTIONS FOR USE\" instead (section 17). An online store, or any ad that lets someone buy a medicine they can't inspect first, must also give the dosage form, the quantity, each active ingredient and, where the medicine has health warnings, the warnings or a link that goes straight to them. A health warning here is a warning, contra-indication, precaution or restriction that the medicine's label must carry and that is \"reasonably necessary to inform a decision of a consumer to purchase the medicine\".","items":[{"lead":"The medicine's name,","text":"as TGO 116 defines it (TGO 92 until the Code was amended on 30 September 2026)."},{"lead":"One or more of its accepted indications.","text":"3. \"ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE\", prominently displayed or communicated. A short-form ad carries \"ALWAYS FOLLOW THE DIRECTIONS FOR USE\" instead (section 17)."}],"tables":[]},{"heading":"Testimonials, endorsements and influencers","anchor":"testimonials-endorsements-and-influencers","markdown":"The TGA draws the line between the two. \"A testimonial is a statement about a therapeutic good made by a person who claims to have used that good personally\", or to have used it while caring for someone else. \"An endorsement is a form of support, approval or sanction.\"\n\n**Testimonials.** An ad can't use a testimonial from anyone \"engaged in the production, marketing or supply of the goods\", and the Code's note says that includes \"influencers, direct sellers and other persons who have, or will receive, valuable consideration for making the testimonial\". Nor from an undisclosed member of their immediate family, a person in one of the first five groups excluded from endorsing (below), or a corporation. Any health benefit a testimonial mentions must be typical of what the goods deliver when used as the label directs, and the advertiser must verify both the content and the identity of the person making it (section 24).\n\n**What counts as payment.** The TGA's examples of valuable consideration: \"cash payment\", \"provision of services\", \"gifts\", \"discounts on product\", \"free product\", \"flights\", \"accommodation\" and a \"promise of future benefit\". A sale or discount offered to all customers equally, and not tied to giving a testimonial, isn't one. Or, as the TGA puts it to influencers: \"You cannot share your personal experience of using the product if you receive any payment or reward in exchange.\"\n\n**Endorsements.** Under section 24, no endorsement may come from:\n\n1. a government or government authority, unless the Act or Regulations allow it;\n2. a hospital or healthcare facility, other than a community pharmacy;\n3. the employees or contractors of either;\n4. \"a current or former health practitioner, health professional or medical researcher\";\n5. a person who represents themselves as qualified or trained to diagnose, treat or prevent disease;\n6. an organisation representing the interests of healthcare consumers, or of the people in group 4, unless the ad names it and says whether it has received, or will receive, anything for the endorsement.\n\n**Influencers can still advertise.** In the TGA's guidance, \"social media influencers, bloggers and brand ambassadors can endorse therapeutic goods even if they have received valuable consideration for the endorsement\", as long as they aren't in one of the excluded groups and the payment is disclosed: the TGA's example is words like \"paid partnership\" in the post. What they can't do is tell their own story of using the product.","text":"The TGA draws the line between the two. \"A testimonial is a statement about a therapeutic good made by a person who claims to have used that good personally\", or to have used it while caring for someone else. \"An endorsement is a form of support, approval or sanction.\" Testimonials. An ad can't use a testimonial from anyone \"engaged in the production, marketing or supply of the goods\", and the Code's note says that includes \"influencers, direct sellers and other persons who have, or will receive, valuable consideration for making the testimonial\". Nor from an undisclosed member of their immediate family, a person in one of the first five groups excluded from endorsing (below), or a corporation. Any health benefit a testimonial mentions must be typical of what the goods deliver when used as the label directs, and the advertiser must verify both the content and the identity of the person making it (section 24). What counts as payment. The TGA's examples of valuable consideration: \"cash payment\", \"provision of services\", \"gifts\", \"discounts on product\", \"free product\", \"flights\", \"accommodation\" and a \"promise of future benefit\". A sale or discount offered to all customers equally, and not tied to giving a testimonial, isn't one. Or, as the TGA puts it to influencers: \"You cannot share your personal experience of using the product if you receive any payment or reward in exchange.\" Endorsements. Under section 24, no endorsement may come from: a government or government authority, unless the Act or Regulations allow it; a hospital or healthcare facility, other than a community pharmacy; the employees or contractors of either; \"a current or former health practitioner, health professional or medical researcher\"; a person who represents themselves as qualified or trained to diagnose, treat or prevent disease; an organisation representing the interests of healthcare consumers, or of the people in group 4, unless the ad names it and says whether it has received, or will receive, anything for the endorsement. Influencers can still advertise. In the TGA's guidance, \"social media influencers, bloggers and brand ambassadors can endorse therapeutic goods even if they have received valuable consideration for the endorsement\", as long as they aren't in one of the excluded groups and the payment is disclosed: the TGA's example is words like \"paid partnership\" in the post. What they can't do is tell their own story of using the product.","items":[],"tables":[]},{"heading":"Social media and reviews","anchor":"social-media-and-reviews","markdown":"- **Your page, your responsibility.** \"Business owners are responsible for the content of any social media page created or managed by them, including third-party comments.\" A comment from someone claiming to have used the product is a testimonial, and \"when an endorsement or testimonial is made on (or linked to) your content, it becomes a part of your advertising.\"\n- **Sharing counts.** The TGA says liking a post on LinkedIn, re-posting on X or tagging a website or account \"may be considered a type of sharing/resharing\".\n- **Paid posts.** Where advertising is paid for and posted on a business's behalf, the business \"may be responsible for any non-compliance\".\n- **Reviews.** Writing fake or misleading reviews, or leaving out genuine negative ones to skew perception, \"is deceptive advertising and against the law.\"","text":"Your page, your responsibility. \"Business owners are responsible for the content of any social media page created or managed by them, including third-party comments.\" A comment from someone claiming to have used the product is a testimonial, and \"when an endorsement or testimonial is made on (or linked to) your content, it becomes a part of your advertising.\" Sharing counts. The TGA says liking a post on LinkedIn, re-posting on X or tagging a website or account \"may be considered a type of sharing/resharing\". Paid posts. Where advertising is paid for and posted on a business's behalf, the business \"may be responsible for any non-compliance\". Reviews. Writing fake or misleading reviews, or leaving out genuine negative ones to skew perception, \"is deceptive advertising and against the law.\"","items":[{"lead":"Your page, your responsibility.","text":"\"Business owners are responsible for the content of any social media page created or managed by them, including third-party comments.\" A comment from someone claiming to have used the product is a testimonial, and \"when an endorsement or testimonial is made on (or linked to) your content, it becomes a part of your advertising.\""},{"lead":"Sharing counts.","text":"The TGA says liking a post on LinkedIn, re-posting on X or tagging a website or account \"may be considered a type of sharing/resharing\"."},{"lead":"Paid posts.","text":"Where advertising is paid for and posted on a business's behalf, the business \"may be responsible for any non-compliance\"."},{"lead":"Reviews.","text":"Writing fake or misleading reviews, or leaving out genuine negative ones to skew perception, \"is deceptive advertising and against the law.\""}],"tables":[]},{"heading":"Restricted and prohibited representations","anchor":"restricted-and-prohibited-representations","markdown":"A restricted representation refers to a serious form of a disease, condition, ailment or defect: one that requires \"a health professional to diagnose, follow-up or treat\". It can only be used with the TGA's prior approval, applied for through its Regulatory and Compliance portal, or under a permission the TGA has granted (a permission can't be applied for). Prohibited representations, such as claims about treating cancer, are listed in Part 1 of Schedule 2 of the Therapeutic Goods Regulations 1990 and can't be applied for, though the TGA can permit one in a specific ad where public health or the appropriate use of the goods needs it. More in our [claims and indications guide](/guides/permitted-indications#advertising-the-therapeutic-goods-advertising-code).","text":"A restricted representation refers to a serious form of a disease, condition, ailment or defect: one that requires \"a health professional to diagnose, follow-up or treat\". It can only be used with the TGA's prior approval, applied for through its Regulatory and Compliance portal, or under a permission the TGA has granted (a permission can't be applied for). Prohibited representations, such as claims about treating cancer, are listed in Part 1 of Schedule 2 of the Therapeutic Goods Regulations 1990 and can't be applied for, though the TGA can permit one in a specific ad where public health or the appropriate use of the goods needs it. More in our claims and indications guide.","items":[],"tables":[]},{"heading":"No pre-approval: what the TGA can do instead","anchor":"no-pre-approval-what-the-tga-can-do-instead","markdown":"Since 1 July 2020, medicine ads in specified media no longer need the TGA's approval before they run. The rules didn't change: the advertiser checks its own ads, and the TGA acts after the fact. Its tools range from an educational or warning letter, a substantiation notice and a direction to withdraw or correct an ad, to a public warning notice, suspension or cancellation of the ARTG entry, an infringement notice, an enforceable undertaking, civil proceedings and prosecution.\n\n| Measure | The maximum |\n| --- | --- |\n| Infringement notice for non-compliant advertising | 12 penalty units for an individual, 60 for a company: $4,368 and $21,840 at $364 a unit |\n| Criminal offence where using the goods as advertised results, or is likely to result, in harm or injury | 5 years' imprisonment or 4,000 penalty units, or both |\n| Criminal offence for intentional non-compliance | 12 months' imprisonment or 1,000 penalty units, or both |\n| Strict liability offence | 100 penalty units |\n\nA company can face up to five times the penalty units for an offence. A Commonwealth penalty unit has been $364 since 1 July 2026 (for offences from that date). In civil proceedings, section 42DLB of the Act carries a maximum of 5,000 penalty units for an individual and 50,000 for a company for each contravention, as the Federal Court set out in 2021.\n\nThe TGA uses these powers. In 2024–25 it gave 30 infringement notices, mostly for alleged unlawful advertising, and asked online platforms to remove over 13,700 alleged unlawful advertisements or user and seller profiles. From July to December 2025 it gave over 75, again mostly for alleged unlawful advertising, and completed a second targeted campaign on compliance by influencers, particularly on social media.","text":"Since 1 July 2020, medicine ads in specified media no longer need the TGA's approval before they run. The rules didn't change: the advertiser checks its own ads, and the TGA acts after the fact. Its tools range from an educational or warning letter, a substantiation notice and a direction to withdraw or correct an ad, to a public warning notice, suspension or cancellation of the ARTG entry, an infringement notice, an enforceable undertaking, civil proceedings and prosecution. Measure: Infringement notice for non-compliant advertising; The maximum: 12 penalty units for an individual, 60 for a company: $4,368 and $21,840 at $364 a unit. Measure: Criminal offence where using the goods as advertised results, or is likely to result, in harm or injury; The maximum: 5 years' imprisonment or 4,000 penalty units, or both. Measure: Criminal offence for intentional non-compliance; The maximum: 12 months' imprisonment or 1,000 penalty units, or both. Measure: Strict liability offence; The maximum: 100 penalty units. A company can face up to five times the penalty units for an offence. A Commonwealth penalty unit has been $364 since 1 July 2026 (for offences from that date). In civil proceedings, section 42DLB of the Act carries a maximum of 5,000 penalty units for an individual and 50,000 for a company for each contravention, as the Federal Court set out in 2021. The TGA uses these powers. In 2024–25 it gave 30 infringement notices, mostly for alleged unlawful advertising, and asked online platforms to remove over 13,700 alleged unlawful advertisements or user and seller profiles. From July to December 2025 it gave over 75, again mostly for alleged unlawful advertising, and completed a second targeted campaign on compliance by influencers, particularly on social media.","items":[],"tables":[{"header":["Measure","The maximum"],"rows":[["Infringement notice for non-compliant advertising","12 penalty units for an individual, 60 for a company: $4,368 and $21,840 at $364 a unit"],["Criminal offence where using the goods as advertised results, or is likely to result, in harm or injury","5 years' imprisonment or 4,000 penalty units, or both"],["Criminal offence for intentional non-compliance","12 months' imprisonment or 1,000 penalty units, or both"],["Strict liability offence","100 penalty units"]]}]},{"heading":"What changed in 2026","anchor":"what-changed-in-2026","markdown":"- **The Code now points to TGO 116.** From 30 September 2026, the amending instrument (F2026L01329) replaced the Code's references to TGO 92 with TGO 116, the new labelling standard for non-prescription medicines, in the rules on what an ad must say. See [TGO 92 is now TGO 116](/guides/tga-approval#tgo-92-is-now-tgo-116).\n- **Changes under consultation.** The TGA consulted on \"Improvements to the Therapeutic Goods Advertising Code\" from 9 July to 3 September 2026: \"It is not a full review of the Code.\" Its proposals include defining \"prominently displayed or communicated\" to include \"standing out\", and continuing to prohibit paid testimonials for therapeutic sunscreens. No outcome had been published by 22 October 2026.","text":"The Code now points to TGO 116. From 30 September 2026, the amending instrument (F2026L01329) replaced the Code's references to TGO 92 with TGO 116, the new labelling standard for non-prescription medicines, in the rules on what an ad must say. See TGO 92 is now TGO 116. Changes under consultation. The TGA consulted on \"Improvements to the Therapeutic Goods Advertising Code\" from 9 July to 3 September 2026: \"It is not a full review of the Code.\" Its proposals include defining \"prominently displayed or communicated\" to include \"standing out\", and continuing to prohibit paid testimonials for therapeutic sunscreens. No outcome had been published by 22 October 2026.","items":[{"lead":"The Code now points to TGO 116.","text":"From 30 September 2026, the amending instrument (F2026L01329) replaced the Code's references to TGO 92 with TGO 116, the new labelling standard for non-prescription medicines, in the rules on what an ad must say. See TGO 92 is now TGO 116."},{"lead":"Changes under consultation.","text":"The TGA consulted on \"Improvements to the Therapeutic Goods Advertising Code\" from 9 July to 3 September 2026: \"It is not a full review of the Code.\" Its proposals include defining \"prominently displayed or communicated\" to include \"standing out\", and continuing to prohibit paid testimonials for therapeutic sunscreens. No outcome had been published by 22 October 2026."}],"tables":[]},{"heading":"Foods and cosmetics","anchor":"foods-and-cosmetics","markdown":"A supplement sold as a food isn't advertised under the TGA's Code. Its health claims must follow Standard 1.2.7 of the Food Standards Code, which state and territory agencies and local councils enforce, and the Australian Consumer Law applies to every claim: the ACCC and state and territory consumer authorities enforce it, and food businesses \"must not make false or misleading claims\". See [supplements as foods](/pathways/foods).\n\nA cosmetic's claims stay with appearance, cleansing, odour and keeping the skin in good condition; a claim to treat a condition makes it a therapeutic good, advertised under the Code. See [medicine, food or cosmetic?](/pathways) and [skincare](/skincare).","text":"A supplement sold as a food isn't advertised under the TGA's Code. Its health claims must follow Standard 1.2.7 of the Food Standards Code, which state and territory agencies and local councils enforce, and the Australian Consumer Law applies to every claim: the ACCC and state and territory consumer authorities enforce it, and food businesses \"must not make false or misleading claims\". See supplements as foods. A cosmetic's claims stay with appearance, cleansing, odour and keeping the skin in good condition; a claim to treat a condition makes it a therapeutic good, advertised under the Code. See medicine, food or cosmetic? and skincare.","items":[],"tables":[]},{"heading":"Where we come in","anchor":"where-we-come-in","markdown":"The same rules cover your website, your Instagram and your TikTok as your label. So we check the claims at the brief, and build the evidence for them alongside the formula, so the label and the marketing say the same thing from day one. For [EverLeanBody](/work/everleanbody-saffron-capsule) and [Your Skin Scan](/work/your-skin-scan-nicotinamide-tablet) we built the claims evidence and handled the label's compliance; on [Arxi's prenatal](/work/arxi-prenatal-chewable), our label review caught two errors before print. More on [formulation](/formulation) and [packaging and labelling](/packaging), or [book a call](/contact).","text":"The same rules cover your website, your Instagram and your TikTok as your label. So we check the claims at the brief, and build the evidence for them alongside the formula, so the label and the marketing say the same thing from day one. For EverLeanBody and Your Skin Scan we built the claims evidence and handled the label's compliance; on Arxi's prenatal, our label review caught two errors before print. More on formulation and packaging and labelling, or book a call.","items":[],"tables":[]}],"faqs":[{"q":"Does the TGA have to approve my supplement ads?","a":"No. Since 1 July 2020, medicine ads in specified media don't need the TGA's approval before they run. The advertiser must make sure each one complies with the Act and the Advertising Code, and the TGA can act after it is published, with anything from a warning letter to an infringement notice, a public warning or court proceedings.","md":"No. Since 1 July 2020, medicine ads in specified media don't need the TGA's approval before they run. The advertiser must make sure each one complies with the Act and the Advertising Code, and the TGA can act after it is published, with anything from a warning letter to an infringement notice, a public warning or court proceedings."},{"q":"Can influencers promote a supplement in Australia?","a":"Yes, with limits. A paid influencer can't give a testimonial, a story of their own use of the product, because anyone who receives valuable consideration counts as engaged in its marketing. They can endorse it, as long as the payment is disclosed, for example as a \"paid partnership\", and they aren't in a group the Code excludes, such as current or former health practitioners.","md":"Yes, with limits. A paid influencer can't give a testimonial, a story of their own use of the product, because anyone who receives valuable consideration counts as engaged in its marketing. They can endorse it, as long as the payment is disclosed, for example as a \"paid partnership\", and they aren't in a group the Code excludes, such as current or former health practitioners."},{"q":"What statements does a supplement ad need?","a":"Most must carry the medicine's name, one or more of its accepted indications and \"ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE\", prominently displayed or communicated; a short-form ad carries \"ALWAYS FOLLOW THE DIRECTIONS FOR USE\". An online store must also show the dosage form, the quantity, each active ingredient and the health warnings, or a link straight to them.","md":"Most must carry the medicine's name, one or more of its accepted indications and \"ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE\", prominently displayed or communicated; a short-form ad carries \"ALWAYS FOLLOW THE DIRECTIONS FOR USE\". An online store must also show the dosage form, the quantity, each active ingredient and the health warnings, or a link straight to them."},{"q":"Can I say my supplement is TGA approved?","a":"No. The TGA says advertisers must not use terms such as \"TGA approved\" or \"TGA registered\", including on labels and packaging, or its logo. An assessed listed medicine (AUST L(A)) can carry \"TGA assessed\" on its label, and show it in an ad only on the label in a pack shot; a listed medicine (AUST L) can't use it.","md":"No. The TGA says advertisers must not use terms such as \"TGA approved\" or \"TGA registered\", including on labels and packaging, or its logo. An assessed listed medicine (AUST L(A)) can carry \"TGA assessed\" on its label, and show it in an ad only on the label in a pack shot; a listed medicine (AUST L) can't use it."},{"q":"Am I responsible for comments on my brand's social media?","a":"Yes. The TGA says business owners are responsible for the content of the social media pages they create or manage, including third-party comments. A comment from someone who says they used the product is a testimonial, and it becomes part of your advertising.","md":"Yes. The TGA says business owners are responsible for the content of the social media pages they create or manage, including third-party comments. A comment from someone who says they used the product is a testimonial, and it becomes part of your advertising."},{"q":"What are the penalties for breaking the advertising rules?","a":"An infringement notice for non-compliant advertising carries up to 12 penalty units for an individual and 60 for a company, which is $4,368 and $21,840 at the $364 penalty unit in force since 1 July 2026. Criminal offences carry up to 5 years' imprisonment or 4,000 penalty units where use of the goods results, or is likely to result, in harm, and civil penalties can be far higher.","md":"An infringement notice for non-compliant advertising carries up to 12 penalty units for an individual and 60 for a company, which is $4,368 and $21,840 at the $364 penalty unit in force since 1 July 2026. Criminal offences carry up to 5 years' imprisonment or 4,000 penalty units where use of the goods results, or is likely to result, in harm, and civil penalties can be far higher."}],"sources":{"note":"General information, checked against these sources on 22 October 2026. It isn't legal advice or advice on a particular product. The way we work is from Take Friday Off's records.","markdown":"General information, checked against these sources on 22 October 2026. It isn't legal advice or advice on a particular product. The way we work is from Take Friday Off's records.\n\n- [Therapeutic Goods Act 1989](https://www.legislation.gov.au/C2004A03952/latest/text), section 3 (the meaning of advertise), Federal Register of Legislation\n- [Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021](https://www.legislation.gov.au/F2021L01661/latest/versions) and the [amendment of 30 September 2026](https://www.legislation.gov.au/F2026L01329/asmade/2026-09-29/text/original/pdf) (TGO 116), Federal Register of Legislation\n- [Advertising therapeutic goods on social media](https://www.tga.gov.au/node/452623), [Social media advertising hub](https://www.tga.gov.au/node/524235), [Testimonials and endorsements in advertising](https://www.tga.gov.au/node/491816), [Use your influence to promote better health](https://www.tga.gov.au/news/blog/use-your-influence-promote-better-health) and [Applying the Advertising Code rules, part 6](https://www.tga.gov.au/sites/default/files/2022-07/guidance-applying-advertising-code-rules-pt-6.docx) (June 2022), Therapeutic Goods Administration\n- [Using \"TGA approved\" and other government endorsements](https://www.tga.gov.au/node/491806) and [Restricted and prohibited representations in advertising](https://www.tga.gov.au/node/288050), Therapeutic Goods Administration\n- [Guidelines for using the TGA assessed claim on medicine labels](https://www.tga.gov.au/sites/default/files/guidelines-using-tga-assessed-claim-medicine-labels.pdf), version 1.1, August 2020, Therapeutic Goods Administration\n- [Advertising pre-approval ends on 30 June 2020](https://www.tga.gov.au/node/284789) and [Sanctions and penalties for non-compliant advertising](https://tga.gov.au/book-page/sanctions-and-penalties-non-compliant-advertising), Therapeutic Goods Administration\n- [Unlawful activities surrounding therapeutic goods, 2024–25](https://www.tga.gov.au/sites/default/files/2026-04/unlawful-activities-surrounding-therapeutic-goods-2024-25.PDF) and [2025–26](https://www.tga.gov.au/sites/default/files/2026-04/unlawful-activities-surrounding-therapeutic-goods-2025-26.PDF), Therapeutic Goods Administration\n- [Improvements to the Therapeutic Goods Advertising Code](https://consultations.tga.gov.au/tga/improvements-to-the-advertising-code/), TGA consultation, July to September 2026\n- [Crimes (Amount of a Penalty Unit) Instrument 2026](https://www.legislation.gov.au/F2026N00424/asmade/2026-06-16/text/original/pdf), Federal Register of Legislation, and [Secretary, Department of Health v Oxymed Australia Pty Ltd [2021] FCA 1518](https://www.judgments.fedcourt.gov.au/judgments/Judgments/fca/single/2021/2021fca1518), Federal Court of Australia\n- [Cosmetics or therapeutic goods: guidance for advertisers and suppliers](https://www.tga.gov.au/sites/default/files/2024-06/cosmetics-therapeutic-goods-guidance-for-advertisers-suppliers.pdf), Therapeutic Goods Administration, June 2024\n- [Nutrition content claims and health claims](https://www.foodstandards.gov.au/consumer/labelling/nutrition) and [What we do](https://www.foodstandards.gov.au/about-us/whatwedo), Food Standards Australia New Zealand, and [Getting your claims right](https://www.foodregulation.gov.au/sites/default/files/2023-09/getting-your-claims-right.pdf), Food Regulation Secretariat","items":[{"text":"Therapeutic Goods Act 1989, section 3 (the meaning of advertise), Federal Register of Legislation","links":[{"title":"Therapeutic Goods Act 1989","url":"https://www.legislation.gov.au/C2004A03952/latest/text"}]},{"text":"Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 and the amendment of 30 September 2026 (TGO 116), Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021","url":"https://www.legislation.gov.au/F2021L01661/latest/versions"},{"title":"amendment of 30 September 2026","url":"https://www.legislation.gov.au/F2026L01329/asmade/2026-09-29/text/original/pdf"}]},{"text":"Advertising therapeutic goods on social media, Social media advertising hub, Testimonials and endorsements in advertising, Use your influence to promote better health and Applying the Advertising Code rules, part 6 (June 2022), Therapeutic Goods Administration","links":[{"title":"Advertising therapeutic goods on social media","url":"https://www.tga.gov.au/node/452623"},{"title":"Social media advertising hub","url":"https://www.tga.gov.au/node/524235"},{"title":"Testimonials and endorsements in advertising","url":"https://www.tga.gov.au/node/491816"},{"title":"Use your influence to promote better health","url":"https://www.tga.gov.au/news/blog/use-your-influence-promote-better-health"},{"title":"Applying the Advertising Code rules, part 6","url":"https://www.tga.gov.au/sites/default/files/2022-07/guidance-applying-advertising-code-rules-pt-6.docx"}]},{"text":"Using \"TGA approved\" and other government endorsements and Restricted and prohibited representations in advertising, Therapeutic Goods Administration","links":[{"title":"Using \"TGA approved\" and other government endorsements","url":"https://www.tga.gov.au/node/491806"},{"title":"Restricted and prohibited representations in advertising","url":"https://www.tga.gov.au/node/288050"}]},{"text":"Guidelines for using the TGA assessed claim on medicine labels, version 1.1, August 2020, Therapeutic Goods Administration","links":[{"title":"Guidelines for using the TGA assessed claim on medicine labels","url":"https://www.tga.gov.au/sites/default/files/guidelines-using-tga-assessed-claim-medicine-labels.pdf"}]},{"text":"Advertising pre-approval ends on 30 June 2020 and Sanctions and penalties for non-compliant advertising, Therapeutic Goods Administration","links":[{"title":"Advertising pre-approval ends on 30 June 2020","url":"https://www.tga.gov.au/node/284789"},{"title":"Sanctions and penalties for non-compliant advertising","url":"https://tga.gov.au/book-page/sanctions-and-penalties-non-compliant-advertising"}]},{"text":"Unlawful activities surrounding therapeutic goods, 2024–25 and 2025–26, Therapeutic Goods Administration","links":[{"title":"Unlawful activities surrounding therapeutic goods, 2024–25","url":"https://www.tga.gov.au/sites/default/files/2026-04/unlawful-activities-surrounding-therapeutic-goods-2024-25.PDF"},{"title":"2025–26","url":"https://www.tga.gov.au/sites/default/files/2026-04/unlawful-activities-surrounding-therapeutic-goods-2025-26.PDF"}]},{"text":"Improvements to the Therapeutic Goods Advertising Code, TGA consultation, July to September 2026","links":[{"title":"Improvements to the Therapeutic Goods Advertising Code","url":"https://consultations.tga.gov.au/tga/improvements-to-the-advertising-code/"}]},{"text":"Crimes (Amount of a Penalty Unit) Instrument 2026, Federal Register of Legislation, and [Secretary, Department of Health v Oxymed Australia Pty Ltd [2021] FCA 1518](https://www.judgments.fedcourt.gov.au/judgments/Judgments/fca/single/2021/2021fca1518), Federal Court of Australia","links":[{"title":"Crimes (Amount of a Penalty Unit) Instrument 2026","url":"https://www.legislation.gov.au/F2026N00424/asmade/2026-06-16/text/original/pdf"}]},{"text":"Cosmetics or therapeutic goods: guidance for advertisers and suppliers, Therapeutic Goods Administration, June 2024","links":[{"title":"Cosmetics or therapeutic goods: guidance for advertisers and suppliers","url":"https://www.tga.gov.au/sites/default/files/2024-06/cosmetics-therapeutic-goods-guidance-for-advertisers-suppliers.pdf"}]},{"text":"Nutrition content claims and health claims and What we do, Food Standards Australia New Zealand, and Getting your claims right, Food Regulation Secretariat","links":[{"title":"Nutrition content claims and health claims","url":"https://www.foodstandards.gov.au/consumer/labelling/nutrition"},{"title":"What we do","url":"https://www.foodstandards.gov.au/about-us/whatwedo"},{"title":"Getting your claims right","url":"https://www.foodregulation.gov.au/sites/default/files/2023-09/getting-your-claims-right.pdf"}]}]}},{"slug":"pet-supplements","kind":"guide","url":"/guides/pet-supplements","title":"Pet supplements in Australia: APVMA registration or pet food?","name":"Pet supplements guide","description":"When a pet supplement needs APVMA registration and when it is a pet food: the claims test, excluded and listed products, fees, timeframes and labels.","eyebrow":"Guide","lead":"A supplement for a dog, cat or horse isn't regulated by the TGA. If it is represented as preventing or treating a disease or condition, or as modifying the animal's physiology in the ways the law sets out, it is a veterinary chemical product, and the Australian Pesticides and Veterinary Medicines Authority (APVMA) must register it before it is sold, unless the law excludes or exempts it. Some products, such as joint health products for dogs and horses, can take a simpler route to registration as listed products. A pet food or feed supplement that makes no therapeutic claim generally needs no registration. This guide covers where the line falls, the products the law excludes or lists, what registration involves, the APVMA's fees and timeframes, and pet food.","parent":"/pathways","studies":["nectar-of-the-dogs-pet-supplements"],"formats":[],"order":69,"updated":"2026-10-22","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- A pet supplement is regulated by the APVMA, not the TGA, when it is a veterinary chemical product: represented as suitable for, or supplied or used for, preventing, curing or alleviating a disease or condition in an animal, or modifying its physiology in the ways the Agvet Code lists. The label, the website and the marketing all count.\n- Naming a disease or condition, or claiming to prevent, reduce, treat or cure one, means registration, unless the product meets the conditions for an excluded nutritional or digestive product.\n- A pet food or feed supplement that only supports normal health, and makes no therapeutic claim, generally needs no APVMA registration. Since 5 March 2015, some nutritional and digestive products are excluded, if they meet conditions on their ingredients, manufacturing, label and claims.\n- Joint health products for dogs and horses can be registered as listed products, against a standard with a set claim.\n- The APVMA's fees run from $2,632 to register a listed product, assessed in 2 months, to $116,501 to approve a new active constituent and register its product, assessed in 18 months. They haven't changed since 2019, and new fees are proposed from 1 July 2027.","text":"A pet supplement is regulated by the APVMA, not the TGA, when it is a veterinary chemical product: represented as suitable for, or supplied or used for, preventing, curing or alleviating a disease or condition in an animal, or modifying its physiology in the ways the Agvet Code lists. The label, the website and the marketing all count. Naming a disease or condition, or claiming to prevent, reduce, treat or cure one, means registration, unless the product meets the conditions for an excluded nutritional or digestive product. A pet food or feed supplement that only supports normal health, and makes no therapeutic claim, generally needs no APVMA registration. Since 5 March 2015, some nutritional and digestive products are excluded, if they meet conditions on their ingredients, manufacturing, label and claims. Joint health products for dogs and horses can be registered as listed products, against a standard with a set claim. The APVMA's fees run from $2,632 to register a listed product, assessed in 2 months, to $116,501 to approve a new active constituent and register its product, assessed in 18 months. They haven't changed since 2019, and new fees are proposed from 1 July 2027.","items":[],"tables":[]},{"heading":"Medicine or food: where the line falls for animals","anchor":"medicine-or-food-where-the-line-falls-for-animals","markdown":"The Agricultural and Veterinary Chemicals Code (the Agvet Code) defines a veterinary chemical product by what it is for. It is a substance or mixture \"represented as being suitable for, or is manufactured, supplied or used for, administration or application to an animal by any means, or consumption by an animal\", as a way of, among other things, \"preventing, diagnosing, curing or alleviating a disease or condition in the animal\", or modifying its physiology to alter its natural development, productivity, quality or reproductive capacity, or to make it more manageable. In the Code, \"claim includes any statement\".\n\nSo the APVMA looks at two things: in its words, \"both the chemical nature of your product and the claims made about it are considered when deciding whether your product needs to be registered.\" Represented as suitable \"refers to any written or spoken words in or on the product label or other promotional material (including websites)\".\n\n- **A disease or condition means registration.** \"Any product that mentions a specific disease or condition or refers to the prevention, reduction, treatment, alleviation or cure of any disease or condition is considered a veterinary product and requires registration.\" In the APVMA's examples, \"helps maintain healthy bones\" is acceptable for a feed; a claim about \"primary behavioural disorders or aggression\" or \"musculoskeletal disease or conditions\" isn't. The exception is an excluded nutritional or digestive product whose therapeutic claim meets the conditions below.\n- **Doses above nutrition, with a cure claim.** Among the APVMA's examples of products that claim to cure a condition or disease, aren't provided by a veterinarian and need registration: nutraceuticals such as oral vitamins, minerals, amino acids and fatty acids \"when used at daily doses higher than the normal daily nutritional requirement\", even where the condition comes from low levels of that nutrient.\n- **What is in a normal diet is food.** Plant or animal material that is an ingredient of an animal's normal diet, and \"that is only represented as being suitable and used to help maintain normal (optimal) health, production or performance, is a food and not a veterinary chemical product.\"\n- **Natural doesn't change it.** \"The Agvet Code does not distinguish between naturally derived remedies and synthetic pharmaceutical medicines.\" The APVMA names \"complementary animal health products (including herbal, nutraceutical, direct-fed microbial and homeopathic remedies)\" among the products that may need registration.\n\nAnimal feed products generally don't need registration, though, in the APVMA's words, \"they may be subject to regulation by other Commonwealth, state or territory authorities.\"","text":"The Agricultural and Veterinary Chemicals Code (the Agvet Code) defines a veterinary chemical product by what it is for. It is a substance or mixture \"represented as being suitable for, or is manufactured, supplied or used for, administration or application to an animal by any means, or consumption by an animal\", as a way of, among other things, \"preventing, diagnosing, curing or alleviating a disease or condition in the animal\", or modifying its physiology to alter its natural development, productivity, quality or reproductive capacity, or to make it more manageable. In the Code, \"claim includes any statement\". So the APVMA looks at two things: in its words, \"both the chemical nature of your product and the claims made about it are considered when deciding whether your product needs to be registered.\" Represented as suitable \"refers to any written or spoken words in or on the product label or other promotional material (including websites)\". A disease or condition means registration. \"Any product that mentions a specific disease or condition or refers to the prevention, reduction, treatment, alleviation or cure of any disease or condition is considered a veterinary product and requires registration.\" In the APVMA's examples, \"helps maintain healthy bones\" is acceptable for a feed; a claim about \"primary behavioural disorders or aggression\" or \"musculoskeletal disease or conditions\" isn't. The exception is an excluded nutritional or digestive product whose therapeutic claim meets the conditions below. Doses above nutrition, with a cure claim. Among the APVMA's examples of products that claim to cure a condition or disease, aren't provided by a veterinarian and need registration: nutraceuticals such as oral vitamins, minerals, amino acids and fatty acids \"when used at daily doses higher than the normal daily nutritional requirement\", even where the condition comes from low levels of that nutrient. What is in a normal diet is food. Plant or animal material that is an ingredient of an animal's normal diet, and \"that is only represented as being suitable and used to help maintain normal (optimal) health, production or performance, is a food and not a veterinary chemical product.\" Natural doesn't change it. \"The Agvet Code does not distinguish between naturally derived remedies and synthetic pharmaceutical medicines.\" The APVMA names \"complementary animal health products (including herbal, nutraceutical, direct-fed microbial and homeopathic remedies)\" among the products that may need registration. Animal feed products generally don't need registration, though, in the APVMA's words, \"they may be subject to regulation by other Commonwealth, state or territory authorities.\"","items":[{"lead":"A disease or condition means registration.","text":"\"Any product that mentions a specific disease or condition or refers to the prevention, reduction, treatment, alleviation or cure of any disease or condition is considered a veterinary product and requires registration.\" In the APVMA's examples, \"helps maintain healthy bones\" is acceptable for a feed; a claim about \"primary behavioural disorders or aggression\" or \"musculoskeletal disease or conditions\" isn't. The exception is an excluded nutritional or digestive product whose therapeutic claim meets the conditions below."},{"lead":"Doses above nutrition, with a cure claim.","text":"Among the APVMA's examples of products that claim to cure a condition or disease, aren't provided by a veterinarian and need registration: nutraceuticals such as oral vitamins, minerals, amino acids and fatty acids \"when used at daily doses higher than the normal daily nutritional requirement\", even where the condition comes from low levels of that nutrient."},{"lead":"What is in a normal diet is food.","text":"Plant or animal material that is an ingredient of an animal's normal diet, and \"that is only represented as being suitable and used to help maintain normal (optimal) health, production or performance, is a food and not a veterinary chemical product.\""},{"lead":"Natural doesn't change it.","text":"\"The Agvet Code does not distinguish between naturally derived remedies and synthetic pharmaceutical medicines.\" The APVMA names \"complementary animal health products (including herbal, nutraceutical, direct-fed microbial and homeopathic remedies)\" among the products that may need registration."}],"tables":[]},{"heading":"Products the law excludes or lists","anchor":"products-the-law-excludes-or-lists","markdown":"- **Excluded nutritional or digestive products.** Since 5 March 2015, certain feeds for livestock and companion animals are excluded from the Agvet Code. The product \"must be one that is fed to, and voluntarily consumed by, an animal and meet specified requirements in relation to ingredients, manufacturing, labelling and claims.\" It can only make a therapeutic claim if the claim is supported by scientific evidence accessible to the supplier, of a standard \"suitable for publication in recognised peer-reviewed scientific journals\" and provided to the APVMA on request, or if it is supplied only through the treating veterinarian, with the claims supported by that veterinarian. Its manufacturing options include the Australian Standard for pet food, AS 5812-2023.\n- **Feed supplements.** The APVMA's guidance for a nutritional supplement mixed into feed: it is presented in whole food, a food premix, a block or a lick, or added to feed \"(as opposed to being administered in water or as a paste or drench, or by stomach tube)\"; its claim is limited to \"to supplement diets where levels may be low\", or words to that effect; its label carries a statement such as \"Nutritional supplement product for inclusion in animal's feed. Product has no therapeutic effect\"; and it doesn't use words such as \"dose\", \"dosage\" or \"administration\".\n- **Listed products: joint health for dogs and horses.** Some products are registered as listed chemical products, against a standard the APVMA has set, so a complying product needs no individual assessment. The APVMA's list \"currently lists certain home swimming pool and spa products and joint health products for dogs and horses.\" The only label claim the joint health standard allows is \"long term use may help improve joint health and function\", and for vitamins and minerals, \"to supplement diets where levels may be low\".","text":"Excluded nutritional or digestive products. Since 5 March 2015, certain feeds for livestock and companion animals are excluded from the Agvet Code. The product \"must be one that is fed to, and voluntarily consumed by, an animal and meet specified requirements in relation to ingredients, manufacturing, labelling and claims.\" It can only make a therapeutic claim if the claim is supported by scientific evidence accessible to the supplier, of a standard \"suitable for publication in recognised peer-reviewed scientific journals\" and provided to the APVMA on request, or if it is supplied only through the treating veterinarian, with the claims supported by that veterinarian. Its manufacturing options include the Australian Standard for pet food, AS 5812-2023. Feed supplements. The APVMA's guidance for a nutritional supplement mixed into feed: it is presented in whole food, a food premix, a block or a lick, or added to feed \"(as opposed to being administered in water or as a paste or drench, or by stomach tube)\"; its claim is limited to \"to supplement diets where levels may be low\", or words to that effect; its label carries a statement such as \"Nutritional supplement product for inclusion in animal's feed. Product has no therapeutic effect\"; and it doesn't use words such as \"dose\", \"dosage\" or \"administration\". Listed products: joint health for dogs and horses. Some products are registered as listed chemical products, against a standard the APVMA has set, so a complying product needs no individual assessment. The APVMA's list \"currently lists certain home swimming pool and spa products and joint health products for dogs and horses.\" The only label claim the joint health standard allows is \"long term use may help improve joint health and function\", and for vitamins and minerals, \"to supplement diets where levels may be low\".","items":[{"lead":"Excluded nutritional or digestive products.","text":"Since 5 March 2015, certain feeds for livestock and companion animals are excluded from the Agvet Code. The product \"must be one that is fed to, and voluntarily consumed by, an animal and meet specified requirements in relation to ingredients, manufacturing, labelling and claims.\" It can only make a therapeutic claim if the claim is supported by scientific evidence accessible to the supplier, of a standard \"suitable for publication in recognised peer-reviewed scientific journals\" and provided to the APVMA on request, or if it is supplied only through the treating veterinarian, with the claims supported by that veterinarian. Its manufacturing options include the Australian Standard for pet food, AS 5812-2023."},{"lead":"Feed supplements.","text":"The APVMA's guidance for a nutritional supplement mixed into feed: it is presented in whole food, a food premix, a block or a lick, or added to feed \"(as opposed to being administered in water or as a paste or drench, or by stomach tube)\"; its claim is limited to \"to supplement diets where levels may be low\", or words to that effect; its label carries a statement such as \"Nutritional supplement product for inclusion in animal's feed. Product has no therapeutic effect\"; and it doesn't use words such as \"dose\", \"dosage\" or \"administration\"."},{"lead":"Listed products: joint health for dogs and horses.","text":"Some products are registered as listed chemical products, against a standard the APVMA has set, so a complying product needs no individual assessment. The APVMA's list \"currently lists certain home swimming pool and spa products and joint health products for dogs and horses.\" The only label claim the joint health standard allows is \"long term use may help improve joint health and function\", and for vitamins and minerals, \"to supplement diets where levels may be low\"."}],"tables":[]},{"heading":"What registration involves","anchor":"what-registration-involves","markdown":"- **Who applies.** \"Any individual or a body corporate\" can apply. Under the Agvet Code, a holder that neither lives nor carries on business in Australia must have an Australian nominated agent.\n- **The active first.** If the product's active constituent isn't already approved, \"the APVMA must approve the active constituent before we register the product.\"\n- **The data.** An application must meet the statutory criteria for safety, trade, efficacy and labelling. For a herbal or marine-derived remedy, the data cover chemistry and manufacture, health (toxicology), and efficacy and target animal safety; for companion animals, data such as residues and the environment \"are not normally expected\". The toxicology can be addressed by nominating a registered reference product, or by showing the actives are in a registered (AUST R) medicine on the ARTG.\n- **Manufacturing.** \"The Agvet Code requires all veterinary chemical products manufactured within Australia to be manufactured in licensed premises, unless those chemical products are listed, reserved or exempt.\" The standard is the Australian Code of Good Manufacturing Practice for Veterinary Chemical Products 2007, and an imported product must be made to an equivalent standard.\n- **The label.** \"The APVMA cannot register a veterinary chemical product without also approving a label\", under the Veterinary Labelling Code. A complementary product must carry \"This product is registered as a complementary animal health product\".","text":"Who applies. \"Any individual or a body corporate\" can apply. Under the Agvet Code, a holder that neither lives nor carries on business in Australia must have an Australian nominated agent. The active first. If the product's active constituent isn't already approved, \"the APVMA must approve the active constituent before we register the product.\" The data. An application must meet the statutory criteria for safety, trade, efficacy and labelling. For a herbal or marine-derived remedy, the data cover chemistry and manufacture, health (toxicology), and efficacy and target animal safety; for companion animals, data such as residues and the environment \"are not normally expected\". The toxicology can be addressed by nominating a registered reference product, or by showing the actives are in a registered (AUST R) medicine on the ARTG. Manufacturing. \"The Agvet Code requires all veterinary chemical products manufactured within Australia to be manufactured in licensed premises, unless those chemical products are listed, reserved or exempt.\" The standard is the Australian Code of Good Manufacturing Practice for Veterinary Chemical Products 2007, and an imported product must be made to an equivalent standard. The label. \"The APVMA cannot register a veterinary chemical product without also approving a label\", under the Veterinary Labelling Code. A complementary product must carry \"This product is registered as a complementary animal health product\".","items":[{"lead":"Who applies.","text":"\"Any individual or a body corporate\" can apply. Under the Agvet Code, a holder that neither lives nor carries on business in Australia must have an Australian nominated agent."},{"lead":"The active first.","text":"If the product's active constituent isn't already approved, \"the APVMA must approve the active constituent before we register the product.\""},{"lead":"The data.","text":"An application must meet the statutory criteria for safety, trade, efficacy and labelling. For a herbal or marine-derived remedy, the data cover chemistry and manufacture, health (toxicology), and efficacy and target animal safety; for companion animals, data such as residues and the environment \"are not normally expected\". The toxicology can be addressed by nominating a registered reference product, or by showing the actives are in a registered (AUST R) medicine on the ARTG."},{"lead":"Manufacturing.","text":"\"The Agvet Code requires all veterinary chemical products manufactured within Australia to be manufactured in licensed premises, unless those chemical products are listed, reserved or exempt.\" The standard is the Australian Code of Good Manufacturing Practice for Veterinary Chemical Products 2007, and an imported product must be made to an equivalent standard."},{"lead":"The label.","text":"\"The APVMA cannot register a veterinary chemical product without also approving a label\", under the Veterinary Labelling Code. A complementary product must carry \"This product is registered as a complementary animal health product\"."}],"tables":[]},{"heading":"APVMA fees and timeframes","anchor":"apvma-fees-and-timeframes","markdown":"| Application | Assessment period | Fee |\n| --- | --- | --- |\n| Approval of a new active constituent and registration of its product (item 1) | 18 months | $116,501 |\n| A new product with an approved active constituent that no registered product contains (item 3) | 18 months | $83,511 |\n| A new product whose approved active constituent is already in a registered product, with a full assessment (item 4) | 18 months | $44,644 |\n| A product similar to a registered product, where chemistry and manufacture, efficacy and target species safety are the only data needed to show it (item 5) | 8 months | $7,566 |\n| Registration of a listed product, such as a joint health product (item 9) | 2 months | $2,632 |\n\nEach item has further conditions, set out in the APVMA's table. \"The legislation prescribes the assessment period for most application types.\" The APVMA's fees \"have not been updated since 2019\", and its consultation on the 2027–28 fees, which closed on 4 September 2026, proposes changes \"intended to commence from 1 July 2027\", including a minimum upfront fee of $2,480 for a veterinary product application.","text":"Application: Approval of a new active constituent and registration of its product (item 1); Assessment period: 18 months; Fee: $116,501. Application: A new product with an approved active constituent that no registered product contains (item 3); Assessment period: 18 months; Fee: $83,511. Application: A new product whose approved active constituent is already in a registered product, with a full assessment (item 4); Assessment period: 18 months; Fee: $44,644. Application: A product similar to a registered product, where chemistry and manufacture, efficacy and target species safety are the only data needed to show it (item 5); Assessment period: 8 months; Fee: $7,566. Application: Registration of a listed product, such as a joint health product (item 9); Assessment period: 2 months; Fee: $2,632. Each item has further conditions, set out in the APVMA's table. \"The legislation prescribes the assessment period for most application types.\" The APVMA's fees \"have not been updated since 2019\", and its consultation on the 2027–28 fees, which closed on 4 September 2026, proposes changes \"intended to commence from 1 July 2027\", including a minimum upfront fee of $2,480 for a veterinary product application.","items":[],"tables":[{"header":["Application","Assessment period","Fee"],"rows":[["Approval of a new active constituent and registration of its product (item 1)","18 months","$116,501"],["A new product with an approved active constituent that no registered product contains (item 3)","18 months","$83,511"],["A new product whose approved active constituent is already in a registered product, with a full assessment (item 4)","18 months","$44,644"],["A product similar to a registered product, where chemistry and manufacture, efficacy and target species safety are the only data needed to show it (item 5)","8 months","$7,566"],["Registration of a listed product, such as a joint health product (item 9)","2 months","$2,632"]]}]},{"heading":"Pet food and its claims","anchor":"pet-food-and-its-claims","markdown":"Most pet food sits outside the APVMA's registration scheme. The APVMA regulates direct-fed microbial, nutritional or digestive pet foods \"unless deemed as excluded nutritional or digestive (END) products\", and animal feed products generally don't need registration. \"States and territories have primary responsibility for overseeing the manufacture and sale of pet food in Australia.\" The Australian Standard for manufacturing and marketing pet food, AS 5812, is voluntary, though the Pet Food Industry Association of Australia requires its manufacturing members to comply with it. On 24 April 2026 the agriculture ministers \"agreed that a regulatory approach is not warranted at this time, based on the available evidence.\"\n\nClaims are still covered by the Australian Consumer Law: the Competition and Consumer Act \"prohibits misleading and deceptive conduct\", and the ACCC administers it.","text":"Most pet food sits outside the APVMA's registration scheme. The APVMA regulates direct-fed microbial, nutritional or digestive pet foods \"unless deemed as excluded nutritional or digestive (END) products\", and animal feed products generally don't need registration. \"States and territories have primary responsibility for overseeing the manufacture and sale of pet food in Australia.\" The Australian Standard for manufacturing and marketing pet food, AS 5812, is voluntary, though the Pet Food Industry Association of Australia requires its manufacturing members to comply with it. On 24 April 2026 the agriculture ministers \"agreed that a regulatory approach is not warranted at this time, based on the available evidence.\" Claims are still covered by the Australian Consumer Law: the Competition and Consumer Act \"prohibits misleading and deceptive conduct\", and the ACCC administers it.","items":[],"tables":[]},{"heading":"What happens on the wrong side","anchor":"what-happens-on-the-wrong-side","markdown":"\"Unless we grant a formal exemption or a permit, it is an offence under the Agvet Code to supply a chemical product that is not a registered chemical product where it is required by law to be registered. Monetary penalties apply.\" In 2024 the Federal Court found that 71 of the 74 products Bonnie & I Pty Ltd advertised on its website, represented as homeopathic or naturopathic remedies, were veterinary chemical products. It ordered the company to pay $850,000, for supplying them, for advertising them and for not complying with a recall notice, and its director $135,000. In September 2025, amending regulations on infringement notices were also registered; their changes are now part of the Agvet Code Regulations.","text":"\"Unless we grant a formal exemption or a permit, it is an offence under the Agvet Code to supply a chemical product that is not a registered chemical product where it is required by law to be registered. Monetary penalties apply.\" In 2024 the Federal Court found that 71 of the 74 products Bonnie & I Pty Ltd advertised on its website, represented as homeopathic or naturopathic remedies, were veterinary chemical products. It ordered the company to pay $850,000, for supplying them, for advertising them and for not complying with a recall notice, and its director $135,000. In September 2025, amending regulations on infringement notices were also registered; their changes are now part of the Agvet Code Regulations.","items":[],"tables":[]},{"heading":"Human supplements are a different system","anchor":"human-supplements-are-a-different-system","markdown":"The TGA's law is about people: its definition of therapeutic use begins with \"preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons\". For animals the TGA points to the APVMA, which \"assesses veterinary products\", and it warns that \"you shouldn't be giving medicines made for humans to your pets.\" For a product for people, see [medicine, food or cosmetic?](/pathways)","text":"The TGA's law is about people: its definition of therapeutic use begins with \"preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons\". For animals the TGA points to the APVMA, which \"assesses veterinary products\", and it warns that \"you shouldn't be giving medicines made for humans to your pets.\" For a product for people, see medicine, food or cosmetic?","items":[],"tables":[]},{"heading":"Where we come in","anchor":"where-we-come-in","markdown":"Our founder, Gabriel Perera, founded [Nectar of the Dogs](/work/nectar-of-the-dogs-pet-supplements): plant-based supplement powders and water treats for dogs, formulated to evidence-based standards with vet surgeons and naturopaths. In 2022 The Real Pet Food Company, the group behind Ivory Coat, Billy + Margot and Nature's Gift, bought a majority stake, its first move into pet supplements.\n\nSo we work on pet products too. They aren't therapeutic goods: where they are veterinary chemical products they follow the APVMA's rules, therapeutic claims get closer scrutiny, and retailers may ask for an evidence dossier. We settle the line at the brief, as we do for products for people: the claims, the doses and the form decide which rules a product meets, before the formula is set. More on [formulation](/formulation), or [book a call](/contact).","text":"Our founder, Gabriel Perera, founded Nectar of the Dogs: plant-based supplement powders and water treats for dogs, formulated to evidence-based standards with vet surgeons and naturopaths. In 2022 The Real Pet Food Company, the group behind Ivory Coat, Billy + Margot and Nature's Gift, bought a majority stake, its first move into pet supplements. So we work on pet products too. They aren't therapeutic goods: where they are veterinary chemical products they follow the APVMA's rules, therapeutic claims get closer scrutiny, and retailers may ask for an evidence dossier. We settle the line at the brief, as we do for products for people: the claims, the doses and the form decide which rules a product meets, before the formula is set. More on formulation, or book a call.","items":[],"tables":[]}],"faqs":[{"q":"Does a pet supplement need APVMA registration?","a":"It does if it is a veterinary chemical product: represented as suitable for, or supplied or used for, preventing, curing or alleviating a disease or condition in an animal, or modifying its physiology in the ways the Agvet Code lists, and not excluded or exempt. A product that names a disease or condition needs registration unless it meets the conditions for an excluded nutritional or digestive product. A listed product, such as a joint health product for dogs, still needs registration, through a simpler route. A pet food or feed supplement that only supports normal health generally doesn't.","md":"It does if it is a veterinary chemical product: represented as suitable for, or supplied or used for, preventing, curing or alleviating a disease or condition in an animal, or modifying its physiology in the ways the Agvet Code lists, and not excluded or exempt. A product that names a disease or condition needs registration unless it meets the conditions for an excluded nutritional or digestive product. A listed product, such as a joint health product for dogs, still needs registration, through a simpler route. A pet food or feed supplement that only supports normal health generally doesn't."},{"q":"Is a dog supplement regulated by the TGA?","a":"No. The TGA's law is about therapeutic use in people. A product for animals is regulated by the APVMA when it is a veterinary chemical product; otherwise, as a pet food or feed, it falls to the states and territories and the Australian Consumer Law.","md":"No. The TGA's law is about therapeutic use in people. A product for animals is regulated by the APVMA when it is a veterinary chemical product; otherwise, as a pet food or feed, it falls to the states and territories and the Australian Consumer Law."},{"q":"What can a pet supplement claim without registration?","a":"Claims about maintaining normal health, such as the APVMA's example \"helps maintain healthy bones\", and for a feed supplement \"to supplement diets where levels may be low\". A claim that mentions a disease or condition, or preventing, reducing, treating or curing one, is only possible without registration for an excluded nutritional or digestive product whose claim is backed by suitable scientific evidence, or which is supplied only through the treating veterinarian. A registered listed joint health product for dogs or horses can claim \"long term use may help improve joint health and function\".","md":"Claims about maintaining normal health, such as the APVMA's example \"helps maintain healthy bones\", and for a feed supplement \"to supplement diets where levels may be low\". A claim that mentions a disease or condition, or preventing, reducing, treating or curing one, is only possible without registration for an excluded nutritional or digestive product whose claim is backed by suitable scientific evidence, or which is supplied only through the treating veterinarian. A registered listed joint health product for dogs or horses can claim \"long term use may help improve joint health and function\"."},{"q":"How much does APVMA registration cost, and how long does it take?","a":"On the APVMA's current fee table, from $2,632 and 2 months to register a listed product, such as a joint health product, and $7,566 and 8 months for a product similar to a registered one, to $44,644 and 18 months for a new product whose approved active is already in a registered product, $83,511 and 18 months for one whose approved active isn't, and $116,501 and 18 months where the active itself needs approval. New fees are proposed from 1 July 2027.","md":"On the APVMA's current fee table, from $2,632 and 2 months to register a listed product, such as a joint health product, and $7,566 and 8 months for a product similar to a registered one, to $44,644 and 18 months for a new product whose approved active is already in a registered product, $83,511 and 18 months for one whose approved active isn't, and $116,501 and 18 months where the active itself needs approval. New fees are proposed from 1 July 2027."},{"q":"Is pet food regulated in Australia?","a":"By the states and territories, which have primary responsibility for its manufacture and sale, and by the Australian Consumer Law, which prohibits misleading and deceptive conduct. The pet food standard, AS 5812, is voluntary, and in April 2026 the agriculture ministers decided a regulatory approach wasn't warranted at this time.","md":"By the states and territories, which have primary responsibility for its manufacture and sale, and by the Australian Consumer Law, which prohibits misleading and deceptive conduct. The pet food standard, AS 5812, is voluntary, and in April 2026 the agriculture ministers decided a regulatory approach wasn't warranted at this time."},{"q":"Can a pet supplement be made overseas?","a":"A veterinary chemical product made in Australia must be made in licensed premises unless it is listed, reserved or exempt, and an imported one must be made to a standard equivalent to the APVMA's manufacturing principles and GMP Code. A holder that neither lives nor carries on business in Australia must have an Australian nominated agent.","md":"A veterinary chemical product made in Australia must be made in licensed premises unless it is listed, reserved or exempt, and an imported one must be made to a standard equivalent to the APVMA's manufacturing principles and GMP Code. A holder that neither lives nor carries on business in Australia must have an Australian nominated agent."}],"sources":{"note":"General information, checked against these sources on 22 October 2026. It isn't advice on a particular product. Nectar of the Dogs and our approach to pet products are from Take Friday Off's records.","markdown":"General information, checked against these sources on 22 October 2026. It isn't advice on a particular product. Nectar of the Dogs and our approach to pet products are from Take Friday Off's records.\n\n- [Agricultural and Veterinary Chemicals Code](https://www.legislation.gov.au/C2004A04723/latest/text), sections 3, 5 and 8N, and the [Agricultural and Veterinary Chemicals Code Regulations 1995](https://www.legislation.gov.au/F1996B00288/latest/text), Federal Register of Legislation\n- APVMA guidance: [does my product need registration](https://apvma.gov.au/node/10606), [claims for feeds](https://apvma.gov.au/node/10611), [feed supplements](https://apvma.gov.au/node/10631), [complementary animal health products](https://www.apvma.gov.au/node/490), [excluded nutritional or digestive products](https://apvma.gov.au/node/13021), [the 2015 reforms](https://apvma.gov.au/node/10646), [listed products](https://apvma.gov.au/node/173) and [what the APVMA regulates](https://apvma.gov.au/node/15931), Australian Pesticides and Veterinary Medicines Authority\n- [Agricultural and Veterinary Chemicals Code (Listed Chemical Product – Joint Health Products for Dogs and Horses) Standard 2014](https://www.legislation.gov.au/F2014L00863) and the [Ingredient Determination 2015](https://www.legislation.gov.au/F2015L00785), Federal Register of Legislation\n- APVMA: [applying for approvals and registrations](https://www.apvma.gov.au/registrations-and-permits/chemical-product-registration/applying-approvals-registrations-and-variations), [who can apply](https://apvma.gov.au/node/48), [manufacturing licences](https://www.apvma.gov.au/node/294), [good manufacturing practice](https://www.apvma.gov.au/regulation/manufacturing/good-manufacturing-practice/legislative-basis-apvmas-role-manufacturing-quality-and-licensing), [the Veterinary Labelling Code](https://apvma.gov.au/node/924) and [complementary products' labels](https://www.apvma.gov.au/registrations-and-permits/labelling-codes/veterinary-labelling-code/specific-labelling-requirements-veterinary-chemical-products/complementary-products)\n- APVMA: [fees and timeframes](https://www.apvma.gov.au/node/83) and the [fees and charges 2027–28 consultation paper](https://www.apvma.gov.au/sites/default/files/documents/2026-07/APVMA%20-%20Fees%20and%20Charges%202027%E2%80%9328%20Consultation%20Paper.pdf)\n- APVMA: [the registration self-assessment tool](https://www.apvma.gov.au/registrations-and-permits/chemical-product-registration/registration-self-assessment-tool-vet) and [the Bonnie & I penalties](https://www.apvma.gov.au/node/293364), and [APVMA v Bonnie and I Pty Ltd [2024] FCA 642](https://www.judgments.fedcourt.gov.au/judgments/Judgments/fca/single/2024/2024fca0642), Federal Court of Australia\n- [Agricultural and Veterinary Chemicals Legislation Amendment (Infringement Notices) Regulations 2025](https://www.legislation.gov.au/F2025L01174/latest/details), Federal Register of Legislation\n- [Pet food safety](https://www.agriculture.gov.au/agriculture-land/animal/health/pet-food-safety) and [Pet food safety in Australia: report to agriculture ministers](https://www.agriculture.gov.au/sites/default/files/documents/pet-food-safety-in-aus-report-to-agriculture-ministers-incl-cba-report.pdf), Department of Agriculture, Fisheries and Forestry\n- [Therapeutic Goods Act 1989](https://www.legislation.gov.au/C2004A03952/latest/text), section 3, Federal Register of Legislation, and [The dangers of taking your pet's medication](https://www.tga.gov.au/blogs/tga-topics/dangers-taking-your-pets-medication), Therapeutic Goods Administration","items":[{"text":"Agricultural and Veterinary Chemicals Code, sections 3, 5 and 8N, and the Agricultural and Veterinary Chemicals Code Regulations 1995, Federal Register of Legislation","links":[{"title":"Agricultural and Veterinary Chemicals Code","url":"https://www.legislation.gov.au/C2004A04723/latest/text"},{"title":"Agricultural and Veterinary Chemicals Code Regulations 1995","url":"https://www.legislation.gov.au/F1996B00288/latest/text"}]},{"text":"APVMA guidance: does my product need registration, claims for feeds, feed supplements, complementary animal health products, excluded nutritional or digestive products, the 2015 reforms, listed products and what the APVMA regulates, Australian Pesticides and Veterinary Medicines Authority","links":[{"title":"does my product need registration","url":"https://apvma.gov.au/node/10606"},{"title":"claims for feeds","url":"https://apvma.gov.au/node/10611"},{"title":"feed supplements","url":"https://apvma.gov.au/node/10631"},{"title":"complementary animal health products","url":"https://www.apvma.gov.au/node/490"},{"title":"excluded nutritional or digestive products","url":"https://apvma.gov.au/node/13021"},{"title":"the 2015 reforms","url":"https://apvma.gov.au/node/10646"},{"title":"listed products","url":"https://apvma.gov.au/node/173"},{"title":"what the APVMA regulates","url":"https://apvma.gov.au/node/15931"}]},{"text":"Agricultural and Veterinary Chemicals Code (Listed Chemical Product – Joint Health Products for Dogs and Horses) Standard 2014 and the Ingredient Determination 2015, Federal Register of Legislation","links":[{"title":"Agricultural and Veterinary Chemicals Code (Listed Chemical Product – Joint Health Products for Dogs and Horses) Standard 2014","url":"https://www.legislation.gov.au/F2014L00863"},{"title":"Ingredient Determination 2015","url":"https://www.legislation.gov.au/F2015L00785"}]},{"text":"APVMA: applying for approvals and registrations, who can apply, manufacturing licences, good manufacturing practice, the Veterinary Labelling Code and complementary products' labels","links":[{"title":"applying for approvals and registrations","url":"https://www.apvma.gov.au/registrations-and-permits/chemical-product-registration/applying-approvals-registrations-and-variations"},{"title":"who can apply","url":"https://apvma.gov.au/node/48"},{"title":"manufacturing licences","url":"https://www.apvma.gov.au/node/294"},{"title":"good manufacturing practice","url":"https://www.apvma.gov.au/regulation/manufacturing/good-manufacturing-practice/legislative-basis-apvmas-role-manufacturing-quality-and-licensing"},{"title":"the Veterinary Labelling Code","url":"https://apvma.gov.au/node/924"},{"title":"complementary products' labels","url":"https://www.apvma.gov.au/registrations-and-permits/labelling-codes/veterinary-labelling-code/specific-labelling-requirements-veterinary-chemical-products/complementary-products"}]},{"text":"APVMA: fees and timeframes and the fees and charges 2027–28 consultation paper","links":[{"title":"fees and timeframes","url":"https://www.apvma.gov.au/node/83"},{"title":"fees and charges 2027–28 consultation paper","url":"https://www.apvma.gov.au/sites/default/files/documents/2026-07/APVMA%20-%20Fees%20and%20Charges%202027%E2%80%9328%20Consultation%20Paper.pdf"}]},{"text":"APVMA: the registration self-assessment tool and the Bonnie & I penalties, and [APVMA v Bonnie and I Pty Ltd [2024] FCA 642](https://www.judgments.fedcourt.gov.au/judgments/Judgments/fca/single/2024/2024fca0642), Federal Court of Australia","links":[{"title":"the registration self-assessment tool","url":"https://www.apvma.gov.au/registrations-and-permits/chemical-product-registration/registration-self-assessment-tool-vet"},{"title":"the Bonnie & I penalties","url":"https://www.apvma.gov.au/node/293364"}]},{"text":"Agricultural and Veterinary Chemicals Legislation Amendment (Infringement Notices) Regulations 2025, Federal Register of Legislation","links":[{"title":"Agricultural and Veterinary Chemicals Legislation Amendment (Infringement Notices) Regulations 2025","url":"https://www.legislation.gov.au/F2025L01174/latest/details"}]},{"text":"Pet food safety and Pet food safety in Australia: report to agriculture ministers, Department of Agriculture, Fisheries and Forestry","links":[{"title":"Pet food safety","url":"https://www.agriculture.gov.au/agriculture-land/animal/health/pet-food-safety"},{"title":"Pet food safety in Australia: report to agriculture ministers","url":"https://www.agriculture.gov.au/sites/default/files/documents/pet-food-safety-in-aus-report-to-agriculture-ministers-incl-cba-report.pdf"}]},{"text":"Therapeutic Goods Act 1989, section 3, Federal Register of Legislation, and The dangers of taking your pet's medication, Therapeutic Goods Administration","links":[{"title":"Therapeutic Goods Act 1989","url":"https://www.legislation.gov.au/C2004A03952/latest/text"},{"title":"The dangers of taking your pet's medication","url":"https://www.tga.gov.au/blogs/tga-topics/dangers-taking-your-pets-medication"}]}]}},{"slug":"gmp-clearance","kind":"guide","url":"/guides/gmp-clearance","title":"TGA GMP clearance: making a listed medicine overseas","name":"GMP clearance guide","description":"When an overseas factory needs TGA GMP clearance for a listed medicine: the MRA, compliance verification and inspection routes, evidence, fees and renewal.","eyebrow":"Guide","lead":"Every step in making a listed medicine has to meet good manufacturing practice (GMP), unless it is exempt. In Australia that takes a TGA manufacturing licence; overseas, the Australian sponsor needs a TGA GMP clearance for each site that carries out a step recorded on the medicine's ARTG entry, from making the dosage form to testing, packaging and releasing the batch. This guide covers which steps need one, the three routes to a clearance, why supplements often can't take the two quicker ones, the evidence, the TGA's 2026–27 fees, renewal, and what happens when a clearance lapses.","parent":"/manufacturing","studies":["pump-haircare-hair-supplement","bwellness-practitioner-range","deeply-rooted-organic-oil"],"formats":[],"order":70,"updated":"2026-10-22","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- A listed medicine made overseas needs a TGA GMP clearance for every overseas site that carries out a step of its manufacture recorded on its ARTG entry, unless the step is exempt. The Australian sponsor holds it: one clearance per site, per sponsor.\n- There are three routes: a mutual recognition agreement (MRA) desktop evaluation or a compliance verification (CV) desktop evaluation, both relying on an inspection by another regulator, or an inspection by the TGA.\n- The two desktop routes often aren't open to supplements. They rest on an inspection by a recognised regulator for a human medicinal product, and in many countries dietary supplements aren't regulated as medicines.\n- In 2026–27 the TGA's GMP clearance fees include $818 to process each clearance and $3,130 for compliance verification; an inspection of an overseas site costs $1,748 an hour per inspector, plus costs and expenses.\n- The standard is the PIC/S Guide to GMP, version PE009-17, since 1 September 2025. Apply to renew at least six months before a clearance expires: one expired for more than 12 months can't be reinstated.","text":"A listed medicine made overseas needs a TGA GMP clearance for every overseas site that carries out a step of its manufacture recorded on its ARTG entry, unless the step is exempt. The Australian sponsor holds it: one clearance per site, per sponsor. There are three routes: a mutual recognition agreement (MRA) desktop evaluation or a compliance verification (CV) desktop evaluation, both relying on an inspection by another regulator, or an inspection by the TGA. The two desktop routes often aren't open to supplements. They rest on an inspection by a recognised regulator for a human medicinal product, and in many countries dietary supplements aren't regulated as medicines. In 2026–27 the TGA's GMP clearance fees include $818 to process each clearance and $3,130 for compliance verification; an inspection of an overseas site costs $1,748 an hour per inspector, plus costs and expenses. The standard is the PIC/S Guide to GMP, version PE009-17, since 1 September 2025. Apply to renew at least six months before a clearance expires: one expired for more than 12 months can't be reinstated.","items":[],"tables":[]},{"heading":"Which steps need a clearance","anchor":"which-steps-need-a-clearance","markdown":"\"All steps of manufacture of registered and listed products are required to be GMP compliant unless they are exempt\", and each step must be recorded in the product's ARTG entry. For a listed medicine, the steps that need GMP evidence are:\n\n- **Making the dosage form:** the capsule, tablet or powder itself.\n- **Packaging and labelling.** Secondary packaging can need a clearance too, where that step is done for the product.\n- **Chemical and physical testing,** and **microbial testing.**\n- **Release for supply:** the batch certified by an authorised person.\n\nWhere a step happens overseas, the TGA's certification guidance for listed medicines says the manufacturer must hold a TGA GMP clearance, or a clearance the TGA accepts. The Australian sponsor applies for it, and certifies when it lists the medicine that its manufacturing meets the requirements. A clearance belongs to one site and one sponsor: \"separate applications are required for each unique site address\", and \"each sponsor must obtain their own GMP Clearance for a particular manufacturing site\". More on the sponsor's role in our [TGA sponsor guide](/guides/tga-sponsor).\n\nIn Australia, a TGA manufacturing licence does the same job: \"You need a TGA manufacturing licence to manufacture in Australia therapeutic goods for supply in or export from Australia\", unless Schedule 7 of the Therapeutic Goods Regulations 1990 exempts the goods, or Schedule 8 exempts the person making them. More on [manufacturing](/manufacturing).","text":"\"All steps of manufacture of registered and listed products are required to be GMP compliant unless they are exempt\", and each step must be recorded in the product's ARTG entry. For a listed medicine, the steps that need GMP evidence are: Making the dosage form: the capsule, tablet or powder itself. Packaging and labelling. Secondary packaging can need a clearance too, where that step is done for the product. Chemical and physical testing, and microbial testing. Release for supply: the batch certified by an authorised person. Where a step happens overseas, the TGA's certification guidance for listed medicines says the manufacturer must hold a TGA GMP clearance, or a clearance the TGA accepts. The Australian sponsor applies for it, and certifies when it lists the medicine that its manufacturing meets the requirements. A clearance belongs to one site and one sponsor: \"separate applications are required for each unique site address\", and \"each sponsor must obtain their own GMP Clearance for a particular manufacturing site\". More on the sponsor's role in our TGA sponsor guide. In Australia, a TGA manufacturing licence does the same job: \"You need a TGA manufacturing licence to manufacture in Australia therapeutic goods for supply in or export from Australia\", unless Schedule 7 of the Therapeutic Goods Regulations 1990 exempts the goods, or Schedule 8 exempts the person making them. More on manufacturing.","items":[{"lead":"Making the dosage form:","text":"the capsule, tablet or powder itself."},{"lead":"Packaging and labelling.","text":"Secondary packaging can need a clearance too, where that step is done for the product."},{"lead":"Chemical and physical testing,","text":"and microbial testing."},{"lead":"Release for supply:","text":"the batch certified by an authorised person."}],"tables":[]},{"heading":"Three routes to a clearance","anchor":"three-routes-to-a-clearance","markdown":"| Route | When it applies | Who it can rely on |\n| --- | --- | --- |\n| Mutual recognition agreement (MRA) desktop evaluation | The regulator inspected a manufacturer within its own borders | The European Union (with Norway, Iceland and Liechtenstein), the United Kingdom, Canada, Singapore and New Zealand; Switzerland under a memorandum of understanding |\n| Compliance verification (CV) desktop evaluation | The regulator inspected a manufacturer outside its own borders, or works with the TGA under a cooperative arrangement | An MRA partner's inspection outside its own borders; Health Canada outside Canada; the US FDA, inside or outside the US; the EDQM outside the EU with an EU member state; and, in some cases, other PIC/S members' inspections within their own countries |\n| TGA inspection | No acceptable evidence from another regulator | The TGA's own inspectors, requested through a certification application |\n\nFor other regulators in PIC/S, the international GMP inspection scheme, the TGA doesn't accept evidence from an inspection performed outside that regulator's own country.","text":"Route: Mutual recognition agreement (MRA) desktop evaluation; When it applies: The regulator inspected a manufacturer within its own borders; Who it can rely on: The European Union (with Norway, Iceland and Liechtenstein), the United Kingdom, Canada, Singapore and New Zealand; Switzerland under a memorandum of understanding. Route: Compliance verification (CV) desktop evaluation; When it applies: The regulator inspected a manufacturer outside its own borders, or works with the TGA under a cooperative arrangement; Who it can rely on: An MRA partner's inspection outside its own borders; Health Canada outside Canada; the US FDA, inside or outside the US; the EDQM outside the EU with an EU member state; and, in some cases, other PIC/S members' inspections within their own countries. Route: TGA inspection; When it applies: No acceptable evidence from another regulator; Who it can rely on: The TGA's own inspectors, requested through a certification application. For other regulators in PIC/S, the international GMP inspection scheme, the TGA doesn't accept evidence from an inspection performed outside that regulator's own country.","items":[],"tables":[{"header":["Route","When it applies","Who it can rely on"],"rows":[["Mutual recognition agreement (MRA) desktop evaluation","The regulator inspected a manufacturer within its own borders","The European Union (with Norway, Iceland and Liechtenstein), the United Kingdom, Canada, Singapore and New Zealand; Switzerland under a memorandum of understanding"],["Compliance verification (CV) desktop evaluation","The regulator inspected a manufacturer outside its own borders, or works with the TGA under a cooperative arrangement","An MRA partner's inspection outside its own borders; Health Canada outside Canada; the US FDA, inside or outside the US; the EDQM outside the EU with an EU member state; and, in some cases, other PIC/S members' inspections within their own countries"],["TGA inspection","No acceptable evidence from another regulator","The TGA's own inspectors, requested through a certification application"]]}]},{"heading":"Why supplements often need an inspection","anchor":"why-supplements-often-need-an-inspection","markdown":"The two desktop routes rely on another regulator having inspected the site as a medicines manufacturer. The TGA says the MRA and CV pathways are unavailable for \"some complementary and listed medicines, including sunscreens and dietary supplements\", because they \"may not be regulated as medicines in other countries\": \"The site must be inspected by a recognised regulatory authority for a human medicinal product\". An older TGA guide puts it plainly: \"It is often not possible to obtain GMP clearance using evidence from another regulator\" for listed medicines.\n\nThere is one way through for a medicines plant. Where supplements are made \"in the same facility under the same standard and controls\" as the medicines its certificate covers, the TGA may accept a complementary medicine declaration with the site's most recent GMP certificate.\n\nSo a factory that makes supplements under food rules in its own country often can't be cleared on paper, and the options are a TGA inspection or a site that can be cleared.","text":"The two desktop routes rely on another regulator having inspected the site as a medicines manufacturer. The TGA says the MRA and CV pathways are unavailable for \"some complementary and listed medicines, including sunscreens and dietary supplements\", because they \"may not be regulated as medicines in other countries\": \"The site must be inspected by a recognised regulatory authority for a human medicinal product\". An older TGA guide puts it plainly: \"It is often not possible to obtain GMP clearance using evidence from another regulator\" for listed medicines. There is one way through for a medicines plant. Where supplements are made \"in the same facility under the same standard and controls\" as the medicines its certificate covers, the TGA may accept a complementary medicine declaration with the site's most recent GMP certificate. So a factory that makes supplements under food rules in its own country often can't be cleared on paper, and the options are a TGA inspection or a site that can be cleared.","items":[],"tables":[]},{"heading":"The evidence for compliance verification","anchor":"the-evidence-for-compliance-verification","markdown":"A CV application needs, among other documents:\n\n- A GMP certificate from an overseas regulator \"issued after an on-site inspection\", and the most recent inspection report.\n- A list of the regulators' on-site inspections in the three years before the application, and details of any regulatory action.\n- The site master file, the list of products intended for supply, the GMP agreement, the release procedures, the validation master plan, the latest product quality review and, for a contract testing laboratory, the list of authorised tests.\n\nSince 1 July 2025 the TGA has gone back to its pre-pandemic rule for CV applications: it no longer accepts evidence from an inspection more than three years old. An MRA evaluation rests on an MRA GMP certificate.","text":"A CV application needs, among other documents: A GMP certificate from an overseas regulator \"issued after an on-site inspection\", and the most recent inspection report. A list of the regulators' on-site inspections in the three years before the application, and details of any regulatory action. The site master file, the list of products intended for supply, the GMP agreement, the release procedures, the validation master plan, the latest product quality review and, for a contract testing laboratory, the list of authorised tests. Since 1 July 2025 the TGA has gone back to its pre-pandemic rule for CV applications: it no longer accepts evidence from an inspection more than three years old. An MRA evaluation rests on an MRA GMP certificate.","items":[],"tables":[]},{"heading":"GMP clearance fees for 2026–27","anchor":"gmp-clearance-fees-for-202627","markdown":"| Fee | Amount |\n| --- | --- |\n| GMP clearance application processing, per manufacturer, site and sponsor | $818 |\n| Obtaining evidence from an overseas regulatory authority, per manufacturer, site and sponsor | $880 |\n| Compliance verification, in lieu of an overseas GMP inspection | $3,130 |\n| Reinstating an expired GMP clearance, per manufacturer, site and sponsor, on top of the fees that apply | $1,479 |\n| Inspecting an overseas manufacturing site | $1,748 an hour per inspector, plus costs and reasonable expenses, including accommodation and allowances outside Australia |\n\nWhich fees apply depends on the route and the evidence. The TGA charges no separate application fee for a GMP clearance, or for the certification of an overseas site, and the fees are set in Schedule 9 of the Therapeutic Goods Regulations 1990. The [calculator in our TGA approval guide](/guides/tga-approval#what-it-costs-tga-fees-for-202627) adds the processing fee to a whole plan's other TGA fees.","text":"Fee: GMP clearance application processing, per manufacturer, site and sponsor; Amount: $818. Fee: Obtaining evidence from an overseas regulatory authority, per manufacturer, site and sponsor; Amount: $880. Fee: Compliance verification, in lieu of an overseas GMP inspection; Amount: $3,130. Fee: Reinstating an expired GMP clearance, per manufacturer, site and sponsor, on top of the fees that apply; Amount: $1,479. Fee: Inspecting an overseas manufacturing site; Amount: $1,748 an hour per inspector, plus costs and reasonable expenses, including accommodation and allowances outside Australia. Which fees apply depends on the route and the evidence. The TGA charges no separate application fee for a GMP clearance, or for the certification of an overseas site, and the fees are set in Schedule 9 of the Therapeutic Goods Regulations 1990. The calculator in our TGA approval guide adds the processing fee to a whole plan's other TGA fees.","items":[],"tables":[{"header":["Fee","Amount"],"rows":[["GMP clearance application processing, per manufacturer, site and sponsor","$818"],["Obtaining evidence from an overseas regulatory authority, per manufacturer, site and sponsor","$880"],["Compliance verification, in lieu of an overseas GMP inspection","$3,130"],["Reinstating an expired GMP clearance, per manufacturer, site and sponsor, on top of the fees that apply","$1,479"],["Inspecting an overseas manufacturing site","$1,748 an hour per inspector, plus costs and reasonable expenses, including accommodation and allowances outside Australia"]]}]},{"heading":"How long a clearance lasts, and renewing it","anchor":"how-long-a-clearance-lasts-and-renewing-it","markdown":"- **No fixed term.** The TGA sets each clearance's expiry date, and \"may shorten the expiry date of your GMP Clearance depending on the level of compliance evaluated\", or because of restrictions identified in the evidence.\n- **Renew early.** A renewal is a variation application, and the TGA asks for it at least six months before the current clearance expires.\n- **Extensions are short and few.** The TGA can grant a short-term extension for valid reasons, \"usually no more than one extension\" on top of the six months already applied to an issued clearance, and it gives priority to requests made more than a month before expiry.\n- **The 2025 backlog measures.** MRA clearances and CV clearances for non-sterile active ingredients due to expire between 1 July 2025 and 30 June 2027 were extended by two years without an application: 6,258 extensions in all. The TGA's dashboard, with data from 1 June 2026, reports its queue of CV applications falling from 2,185 at the end of June 2025 to 1,203.\n- **Processing times.** The TGA took target processing timeframes out of its guidance in November 2023; its GMP clearance dashboard now reports processing times, with a target for MRA applications.\n- **A new portal.** The TGA has said new GMP clearances will be submitted through its new business services portal once it goes live, which it expected in mid to late 2026.","text":"No fixed term. The TGA sets each clearance's expiry date, and \"may shorten the expiry date of your GMP Clearance depending on the level of compliance evaluated\", or because of restrictions identified in the evidence. Renew early. A renewal is a variation application, and the TGA asks for it at least six months before the current clearance expires. Extensions are short and few. The TGA can grant a short-term extension for valid reasons, \"usually no more than one extension\" on top of the six months already applied to an issued clearance, and it gives priority to requests made more than a month before expiry. The 2025 backlog measures. MRA clearances and CV clearances for non-sterile active ingredients due to expire between 1 July 2025 and 30 June 2027 were extended by two years without an application: 6,258 extensions in all. The TGA's dashboard, with data from 1 June 2026, reports its queue of CV applications falling from 2,185 at the end of June 2025 to 1,203. Processing times. The TGA took target processing timeframes out of its guidance in November 2023; its GMP clearance dashboard now reports processing times, with a target for MRA applications. A new portal. The TGA has said new GMP clearances will be submitted through its new business services portal once it goes live, which it expected in mid to late 2026.","items":[{"lead":"No fixed term.","text":"The TGA sets each clearance's expiry date, and \"may shorten the expiry date of your GMP Clearance depending on the level of compliance evaluated\", or because of restrictions identified in the evidence."},{"lead":"Renew early.","text":"A renewal is a variation application, and the TGA asks for it at least six months before the current clearance expires."},{"lead":"Extensions are short and few.","text":"The TGA can grant a short-term extension for valid reasons, \"usually no more than one extension\" on top of the six months already applied to an issued clearance, and it gives priority to requests made more than a month before expiry."},{"lead":"The 2025 backlog measures.","text":"MRA clearances and CV clearances for non-sterile active ingredients due to expire between 1 July 2025 and 30 June 2027 were extended by two years without an application: 6,258 extensions in all. The TGA's dashboard, with data from 1 June 2026, reports its queue of CV applications falling from 2,185 at the end of June 2025 to 1,203."},{"lead":"Processing times.","text":"The TGA took target processing timeframes out of its guidance in November 2023; its GMP clearance dashboard now reports processing times, with a target for MRA applications."},{"lead":"A new portal.","text":"The TGA has said new GMP clearances will be submitted through its new business services portal once it goes live, which it expected in mid to late 2026."}],"tables":[]},{"heading":"When a clearance lapses","anchor":"when-a-clearance-lapses","markdown":"- **After 30 days,** the sponsor can no longer submit variation applications for it.\n- **After 12 months,** it can't be reinstated.\n- **No transfers.** An expired clearance can't be transferred.\n- **The ARTG.** The TGA can only update ARTG entries with current GMP clearances.\n- **Cancellation.** The TGA can cancel, suspend, add conditions to or reduce the scope of a clearance, including where the sponsor doesn't meet its responsibilities.\n- **The medicine.** If a listed medicine doesn't meet its certifications, \"penalties can apply and in some cases we can remove your product from the ARTG\", \"making it illegal for you to continue selling or supplying in Australia.\"","text":"After 30 days, the sponsor can no longer submit variation applications for it. After 12 months, it can't be reinstated. No transfers. An expired clearance can't be transferred. The ARTG. The TGA can only update ARTG entries with current GMP clearances. Cancellation. The TGA can cancel, suspend, add conditions to or reduce the scope of a clearance, including where the sponsor doesn't meet its responsibilities. The medicine. If a listed medicine doesn't meet its certifications, \"penalties can apply and in some cases we can remove your product from the ARTG\", \"making it illegal for you to continue selling or supplying in Australia.\"","items":[{"lead":"After 30 days,","text":"the sponsor can no longer submit variation applications for it."},{"lead":"After 12 months,","text":"it can't be reinstated."},{"lead":"No transfers.","text":"An expired clearance can't be transferred."},{"lead":"The ARTG.","text":"The TGA can only update ARTG entries with current GMP clearances."},{"lead":"Cancellation.","text":"The TGA can cancel, suspend, add conditions to or reduce the scope of a clearance, including where the sponsor doesn't meet its responsibilities."},{"lead":"The medicine.","text":"If a listed medicine doesn't meet its certifications, \"penalties can apply and in some cases we can remove your product from the ARTG\", \"making it illegal for you to continue selling or supplying in Australia.\""}],"tables":[]},{"heading":"The standard: the PIC/S Guide, version 17","anchor":"the-standard-the-pics-guide-version-17","markdown":"From 1 September 2025, version PE009-17 of the PIC/S Guide to GMP (25 August 2023) applies to the manufacture of medicines, active pharmaceutical ingredients and sunscreens in Australia, unless they are exempt. Its Annexes 4, 5 and 14 are not adopted in Australia. It applies through the Therapeutic Goods (Manufacturing Principles) Determination 2020, as amended in 2025.","text":"From 1 September 2025, version PE009-17 of the PIC/S Guide to GMP (25 August 2023) applies to the manufacture of medicines, active pharmaceutical ingredients and sunscreens in Australia, unless they are exempt. Its Annexes 4, 5 and 14 are not adopted in Australia. It applies through the Therapeutic Goods (Manufacturing Principles) Determination 2020, as amended in 2025.","items":[],"tables":[]},{"heading":"Where we come in","anchor":"where-we-come-in","markdown":"For a listed medicine, every step is made under the TGA licence or GMP clearance it needs; within that, we match on format, volume and margin. Overseas, the clearance is the sponsor's own, even where the factory already supplies other Australian brands. A site that can't be cleared changes the timeline and the cost, so we settle it when we choose the manufacturer, before the quote you approve. For an overseas brand coming to Australia, the clearance is one step of several: see [bringing a supplement brand to Australia](/guides/bringing-a-supplement-brand-to-australia). We have managed manufacturing, imports and air freight through to delivery for [Pump's hair supplement](/work/pump-haircare-hair-supplement), imported ingredients, customs and freight for [BWellness](/work/bwellness-practitioner-range), and a whole cross-border supply chain from a New Zealand maker for [Deeply Rooted](/work/deeply-rooted-organic-oil). More on [manufacturing](/manufacturing), or [book a call](/contact).","text":"For a listed medicine, every step is made under the TGA licence or GMP clearance it needs; within that, we match on format, volume and margin. Overseas, the clearance is the sponsor's own, even where the factory already supplies other Australian brands. A site that can't be cleared changes the timeline and the cost, so we settle it when we choose the manufacturer, before the quote you approve. For an overseas brand coming to Australia, the clearance is one step of several: see bringing a supplement brand to Australia. We have managed manufacturing, imports and air freight through to delivery for Pump's hair supplement, imported ingredients, customs and freight for BWellness, and a whole cross-border supply chain from a New Zealand maker for Deeply Rooted. More on manufacturing, or book a call.","items":[],"tables":[]}],"faqs":[{"q":"Does an overseas supplement manufacturer need TGA GMP clearance?","a":"For a listed medicine, yes: every overseas site that carries out a step of its manufacture, from making the dosage form to testing, packaging and release for supply, needs a TGA GMP clearance held by the Australian sponsor, unless the step is exempt. A supplement sold as a food in Australia isn't a listed medicine and needs no clearance.","md":"For a listed medicine, yes: every overseas site that carries out a step of its manufacture, from making the dosage form to testing, packaging and release for supply, needs a TGA GMP clearance held by the Australian sponsor, unless the step is exempt. A supplement sold as a food in Australia isn't a listed medicine and needs no clearance."},{"q":"How do you get a TGA GMP clearance?","a":"The sponsor applies for each site, through one of three routes: an MRA desktop evaluation, relying on an inspection by a regulator the TGA has a mutual recognition agreement with; a compliance verification desktop evaluation, relying on another recognised regulator's inspection; or an inspection by the TGA.","md":"The sponsor applies for each site, through one of three routes: an MRA desktop evaluation, relying on an inspection by a regulator the TGA has a mutual recognition agreement with; a compliance verification desktop evaluation, relying on another recognised regulator's inspection; or an inspection by the TGA."},{"q":"Can an overseas supplement factory use its own GMP certificate?","a":"Only if the certificate comes from a recognised regulator's inspection for a human medicinal product. The TGA says the desktop routes are unavailable for some listed medicines, including dietary supplements, that may not be regulated as medicines in other countries; such a site usually needs a TGA inspection. A medicines plant making supplements under the same standard and controls may be able to use a complementary medicine declaration with its GMP certificate.","md":"Only if the certificate comes from a recognised regulator's inspection for a human medicinal product. The TGA says the desktop routes are unavailable for some listed medicines, including dietary supplements, that may not be regulated as medicines in other countries; such a site usually needs a TGA inspection. A medicines plant making supplements under the same standard and controls may be able to use a complementary medicine declaration with its GMP certificate."},{"q":"How much does a TGA GMP clearance cost?","a":"In 2026–27 the TGA charges $818 to process each clearance, per manufacturer, site and sponsor, $880 to obtain evidence from an overseas regulator and $3,130 for compliance verification. An inspection of an overseas site costs $1,748 an hour per inspector, plus costs and reasonable expenses. Which fees apply depends on the route.","md":"In 2026–27 the TGA charges $818 to process each clearance, per manufacturer, site and sponsor, $880 to obtain evidence from an overseas regulator and $3,130 for compliance verification. An inspection of an overseas site costs $1,748 an hour per inspector, plus costs and reasonable expenses. Which fees apply depends on the route."},{"q":"How long does a GMP clearance last?","a":"There is no fixed term: the TGA sets each clearance's expiry date and can shorten it depending on the level of compliance. Apply to renew at least six months before it expires; a clearance expired for more than 12 months can't be reinstated.","md":"There is no fixed term: the TGA sets each clearance's expiry date and can shorten it depending on the level of compliance. Apply to renew at least six months before it expires; a clearance expired for more than 12 months can't be reinstated."},{"q":"Who applies for the GMP clearance?","a":"The Australian sponsor of the medicine, for each overseas site. Each sponsor needs its own clearance for a site, even if another sponsor already holds one for the same factory.","md":"The Australian sponsor of the medicine, for each overseas site. Each sponsor needs its own clearance for a site, even if another sponsor already holds one for the same factory."}],"sources":{"note":"General information, checked against these sources on 22 October 2026. It isn't advice on a particular product or site. How we choose and manage manufacturers is from Take Friday Off's records.","markdown":"General information, checked against these sources on 22 October 2026. It isn't advice on a particular product or site. How we choose and manage manufacturers is from Take Friday Off's records.\n\n- [How to obtain GMP clearance through inspection reliance](https://www.tga.gov.au/sites/default/files/2024-11/How-to-obtain-GMP-clearance-through-inspection-reliance.docx), version 18.6, May 2025, and [GMP clearance: application and submission user guide](https://www.tga.gov.au/sites/default/files/2023-12/gmp-clearance-application-submission-user-guide.docx), version 1.1, May 2025, Therapeutic Goods Administration\n- [GMP clearance code tables guidance](https://www.tga.gov.au/sites/default/files/gmp-clearance-code-tables-guidance.pdf), July 2020, and [International agreements and arrangements for GMP clearance](https://www.tga.gov.au/node/287685), version 1.3, May 2025, Therapeutic Goods Administration\n- [Listed medicine certifications](https://www.tga.gov.au/node/290088), [manufacturing listed medicines](https://www.tga.gov.au/node/366) and [sponsor responsibilities for GMP clearance](https://www.tga.gov.au/node/289368), Therapeutic Goods Administration\n- [Fees and charges: summary, from 1 July 2026](https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf), tables 27 and 28, Therapeutic Goods Administration\n- [GMP clearance backlog reduction strategy](https://www.tga.gov.au/node/499043), [the completed extensions](https://www.tga.gov.au/node/504840) and the [GMP clearance sponsor information dashboard](https://www.tga.gov.au/products/regulations-all-products/manufacturing/gmp-clearance-sponsor-information-dashboard-sid), Therapeutic Goods Administration\n- [TGA digital transformation webinar: questions and answers](https://www.tga.gov.au/sites/default/files/2026-01/tga-digital-transformation-exploring-beta-version-new-tga-business-services-portal-webinar-q-a.pdf), December 2025, Therapeutic Goods Administration\n- [The PIC/S Guide to GMP for medicinal products, version 17](https://www.tga.gov.au/node/290180), Therapeutic Goods Administration, and the [Therapeutic Goods (Manufacturing Principles) Amendment (PIC/S Guide) Determination 2025](https://legislation.gov.au/F2025L00990/asmade/2025-08-28/text/original/epub/OEBPS/document_1/document_1.html), Federal Register of Legislation\n- [Australian manufacturing licences and overseas GMP certification](https://www.tga.gov.au/sites/default/files/australian-manufacturing-licences-and-overseas-gmp-certification.pdf), version 2.2, December 2021, Therapeutic Goods Administration","items":[{"text":"How to obtain GMP clearance through inspection reliance, version 18.6, May 2025, and GMP clearance: application and submission user guide, version 1.1, May 2025, Therapeutic Goods Administration","links":[{"title":"How to obtain GMP clearance through inspection reliance","url":"https://www.tga.gov.au/sites/default/files/2024-11/How-to-obtain-GMP-clearance-through-inspection-reliance.docx"},{"title":"GMP clearance: application and submission user guide","url":"https://www.tga.gov.au/sites/default/files/2023-12/gmp-clearance-application-submission-user-guide.docx"}]},{"text":"GMP clearance code tables guidance, July 2020, and International agreements and arrangements for GMP clearance, version 1.3, May 2025, Therapeutic Goods Administration","links":[{"title":"GMP clearance code tables guidance","url":"https://www.tga.gov.au/sites/default/files/gmp-clearance-code-tables-guidance.pdf"},{"title":"International agreements and arrangements for GMP clearance","url":"https://www.tga.gov.au/node/287685"}]},{"text":"Listed medicine certifications, manufacturing listed medicines and sponsor responsibilities for GMP clearance, Therapeutic Goods Administration","links":[{"title":"Listed medicine certifications","url":"https://www.tga.gov.au/node/290088"},{"title":"manufacturing listed medicines","url":"https://www.tga.gov.au/node/366"},{"title":"sponsor responsibilities for GMP clearance","url":"https://www.tga.gov.au/node/289368"}]},{"text":"Fees and charges: summary, from 1 July 2026, tables 27 and 28, Therapeutic Goods Administration","links":[{"title":"Fees and charges: summary, from 1 July 2026","url":"https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf"}]},{"text":"GMP clearance backlog reduction strategy, the completed extensions and the GMP clearance sponsor information dashboard, Therapeutic Goods Administration","links":[{"title":"GMP clearance backlog reduction strategy","url":"https://www.tga.gov.au/node/499043"},{"title":"the completed extensions","url":"https://www.tga.gov.au/node/504840"},{"title":"GMP clearance sponsor information dashboard","url":"https://www.tga.gov.au/products/regulations-all-products/manufacturing/gmp-clearance-sponsor-information-dashboard-sid"}]},{"text":"TGA digital transformation webinar: questions and answers, December 2025, Therapeutic Goods Administration","links":[{"title":"TGA digital transformation webinar: questions and answers","url":"https://www.tga.gov.au/sites/default/files/2026-01/tga-digital-transformation-exploring-beta-version-new-tga-business-services-portal-webinar-q-a.pdf"}]},{"text":"The PIC/S Guide to GMP for medicinal products, version 17, Therapeutic Goods Administration, and the Therapeutic Goods (Manufacturing Principles) Amendment (PIC/S Guide) Determination 2025, Federal Register of Legislation","links":[{"title":"The PIC/S Guide to GMP for medicinal products, version 17","url":"https://www.tga.gov.au/node/290180"},{"title":"Therapeutic Goods (Manufacturing Principles) Amendment (PIC/S Guide) Determination 2025","url":"https://legislation.gov.au/F2025L00990/asmade/2025-08-28/text/original/epub/OEBPS/document_1/document_1.html"}]},{"text":"Australian manufacturing licences and overseas GMP certification, version 2.2, December 2021, Therapeutic Goods Administration","links":[{"title":"Australian manufacturing licences and overseas GMP certification","url":"https://www.tga.gov.au/sites/default/files/australian-manufacturing-licences-and-overseas-gmp-certification.pdf"}]}]}},{"slug":"novel-foods","kind":"guide","url":"/guides/novel-foods","title":"Novel foods in Australia: when a new ingredient needs FSANZ approval","name":"Novel foods guide","description":"When a food or ingredient is a novel food under the Food Standards Code, how to check, the FSANZ application, its fees and timeframes, and exclusive use.","eyebrow":"Guide","lead":"A novel food is a food or ingredient without a history of human consumption in Australia or New Zealand that needs a safety assessment before it can be sold. Under the Food Standards Code it can't be sold at retail unless it is listed in Schedule 25 and used within its conditions, and a listing takes an application to Food Standards Australia New Zealand (FSANZ). This guide covers what makes a food novel, how to check, the application, its fees and timeframes, the up to 15 months of exclusive use an applicant can ask for, and the other approvals a new ingredient might need instead.","parent":"/pathways/foods","studies":["ora-practitioner-natural-medicine","sports-brand-core-range"],"formats":[],"order":71,"updated":"2026-10-22","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- A novel food is a non-traditional food, one without a history of human consumption in Australia or New Zealand, that needs an assessment of its public health and safety.\n- A food for retail sale can't be or contain a novel food unless it is listed in Schedule 25 of the Food Standards Code and used within its conditions.\n- A listing takes an application to FSANZ to change the Code, with a pre-market safety assessment. FSANZ's advisory committee on novel foods isn't taking new enquiries while it is reviewed, and its views were never binding: the agencies that enforce the Code decide.\n- FSANZ charges no fee unless the applicant stands to gain an exclusive commercial benefit, as when it asks for exclusive use, or pays to start sooner. An unpaid application waits about 12 months for its assessment to start.\n- A paid application costs from $49,627 for the smallest general procedure to $137,767 or more for a major one. Counted from the start of the assessment, FSANZ's Board decides within 9 months under the general procedure or 12 under the major one, then the Food Ministers have 60 days.\n- An applicant can ask FSANZ for up to 15 months of exclusive use after gazettal, tied to its brand, though FSANZ can still approve the same food for others in that time.","text":"A novel food is a non-traditional food, one without a history of human consumption in Australia or New Zealand, that needs an assessment of its public health and safety. A food for retail sale can't be or contain a novel food unless it is listed in Schedule 25 of the Food Standards Code and used within its conditions. A listing takes an application to FSANZ to change the Code, with a pre-market safety assessment. FSANZ's advisory committee on novel foods isn't taking new enquiries while it is reviewed, and its views were never binding: the agencies that enforce the Code decide. FSANZ charges no fee unless the applicant stands to gain an exclusive commercial benefit, as when it asks for exclusive use, or pays to start sooner. An unpaid application waits about 12 months for its assessment to start. A paid application costs from $49,627 for the smallest general procedure to $137,767 or more for a major one. Counted from the start of the assessment, FSANZ's Board decides within 9 months under the general procedure or 12 under the major one, then the Food Ministers have 60 days. An applicant can ask FSANZ for up to 15 months of exclusive use after gazettal, tied to its brand, though FSANZ can still approve the same food for others in that time.","items":[],"tables":[]},{"heading":"What makes a food novel","anchor":"what-makes-a-food-novel","markdown":"The Code's definition works in two steps. First, a non-traditional food is:\n\n- a food that doesn't have a history of human consumption in Australia or New Zealand;\n- a substance derived from a food, where the substance has no such history other than as a component of that food; or\n- any other substance, where neither it nor its source has a history of human consumption as a food in Australia or New Zealand.\n\nSecond, a non-traditional food is novel if it \"requires an assessment of the public health and safety considerations\", having regard to the potential for adverse effects in humans, its composition or structure, how it was prepared, its source, the patterns and levels of its consumption, or any other relevant matters.\n\nSo an extract of a familiar food can be non-traditional when the food itself isn't, and a non-traditional food is only novel if its safety needs assessing. Use in a food for special medical purposes doesn't count as a history of human consumption.\n\nThe rule follows from that. Unless the Code expressly permits it, a food for retail sale must not be a novel food. Standard 1.5.1 gives the permission: a retail food may be or contain a novel food listed in the table in Schedule 25, as long as the conditions of use in its row are met, and an infant formula product only if the table expressly permits it. Those conditions can name the brand it may be sold under for its first 15 months.","text":"The Code's definition works in two steps. First, a non-traditional food is: a food that doesn't have a history of human consumption in Australia or New Zealand; a substance derived from a food, where the substance has no such history other than as a component of that food; or any other substance, where neither it nor its source has a history of human consumption as a food in Australia or New Zealand. Second, a non-traditional food is novel if it \"requires an assessment of the public health and safety considerations\", having regard to the potential for adverse effects in humans, its composition or structure, how it was prepared, its source, the patterns and levels of its consumption, or any other relevant matters. So an extract of a familiar food can be non-traditional when the food itself isn't, and a non-traditional food is only novel if its safety needs assessing. Use in a food for special medical purposes doesn't count as a history of human consumption. The rule follows from that. Unless the Code expressly permits it, a food for retail sale must not be a novel food. Standard 1.5.1 gives the permission: a retail food may be or contain a novel food listed in the table in Schedule 25, as long as the conditions of use in its row are met, and an infant formula product only if the table expressly permits it. Those conditions can name the brand it may be sold under for its first 15 months.","items":[],"tables":[]},{"heading":"How to tell if an ingredient is novel","anchor":"how-to-tell-if-an-ingredient-is-novel","markdown":"There is no simple register to check. FSANZ suggests three routes:\n\n- **Its guidance tool**, which weighs the length, extent, quantity and purpose of an ingredient's use as food. As a general guide, it says 2 to 3 generations would be a long period of use, and 5 years or less a short one.\n- **Advice** from a food consultant, or legal advice.\n- **The record of views** of its Advisory Committee on Novel Foods (ACNF): a table of the committee's views on whether foods it was asked about are novel. In its September 2026 edition, for example, the committee's view is that freeze-dried miracle berry powder is a novel food, as its safety isn't established.\n\nNone of these is a ruling. FSANZ says the record of views is \"not legal advice\" and not legally binding, isn't a decision by FSANZ, and isn't a safety assessment. Whether a food is novel is \"ultimately the responsibility\" of the agencies that enforce the Code: in Australia, state and territory agencies and local councils, and the Department of Agriculture, Fisheries and Forestry at the border. And while the ACNF is under review, it \"is not considering new enquiries\".","text":"There is no simple register to check. FSANZ suggests three routes: Its guidance tool, which weighs the length, extent, quantity and purpose of an ingredient's use as food. As a general guide, it says 2 to 3 generations would be a long period of use, and 5 years or less a short one. Advice from a food consultant, or legal advice. The record of views of its Advisory Committee on Novel Foods (ACNF): a table of the committee's views on whether foods it was asked about are novel. In its September 2026 edition, for example, the committee's view is that freeze-dried miracle berry powder is a novel food, as its safety isn't established. None of these is a ruling. FSANZ says the record of views is \"not legal advice\" and not legally binding, isn't a decision by FSANZ, and isn't a safety assessment. Whether a food is novel is \"ultimately the responsibility\" of the agencies that enforce the Code: in Australia, state and territory agencies and local councils, and the Department of Agriculture, Fisheries and Forestry at the border. And while the ACNF is under review, it \"is not considering new enquiries\".","items":[{"lead":"Its guidance tool","text":", which weighs the length, extent, quantity and purpose of an ingredient's use as food. As a general guide, it says 2 to 3 generations would be a long period of use, and 5 years or less a short one."},{"lead":"Advice","text":"from a food consultant, or legal advice."},{"lead":"The record of views","text":"of its Advisory Committee on Novel Foods (ACNF): a table of the committee's views on whether foods it was asked about are novel. In its September 2026 edition, for example, the committee's view is that freeze-dried miracle berry powder is a novel food, as its safety isn't established."}],"tables":[]},{"heading":"Applying to FSANZ","anchor":"applying-to-fsanz","markdown":"Anyone who wants to sell a novel food, or a food containing one, must apply to FSANZ to have it listed in Schedule 25, and the application goes through \"a statutory assessment which includes a pre-market safety assessment\". FSANZ encourages applicants to contact it before applying.\n\n1. **Acceptance.** FSANZ has 15 business days to accept or reject an application. It also decides then which procedure applies (general, minor, major or high level health claim variation), mainly by the kind of change sought, and, for a paid application, the charge level, from the estimated hours of work.\n2. **Assessment.** For a novel food, FSANZ considers \"a variety of toxicological and nutritional issues together with information about its chemistry and how much of it we expect people to eat\", and drafts the change to the Code.\n3. **Consultation.** Generally for six weeks.\n4. **The Board's decision.** Counted from the start of the assessment, and not counting time spent waiting for information, FSANZ's Board must decide within 9 months under the general procedure, 3 months under the minor procedure or 12 months under the major one, which can be extended by up to 6 months.\n5. **The Food Ministers.** They have 60 days to ask FSANZ to review the change, or to tell FSANZ they won't. They can only amend or reject it after a review.\n6. **Gazettal.** Generally within two weeks of the Ministers' decision. From then, the food can be sold within the conditions of its listing.\n\nOnce accepted, an unpaid application waits for its assessment to start: FSANZ's August 2026 work plan puts the wait at about 12 months, and an applicant can pay to bring the start forward.","text":"Anyone who wants to sell a novel food, or a food containing one, must apply to FSANZ to have it listed in Schedule 25, and the application goes through \"a statutory assessment which includes a pre-market safety assessment\". FSANZ encourages applicants to contact it before applying. Acceptance. FSANZ has 15 business days to accept or reject an application. It also decides then which procedure applies (general, minor, major or high level health claim variation), mainly by the kind of change sought, and, for a paid application, the charge level, from the estimated hours of work. Assessment. For a novel food, FSANZ considers \"a variety of toxicological and nutritional issues together with information about its chemistry and how much of it we expect people to eat\", and drafts the change to the Code. Consultation. Generally for six weeks. The Board's decision. Counted from the start of the assessment, and not counting time spent waiting for information, FSANZ's Board must decide within 9 months under the general procedure, 3 months under the minor procedure or 12 months under the major one, which can be extended by up to 6 months. The Food Ministers. They have 60 days to ask FSANZ to review the change, or to tell FSANZ they won't. They can only amend or reject it after a review. Gazettal. Generally within two weeks of the Ministers' decision. From then, the food can be sold within the conditions of its listing. Once accepted, an unpaid application waits for its assessment to start: FSANZ's August 2026 work plan puts the wait at about 12 months, and an applicant can pay to bring the start forward.","items":[{"lead":"Acceptance.","text":"FSANZ has 15 business days to accept or reject an application. It also decides then which procedure applies (general, minor, major or high level health claim variation), mainly by the kind of change sought, and, for a paid application, the charge level, from the estimated hours of work."},{"lead":"Assessment.","text":"For a novel food, FSANZ considers \"a variety of toxicological and nutritional issues together with information about its chemistry and how much of it we expect people to eat\", and drafts the change to the Code."},{"lead":"Consultation.","text":"Generally for six weeks."},{"lead":"The Board's decision.","text":"Counted from the start of the assessment, and not counting time spent waiting for information, FSANZ's Board must decide within 9 months under the general procedure, 3 months under the minor procedure or 12 months under the major one, which can be extended by up to 6 months."},{"lead":"The Food Ministers.","text":"They have 60 days to ask FSANZ to review the change, or to tell FSANZ they won't. They can only amend or reject it after a review."},{"lead":"Gazettal.","text":"Generally within two weeks of the Ministers' decision. From then, the food can be sold within the conditions of its listing."}],"tables":[]},{"heading":"What FSANZ charges","anchor":"what-fsanz-charges","markdown":"FSANZ doesn't charge for assessing an application unless:\n\n- it decides the applicant has an exclusive capturable commercial benefit (ECCB): broadly, the applicant stands to gain financially from the change to the Code, and others would need its agreement to benefit from it. FSANZ's own example is a novel food application that asks for an exclusive permission; or\n- the applicant wants the assessment to start immediately, rather than when FSANZ would reach it.\n\nFor applications made since 1 October 2025, a paid application costs a fixed charge of $23,697 plus a variable charge set by the estimated hours of work: $25,180 for up to 180 hours, rising to $113,320 or more for a major procedure. With FSANZ's $750 administration charge, that runs from $49,627 for the smallest general procedure to $137,767 or more for a major one. Applications under the minor procedure aren't charged. FSANZ proposed no fee changes for 2026–27.","text":"FSANZ doesn't charge for assessing an application unless: it decides the applicant has an exclusive capturable commercial benefit (ECCB): broadly, the applicant stands to gain financially from the change to the Code, and others would need its agreement to benefit from it. FSANZ's own example is a novel food application that asks for an exclusive permission; or the applicant wants the assessment to start immediately, rather than when FSANZ would reach it. For applications made since 1 October 2025, a paid application costs a fixed charge of $23,697 plus a variable charge set by the estimated hours of work: $25,180 for up to 180 hours, rising to $113,320 or more for a major procedure. With FSANZ's $750 administration charge, that runs from $49,627 for the smallest general procedure to $137,767 or more for a major one. Applications under the minor procedure aren't charged. FSANZ proposed no fee changes for 2026–27.","items":[],"tables":[]},{"heading":"Up to 15 months of exclusive use","anchor":"up-to-15-months-of-exclusive-use","markdown":"An applicant can ask for its permission to be exclusive \"for up to 15 months\". FSANZ usually only considers it if the applicant expressly applies for it, and decides whether to grant it against set criteria. Schedule 25 then ties the novel food to a brand, or a class of food, for up to 15 months after gazettal: plant-based drinks with added plant sterols, for example, could \"only be sold under the brand SANITARIUM HEALTH FOOD COMPANY\" during their exclusive use period. After that, \"the permission becomes generic and non-brand specific\", and the food can be sold under any brand within its conditions.\n\nExclusivity doesn't stop a competitor applying. FSANZ says nothing in its Act or the Code prevents it approving the same novel food for another company, under a different brand, within the 15 months. And asking for it makes the application one FSANZ is likely to charge for.","text":"An applicant can ask for its permission to be exclusive \"for up to 15 months\". FSANZ usually only considers it if the applicant expressly applies for it, and decides whether to grant it against set criteria. Schedule 25 then ties the novel food to a brand, or a class of food, for up to 15 months after gazettal: plant-based drinks with added plant sterols, for example, could \"only be sold under the brand SANITARIUM HEALTH FOOD COMPANY\" during their exclusive use period. After that, \"the permission becomes generic and non-brand specific\", and the food can be sold under any brand within its conditions. Exclusivity doesn't stop a competitor applying. FSANZ says nothing in its Act or the Code prevents it approving the same novel food for another company, under a different brand, within the 15 months. And asking for it makes the application one FSANZ is likely to charge for.","items":[],"tables":[]},{"heading":"Other approvals a new ingredient might need","anchor":"other-approvals-a-new-ingredient-might-need","markdown":"Not every new ingredient is a novel food question. The Code has other routes, each needing FSANZ's approval:\n\n- **Food additives.** FSANZ assesses their safety before they can be used, and the permitted ones are listed in Standard 1.3.1.\n- **Processing aids.** A food can't contain a substance used as a processing aid unless the Code permits it, under Standard 1.3.3.\n- **Nutritive substances.** A vitamin, mineral or other listed substance added to a food to achieve a nutritional purpose needs the Code's permission too. Unless another part of the Code allows it, a vitamin or mineral can only be added to the foods Schedule 17 lists for it, in a permitted form and within any limit.\n- **Genetically modified food.** Standard 1.5.2 requires pre-market approval, including a food safety assessment, and labelling.\n- **Cell-cultured food.** A newer route: Standard 1.5.4 and Schedule 25A, made in June 2025 with the approval of cultured quail.","text":"Not every new ingredient is a novel food question. The Code has other routes, each needing FSANZ's approval: Food additives. FSANZ assesses their safety before they can be used, and the permitted ones are listed in Standard 1.3.1. Processing aids. A food can't contain a substance used as a processing aid unless the Code permits it, under Standard 1.3.3. Nutritive substances. A vitamin, mineral or other listed substance added to a food to achieve a nutritional purpose needs the Code's permission too. Unless another part of the Code allows it, a vitamin or mineral can only be added to the foods Schedule 17 lists for it, in a permitted form and within any limit. Genetically modified food. Standard 1.5.2 requires pre-market approval, including a food safety assessment, and labelling. Cell-cultured food. A newer route: Standard 1.5.4 and Schedule 25A, made in June 2025 with the approval of cultured quail.","items":[{"lead":"Food additives.","text":"FSANZ assesses their safety before they can be used, and the permitted ones are listed in Standard 1.3.1."},{"lead":"Processing aids.","text":"A food can't contain a substance used as a processing aid unless the Code permits it, under Standard 1.3.3."},{"lead":"Nutritive substances.","text":"A vitamin, mineral or other listed substance added to a food to achieve a nutritional purpose needs the Code's permission too. Unless another part of the Code allows it, a vitamin or mineral can only be added to the foods Schedule 17 lists for it, in a permitted form and within any limit."},{"lead":"Genetically modified food.","text":"Standard 1.5.2 requires pre-market approval, including a food safety assessment, and labelling."},{"lead":"Cell-cultured food.","text":"A newer route: Standard 1.5.4 and Schedule 25A, made in June 2025 with the approval of cultured quail."}],"tables":[]},{"heading":"Recent decisions","anchor":"recent-decisions","markdown":"- **Moringa, rejected.** In November 2025 FSANZ rejected an application to permit Moringa oleifera as a novel food: the information \"was not sufficient to establish the safety\" of its leaves, immature seed pods and oil. FSANZ notes that therapeutic products containing it are regulated separately by the TGA.\n- **Cell-cultured duck, approved.** FSANZ approved it on 6 October 2026, and the Food Ministers then have 60 days to consider it.\n- **New applications.** Among them, Rhizomucor pusillus mycelium as a novel food, accepted on 17 September 2026 under the general procedure, and Rhiza mycelium (Neurospora crassa) biomass.\n- **The rules themselves.** FSANZ's review of how novel foods and nutritive substances are regulated is on hold, pending the review of the FSANZ Act.","text":"Moringa, rejected. In November 2025 FSANZ rejected an application to permit Moringa oleifera as a novel food: the information \"was not sufficient to establish the safety\" of its leaves, immature seed pods and oil. FSANZ notes that therapeutic products containing it are regulated separately by the TGA. Cell-cultured duck, approved. FSANZ approved it on 6 October 2026, and the Food Ministers then have 60 days to consider it. New applications. Among them, Rhizomucor pusillus mycelium as a novel food, accepted on 17 September 2026 under the general procedure, and Rhiza mycelium (Neurospora crassa) biomass. The rules themselves. FSANZ's review of how novel foods and nutritive substances are regulated is on hold, pending the review of the FSANZ Act.","items":[{"lead":"Moringa, rejected.","text":"In November 2025 FSANZ rejected an application to permit Moringa oleifera as a novel food: the information \"was not sufficient to establish the safety\" of its leaves, immature seed pods and oil. FSANZ notes that therapeutic products containing it are regulated separately by the TGA."},{"lead":"Cell-cultured duck, approved.","text":"FSANZ approved it on 6 October 2026, and the Food Ministers then have 60 days to consider it."},{"lead":"New applications.","text":"Among them, Rhizomucor pusillus mycelium as a novel food, accepted on 17 September 2026 under the general procedure, and Rhiza mycelium (Neurospora crassa) biomass."},{"lead":"The rules themselves.","text":"FSANZ's review of how novel foods and nutritive substances are regulated is on hold, pending the review of the FSANZ Act."}],"tables":[]},{"heading":"Food or medicine?","anchor":"food-or-medicine","markdown":"The novel food rules are for foods. Whether a product is a food or a medicine turns mainly on whether it is presented as, or likely to be taken to be, for therapeutic use, and whether it has been declared a therapeutic good, and our [food pathway](/pathways/foods) covers the line. As a listed medicine, a supplement's ingredients come from the TGA's Permissible Ingredients Determination instead, and an ingredient that isn't in it needs an application to the TGA: see our [new ingredients guide](/guides/permissible-ingredients).","text":"The novel food rules are for foods. Whether a product is a food or a medicine turns mainly on whether it is presented as, or likely to be taken to be, for therapeutic use, and whether it has been declared a therapeutic good, and our food pathway covers the line. As a listed medicine, a supplement's ingredients come from the TGA's Permissible Ingredients Determination instead, and an ingredient that isn't in it needs an application to the TGA: see our new ingredients guide.","items":[],"tables":[]},{"heading":"Where we come in","anchor":"where-we-come-in","markdown":"When a brand wants an ingredient that may be novel in a food, we check it before the formula is fixed: its history of use, the record of views, and whether the product should be a food or a listed medicine at all. If it would need FSANZ's approval, we'll tell you what that involves, then manage the application ([new ingredient applications](/new-ingredients)) or find a permitted alternative. Our own brand, [Ora](/work/ora-practitioner-natural-medicine), sells premium functional foods beside its listed medicines. More on [supplements as foods](/pathways/foods) and [formulation](/formulation), or [book a call](/contact).","text":"When a brand wants an ingredient that may be novel in a food, we check it before the formula is fixed: its history of use, the record of views, and whether the product should be a food or a listed medicine at all. If it would need FSANZ's approval, we'll tell you what that involves, then manage the application (new ingredient applications) or find a permitted alternative. Our own brand, Ora, sells premium functional foods beside its listed medicines. More on supplements as foods and formulation, or book a call.","items":[],"tables":[]}],"faqs":[{"q":"What is a novel food in Australia?","a":"A non-traditional food, one without a history of human consumption in Australia or New Zealand, that needs an assessment of its public health and safety before it is sold. It can only be sold at retail, or used in a retail food, once it is listed in Schedule 25 of the Food Standards Code, and within the conditions listed with it.","md":"A non-traditional food, one without a history of human consumption in Australia or New Zealand, that needs an assessment of its public health and safety before it is sold. It can only be sold at retail, or used in a retail food, once it is listed in Schedule 25 of the Food Standards Code, and within the conditions listed with it."},{"q":"How do I know if my ingredient is a novel food?","a":"Check its history of use in Australia and New Zealand with FSANZ's guidance tool and the record of views of its Advisory Committee on Novel Foods, and get a food consultant's or legal advice. None of these is binding: the agencies that enforce the Code decide. The committee isn't taking new enquiries while it is reviewed.","md":"Check its history of use in Australia and New Zealand with FSANZ's guidance tool and the record of views of its Advisory Committee on Novel Foods, and get a food consultant's or legal advice. None of these is binding: the agencies that enforce the Code decide. The committee isn't taking new enquiries while it is reviewed."},{"q":"How much does a novel food application cost?","a":"Nothing, unless FSANZ decides the applicant gains an exclusive capturable commercial benefit, as when it asks for exclusive use, or the applicant pays to start sooner. A paid application costs a fixed $23,697, a variable charge set by the estimated hours of work and a $750 administration charge: from $49,627 in all to $137,767 or more. Applications under the minor procedure aren't charged.","md":"Nothing, unless FSANZ decides the applicant gains an exclusive capturable commercial benefit, as when it asks for exclusive use, or the applicant pays to start sooner. A paid application costs a fixed $23,697, a variable charge set by the estimated hours of work and a $750 administration charge: from $49,627 in all to $137,767 or more. Applications under the minor procedure aren't charged."},{"q":"How long does FSANZ take to approve a novel food?","a":"Counted from the start of its assessment, FSANZ's Board must decide within 9 months under the general procedure, or 12 months under the major one, then the Food Ministers have 60 days and gazettal generally follows within two weeks. An unpaid application waits about 12 months for its assessment to start.","md":"Counted from the start of its assessment, FSANZ's Board must decide within 9 months under the general procedure, or 12 months under the major one, then the Food Ministers have 60 days and gazettal generally follows within two weeks. An unpaid application waits about 12 months for its assessment to start."},{"q":"Can I get exclusive use of a novel food?","a":"If you ask for it and FSANZ grants it, the permission is tied to your brand for up to 15 months after gazettal, then becomes generic. It doesn't stop FSANZ approving the same food for another company under its own brand, and asking for it usually means a paid application.","md":"If you ask for it and FSANZ grants it, the permission is tied to your brand for up to 15 months after gazettal, then becomes generic. It doesn't stop FSANZ approving the same food for another company under its own brand, and asking for it usually means a paid application."},{"q":"Can I sell a novel food while the application is assessed?","a":"No. A retail food can't be or contain a novel food until the food is listed in Schedule 25 and used within its conditions.","md":"No. A retail food can't be or contain a novel food until the food is listed in Schedule 25 and used within its conditions."},{"q":"Is a novel food the same as a new ingredient for a listed medicine?","a":"No. A novel food is a question for FSANZ and the Food Standards Code. A listed medicine's ingredients come from the TGA's Permissible Ingredients Determination, and a new one needs an application to the TGA. See our new ingredients guide.","md":"No. A novel food is a question for FSANZ and the Food Standards Code. A listed medicine's ingredients come from the TGA's Permissible Ingredients Determination, and a new one needs an application to the TGA. See our [new ingredients guide](/guides/permissible-ingredients)."}],"sources":{"note":"General information, checked against these sources on 22 October 2026. It isn't legal advice or advice on a particular product. Our approach to ingredients is from Take Friday Off's records.","markdown":"General information, checked against these sources on 22 October 2026. It isn't legal advice or advice on a particular product. Our approach to ingredients is from Take Friday Off's records.\n\n- [Australia New Zealand Food Standards Code – Standard 1.5.1 – Novel foods](https://www.legislation.gov.au/F2015L00403/latest/text), [Schedule 25 – Permitted novel foods](https://www.legislation.gov.au/F2015L00440/latest/text) and [Standard 1.1.2 – Definitions used throughout the Code](https://www.legislation.gov.au/F2015L00385/latest/text), Federal Register of Legislation, and the [Compilation of Australia New Zealand Food Standards and Schedules](https://www.foodstandards.gov.au/sites/default/files/2026-03/Food%20Standards%20Code%20-%20Compilation%20(March%202026)_0.pdf), March 2026 (Standards 1.1.1 and 1.3.2), Food Standards Australia New Zealand\n- [Novel foods](https://www.foodstandards.gov.au/business/novel), [Novel food - Record of views formed in response to enquiries](https://foodstandards.gov.au/business/novel/novelrecs) and its [September 2026 edition](https://www.foodstandards.gov.au/sites/default/files/2026-10/Record%20of%20Views_September%202026.pdf), the [Guidance Tool for Determining Whether a Food is Novel or Not](https://www.foodstandards.gov.au/sites/default/files/business/novel/Documents/Guidance%20Tool%20-%20for%20website%20_2_.pdf) and [Exclusivity of use for novel foods and nutritive substances](https://www.foodstandards.gov.au/business/novel/exclusivity-of-use-for-novel-foods-and-nutritive-substances), Food Standards Australia New Zealand\n- [Changing the Code](https://www.foodstandards.gov.au/food-standards-code/changing-the-code), [Application and proposal process](https://www.foodstandards.gov.au/food-standards-code/changing-the-code/application-and-proposal-process), [Pre-application assistance](https://www.foodstandards.gov.au/food-standards-code/changing-the-code/pre-application-assistance), the [Application Handbook](https://www.foodstandards.gov.au/sites/default/files/2025-09/Application%20Handbook.pdf) (1 October 2025) and the [Food Standards Work Plan](https://www.foodstandards.gov.au/sites/default/files/2026-08/Food%20Standards%20Word%20Plan_August%202026.pdf) (13 August 2026), Food Standards Australia New Zealand\n- [Food Standards Australia New Zealand Act 1991](https://www.legislation.gov.au/C2004A04193/latest/text), sections 8, 16, 25, 26, 84, 88 and 109, the [Food Standards Australia New Zealand Amendment (Charges) Regulations 2025](https://www.legislation.gov.au/F2025L01165/asmade/2025-09-25/text/original/pdf) and the [Food Standards Australia New Zealand Regulations 1994](https://www.legislation.gov.au/F1996B01999/latest/text), Federal Register of Legislation\n- [2026-27 Cost Recovery Arrangements](https://consultations.foodstandards.gov.au/fsanz/2026-27-cost-recovery-arrangements/), Food Standards Australia New Zealand\n- [How FSANZ ensures the safety of food additives](https://www.foodstandards.gov.au/consumer/additives/additivecontrol), [General information about GM foods](https://www.foodstandards.gov.au/consumer/gmfood/gmoverview) and [Amendment No. 239](https://www.foodstandards.gov.au/sites/default/files/2025-06/Amendment%20No.%20239.pdf) (Gazette No. FSC 179, 18 June 2025; Standard 1.5.4), Food Standards Australia New Zealand, and [Standard 1.3.3 – Processing aids](https://www.legislation.gov.au/F2015L00402) and [Schedule 17 – Vitamins and minerals](https://www.legislation.gov.au/F2015L00449/latest/text), Federal Register of Legislation\n- [Moringa oleifera as a novel food](https://www.foodstandards.gov.au/business/novel/moringa-oleifera-novel-food), [Notification Circular 415-26](https://www.foodstandards.gov.au/food-standards-code/circulars/notification-circular-415-26) and [Applications](https://www.foodstandards.gov.au/food-standards-code/applications), Food Standards Australia New Zealand\n- [What we do](https://www.foodstandards.gov.au/about-us/whatwedo), Food Standards Australia New Zealand, and the [Therapeutic Goods Act 1989](https://www.legislation.gov.au/C2004A03952/latest/text), section 3 (therapeutic goods), Federal Register of Legislation","items":[{"text":"Australia New Zealand Food Standards Code – Standard 1.5.1 – Novel foods, Schedule 25 – Permitted novel foods and Standard 1.1.2 – Definitions used throughout the Code, Federal Register of Legislation, and the Compilation of Australia New Zealand Food Standards and Schedules0.pdf), March 2026 (Standards 1.1.1 and 1.3.2), Food Standards Australia New Zealand","links":[{"title":"Australia New Zealand Food Standards Code – Standard 1.5.1 – Novel foods","url":"https://www.legislation.gov.au/F2015L00403/latest/text"},{"title":"Schedule 25 – Permitted novel foods","url":"https://www.legislation.gov.au/F2015L00440/latest/text"},{"title":"Standard 1.1.2 – Definitions used throughout the Code","url":"https://www.legislation.gov.au/F2015L00385/latest/text"},{"title":"Compilation of Australia New Zealand Food Standards and Schedules","url":"https://www.foodstandards.gov.au/sites/default/files/2026-03/Food%20Standards%20Code%20-%20Compilation%20(March%202026"}]},{"text":"Novel foods, Novel food - Record of views formed in response to enquiries and its September 2026 edition, the Guidance Tool for Determining Whether a Food is Novel or Not and Exclusivity of use for novel foods and nutritive substances, Food Standards Australia New Zealand","links":[{"title":"Novel foods","url":"https://www.foodstandards.gov.au/business/novel"},{"title":"Novel food - Record of views formed in response to enquiries","url":"https://foodstandards.gov.au/business/novel/novelrecs"},{"title":"September 2026 edition","url":"https://www.foodstandards.gov.au/sites/default/files/2026-10/Record%20of%20Views_September%202026.pdf"},{"title":"Guidance Tool for Determining Whether a Food is Novel or Not","url":"https://www.foodstandards.gov.au/sites/default/files/business/novel/Documents/Guidance%20Tool%20-%20for%20website%20_2_.pdf"},{"title":"Exclusivity of use for novel foods and nutritive substances","url":"https://www.foodstandards.gov.au/business/novel/exclusivity-of-use-for-novel-foods-and-nutritive-substances"}]},{"text":"Changing the Code, Application and proposal process, Pre-application assistance, the Application Handbook (1 October 2025) and the Food Standards Work Plan (13 August 2026), Food Standards Australia New Zealand","links":[{"title":"Changing the Code","url":"https://www.foodstandards.gov.au/food-standards-code/changing-the-code"},{"title":"Application and proposal process","url":"https://www.foodstandards.gov.au/food-standards-code/changing-the-code/application-and-proposal-process"},{"title":"Pre-application assistance","url":"https://www.foodstandards.gov.au/food-standards-code/changing-the-code/pre-application-assistance"},{"title":"Application Handbook","url":"https://www.foodstandards.gov.au/sites/default/files/2025-09/Application%20Handbook.pdf"},{"title":"Food Standards Work Plan","url":"https://www.foodstandards.gov.au/sites/default/files/2026-08/Food%20Standards%20Word%20Plan_August%202026.pdf"}]},{"text":"Food Standards Australia New Zealand Act 1991, sections 8, 16, 25, 26, 84, 88 and 109, the Food Standards Australia New Zealand Amendment (Charges) Regulations 2025 and the Food Standards Australia New Zealand Regulations 1994, Federal Register of Legislation","links":[{"title":"Food Standards Australia New Zealand Act 1991","url":"https://www.legislation.gov.au/C2004A04193/latest/text"},{"title":"Food Standards Australia New Zealand Amendment (Charges) Regulations 2025","url":"https://www.legislation.gov.au/F2025L01165/asmade/2025-09-25/text/original/pdf"},{"title":"Food Standards Australia New Zealand Regulations 1994","url":"https://www.legislation.gov.au/F1996B01999/latest/text"}]},{"text":"2026-27 Cost Recovery Arrangements, Food Standards Australia New Zealand","links":[{"title":"2026-27 Cost Recovery Arrangements","url":"https://consultations.foodstandards.gov.au/fsanz/2026-27-cost-recovery-arrangements/"}]},{"text":"How FSANZ ensures the safety of food additives, General information about GM foods and Amendment No. 239 (Gazette No. FSC 179, 18 June 2025; Standard 1.5.4), Food Standards Australia New Zealand, and Standard 1.3.3 – Processing aids and Schedule 17 – Vitamins and minerals, Federal Register of Legislation","links":[{"title":"How FSANZ ensures the safety of food additives","url":"https://www.foodstandards.gov.au/consumer/additives/additivecontrol"},{"title":"General information about GM foods","url":"https://www.foodstandards.gov.au/consumer/gmfood/gmoverview"},{"title":"Amendment No. 239","url":"https://www.foodstandards.gov.au/sites/default/files/2025-06/Amendment%20No.%20239.pdf"},{"title":"Standard 1.3.3 – Processing aids","url":"https://www.legislation.gov.au/F2015L00402"},{"title":"Schedule 17 – Vitamins and minerals","url":"https://www.legislation.gov.au/F2015L00449/latest/text"}]},{"text":"Moringa oleifera as a novel food, Notification Circular 415-26 and Applications, Food Standards Australia New Zealand","links":[{"title":"Moringa oleifera as a novel food","url":"https://www.foodstandards.gov.au/business/novel/moringa-oleifera-novel-food"},{"title":"Notification Circular 415-26","url":"https://www.foodstandards.gov.au/food-standards-code/circulars/notification-circular-415-26"},{"title":"Applications","url":"https://www.foodstandards.gov.au/food-standards-code/applications"}]},{"text":"What we do, Food Standards Australia New Zealand, and the Therapeutic Goods Act 1989, section 3 (therapeutic goods), Federal Register of Legislation","links":[{"title":"What we do","url":"https://www.foodstandards.gov.au/about-us/whatwedo"},{"title":"Therapeutic Goods Act 1989","url":"https://www.legislation.gov.au/C2004A03952/latest/text"}]}]}},{"slug":"tga-sponsor","kind":"guide","url":"/guides/tga-sponsor","title":"The TGA sponsor: who is responsible for a listed medicine","name":"TGA sponsor guide","description":"Who can be the TGA sponsor of a supplement, what an overseas brand does, how to become a sponsor, and its duties: evidence, GMP, records, recalls and charges.","eyebrow":"Guide","lead":"Every medicine on the ARTG has a sponsor: the person or company in Australia that is legally responsible for it. For a supplement sold as a listed medicine, the sponsor applies for the listing, certifies that the medicine meets the rules and answers for it for as long as it is on the market. This guide covers who can be a sponsor, what an overseas brand does, how to become one, the sponsor's duties after the listing, what happens when they aren't met, and how a listing moves to a new sponsor.","parent":"/pathways/listed-medicines","studies":["skincare-brand-regulatory-partner","sports-nutrition-joint-formula","pump-haircare-hair-supplement"],"formats":[],"order":72,"updated":"2026-10-22","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- The sponsor is the person or company that imports, exports or manufactures a medicine, or arranges for it to happen, and is legally responsible for it in Australia. Normally, that is the brand's own company.\n- A sponsor must be an Australian resident, or a company incorporated and doing business in Australia with a representative who lives here. An overseas brand needs an Australian sponsor, and an overseas manufacturer can't be one.\n- Becoming a sponsor means a TGA Client ID, through the organisation details form, then access to TGA Business Services. In 2026–27 a listing costs $1,063 to apply for and $1,566 a year once it has had turnover.\n- After the listing, the sponsor holds the evidence for every claim, makes sure every step of manufacture is licensed or cleared, keeps records, reports serious adverse reactions within 15 days, runs any recall, answers the TGA's requests and pays its charges.\n- The responsibility stays with the sponsor when others do the work. A breach can mean an infringement notice, a cancelled listing or prosecution.\n- A listing can move to a new sponsor at no fee, by notifying the TGA within three months.","text":"The sponsor is the person or company that imports, exports or manufactures a medicine, or arranges for it to happen, and is legally responsible for it in Australia. Normally, that is the brand's own company. A sponsor must be an Australian resident, or a company incorporated and doing business in Australia with a representative who lives here. An overseas brand needs an Australian sponsor, and an overseas manufacturer can't be one. Becoming a sponsor means a TGA Client ID, through the organisation details form, then access to TGA Business Services. In 2026–27 a listing costs $1,063 to apply for and $1,566 a year once it has had turnover. After the listing, the sponsor holds the evidence for every claim, makes sure every step of manufacture is licensed or cleared, keeps records, reports serious adverse reactions within 15 days, runs any recall, answers the TGA's requests and pays its charges. The responsibility stays with the sponsor when others do the work. A breach can mean an infringement notice, a cancelled listing or prosecution. A listing can move to a new sponsor at no fee, by notifying the TGA within three months.","items":[],"tables":[]},{"heading":"What a sponsor is","anchor":"what-a-sponsor-is","markdown":"The Therapeutic Goods Act defines a sponsor by what it does. Under section 3, a sponsor of therapeutic goods is a person who:\n\n- exports the goods from Australia, or arranges their export;\n- imports them into Australia, or arranges their import; or\n- in Australia, manufactures them, or arranges for someone else to, for supply in Australia or elsewhere.\n\nThe definition leaves out anyone who does those things on behalf of another person who is a resident of, or carries on business in, Australia. So a contract manufacturer making a product on behalf of an Australian brand isn't its sponsor: the brand that arranged the manufacture is.\n\nEvery medicine on the ARTG names its sponsor, and the [ARTG](/guides/artg) can be searched by sponsor.","text":"The Therapeutic Goods Act defines a sponsor by what it does. Under section 3, a sponsor of therapeutic goods is a person who: exports the goods from Australia, or arranges their export; imports them into Australia, or arranges their import; or in Australia, manufactures them, or arranges for someone else to, for supply in Australia or elsewhere. The definition leaves out anyone who does those things on behalf of another person who is a resident of, or carries on business in, Australia. So a contract manufacturer making a product on behalf of an Australian brand isn't its sponsor: the brand that arranged the manufacture is. Every medicine on the ARTG names its sponsor, and the ARTG can be searched by sponsor.","items":[],"tables":[]},{"heading":"Who can be a sponsor","anchor":"who-can-be-a-sponsor","markdown":"The TGA says \"the sponsor must be a resident of Australia or be an incorporated body in Australia and conducting business in Australia\", with a representative who lives here, and that sponsors \"must be an Australian resident or carry on business in Australia to get a therapeutic good listed\". Its organisation details form adds that sponsors \"must maintain at least one Australian representative at all times\".\n\nThat rules out sponsoring from abroad. The form says \"Sponsors must be located in Australia\", and the TGA says \"overseas manufacturers are unable to sponsor medicines for supply to the Australian market\". An overseas brand needs an Australian sponsor: its own Australian company, or an Australian resident or business that agrees to be the sponsor and take on the duties below.\n\nA sponsor can work through an agent, which the TGA describes as \"a regulatory affairs consultant offering services, including advice and assistance in relation to regulatory requirements\". The agent can do the work, but the TGA says \"the sponsor is responsible for ensuring that their medicine is compliant with all relevant legislation\".","text":"The TGA says \"the sponsor must be a resident of Australia or be an incorporated body in Australia and conducting business in Australia\", with a representative who lives here, and that sponsors \"must be an Australian resident or carry on business in Australia to get a therapeutic good listed\". Its organisation details form adds that sponsors \"must maintain at least one Australian representative at all times\". That rules out sponsoring from abroad. The form says \"Sponsors must be located in Australia\", and the TGA says \"overseas manufacturers are unable to sponsor medicines for supply to the Australian market\". An overseas brand needs an Australian sponsor: its own Australian company, or an Australian resident or business that agrees to be the sponsor and take on the duties below. A sponsor can work through an agent, which the TGA describes as \"a regulatory affairs consultant offering services, including advice and assistance in relation to regulatory requirements\". The agent can do the work, but the TGA says \"the sponsor is responsible for ensuring that their medicine is compliant with all relevant legislation\".","items":[],"tables":[]},{"heading":"Becoming a sponsor","anchor":"becoming-a-sponsor","markdown":"1. **A Client ID.** The TGA's organisation details form registers the company with the TGA. For a company it is signed by a director or the company secretary, who is added to TGA Business Services as an authorised representative, and it is sent to the TGA. The TGA's helpdesk emails the nominated representative within three working days.\n2. **TGA Business Services.** A new sponsor registers for access to the portal where a listing is entered, validated, certified and paid for. The TGA has said a new TGA Business Services, reached through the Health Business Services portal, will go live in mid to late 2026 and replace the current system rather than run alongside it.\n3. **The listing.** The sponsor applies, certifies and pays the application fee, $1,063 in 2026–27. The TGA published a checklist for new sponsors of listed medicines in May 2026, and our [TGA listing guide](/guides/tga-approval) covers the steps.","text":"A Client ID. The TGA's organisation details form registers the company with the TGA. For a company it is signed by a director or the company secretary, who is added to TGA Business Services as an authorised representative, and it is sent to the TGA. The TGA's helpdesk emails the nominated representative within three working days. TGA Business Services. A new sponsor registers for access to the portal where a listing is entered, validated, certified and paid for. The TGA has said a new TGA Business Services, reached through the Health Business Services portal, will go live in mid to late 2026 and replace the current system rather than run alongside it. The listing. The sponsor applies, certifies and pays the application fee, $1,063 in 2026–27. The TGA published a checklist for new sponsors of listed medicines in May 2026, and our TGA listing guide covers the steps.","items":[{"lead":"A Client ID.","text":"The TGA's organisation details form registers the company with the TGA. For a company it is signed by a director or the company secretary, who is added to TGA Business Services as an authorised representative, and it is sent to the TGA. The TGA's helpdesk emails the nominated representative within three working days."},{"lead":"TGA Business Services.","text":"A new sponsor registers for access to the portal where a listing is entered, validated, certified and paid for. The TGA has said a new TGA Business Services, reached through the Health Business Services portal, will go live in mid to late 2026 and replace the current system rather than run alongside it."},{"lead":"The listing.","text":"The sponsor applies, certifies and pays the application fee, $1,063 in 2026–27. The TGA published a checklist for new sponsors of listed medicines in May 2026, and our TGA listing guide covers the steps."}],"tables":[]},{"heading":"What the sponsor certifies","anchor":"what-the-sponsor-certifies","markdown":"At listing, the sponsor makes the certifications in section 26A of the Act. Among them, it certifies that it holds the evidence for the medicine's indications and claims, and the TGA says applicants \"must certify that all information in the medicine's ARTG entry is correct\". The TGA doesn't evaluate the medicine before it goes on the ARTG: its system validates the listing, but the TGA relies on the certifications and can review the listing at any time after. More on the evidence in our [claims and indications guide](/guides/permitted-indications).","text":"At listing, the sponsor makes the certifications in section 26A of the Act. Among them, it certifies that it holds the evidence for the medicine's indications and claims, and the TGA says applicants \"must certify that all information in the medicine's ARTG entry is correct\". The TGA doesn't evaluate the medicine before it goes on the ARTG: its system validates the listing, but the TGA relies on the certifications and can review the listing at any time after. More on the evidence in our claims and indications guide.","items":[],"tables":[]},{"heading":"The sponsor's duties after the listing","anchor":"the-sponsors-duties-after-the-listing","markdown":"The TGA sums up a listed medicine's sponsor's ongoing duties: \"notify us of any changes through variation processes\", \"pay regulatory charges\", \"report any issues or adverse events\" and \"provide us any information that we request from you\". In more detail:\n\n| Duty | What it means |\n| --- | --- |\n| Evidence | Hold the evidence for every indication and claim \"at all times while your medicine is listed in the ARTG\", and give it to the TGA when it asks. |\n| Manufacturing | Every step made in a licensed facility in Australia, or under a TGA GMP clearance overseas, unless the step is exempt. Overseas, the sponsor obtains the clearance. More in our [GMP clearance guide](/guides/gmp-clearance). |\n| Records | Keep distribution records for five years, a condition of listing, and keep safety records for the life of the medicine and five years after it leaves the ARTG. |\n| Adverse events | Report serious adverse reactions that happen in Australia as soon as possible, and no later than 15 calendar days after receiving them; significant safety issues within 72 hours. |\n| Recalls | Start and run any recall, product alert or correction in Australia, under the TGA's Procedure for Recalls, Product Alerts and Product Corrections, in force since 5 March 2025. |\n| The TGA's questions | Answer a request for information under section 31 of the Act in full by its due date. The TGA also picks some listed medicines for compliance review at random. |\n| Charges | Pay the annual charge each financial year. A listing that has never had turnover is exempt, but the sponsor must declare $0 turnover each year between 1 and 22 July, or by 15 September with a late fee, or the exemption ends. |\n| Advertising | Keep every ad within the Advertising Code and consistent with the ARTG entry. More in our [advertising guide](/guides/tga-advertising). |\n| Changes | Apply to vary the listing when certain product details change. |","text":"The TGA sums up a listed medicine's sponsor's ongoing duties: \"notify us of any changes through variation processes\", \"pay regulatory charges\", \"report any issues or adverse events\" and \"provide us any information that we request from you\". In more detail: Duty: Evidence; What it means: Hold the evidence for every indication and claim \"at all times while your medicine is listed in the ARTG\", and give it to the TGA when it asks.. Duty: Manufacturing; What it means: Every step made in a licensed facility in Australia, or under a TGA GMP clearance overseas, unless the step is exempt. Overseas, the sponsor obtains the clearance. More in our GMP clearance guide.. Duty: Records; What it means: Keep distribution records for five years, a condition of listing, and keep safety records for the life of the medicine and five years after it leaves the ARTG.. Duty: Adverse events; What it means: Report serious adverse reactions that happen in Australia as soon as possible, and no later than 15 calendar days after receiving them; significant safety issues within 72 hours.. Duty: Recalls; What it means: Start and run any recall, product alert or correction in Australia, under the TGA's Procedure for Recalls, Product Alerts and Product Corrections, in force since 5 March 2025.. Duty: The TGA's questions; What it means: Answer a request for information under section 31 of the Act in full by its due date. The TGA also picks some listed medicines for compliance review at random.. Duty: Charges; What it means: Pay the annual charge each financial year. A listing that has never had turnover is exempt, but the sponsor must declare $0 turnover each year between 1 and 22 July, or by 15 September with a late fee, or the exemption ends.. Duty: Advertising; What it means: Keep every ad within the Advertising Code and consistent with the ARTG entry. More in our advertising guide.. Duty: Changes; What it means: Apply to vary the listing when certain product details change..","items":[],"tables":[{"header":["Duty","What it means"],"rows":[["Evidence","Hold the evidence for every indication and claim \"at all times while your medicine is listed in the ARTG\", and give it to the TGA when it asks."],["Manufacturing","Every step made in a licensed facility in Australia, or under a TGA GMP clearance overseas, unless the step is exempt. Overseas, the sponsor obtains the clearance. More in our GMP clearance guide."],["Records","Keep distribution records for five years, a condition of listing, and keep safety records for the life of the medicine and five years after it leaves the ARTG."],["Adverse events","Report serious adverse reactions that happen in Australia as soon as possible, and no later than 15 calendar days after receiving them; significant safety issues within 72 hours."],["Recalls","Start and run any recall, product alert or correction in Australia, under the TGA's Procedure for Recalls, Product Alerts and Product Corrections, in force since 5 March 2025."],["The TGA's questions","Answer a request for information under section 31 of the Act in full by its due date. The TGA also picks some listed medicines for compliance review at random."],["Charges","Pay the annual charge each financial year. A listing that has never had turnover is exempt, but the sponsor must declare $0 turnover each year between 1 and 22 July, or by 15 September with a late fee, or the exemption ends."],["Advertising","Keep every ad within the Advertising Code and consistent with the ARTG entry. More in our advertising guide."],["Changes","Apply to vary the listing when certain product details change."]]}]},{"heading":"When the duties aren't met","anchor":"when-the-duties-arent-met","markdown":"In the TGA's words, it \"can cancel or suspend medicines from the ARTG for refusing or failing to comply with a condition\", and it can cancel a listing whose sponsor doesn't answer a request for information in full by the due date. Some contraventions of the Act carry civil penalties of up to 5,000 penalty units for an individual or 50,000 for a body corporate, and criminal penalties can include 5 to 7 years' imprisonment and fines of up to 4,000 penalty units. For offences committed on or after 1 July 2026, a penalty unit is $364.\n\nThe TGA's published cases show how this plays out:\n\n- **A false certification.** Caruso's Natural Health paid $12,600 under an infringement notice for a false or misleading certification that it held evidence for some of a children's eye-care product's indications.\n- **Evidence not held.** Caruso's was also given five infringement notices, $82,500 in all, for an alleged failure to hold evidence for five therapeutic uses across three medicines.\n- **An information notice.** Marvel Health (Australia) was fined $13,320 for an alleged failure to comply with a TGA request for information notice.\n\nA false or misleading declaration of $0 turnover, to keep a listing exempt from the annual charge, is an offence under the Criminal Code.","text":"In the TGA's words, it \"can cancel or suspend medicines from the ARTG for refusing or failing to comply with a condition\", and it can cancel a listing whose sponsor doesn't answer a request for information in full by the due date. Some contraventions of the Act carry civil penalties of up to 5,000 penalty units for an individual or 50,000 for a body corporate, and criminal penalties can include 5 to 7 years' imprisonment and fines of up to 4,000 penalty units. For offences committed on or after 1 July 2026, a penalty unit is $364. The TGA's published cases show how this plays out: A false certification. Caruso's Natural Health paid $12,600 under an infringement notice for a false or misleading certification that it held evidence for some of a children's eye-care product's indications. Evidence not held. Caruso's was also given five infringement notices, $82,500 in all, for an alleged failure to hold evidence for five therapeutic uses across three medicines. An information notice. Marvel Health (Australia) was fined $13,320 for an alleged failure to comply with a TGA request for information notice. A false or misleading declaration of $0 turnover, to keep a listing exempt from the annual charge, is an offence under the Criminal Code.","items":[{"lead":"A false certification.","text":"Caruso's Natural Health paid $12,600 under an infringement notice for a false or misleading certification that it held evidence for some of a children's eye-care product's indications."},{"lead":"Evidence not held.","text":"Caruso's was also given five infringement notices, $82,500 in all, for an alleged failure to hold evidence for five therapeutic uses across three medicines."},{"lead":"An information notice.","text":"Marvel Health (Australia) was fined $13,320 for an alleged failure to comply with a TGA request for information notice."}],"tables":[]},{"heading":"Changing sponsor","anchor":"changing-sponsor","markdown":"- **Within three months.** A change of sponsor must be notified to the TGA within three months, on its \"Notification: transfer of sponsorship\" form, which the new and former sponsors should both sign. There is no fee, and the TGA usually updates the ARTG entries within 10 working days.\n- **The new sponsor is responsible at once.** Its obligations start as soon as the transfer happens, even before the TGA is told, and it may be an offence for the former sponsor to keep supplying the goods.\n- **A new ABN or ACN counts.** The TGA treats a change of ABN or ACN as forming a new business entity, so a restructure that creates a new ABN or ACN means a change of sponsor.","text":"Within three months. A change of sponsor must be notified to the TGA within three months, on its \"Notification: transfer of sponsorship\" form, which the new and former sponsors should both sign. There is no fee, and the TGA usually updates the ARTG entries within 10 working days. The new sponsor is responsible at once. Its obligations start as soon as the transfer happens, even before the TGA is told, and it may be an offence for the former sponsor to keep supplying the goods. A new ABN or ACN counts. The TGA treats a change of ABN or ACN as forming a new business entity, so a restructure that creates a new ABN or ACN means a change of sponsor.","items":[{"lead":"Within three months.","text":"A change of sponsor must be notified to the TGA within three months, on its \"Notification: transfer of sponsorship\" form, which the new and former sponsors should both sign. There is no fee, and the TGA usually updates the ARTG entries within 10 working days."},{"lead":"The new sponsor is responsible at once.","text":"Its obligations start as soon as the transfer happens, even before the TGA is told, and it may be an offence for the former sponsor to keep supplying the goods."},{"lead":"A new ABN or ACN counts.","text":"The TGA treats a change of ABN or ACN as forming a new business entity, so a restructure that creates a new ABN or ACN means a change of sponsor."}],"tables":[]},{"heading":"Where we come in","anchor":"where-we-come-in","markdown":"The sponsor is normally your company, and our advice is to sign as the company, not as an individual. We do the work behind what the sponsor certifies: the formula inside the permitted ingredients and indications, the evidence for every claim, the label, the stability program and the listing, then we manage the manufacture, with the licence or clearance each step needs. For brands already on the market we can run the regulatory work, as we have done for [an international skincare brand](/work/skincare-brand-regulatory-partner) on a monthly retainer since 2024. More on [listed medicines](/pathways/listed-medicines), or [book a call](/contact).","text":"The sponsor is normally your company, and our advice is to sign as the company, not as an individual. We do the work behind what the sponsor certifies: the formula inside the permitted ingredients and indications, the evidence for every claim, the label, the stability program and the listing, then we manage the manufacture, with the licence or clearance each step needs. For brands already on the market we can run the regulatory work, as we have done for an international skincare brand on a monthly retainer since 2024. More on listed medicines, or book a call.","items":[],"tables":[]}],"faqs":[{"q":"Can an overseas company be a TGA sponsor?","a":"Not from overseas. The TGA requires a sponsor to be an Australian resident, or a company incorporated and doing business in Australia with a representative who lives here, and says overseas manufacturers can't sponsor medicines for the Australian market. An overseas brand needs an Australian sponsor: its own Australian company, or an Australian resident or business that takes on the role and its duties. The other steps for an overseas brand are in bringing a supplement brand to Australia.","md":"Not from overseas. The TGA requires a sponsor to be an Australian resident, or a company incorporated and doing business in Australia with a representative who lives here, and says overseas manufacturers can't sponsor medicines for the Australian market. An overseas brand needs an Australian sponsor: its own Australian company, or an Australian resident or business that takes on the role and its duties. The other steps for an overseas brand are in [bringing a supplement brand to Australia](/guides/bringing-a-supplement-brand-to-australia)."},{"q":"Who is legally responsible for a listed medicine?","a":"The sponsor. It certifies at listing that the medicine meets the rules, and the TGA says the sponsor is responsible for making sure the medicine complies with all relevant legislation, even when others do the work. Normally, the sponsor is the brand's own company.","md":"The sponsor. It certifies at listing that the medicine meets the rules, and the TGA says the sponsor is responsible for making sure the medicine complies with all relevant legislation, even when others do the work. Normally, the sponsor is the brand's own company."},{"q":"How do I become a TGA sponsor?","a":"Get a Client ID from the TGA with its organisation details form, signed for a company by a director or the company secretary, then register for TGA Business Services. The TGA's helpdesk replies within three working days. A listing then costs $1,063 to apply for in 2026–27.","md":"Get a Client ID from the TGA with its organisation details form, signed for a company by a director or the company secretary, then register for TGA Business Services. The TGA's helpdesk replies within three working days. A listing then costs $1,063 to apply for in 2026–27."},{"q":"What does a sponsor have to do after the listing?","a":"Hold the evidence for every claim, keep every step of manufacture licensed or cleared, keep distribution and safety records, report serious adverse reactions within 15 calendar days, run any recall, answer the TGA's requests for information, pay the annual charge, and keep the advertising within the Code and the ARTG entry.","md":"Hold the evidence for every claim, keep every step of manufacture licensed or cleared, keep distribution and safety records, report serious adverse reactions within 15 calendar days, run any recall, answer the TGA's requests for information, pay the annual charge, and keep the advertising within the Code and the ARTG entry."},{"q":"Can a manufacturer or a consultant be the sponsor?","a":"A contract manufacturer making a product for an Australian brand isn't its sponsor under the Act: the brand that arranged the manufacture is. An overseas manufacturer can't be a sponsor at all. A consultant can act as the sponsor's agent and do the regulatory work, but the sponsor stays responsible.","md":"A contract manufacturer making a product for an Australian brand isn't its sponsor under the Act: the brand that arranged the manufacture is. An overseas manufacturer can't be a sponsor at all. A consultant can act as the sponsor's agent and do the regulatory work, but the sponsor stays responsible."},{"q":"How do I transfer a listing to a new sponsor?","a":"Notify the TGA within three months on its transfer of sponsorship form, which both sponsors should sign. There is no fee, and the ARTG entries are usually updated within 10 working days. A new ABN or ACN counts as a change of sponsor.","md":"Notify the TGA within three months on its transfer of sponsorship form, which both sponsors should sign. There is no fee, and the ARTG entries are usually updated within 10 working days. A new ABN or ACN counts as a change of sponsor."}],"sources":{"note":"General information, checked against these sources on 22 October 2026. It isn't legal advice or advice on a particular product. Our advice on signing, and our work, are from Take Friday Off's records.","markdown":"General information, checked against these sources on 22 October 2026. It isn't legal advice or advice on a particular product. Our advice on signing, and our work, are from Take Friday Off's records.\n\n- [Therapeutic Goods Act 1989](https://www.legislation.gov.au/C2004A03952/latest/text), section 3 (the meaning of sponsor), Federal Register of Legislation\n- [Determine if you are a sponsor](https://www.tga.gov.au/node/289), [About listed medicines](https://www.tga.gov.au/node/546608) and [Organisation Details: Sponsor, Agent and Manufacturer](https://www.tga.gov.au/sites/default/files/2026-04/form-tga-business-services-organisation-details.pdf), March 2026, Therapeutic Goods Administration\n- [TGA Business Services: getting started with the TGA](https://www.tga.gov.au/tga-business-services-getting-started-tga) and [Navigating the listed medicines framework: Listed medicines checklist for new sponsors](https://www.tga.gov.au/sites/default/files/2026-05/navigating-listed-medicines-framework-checklist.pdf), May 2026, Therapeutic Goods Administration\n- [Declaration of intent to supply the Australian market](https://www.tga.gov.au/node/287676), January 2017, and [Determining whether licensing or certification required](https://www.tga.gov.au/node/286068), from Australian manufacturing licences and overseas GMP certification, Therapeutic Goods Administration\n- The TGA's pages on [sponsor certification](https://www.tga.gov.au/node/290088) and [monitoring and compliance](https://www.tga.gov.au/node/513709) for listed medicines, and [Evidence for listed medicines](https://www.tga.gov.au/resources/decision-trees/what-do-i-require-have-listed-medicine-artg/lm-evidence-12), Therapeutic Goods Administration\n- [Pharmacovigilance responsibilities of medicine sponsors](https://www.tga.gov.au/node/286101), version 3.0, and the [Procedure for Recalls, Product Alerts and Product Corrections](https://www.tga.gov.au/node/287587), Therapeutic Goods Administration\n- [Understanding listed medicines compliance reviews](https://www.tga.gov.au/node/453145), [Applying the Advertising Code rules: general requirements](https://www.tga.gov.au/resources/guidance/applying-advertising-code-rules-general-requirements) and [Changing a listed or assessed listed medicine in the ARTG](https://www.tga.gov.au/resources/guidance/changing-listed-or-assessed-listed-medicine-australian-register-therapeutic-goods-artg), Therapeutic Goods Administration\n- [Fees and charges: summary, from 1 July 2026](https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf) and the [Annual charge exemption scheme: frequently asked questions](https://www.tga.gov.au/products/regulations-all-products/fees-and-payments/annual-charge-exemption-scheme-therapeutic-goods/annual-charge-exemption-scheme-frequently-asked-questions), Therapeutic Goods Administration\n- [Compliance actions and outcomes](https://tga.gov.au/node/145238), Therapeutic Goods Administration, the [Crimes (Amount of a Penalty Unit) Instrument 2026](https://www.legislation.gov.au/F2026N00424/asmade/2026-06-16/text/original/pdf), and the [2022 determination of the conditions of listing for listed medicines](https://legislation.gov.au/F2022L01758/asmade/2022-12-23/text/original/epub/OEBPS/document_1/document_1.html), Federal Register of Legislation\n- [Caruso's Natural Health fined $12,600 for falsely claiming to hold evidence for Caruso's Kids Eye Care](https://www.tga.gov.au/news/media-releases/carusos-natural-health-fined-12600-falsely-claiming-hold-evidence-carusos-kids-eye-care), [Caruso's Natural Health Pty Ltd fined for alleged offences relating to regulatory requirements](https://www.tga.gov.au/news/media-releases/carusos-natural-health-pty-ltd-fined-alleged-offences-relating-regulatory-requirements) and [Marvel Health (Australia) Pty Ltd fined $13,320 for alleged failure to comply with a request for information notice](https://tga.gov.au/node/408098), Therapeutic Goods Administration\n- [Changes to sponsorship of therapeutic goods](https://www.tga.gov.au/products/regulations-all-products/about-australian-register-therapeutic-goods-artg/changes-sponsorship-therapeutic-goods), [Notification: transfer of sponsorship](https://www.tga.gov.au/node/285758) and [Notification of change of sponsorship](https://www.tga.gov.au/node/288262), Therapeutic Goods Administration\n- [TGA digital transformation webinar: questions and answers](https://www.tga.gov.au/sites/default/files/2026-01/tga-digital-transformation-exploring-beta-version-new-tga-business-services-portal-webinar-q-a.pdf), from the webinar of 2 December 2025, Therapeutic Goods Administration","items":[{"text":"Therapeutic Goods Act 1989, section 3 (the meaning of sponsor), Federal Register of Legislation","links":[{"title":"Therapeutic Goods Act 1989","url":"https://www.legislation.gov.au/C2004A03952/latest/text"}]},{"text":"Determine if you are a sponsor, About listed medicines and Organisation Details: Sponsor, Agent and Manufacturer, March 2026, Therapeutic Goods Administration","links":[{"title":"Determine if you are a sponsor","url":"https://www.tga.gov.au/node/289"},{"title":"About listed medicines","url":"https://www.tga.gov.au/node/546608"},{"title":"Organisation Details: Sponsor, Agent and Manufacturer","url":"https://www.tga.gov.au/sites/default/files/2026-04/form-tga-business-services-organisation-details.pdf"}]},{"text":"TGA Business Services: getting started with the TGA and Navigating the listed medicines framework: Listed medicines checklist for new sponsors, May 2026, Therapeutic Goods Administration","links":[{"title":"TGA Business Services: getting started with the TGA","url":"https://www.tga.gov.au/tga-business-services-getting-started-tga"},{"title":"Navigating the listed medicines framework: Listed medicines checklist for new sponsors","url":"https://www.tga.gov.au/sites/default/files/2026-05/navigating-listed-medicines-framework-checklist.pdf"}]},{"text":"Declaration of intent to supply the Australian market, January 2017, and Determining whether licensing or certification required, from Australian manufacturing licences and overseas GMP certification, Therapeutic Goods Administration","links":[{"title":"Declaration of intent to supply the Australian market","url":"https://www.tga.gov.au/node/287676"},{"title":"Determining whether licensing or certification required","url":"https://www.tga.gov.au/node/286068"}]},{"text":"The TGA's pages on sponsor certification and monitoring and compliance for listed medicines, and Evidence for listed medicines, Therapeutic Goods Administration","links":[{"title":"sponsor certification","url":"https://www.tga.gov.au/node/290088"},{"title":"monitoring and compliance","url":"https://www.tga.gov.au/node/513709"},{"title":"Evidence for listed medicines","url":"https://www.tga.gov.au/resources/decision-trees/what-do-i-require-have-listed-medicine-artg/lm-evidence-12"}]},{"text":"Pharmacovigilance responsibilities of medicine sponsors, version 3.0, and the Procedure for Recalls, Product Alerts and Product Corrections, Therapeutic Goods Administration","links":[{"title":"Pharmacovigilance responsibilities of medicine sponsors","url":"https://www.tga.gov.au/node/286101"},{"title":"Procedure for Recalls, Product Alerts and Product Corrections","url":"https://www.tga.gov.au/node/287587"}]},{"text":"Understanding listed medicines compliance reviews, Applying the Advertising Code rules: general requirements and Changing a listed or assessed listed medicine in the ARTG, Therapeutic Goods Administration","links":[{"title":"Understanding listed medicines compliance reviews","url":"https://www.tga.gov.au/node/453145"},{"title":"Applying the Advertising Code rules: general requirements","url":"https://www.tga.gov.au/resources/guidance/applying-advertising-code-rules-general-requirements"},{"title":"Changing a listed or assessed listed medicine in the ARTG","url":"https://www.tga.gov.au/resources/guidance/changing-listed-or-assessed-listed-medicine-australian-register-therapeutic-goods-artg"}]},{"text":"Fees and charges: summary, from 1 July 2026 and the Annual charge exemption scheme: frequently asked questions, Therapeutic Goods Administration","links":[{"title":"Fees and charges: summary, from 1 July 2026","url":"https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf"},{"title":"Annual charge exemption scheme: frequently asked questions","url":"https://www.tga.gov.au/products/regulations-all-products/fees-and-payments/annual-charge-exemption-scheme-therapeutic-goods/annual-charge-exemption-scheme-frequently-asked-questions"}]},{"text":"Compliance actions and outcomes, Therapeutic Goods Administration, the Crimes (Amount of a Penalty Unit) Instrument 2026, and the 2022 determination of the conditions of listing for listed medicines, Federal Register of Legislation","links":[{"title":"Compliance actions and outcomes","url":"https://tga.gov.au/node/145238"},{"title":"Crimes (Amount of a Penalty Unit) Instrument 2026","url":"https://www.legislation.gov.au/F2026N00424/asmade/2026-06-16/text/original/pdf"},{"title":"2022 determination of the conditions of listing for listed medicines","url":"https://legislation.gov.au/F2022L01758/asmade/2022-12-23/text/original/epub/OEBPS/document_1/document_1.html"}]},{"text":"Caruso's Natural Health fined $12,600 for falsely claiming to hold evidence for Caruso's Kids Eye Care, Caruso's Natural Health Pty Ltd fined for alleged offences relating to regulatory requirements and Marvel Health (Australia) Pty Ltd fined $13,320 for alleged failure to comply with a request for information notice, Therapeutic Goods Administration","links":[{"title":"Caruso's Natural Health fined $12,600 for falsely claiming to hold evidence for Caruso's Kids Eye Care","url":"https://www.tga.gov.au/news/media-releases/carusos-natural-health-fined-12600-falsely-claiming-hold-evidence-carusos-kids-eye-care"},{"title":"Caruso's Natural Health Pty Ltd fined for alleged offences relating to regulatory requirements","url":"https://www.tga.gov.au/news/media-releases/carusos-natural-health-pty-ltd-fined-alleged-offences-relating-regulatory-requirements"},{"title":"Marvel Health (Australia) Pty Ltd fined $13,320 for alleged failure to comply with a request for information notice","url":"https://tga.gov.au/node/408098"}]},{"text":"Changes to sponsorship of therapeutic goods, Notification: transfer of sponsorship and Notification of change of sponsorship, Therapeutic Goods Administration","links":[{"title":"Changes to sponsorship of therapeutic goods","url":"https://www.tga.gov.au/products/regulations-all-products/about-australian-register-therapeutic-goods-artg/changes-sponsorship-therapeutic-goods"},{"title":"Notification: transfer of sponsorship","url":"https://www.tga.gov.au/node/285758"},{"title":"Notification of change of sponsorship","url":"https://www.tga.gov.au/node/288262"}]},{"text":"TGA digital transformation webinar: questions and answers, from the webinar of 2 December 2025, Therapeutic Goods Administration","links":[{"title":"TGA digital transformation webinar: questions and answers","url":"https://www.tga.gov.au/sites/default/files/2026-01/tga-digital-transformation-exploring-beta-version-new-tga-business-services-portal-webinar-q-a.pdf"}]}]}},{"slug":"assessed-listed-medicines","kind":"guide","url":"/guides/assessed-listed-medicines","title":"Assessed listed medicines: AUST L(A) claims, fees and timeframes","name":"Assessed listed medicines guide","description":"What an assessed listed medicine (AUST L(A)) can claim, how the TGA evaluates its efficacy, and the 2026–27 fees, timeframes and five-year data protection.","eyebrow":"Guide","lead":"An assessed listed medicine sits between a listed medicine and a registered one. It uses the same pre-approved ingredients as a listed medicine, but it can make intermediate indications, claims stronger than the permitted list allows, because the TGA assesses the evidence for them before it is sold. Its label carries an AUST L(A) number and can say \\\"TGA assessed\\\". This guide covers what it can claim, the application, the three levels with their 2026–27 fees and timeframes, and the five years of data protection a new claim can earn.","parent":"/pathways/listed-medicines","studies":["everleanbody-saffron-capsule","your-skin-scan-nicotinamide-tablet","ashwagandha-capsule-32-days"],"formats":[],"order":73,"updated":"2026-10-22","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- An assessed listed medicine (AUST L(A)) uses ingredients from the same pre-approved list as a listed medicine, but makes at least one intermediate indication: a claim stronger than the permitted indications allow, short of a high-level one.\n- The TGA assesses its efficacy before it is sold. It doesn't evaluate its quality and safety: the sponsor certifies those, as for a listed medicine.\n- Only the indications the TGA assessed can go on its label, and it can carry the TGA's \"TGA assessed\" statement, in words the TGA sets.\n- A new claim evaluated on its own evidence is an L(A)3 application: in 2026–27, $2,310 to apply and $17,723 to evaluate. The annual charge is $1,566.\n- The legislated timeframes give the TGA 40 working days to report its preliminary assessment, then up to 150 working days to evaluate, depending on the category, plus any time the clock is stopped.\n- New clinical trial data behind a new claim can be protected for five years, in which the TGA can't use them to evaluate another assessed listed medicine application without the sponsor's written permission.","text":"An assessed listed medicine (AUST L(A)) uses ingredients from the same pre-approved list as a listed medicine, but makes at least one intermediate indication: a claim stronger than the permitted indications allow, short of a high-level one. The TGA assesses its efficacy before it is sold. It doesn't evaluate its quality and safety: the sponsor certifies those, as for a listed medicine. Only the indications the TGA assessed can go on its label, and it can carry the TGA's \"TGA assessed\" statement, in words the TGA sets. A new claim evaluated on its own evidence is an L(A)3 application: in 2026–27, $2,310 to apply and $17,723 to evaluate. The annual charge is $1,566. The legislated timeframes give the TGA 40 working days to report its preliminary assessment, then up to 150 working days to evaluate, depending on the category, plus any time the clock is stopped. New clinical trial data behind a new claim can be protected for five years, in which the TGA can't use them to evaluate another assessed listed medicine application without the sponsor's written permission.","items":[],"tables":[]},{"heading":"What an assessed listed medicine is","anchor":"what-an-assessed-listed-medicine-is","markdown":"The TGA opened the assessed listed pathway on 19 March 2018. It says these medicines \"present an intermediate level of risk based on their indications and label claims\", and that the pathway sits \"between the existing listed (lower risk) and registered (higher risk) complementary medicines pathways\". The Therapeutic Goods Act deals with them in section 26AE, \"Evaluation and listing of certain medicines\".\n\n| | Listed | Assessed listed | Registered |\n| --- | --- | --- | --- |\n| On the label | AUST L | AUST L(A) | AUST R |\n| Ingredients | Only from the Permissible Ingredients Determination | Only from the Permissible Ingredients Determination | Any complementary medicine ingredient not in Schedule 4, 8 or 9 of the Poisons Standard |\n| What it can claim | Low-level indications from the permitted list | At least one intermediate indication, assessed by the TGA | Claims evaluated as part of registration |\n| Before it is sold, the TGA | Doesn't evaluate it: the sponsor certifies it meets the rules | Assesses its efficacy; the sponsor certifies its quality and safety | Fully assesses it |\n| \"TGA assessed\" on the label | No | Yes, once the TGA authorises it | Yes, for a registered complementary medicine, once authorised |\n\nIn the TGA's words, it \"does assess efficacy pre-market\", but assessed listed medicines \"are not individually evaluated by the TGA for quality and safety\". \"Instead sponsors (product owners) certify that their assessed listed medicine meets requirements in relation to safety and quality.\"\n\nThe ingredients come from the same list as a listed medicine's: the Therapeutic Goods (Permissible Ingredients) Determination. An ingredient that isn't in it needs [its own application](/guides/permissible-ingredients) first, whichever of the two pathways the medicine takes.","text":"The TGA opened the assessed listed pathway on 19 March 2018. It says these medicines \"present an intermediate level of risk based on their indications and label claims\", and that the pathway sits \"between the existing listed (lower risk) and registered (higher risk) complementary medicines pathways\". The Therapeutic Goods Act deals with them in section 26AE, \"Evaluation and listing of certain medicines\". On the label — Listed: AUST L; Assessed listed: AUST L(A); Registered: AUST R. Ingredients — Listed: Only from the Permissible Ingredients Determination; Assessed listed: Only from the Permissible Ingredients Determination; Registered: Any complementary medicine ingredient not in Schedule 4, 8 or 9 of the Poisons Standard. What it can claim — Listed: Low-level indications from the permitted list; Assessed listed: At least one intermediate indication, assessed by the TGA; Registered: Claims evaluated as part of registration. Before it is sold, the TGA — Listed: Doesn't evaluate it: the sponsor certifies it meets the rules; Assessed listed: Assesses its efficacy; the sponsor certifies its quality and safety; Registered: Fully assesses it. \"TGA assessed\" on the label — Listed: No; Assessed listed: Yes, once the TGA authorises it; Registered: Yes, for a registered complementary medicine, once authorised. In the TGA's words, it \"does assess efficacy pre-market\", but assessed listed medicines \"are not individually evaluated by the TGA for quality and safety\". \"Instead sponsors (product owners) certify that their assessed listed medicine meets requirements in relation to safety and quality.\" The ingredients come from the same list as a listed medicine's: the Therapeutic Goods (Permissible Ingredients) Determination. An ingredient that isn't in it needs its own application first, whichever of the two pathways the medicine takes.","items":[],"tables":[{"header":["","Listed","Assessed listed","Registered"],"rows":[["On the label","AUST L","AUST L(A)","AUST R"],["Ingredients","Only from the Permissible Ingredients Determination","Only from the Permissible Ingredients Determination","Any complementary medicine ingredient not in Schedule 4, 8 or 9 of the Poisons Standard"],["What it can claim","Low-level indications from the permitted list","At least one intermediate indication, assessed by the TGA","Claims evaluated as part of registration"],["Before it is sold, the TGA","Doesn't evaluate it: the sponsor certifies it meets the rules","Assesses its efficacy; the sponsor certifies its quality and safety","Fully assesses it"],["\"TGA assessed\" on the label","No","Yes, once the TGA authorises it","Yes, for a registered complementary medicine, once authorised"]]}]},{"heading":"What an intermediate indication is","anchor":"what-an-intermediate-indication-is","markdown":"The TGA defines intermediate level indications as indications that \"exceed the criteria relating to permitted indications\" but \"are not classed as high level indications\". They \"are generally more definitive and may relate to more serious health conditions\", and one of its examples is the \"prevention or alleviation of non-serious forms of a disease, ailment, defect or injury\". Where a listed medicine may claim it \"relieves throat irritation\", the TGA says an assessed listed medicine might be able to reference a condition like tinnitus.\n\nEvery assessed listed medicine must have at least one intermediate indication, and two limits apply:\n\n- **Only what the TGA assessed.** \"The only indications that can be used on the label are those that are assessed by the TGA and included in the ARTG entry.\"\n- **Serious diseases only by exemption.** Restricted and prohibited representations, medical terms for \"serious forms of a disease, condition, ailment, or defect like rheumatoid arthritis or depression\", can't be used by assessed listed medicines unless the TGA grants an exemption, which needs substantial evidence that using the term is accurate, balanced and not misleading.\n\nIts advertising, like any medicine's, must not be inconsistent with the indications on its ARTG entry. More in our [advertising guide](/guides/tga-advertising).","text":"The TGA defines intermediate level indications as indications that \"exceed the criteria relating to permitted indications\" but \"are not classed as high level indications\". They \"are generally more definitive and may relate to more serious health conditions\", and one of its examples is the \"prevention or alleviation of non-serious forms of a disease, ailment, defect or injury\". Where a listed medicine may claim it \"relieves throat irritation\", the TGA says an assessed listed medicine might be able to reference a condition like tinnitus. Every assessed listed medicine must have at least one intermediate indication, and two limits apply: Only what the TGA assessed. \"The only indications that can be used on the label are those that are assessed by the TGA and included in the ARTG entry.\" Serious diseases only by exemption. Restricted and prohibited representations, medical terms for \"serious forms of a disease, condition, ailment, or defect like rheumatoid arthritis or depression\", can't be used by assessed listed medicines unless the TGA grants an exemption, which needs substantial evidence that using the term is accurate, balanced and not misleading. Its advertising, like any medicine's, must not be inconsistent with the indications on its ARTG entry. More in our advertising guide.","items":[{"lead":"Only what the TGA assessed.","text":"\"The only indications that can be used on the label are those that are assessed by the TGA and included in the ARTG entry.\""},{"lead":"Serious diseases only by exemption.","text":"Restricted and prohibited representations, medical terms for \"serious forms of a disease, condition, ailment, or defect like rheumatoid arthritis or depression\", can't be used by assessed listed medicines unless the TGA grants an exemption, which needs substantial evidence that using the term is accurate, balanced and not misleading."}],"tables":[]},{"heading":"The \"TGA assessed\" claim","anchor":"the-tga-assessed-claim","markdown":"An assessed listed medicine can carry the TGA's statement that it has assessed the evidence for its indications, on its own or with the TGA assessed symbol, but never the symbol alone. It's optional, and it is only for assessed listed medicines and registered complementary medicines, once the TGA has authorised its use. The TGA's guidelines for the claim (version 1.1, August 2020) set the rules:\n\n- **The words.** The statement reads \"Evidence for the approved indications has been assessed by the TGA.\", and its wording \"must not be changed\".\n- **On the label.** It can go anywhere on the label, including the primary pack, but no more prominently than the information the label must carry. The symbol is at least 4.7 mm high and 9 mm wide, and the statement's text at least 1.5 mm.\n- **In advertising.** Only on the label in a picture of the pack, with no commentary on it, spoken or written.\n\nA listed medicine can't make the claim, and no medicine can say \"TGA approved\". More in our [advertising guide](/guides/tga-advertising#the-codes-core-rules).","text":"An assessed listed medicine can carry the TGA's statement that it has assessed the evidence for its indications, on its own or with the TGA assessed symbol, but never the symbol alone. It's optional, and it is only for assessed listed medicines and registered complementary medicines, once the TGA has authorised its use. The TGA's guidelines for the claim (version 1.1, August 2020) set the rules: The words. The statement reads \"Evidence for the approved indications has been assessed by the TGA.\", and its wording \"must not be changed\". On the label. It can go anywhere on the label, including the primary pack, but no more prominently than the information the label must carry. The symbol is at least 4.7 mm high and 9 mm wide, and the statement's text at least 1.5 mm. In advertising. Only on the label in a picture of the pack, with no commentary on it, spoken or written. A listed medicine can't make the claim, and no medicine can say \"TGA approved\". More in our advertising guide.","items":[{"lead":"The words.","text":"The statement reads \"Evidence for the approved indications has been assessed by the TGA.\", and its wording \"must not be changed\"."},{"lead":"On the label.","text":"It can go anywhere on the label, including the primary pack, but no more prominently than the information the label must carry. The symbol is at least 4.7 mm high and 9 mm wide, and the statement's text at least 1.5 mm."},{"lead":"In advertising.","text":"Only on the label in a picture of the pack, with no commentary on it, spoken or written."}],"tables":[]},{"heading":"Applying for an assessed listing","anchor":"applying-for-an-assessed-listing","markdown":"1. **A pre-submission meeting.** It is free and optional, but the TGA says it is \"strongly recommended\".\n2. **The dossier.** It uses a simplified version of the Common Technical Document format, with the efficacy evidence in Module 5. The TGA's Assessed listed medicines evidence guidelines, reissued in April 2024, set out the evidence for each application category.\n3. **Apply and pay.** The application goes in through TGA Business Services, and the TGA doesn't start screening it until the application fee is paid.\n4. **Preliminary assessment.** A check that the application meets the requirements of section 23B of the Act, with no evaluation of the science. An application that fails isn't accepted for evaluation, and its application fee isn't refunded.\n5. **Evaluation.** It starts once the evaluation fee is paid in full, and the application lapses if that fee isn't paid within 28 days of becoming payable. The TGA can make formal requests for information, which stop the clock, and may seek advice from an expert advisory committee.\n6. **The decision.** If the TGA's delegate considers the medicine's efficacy established, it is included in the ARTG with its AUST L(A) number and can be sold. A refusal comes with a statement of the reasons.","text":"A pre-submission meeting. It is free and optional, but the TGA says it is \"strongly recommended\". The dossier. It uses a simplified version of the Common Technical Document format, with the efficacy evidence in Module 5. The TGA's Assessed listed medicines evidence guidelines, reissued in April 2024, set out the evidence for each application category. Apply and pay. The application goes in through TGA Business Services, and the TGA doesn't start screening it until the application fee is paid. Preliminary assessment. A check that the application meets the requirements of section 23B of the Act, with no evaluation of the science. An application that fails isn't accepted for evaluation, and its application fee isn't refunded. Evaluation. It starts once the evaluation fee is paid in full, and the application lapses if that fee isn't paid within 28 days of becoming payable. The TGA can make formal requests for information, which stop the clock, and may seek advice from an expert advisory committee. The decision. If the TGA's delegate considers the medicine's efficacy established, it is included in the ARTG with its AUST L(A) number and can be sold. A refusal comes with a statement of the reasons.","items":[{"lead":"A pre-submission meeting.","text":"It is free and optional, but the TGA says it is \"strongly recommended\"."},{"lead":"The dossier.","text":"It uses a simplified version of the Common Technical Document format, with the efficacy evidence in Module 5. The TGA's Assessed listed medicines evidence guidelines, reissued in April 2024, set out the evidence for each application category."},{"lead":"Apply and pay.","text":"The application goes in through TGA Business Services, and the TGA doesn't start screening it until the application fee is paid."},{"lead":"Preliminary assessment.","text":"A check that the application meets the requirements of section 23B of the Act, with no evaluation of the science. An application that fails isn't accepted for evaluation, and its application fee isn't refunded."},{"lead":"Evaluation.","text":"It starts once the evaluation fee is paid in full, and the application lapses if that fee isn't paid within 28 days of becoming payable. The TGA can make formal requests for information, which stop the clock, and may seek advice from an expert advisory committee."},{"lead":"The decision.","text":"If the TGA's delegate considers the medicine's efficacy established, it is included in the ARTG with its AUST L(A) number and can be sold. A refusal comes with a statement of the reasons."}],"tables":[]},{"heading":"Levels, fees and timeframes for 2026–27","anchor":"levels-fees-and-timeframes-for-202627","markdown":"There are three application categories, by risk, L(A)1 the lowest and L(A)3 the highest:\n\n- **L(A)1** is for a medicine identical to one already on the ARTG as an assessed listed medicine, apart from its presentation, colour, flavour or fragrance.\n- **L(A)2** is for a medicine equivalent to an existing one, or one whose efficacy is evaluated from the reports of a comparable overseas regulator.\n- **L(A)3** is for a new claim evaluated on its own evidence: what the TGA calls \"a de novo evaluation of efficacy\".\n\n| Category | Application fee | Evaluation fee | Total | Preliminary assessment | Evaluation |\n| --- | --- | --- | --- | --- | --- |\n| L(A)1 | $563 | $2,139 | $2,702 | 40 working days | 45 working days |\n| L(A)2 | $2,310 | $17,723 | $20,033 | 40 working days | 60 working days |\n| L(A)3 | $2,310 | $17,723 | $20,033 | 40 working days | 150 working days |\n\nThe fees are the TGA's from 1 July 2026. The timeframes are set by regulations 16GH and 16GI of the Therapeutic Goods Regulations 1990, and the figures here are from the TGA's 2018 evidence guidelines. The evaluation clock starts only once the application is accepted for evaluation and the evaluation fee is paid. It stops while the applicant answers a formal request for information, or when the applicant and the TGA agree to stop it.\n\nOnce on the ARTG, an assessed listed medicine pays the annual charge, $1,566 in 2026–27, the same as a listed medicine. Changing its ARTG entry later has its own fees: in 2026–27, $1,003 for a notification (L(A)CN), and $2,505 or $10,940 paid upfront for an L(A)C1 or L(A)C2 change, of which $1,346 or $9,778 is refunded if no evaluation is needed. A change that makes a new, separate medicine is a new application, with its own fees. None of these fees covers the evidence itself or the work of preparing the dossier.","text":"There are three application categories, by risk, L(A)1 the lowest and L(A)3 the highest: L(A)1 is for a medicine identical to one already on the ARTG as an assessed listed medicine, apart from its presentation, colour, flavour or fragrance. L(A)2 is for a medicine equivalent to an existing one, or one whose efficacy is evaluated from the reports of a comparable overseas regulator. L(A)3 is for a new claim evaluated on its own evidence: what the TGA calls \"a de novo evaluation of efficacy\". Category: L(A)1; Application fee: $563; Evaluation fee: $2,139; Total: $2,702; Preliminary assessment: 40 working days; Evaluation: 45 working days. Category: L(A)2; Application fee: $2,310; Evaluation fee: $17,723; Total: $20,033; Preliminary assessment: 40 working days; Evaluation: 60 working days. Category: L(A)3; Application fee: $2,310; Evaluation fee: $17,723; Total: $20,033; Preliminary assessment: 40 working days; Evaluation: 150 working days. The fees are the TGA's from 1 July 2026. The timeframes are set by regulations 16GH and 16GI of the Therapeutic Goods Regulations 1990, and the figures here are from the TGA's 2018 evidence guidelines. The evaluation clock starts only once the application is accepted for evaluation and the evaluation fee is paid. It stops while the applicant answers a formal request for information, or when the applicant and the TGA agree to stop it. Once on the ARTG, an assessed listed medicine pays the annual charge, $1,566 in 2026–27, the same as a listed medicine. Changing its ARTG entry later has its own fees: in 2026–27, $1,003 for a notification (L(A)CN), and $2,505 or $10,940 paid upfront for an L(A)C1 or L(A)C2 change, of which $1,346 or $9,778 is refunded if no evaluation is needed. A change that makes a new, separate medicine is a new application, with its own fees. None of these fees covers the evidence itself or the work of preparing the dossier.","items":[{"lead":"L(A)1","text":"is for a medicine identical to one already on the ARTG as an assessed listed medicine, apart from its presentation, colour, flavour or fragrance."},{"lead":"L(A)2","text":"is for a medicine equivalent to an existing one, or one whose efficacy is evaluated from the reports of a comparable overseas regulator."},{"lead":"L(A)3","text":"is for a new claim evaluated on its own evidence: what the TGA calls \"a de novo evaluation of efficacy\"."}],"tables":[{"header":["Category","Application fee","Evaluation fee","Total","Preliminary assessment","Evaluation"],"rows":[["L(A)1","$563","$2,139","$2,702","40 working days","45 working days"],["L(A)2","$2,310","$17,723","$20,033","40 working days","60 working days"],["L(A)3","$2,310","$17,723","$20,033","40 working days","150 working days"]]}]},{"heading":"Five years of data protection","anchor":"five-years-of-data-protection","markdown":"A sponsor whose application rests on its own new clinical trial can have the data protected for five years. The scheme, under section 26AF of the Act, covers \"the raw clinical trial efficacy data and full clinical trial study report\". To qualify, the data must:\n\n- be for a combination of intermediate indication and active ingredients that no assessed listed medicine has, or has ever had, on the ARTG;\n- contain a clinical trial registry number;\n- not be available in the public domain; and\n- be owned by the sponsor.\n\nLiterature-based submissions aren't eligible. The five years begin on the date the medicine is included in the ARTG, and in that time \"the TGA is not permitted to use the restricted information to evaluate another L(A) medicine application\". The sponsor claims the protection in Module 1.5 of its dossier, and can give the TGA written permission to use the data for another application. The trial can't be published until the medicine is listed and on the TGA's list of assessed listed medicines with data protection.\n\nIt is a different thing from the two years of exclusive use a successful applicant can opt into for a new ingredient: see our [new ingredients guide](/guides/permissible-ingredients#two-years-of-exclusive-use).","text":"A sponsor whose application rests on its own new clinical trial can have the data protected for five years. The scheme, under section 26AF of the Act, covers \"the raw clinical trial efficacy data and full clinical trial study report\". To qualify, the data must: be for a combination of intermediate indication and active ingredients that no assessed listed medicine has, or has ever had, on the ARTG; contain a clinical trial registry number; not be available in the public domain; and be owned by the sponsor. Literature-based submissions aren't eligible. The five years begin on the date the medicine is included in the ARTG, and in that time \"the TGA is not permitted to use the restricted information to evaluate another L(A) medicine application\". The sponsor claims the protection in Module 1.5 of its dossier, and can give the TGA written permission to use the data for another application. The trial can't be published until the medicine is listed and on the TGA's list of assessed listed medicines with data protection. It is a different thing from the two years of exclusive use a successful applicant can opt into for a new ingredient: see our new ingredients guide.","items":[],"tables":[]},{"heading":"Listed or assessed listed?","anchor":"listed-or-assessed-listed","markdown":"Most supplements are listed: in 2024–25 the TGA added 2,143 new listed medicines to the ARTG. Assessed listings are rare. The TGA doesn't publish a running total, but it reported no applications at all by 30 June 2019, and one new assessed listed medicine approved in each of its 2024 and 2025 updates to industry.\n\n- **If a permitted indication says it, list.** A listing costs $1,063 to apply for in 2026–27, and the TGA doesn't evaluate the medicine first. Our [TGA listing guide](/guides/tga-approval) covers it step by step.\n- **If the claim goes further, the evidence has to satisfy the TGA.** An assessed listing adds the dossier, the evaluation fee and the evaluation time, in return for a claim a listed medicine can't make and \"TGA assessed\" on the label.\n- **If the claim is about a serious disease, an assessed listing generally can't make it.** Restricted and prohibited representations need an exemption from the TGA, on substantial evidence; a registered medicine is fully assessed for safety, quality and efficacy before it goes on sale.","text":"Most supplements are listed: in 2024–25 the TGA added 2,143 new listed medicines to the ARTG. Assessed listings are rare. The TGA doesn't publish a running total, but it reported no applications at all by 30 June 2019, and one new assessed listed medicine approved in each of its 2024 and 2025 updates to industry. If a permitted indication says it, list. A listing costs $1,063 to apply for in 2026–27, and the TGA doesn't evaluate the medicine first. Our TGA listing guide covers it step by step. If the claim goes further, the evidence has to satisfy the TGA. An assessed listing adds the dossier, the evaluation fee and the evaluation time, in return for a claim a listed medicine can't make and \"TGA assessed\" on the label. If the claim is about a serious disease, an assessed listing generally can't make it. Restricted and prohibited representations need an exemption from the TGA, on substantial evidence; a registered medicine is fully assessed for safety, quality and efficacy before it goes on sale.","items":[{"lead":"If a permitted indication says it, list.","text":"A listing costs $1,063 to apply for in 2026–27, and the TGA doesn't evaluate the medicine first. Our TGA listing guide covers it step by step."},{"lead":"If the claim goes further, the evidence has to satisfy the TGA.","text":"An assessed listing adds the dossier, the evaluation fee and the evaluation time, in return for a claim a listed medicine can't make and \"TGA assessed\" on the label."},{"lead":"If the claim is about a serious disease, an assessed listing generally can't make it.","text":"Restricted and prohibited representations need an exemption from the TGA, on substantial evidence; a registered medicine is fully assessed for safety, quality and efficacy before it goes on sale."}],"tables":[]},{"heading":"Where we come in","anchor":"where-we-come-in","markdown":"At the brief we check every claim a brand wants against the permitted indications. When a claim would need an intermediate indication, we set out what an assessed listing would take, the evidence, the fees and the evaluation time, beside the nearest permitted wording, so the choice is made before the formula and the label are fixed. More on [listed medicines](/pathways/listed-medicines) and [what a listed medicine can claim](/guides/permitted-indications), or [book a call](/contact).","text":"At the brief we check every claim a brand wants against the permitted indications. When a claim would need an intermediate indication, we set out what an assessed listing would take, the evidence, the fees and the evaluation time, beside the nearest permitted wording, so the choice is made before the formula and the label are fixed. More on listed medicines and what a listed medicine can claim, or book a call.","items":[],"tables":[]}],"faqs":[{"q":"What is the difference between AUST L and AUST L(A)?","a":"Both use ingredients from the same pre-approved list, and for both the sponsor certifies quality and safety. An AUST L medicine can only make low-level indications from the permitted list, and the TGA doesn't evaluate it before sale. An AUST L(A) medicine makes at least one intermediate indication, and the TGA assesses its efficacy before it can be sold.","md":"Both use ingredients from the same pre-approved list, and for both the sponsor certifies quality and safety. An AUST L medicine can only make low-level indications from the permitted list, and the TGA doesn't evaluate it before sale. An AUST L(A) medicine makes at least one intermediate indication, and the TGA assesses its efficacy before it can be sold."},{"q":"What can an assessed listed medicine claim?","a":"Only the indications the TGA assessed and included in its ARTG entry, at least one of them intermediate: stronger than a permitted indication, such as the prevention or alleviation of a non-serious form of a disease, but not a high-level one. It can't use restricted or prohibited representations, such as serious forms of a disease, unless the TGA grants an exemption.","md":"Only the indications the TGA assessed and included in its ARTG entry, at least one of them intermediate: stronger than a permitted indication, such as the prevention or alleviation of a non-serious form of a disease, but not a high-level one. It can't use restricted or prohibited representations, such as serious forms of a disease, unless the TGA grants an exemption."},{"q":"How much does an assessed listed medicine application cost?","a":"For a new claim evaluated on its own evidence, an L(A)3 application, $2,310 to apply and $17,723 for the evaluation in 2026–27: $20,033 in all. L(A)2 costs the same, and L(A)1, for a medicine identical to an existing assessed listed medicine, $2,702. The application fee isn't refunded if the application fails its preliminary assessment, and the annual charge of $1,566 applies once the medicine is on the ARTG.","md":"For a new claim evaluated on its own evidence, an L(A)3 application, $2,310 to apply and $17,723 for the evaluation in 2026–27: $20,033 in all. L(A)2 costs the same, and L(A)1, for a medicine identical to an existing assessed listed medicine, $2,702. The application fee isn't refunded if the application fails its preliminary assessment, and the annual charge of $1,566 applies once the medicine is on the ARTG."},{"q":"How long does the TGA take to evaluate an assessed listed medicine?","a":"The legislated timeframes give it 40 working days to report the preliminary assessment, then 45 working days to evaluate an L(A)1 application, 60 for L(A)2 and 150 for L(A)3, counted from the payment of the evaluation fee. The clock stops while the applicant answers a formal request for information.","md":"The legislated timeframes give it 40 working days to report the preliminary assessment, then 45 working days to evaluate an L(A)1 application, 60 for L(A)2 and 150 for L(A)3, counted from the payment of the evaluation fee. The clock stops while the applicant answers a formal request for information."},{"q":"Can an assessed listed medicine use an ingredient a listed medicine can't?","a":"No. Its ingredients come from the same Permissible Ingredients Determination. An ingredient that isn't in it needs its own application first: see our new ingredients guide.","md":"No. Its ingredients come from the same Permissible Ingredients Determination. An ingredient that isn't in it needs its own application first: see our [new ingredients guide](/guides/permissible-ingredients)."},{"q":"Can I say \"TGA assessed\" in an ad?","a":"Only on the label in a picture of the pack, with no commentary on it. On the label itself, the statement uses the TGA's words, \"Evidence for the approved indications has been assessed by the TGA.\", with or without the symbol, and the medicine must be an assessed listed medicine or a registered complementary medicine authorised to use it. A listed medicine can't.","md":"Only on the label in a picture of the pack, with no commentary on it. On the label itself, the statement uses the TGA's words, \"Evidence for the approved indications has been assessed by the TGA.\", with or without the symbol, and the medicine must be an assessed listed medicine or a registered complementary medicine authorised to use it. A listed medicine can't."},{"q":"Can a competitor rely on my clinical trial?","a":"Not for five years, if the data qualify: the raw efficacy data and full study report of a registered clinical trial, for a combination of intermediate indication and active ingredients no assessed listed medicine has had, not public and owned by you. In that time the TGA can't use them to evaluate another assessed listed medicine application without your written permission. Literature-based submissions aren't protected.","md":"Not for five years, if the data qualify: the raw efficacy data and full study report of a registered clinical trial, for a combination of intermediate indication and active ingredients no assessed listed medicine has had, not public and owned by you. In that time the TGA can't use them to evaluate another assessed listed medicine application without your written permission. Literature-based submissions aren't protected."}],"sources":{"note":"General information, checked against these sources on 22 October 2026. It isn't advice on a particular product. How we work at the brief is from Take Friday Off's records.","markdown":"General information, checked against these sources on 22 October 2026. It isn't advice on a particular product. How we work at the brief is from Take Friday Off's records.\n\n- [About assessed listed medicines](https://www.tga.gov.au/products/medicines/assessed-listed-medicines/overview/about-assessed-listed-medicines), [Application and market authorisation](https://www.tga.gov.au/products/medicines/assessed-listed-medicines/application-and-market-authorisation) and [Assessed listed medicines pathway: frequently asked questions](https://www.tga.gov.au/products/medicines/assessed-listed-medicines/application-and-market-authorisation/assessed-listed-medicines-pathway-complementary-medicines/assessed-listed-medicines-pathway-frequently-asked-questions), Therapeutic Goods Administration\n- [Assessed listed medicines pathway for complementary medicines](https://tga.gov.au/sites/default/files/assessed-listed-medicines-factsheet.pdf) and [The three-tiered risk-based framework for complementary medicines](https://www.tga.gov.au/sites/default/files/three-tiered-risk-based-framework-factsheet.pdf), fact sheets, Therapeutic Goods Administration\n- [Indication requirements for non-prescription medicines](https://www.tga.gov.au/node/290083) and [Listed, assessed listed and registered medicines](https://www.tga.gov.au/node/497532), Therapeutic Goods Administration\n- [Understanding the application requirements for an assessed listed medicine](https://www.tga.gov.au/node/452007), and the Assessed listed medicines evidence guidelines, version 1.1 (2018): [9. Application and approval processes](https://www.tga.gov.au/book-page/9-application-and-approval-processes) and [10. Timeframes and fees](https://www.tga.gov.au/book-page/10-timeframes-and-fees), Therapeutic Goods Administration\n- [Mandatory requirements for an assessed listed medicine application to pass preliminary assessment](https://www.tga.gov.au/sites/default/files/mandatory-requirements-assessed-listed-medicine-application-pass-preliminary-assessment.pdf), Therapeutic Goods Administration, March 2018\n- [Understanding timeframes for the Comparable Overseas Bodies process for registered complementary medicines, assessed listed medicines and substances in listed medicines](https://www.tga.gov.au/node/458388), Therapeutic Goods Administration\n- [Guidelines for using the TGA assessed claim on medicine labels](https://www.tga.gov.au/sites/default/files/guidelines-using-tga-assessed-claim-medicine-labels.pdf), version 1.1, August 2020, Therapeutic Goods Administration\n- [Explaining the Data Protection Scheme for assessed listed medicine](https://www.tga.gov.au/node/289675), Therapeutic Goods Administration\n- [Fees and charges: summary, from 1 July 2026](https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf), Therapeutic Goods Administration\n- [Therapeutic Goods Act 1989](https://www.legislation.gov.au/C2004A03952/latest/text), sections 23B, 26AE and 26AF, the [Therapeutic Goods Regulations 1990](https://www.legislation.gov.au/F1996B00406/latest/text), regulation 2 (the application categories) and regulations 16GH and 16GI, and the [Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021](https://www.legislation.gov.au/F2021L01661/latest/text), section 8, Federal Register of Legislation\n- [Using \"TGA approved\" and other government endorsements](https://www.tga.gov.au/node/491806), Therapeutic Goods Administration\n- [Annual performance statistics report: July 2018 to June 2019](https://www.tga.gov.au/node/285473), the updates from the Complementary and OTC Medicines Branch at [ARCS 2024](https://tga.gov.au/sites/default/files/2024-07/a25-update-from-the-complementary-and-otc-medicines-branch-arcs-2024-presentation.pdf) and [ARCS 2025](https://www.tga.gov.au/sites/default/files/2025-06/b22a-update-from-complementary-over-the-counter-medicines-branch-arcs-2025-presentation.pdf), and the [TGA Performance Report 2024–25](https://www.tga.gov.au/sites/default/files/2026-05/therapeutic-goods-administration-performance-report-2024-25.PDF), Therapeutic Goods Administration","items":[{"text":"About assessed listed medicines, Application and market authorisation and Assessed listed medicines pathway: frequently asked questions, Therapeutic Goods Administration","links":[{"title":"About assessed listed medicines","url":"https://www.tga.gov.au/products/medicines/assessed-listed-medicines/overview/about-assessed-listed-medicines"},{"title":"Application and market authorisation","url":"https://www.tga.gov.au/products/medicines/assessed-listed-medicines/application-and-market-authorisation"},{"title":"Assessed listed medicines pathway: frequently asked questions","url":"https://www.tga.gov.au/products/medicines/assessed-listed-medicines/application-and-market-authorisation/assessed-listed-medicines-pathway-complementary-medicines/assessed-listed-medicines-pathway-frequently-asked-questions"}]},{"text":"Assessed listed medicines pathway for complementary medicines and The three-tiered risk-based framework for complementary medicines, fact sheets, Therapeutic Goods Administration","links":[{"title":"Assessed listed medicines pathway for complementary medicines","url":"https://tga.gov.au/sites/default/files/assessed-listed-medicines-factsheet.pdf"},{"title":"The three-tiered risk-based framework for complementary medicines","url":"https://www.tga.gov.au/sites/default/files/three-tiered-risk-based-framework-factsheet.pdf"}]},{"text":"Indication requirements for non-prescription medicines and Listed, assessed listed and registered medicines, Therapeutic Goods Administration","links":[{"title":"Indication requirements for non-prescription medicines","url":"https://www.tga.gov.au/node/290083"},{"title":"Listed, assessed listed and registered medicines","url":"https://www.tga.gov.au/node/497532"}]},{"text":"Understanding the application requirements for an assessed listed medicine, and the Assessed listed medicines evidence guidelines, version 1.1 (2018): 9. Application and approval processes and 10. Timeframes and fees, Therapeutic Goods Administration","links":[{"title":"Understanding the application requirements for an assessed listed medicine","url":"https://www.tga.gov.au/node/452007"},{"title":"9. Application and approval processes","url":"https://www.tga.gov.au/book-page/9-application-and-approval-processes"},{"title":"10. Timeframes and fees","url":"https://www.tga.gov.au/book-page/10-timeframes-and-fees"}]},{"text":"Mandatory requirements for an assessed listed medicine application to pass preliminary assessment, Therapeutic Goods Administration, March 2018","links":[{"title":"Mandatory requirements for an assessed listed medicine application to pass preliminary assessment","url":"https://www.tga.gov.au/sites/default/files/mandatory-requirements-assessed-listed-medicine-application-pass-preliminary-assessment.pdf"}]},{"text":"Understanding timeframes for the Comparable Overseas Bodies process for registered complementary medicines, assessed listed medicines and substances in listed medicines, Therapeutic Goods Administration","links":[{"title":"Understanding timeframes for the Comparable Overseas Bodies process for registered complementary medicines, assessed listed medicines and substances in listed medicines","url":"https://www.tga.gov.au/node/458388"}]},{"text":"Guidelines for using the TGA assessed claim on medicine labels, version 1.1, August 2020, Therapeutic Goods Administration","links":[{"title":"Guidelines for using the TGA assessed claim on medicine labels","url":"https://www.tga.gov.au/sites/default/files/guidelines-using-tga-assessed-claim-medicine-labels.pdf"}]},{"text":"Explaining the Data Protection Scheme for assessed listed medicine, Therapeutic Goods Administration","links":[{"title":"Explaining the Data Protection Scheme for assessed listed medicine","url":"https://www.tga.gov.au/node/289675"}]},{"text":"Fees and charges: summary, from 1 July 2026, Therapeutic Goods Administration","links":[{"title":"Fees and charges: summary, from 1 July 2026","url":"https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf"}]},{"text":"Therapeutic Goods Act 1989, sections 23B, 26AE and 26AF, the Therapeutic Goods Regulations 1990, regulation 2 (the application categories) and regulations 16GH and 16GI, and the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021, section 8, Federal Register of Legislation","links":[{"title":"Therapeutic Goods Act 1989","url":"https://www.legislation.gov.au/C2004A03952/latest/text"},{"title":"Therapeutic Goods Regulations 1990","url":"https://www.legislation.gov.au/F1996B00406/latest/text"},{"title":"Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021","url":"https://www.legislation.gov.au/F2021L01661/latest/text"}]},{"text":"Using \"TGA approved\" and other government endorsements, Therapeutic Goods Administration","links":[{"title":"Using \"TGA approved\" and other government endorsements","url":"https://www.tga.gov.au/node/491806"}]},{"text":"Annual performance statistics report: July 2018 to June 2019, the updates from the Complementary and OTC Medicines Branch at ARCS 2024 and ARCS 2025, and the TGA Performance Report 2024–25, Therapeutic Goods Administration","links":[{"title":"Annual performance statistics report: July 2018 to June 2019","url":"https://www.tga.gov.au/node/285473"},{"title":"ARCS 2024","url":"https://tga.gov.au/sites/default/files/2024-07/a25-update-from-the-complementary-and-otc-medicines-branch-arcs-2024-presentation.pdf"},{"title":"ARCS 2025","url":"https://www.tga.gov.au/sites/default/files/2025-06/b22a-update-from-complementary-over-the-counter-medicines-branch-arcs-2025-presentation.pdf"},{"title":"TGA Performance Report 2024–25","url":"https://www.tga.gov.au/sites/default/files/2026-05/therapeutic-goods-administration-performance-report-2024-25.PDF"}]}]}},{"slug":"exporting-supplements","kind":"guide","url":"/guides/exporting-supplements","title":"Exporting an Australian-made supplement: export-only listings and TGA certificates","name":"Export guide","description":"Exporting a supplement made in Australia: export-only ARTG listings, the TGA's CPP and CLP certificates, 2026–27 fees, and what the importing country decides.","eyebrow":"Guide","lead":"An Australian-made supplement can go overseas in two ways: as the same listed medicine sold here, or as an export-only medicine made for markets abroad. Either way, the importing country decides what it will accept, and some ask for a TGA certificate. This guide covers what each route allows, the manufacturing licence an Australian step needs, the TGA's export certificates and their 2026–27 fees, what the destination decides, and what changes when the supplement is a food.","parent":"/pathways/listed-medicines","studies":["sports-brand-core-range","eye-health-tablet-format-rescue","areds2-eye-health-formula"],"formats":[],"order":74,"updated":"2026-10-22","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- A medicine already on the ARTG for sale in Australia can be exported unchanged by its sponsor without a separate entry. One made only for export goes on the ARTG as an export-only medicine, and can't then be sold in Australia.\n- An export-only medicine is assessed by the TGA for safety and quality, must meet a pharmacopoeia standard under TGO 114 and needs at least one step of its manufacture in Australia, but it doesn't follow Australia's labelling order, TGO 116.\n- Unless it is exempt, every manufacturing step in Australia needs a TGA manufacturing licence, export or not.\n- The TGA's certificates aren't required by Australia, but an importing country may ask for one: a Certificate of Pharmaceutical Product (CPP) or a Certificate of Listed Product (CLP), $221 each in 2026–27. An export-only listing costs $1,063, with no annual charge.\n- The importing country decides what it accepts: registration, labelling and claims.\n- A supplement sold as a food in Australia generally isn't regulated by Australian export law, and the Department of Agriculture is involved only when the importing country requires export documents or certificates.","text":"A medicine already on the ARTG for sale in Australia can be exported unchanged by its sponsor without a separate entry. One made only for export goes on the ARTG as an export-only medicine, and can't then be sold in Australia. An export-only medicine is assessed by the TGA for safety and quality, must meet a pharmacopoeia standard under TGO 114 and needs at least one step of its manufacture in Australia, but it doesn't follow Australia's labelling order, TGO 116. Unless it is exempt, every manufacturing step in Australia needs a TGA manufacturing licence, export or not. The TGA's certificates aren't required by Australia, but an importing country may ask for one: a Certificate of Pharmaceutical Product (CPP) or a Certificate of Listed Product (CLP), $221 each in 2026–27. An export-only listing costs $1,063, with no annual charge. The importing country decides what it accepts: registration, labelling and claims. A supplement sold as a food in Australia generally isn't regulated by Australian export law, and the Department of Agriculture is involved only when the importing country requires export documents or certificates.","items":[],"tables":[]},{"heading":"The same medicine, exported","anchor":"the-same-medicine-exported","markdown":"A medicine listed or registered for sale in Australia is already permitted for export, without a separate ARTG entry, as long as:\n\n- the exporter is the person the medicine is entered for, generally its sponsor, or an agent authorised to act for it in the export; and\n- the medicine is unchanged from the one authorised for supply in Australia.\n\nAny change to it, including one made for export, must generally be approved by the TGA before export. To sell it overseas under another name, the sponsor submits a grouping application to add the export name, and the ARTG number stays the same. More on who the sponsor is in our [TGA sponsor guide](/guides/tga-sponsor).","text":"A medicine listed or registered for sale in Australia is already permitted for export, without a separate ARTG entry, as long as: the exporter is the person the medicine is entered for, generally its sponsor, or an agent authorised to act for it in the export; and the medicine is unchanged from the one authorised for supply in Australia. Any change to it, including one made for export, must generally be approved by the TGA before export. To sell it overseas under another name, the sponsor submits a grouping application to add the export name, and the ARTG number stays the same. More on who the sponsor is in our TGA sponsor guide.","items":[],"tables":[]},{"heading":"An export-only medicine","anchor":"an-export-only-medicine","markdown":"In the Act, an \"export only medicine\" is one made in Australia, or imported, for export only, and listable only for that reason. It must be listed on the ARTG and \"cannot be supplied in Australia, including Australian duty free outlets\". The TGA assesses every application manually, against the listing criteria in section 26 of the Act, for safety and quality, and it aims to process one in 30 working days. What differs from a listing for Australia:\n\n- **The label.** TGO 116, the labelling order for non-prescription medicines in Australia, doesn't apply to an export-only medicine, and one in its final dosage form can be exported in bulk to be packed and labelled overseas. The TGA still assesses its presentation, and won't approve one that is misleading, confusing or false.\n- **The standard.** Under TGO 114, in force since 30 September 2024, an export-only medicine must meet the monographs of at least one of the British, European, Japanese or United States pharmacopoeias. Where it isn't regulated as a medicine in the country it is going to, it must also meet that country's requirements: if the destination treats it as a food, its food rules.\n- **The ingredients and claims.** Every ingredient needs an Australian Approved Name, and the sponsor must hold evidence for any therapeutic claim. It needn't be a medicine that could be listed for sale here: under the Act, it is listable only because it is made or imported for export.\n- **Made here, at least in part.** At least one step of its manufacture must take place in Australia.\n- **The importing country's say.** An export-only medicine that is new to the importing country may need confirmation that the country will accept it.","text":"In the Act, an \"export only medicine\" is one made in Australia, or imported, for export only, and listable only for that reason. It must be listed on the ARTG and \"cannot be supplied in Australia, including Australian duty free outlets\". The TGA assesses every application manually, against the listing criteria in section 26 of the Act, for safety and quality, and it aims to process one in 30 working days. What differs from a listing for Australia: The label. TGO 116, the labelling order for non-prescription medicines in Australia, doesn't apply to an export-only medicine, and one in its final dosage form can be exported in bulk to be packed and labelled overseas. The TGA still assesses its presentation, and won't approve one that is misleading, confusing or false. The standard. Under TGO 114, in force since 30 September 2024, an export-only medicine must meet the monographs of at least one of the British, European, Japanese or United States pharmacopoeias. Where it isn't regulated as a medicine in the country it is going to, it must also meet that country's requirements: if the destination treats it as a food, its food rules. The ingredients and claims. Every ingredient needs an Australian Approved Name, and the sponsor must hold evidence for any therapeutic claim. It needn't be a medicine that could be listed for sale here: under the Act, it is listable only because it is made or imported for export. Made here, at least in part. At least one step of its manufacture must take place in Australia. The importing country's say. An export-only medicine that is new to the importing country may need confirmation that the country will accept it.","items":[{"lead":"The label.","text":"TGO 116, the labelling order for non-prescription medicines in Australia, doesn't apply to an export-only medicine, and one in its final dosage form can be exported in bulk to be packed and labelled overseas. The TGA still assesses its presentation, and won't approve one that is misleading, confusing or false."},{"lead":"The standard.","text":"Under TGO 114, in force since 30 September 2024, an export-only medicine must meet the monographs of at least one of the British, European, Japanese or United States pharmacopoeias. Where it isn't regulated as a medicine in the country it is going to, it must also meet that country's requirements: if the destination treats it as a food, its food rules."},{"lead":"The ingredients and claims.","text":"Every ingredient needs an Australian Approved Name, and the sponsor must hold evidence for any therapeutic claim. It needn't be a medicine that could be listed for sale here: under the Act, it is listable only because it is made or imported for export."},{"lead":"Made here, at least in part.","text":"At least one step of its manufacture must take place in Australia."},{"lead":"The importing country's say.","text":"An export-only medicine that is new to the importing country may need confirmation that the country will accept it."}],"tables":[]},{"heading":"Manufacturing for export","anchor":"manufacturing-for-export","markdown":"Making a medicine in Australia for export takes the same TGA manufacturing licence as making it for sale here, unless the step is exempt, and an export-only medicine must be made to GMP under the TGA's manufacturing principles. The licence has its own fees, paid by the licence holder: $1,003 to apply in 2026–27, plus an annual charge and inspection fees. A licensed manufacturer can ask the TGA for a certificate of GMP compliance, which isn't issued automatically after an inspection: $221 in 2026–27, or $407 for a certificate under a mutual recognition agreement with Canada, the EU, Iceland, Liechtenstein, Norway, Singapore or the UK. It is signed electronically and emailed. More in our [manufacturing](/manufacturing) page.","text":"Making a medicine in Australia for export takes the same TGA manufacturing licence as making it for sale here, unless the step is exempt, and an export-only medicine must be made to GMP under the TGA's manufacturing principles. The licence has its own fees, paid by the licence holder: $1,003 to apply in 2026–27, plus an annual charge and inspection fees. A licensed manufacturer can ask the TGA for a certificate of GMP compliance, which isn't issued automatically after an inspection: $221 in 2026–27, or $407 for a certificate under a mutual recognition agreement with Canada, the EU, Iceland, Liechtenstein, Norway, Singapore or the UK. It is signed electronically and emailed. More in our manufacturing page.","items":[],"tables":[]},{"heading":"The TGA's export certificates","anchor":"the-tgas-export-certificates","markdown":"\"Export certification is not a requirement of the Australian Government\", the TGA says, but an importing country may ask for it, as Vietnam does for supplements that are medicines here. The TGA issues four kinds for medicines; for a supplement, two matter:\n\n| Certificate | What it says | Fee, 2026–27 |\n| --- | --- | --- |\n| Certificate of Pharmaceutical Product (CPP) | Issued under the WHO Certification Scheme: the product's regulatory status in Australia, and that its manufacture conforms to GMP as the WHO recommends. There is a version for export-only medicines. | $221 |\n| Certificate of Listed Product (CLP) | Not a WHO certificate: for a single listed complementary medicine, noting that it can be legally supplied in Australia. The TGA says it is \"widely accepted in international jurisdictions in place of a Certificate of Free Sale\". | $221 |\n\n- **Who applies.** The person the medicine is entered for, generally the sponsor, or an agent it authorises, through TGA Business Services. The TGA confirms GMP as part of a CPP application.\n- **How long.** The TGA starts once the invoice is paid, aims to process an application in about 15 working days, and posts the certificate by Express Post.\n- **What it won't certify.** The TGA's certificate of free sale is only for medical devices, not listed or registered medicines, and it doesn't certify kits of several products.\n- **Vietnam.** For products Vietnam regulates as health, dietary or food supplements, a CLP has extra requirements, and the TGA can't advise which product category to put on it.","text":"\"Export certification is not a requirement of the Australian Government\", the TGA says, but an importing country may ask for it, as Vietnam does for supplements that are medicines here. The TGA issues four kinds for medicines; for a supplement, two matter: Certificate: Certificate of Pharmaceutical Product (CPP); What it says: Issued under the WHO Certification Scheme: the product's regulatory status in Australia, and that its manufacture conforms to GMP as the WHO recommends. There is a version for export-only medicines.; Fee, 2026–27: $221. Certificate: Certificate of Listed Product (CLP); What it says: Not a WHO certificate: for a single listed complementary medicine, noting that it can be legally supplied in Australia. The TGA says it is \"widely accepted in international jurisdictions in place of a Certificate of Free Sale\".; Fee, 2026–27: $221. Who applies. The person the medicine is entered for, generally the sponsor, or an agent it authorises, through TGA Business Services. The TGA confirms GMP as part of a CPP application. How long. The TGA starts once the invoice is paid, aims to process an application in about 15 working days, and posts the certificate by Express Post. What it won't certify. The TGA's certificate of free sale is only for medical devices, not listed or registered medicines, and it doesn't certify kits of several products. Vietnam. For products Vietnam regulates as health, dietary or food supplements, a CLP has extra requirements, and the TGA can't advise which product category to put on it.","items":[{"lead":"Who applies.","text":"The person the medicine is entered for, generally the sponsor, or an agent it authorises, through TGA Business Services. The TGA confirms GMP as part of a CPP application."},{"lead":"How long.","text":"The TGA starts once the invoice is paid, aims to process an application in about 15 working days, and posts the certificate by Express Post."},{"lead":"What it won't certify.","text":"The TGA's certificate of free sale is only for medical devices, not listed or registered medicines, and it doesn't certify kits of several products."},{"lead":"Vietnam.","text":"For products Vietnam regulates as health, dietary or food supplements, a CLP has extra requirements, and the TGA can't advise which product category to put on it."}],"tables":[{"header":["Certificate","What it says","Fee, 2026–27"],"rows":[["Certificate of Pharmaceutical Product (CPP)","Issued under the WHO Certification Scheme: the product's regulatory status in Australia, and that its manufacture conforms to GMP as the WHO recommends. There is a version for export-only medicines.","$221"],["Certificate of Listed Product (CLP)","Not a WHO certificate: for a single listed complementary medicine, noting that it can be legally supplied in Australia. The TGA says it is \"widely accepted in international jurisdictions in place of a Certificate of Free Sale\".","$221"]]}]},{"heading":"Export fees for 2026–27","anchor":"export-fees-for-202627","markdown":"| Fee | Amount |\n| --- | --- |\n| New export-only listing | $1,063 |\n| Grouping application for an existing export-only listing | $1,063 |\n| Varying an export-only listing | $537 |\n| Certificate of Pharmaceutical Product, or Certificate of Listed Product | $221 each |\n| Certificate of GMP compliance | $221, or $407 under a mutual recognition agreement |\n\nAn export-only listing pays no annual charge: the listed medicine's annual charge applies to goods \"other than goods produced for export\". For a medicine listed for sale in Australia, the annual charge and the other fees in our [TGA listing guide](/guides/tga-approval#what-it-costs-tga-fees-for-202627) still apply.","text":"Fee: New export-only listing; Amount: $1,063. Fee: Grouping application for an existing export-only listing; Amount: $1,063. Fee: Varying an export-only listing; Amount: $537. Fee: Certificate of Pharmaceutical Product, or Certificate of Listed Product; Amount: $221 each. Fee: Certificate of GMP compliance; Amount: $221, or $407 under a mutual recognition agreement. An export-only listing pays no annual charge: the listed medicine's annual charge applies to goods \"other than goods produced for export\". For a medicine listed for sale in Australia, the annual charge and the other fees in our TGA listing guide still apply.","items":[],"tables":[{"header":["Fee","Amount"],"rows":[["New export-only listing","$1,063"],["Grouping application for an existing export-only listing","$1,063"],["Varying an export-only listing","$537"],["Certificate of Pharmaceutical Product, or Certificate of Listed Product","$221 each"],["Certificate of GMP compliance","$221, or $407 under a mutual recognition agreement"]]}]},{"heading":"What the importing country decides","anchor":"what-the-importing-country-decides","markdown":"An Australian listing doesn't decide what a supplement can be sold as overseas. The TGA tells exporters to \"contact the relevant Embassy, High Commission or Consulate of the importing country\" to make sure they meet its requirements, and a product treated there as a food must meet its food rules.\n\nAustrade's report on complementary medicines in China (2022) describes two routes there: a product filing or registration under China's \"blue hat\" system, or cross-border e-commerce, which sells online direct to consumers only and needs no formal product registration for products on its whitelist, and no entity in China. Austrade called cross-border e-commerce \"the most realistic way for many international brands to enter the market\", and said firms should check that their products' HS codes are whitelisted first. Rules move, too: an Austrade article in May 2026 reported that Vietnam had introduced stricter rules for registering, testing and importing food supplements.","text":"An Australian listing doesn't decide what a supplement can be sold as overseas. The TGA tells exporters to \"contact the relevant Embassy, High Commission or Consulate of the importing country\" to make sure they meet its requirements, and a product treated there as a food must meet its food rules. Austrade's report on complementary medicines in China (2022) describes two routes there: a product filing or registration under China's \"blue hat\" system, or cross-border e-commerce, which sells online direct to consumers only and needs no formal product registration for products on its whitelist, and no entity in China. Austrade called cross-border e-commerce \"the most realistic way for many international brands to enter the market\", and said firms should check that their products' HS codes are whitelisted first. Rules move, too: an Austrade article in May 2026 reported that Vietnam had introduced stricter rules for registering, testing and importing food supplements.","items":[],"tables":[]},{"heading":"If the supplement is a food","anchor":"if-the-supplement-is-a-food","markdown":"Australian export law generally doesn't regulate a supplement sold as a food: the Department of Agriculture, Fisheries and Forestry lists nutritional supplements among its examples of \"non-prescribed goods\", though organic goods are always prescribed, and the department says confirming that goods are non-prescribed \"can be complex\". The department is \"only involved if it is a condition set by the importing country\", and can issue government export documents or certificates when the importing country requires them. For a product that isn't a medicine in Australia, the TGA's guidance points to authorities such as the department, under its former name, or the Australian Chamber of Commerce and Industry for a certificate of free sale. Our [food pathway](/pathways/foods) covers when a supplement can be a food.","text":"Australian export law generally doesn't regulate a supplement sold as a food: the Department of Agriculture, Fisheries and Forestry lists nutritional supplements among its examples of \"non-prescribed goods\", though organic goods are always prescribed, and the department says confirming that goods are non-prescribed \"can be complex\". The department is \"only involved if it is a condition set by the importing country\", and can issue government export documents or certificates when the importing country requires them. For a product that isn't a medicine in Australia, the TGA's guidance points to authorities such as the department, under its former name, or the Australian Chamber of Commerce and Industry for a certificate of free sale. Our food pathway covers when a supplement can be a food.","items":[],"tables":[]},{"heading":"Where we come in","anchor":"where-we-come-in","markdown":"Export works best when it is planned at the brief. As our FAQ puts it: if export is in your plans, we design the formula for both markets from the start. Among our clients are brands that export: [a sports and wellness brand](/work/sports-brand-core-range) selling into New Zealand, the UK and the UAE, and [an established natural health company](/work/eye-health-tablet-format-rescue) with export customers. More on [listed medicines](/pathways/listed-medicines) and [manufacturing](/manufacturing), or [book a call](/contact).","text":"Export works best when it is planned at the brief. As our FAQ puts it: if export is in your plans, we design the formula for both markets from the start. Among our clients are brands that export: a sports and wellness brand selling into New Zealand, the UK and the UAE, and an established natural health company with export customers. More on listed medicines and manufacturing, or book a call.","items":[],"tables":[]}],"faqs":[{"q":"Can I export a TGA-listed supplement?","a":"Yes. A medicine on the ARTG for sale in Australia can be exported unchanged by its sponsor, or an agent it authorises, without a separate entry. A change for export generally needs the TGA's approval first, and an export name is added with a grouping application.","md":"Yes. A medicine on the ARTG for sale in Australia can be exported unchanged by its sponsor, or an agent it authorises, without a separate entry. A change for export generally needs the TGA's approval first, and an export name is added with a grouping application."},{"q":"What is an export-only listing?","a":"An ARTG listing for a medicine made in Australia, or imported, for export only, and listable only for that reason. It can't be sold in Australia, its label doesn't follow TGO 116, it must meet a pharmacopoeia standard under TGO 114, and at least one step of its manufacture must be in Australia. It costs $1,063 to apply for in 2026–27, with no annual charge.","md":"An ARTG listing for a medicine made in Australia, or imported, for export only, and listable only for that reason. It can't be sold in Australia, its label doesn't follow TGO 116, it must meet a pharmacopoeia standard under TGO 114, and at least one step of its manufacture must be in Australia. It costs $1,063 to apply for in 2026–27, with no annual charge."},{"q":"What is a Certificate of Listed Product?","a":"A TGA certificate for a single listed complementary medicine, noting that it can be legally supplied in Australia. It isn't issued under the WHO scheme, but the TGA says it is widely accepted in place of a certificate of free sale. It costs $221 in 2026–27.","md":"A TGA certificate for a single listed complementary medicine, noting that it can be legally supplied in Australia. It isn't issued under the WHO scheme, but the TGA says it is widely accepted in place of a certificate of free sale. It costs $221 in 2026–27."},{"q":"Does the TGA issue a certificate of free sale for supplements?","a":"No. The TGA's certificate of free sale is only for medical devices. For a listed medicine, the Certificate of Listed Product does that job; for a product that isn't a medicine in Australia, the TGA's guidance points to other authorities, such as the Department of Agriculture (by its former name) or the Australian Chamber of Commerce and Industry.","md":"No. The TGA's certificate of free sale is only for medical devices. For a listed medicine, the Certificate of Listed Product does that job; for a product that isn't a medicine in Australia, the TGA's guidance points to other authorities, such as the Department of Agriculture (by its former name) or the Australian Chamber of Commerce and Industry."},{"q":"How long does a TGA export certificate take?","a":"The TGA aims to process an application in about 15 working days, once its invoice is paid, and posts the certificate by Express Post.","md":"The TGA aims to process an application in about 15 working days, once its invoice is paid, and posts the certificate by Express Post."},{"q":"Do I need to register my supplement in the country I export to?","a":"That is for the importing country to decide, and the TGA tells exporters to check its requirements with its embassy, high commission or consulate. In China, for example, Austrade describes two routes: a \"blue hat\" filing or registration, or cross-border e-commerce, which needs no formal product registration for whitelisted products.","md":"That is for the importing country to decide, and the TGA tells exporters to check its requirements with its embassy, high commission or consulate. In China, for example, Austrade describes two routes: a \"blue hat\" filing or registration, or cross-border e-commerce, which needs no formal product registration for whitelisted products."}],"sources":{"note":"General information, checked against these sources on 22 October 2026. It isn't legal advice or advice on a particular product or market. Our approach and our clients' markets are from Take Friday Off's records.","markdown":"General information, checked against these sources on 22 October 2026. It isn't legal advice or advice on a particular product or market. Our approach and our clients' markets are from Take Friday Off's records.\n\n- [Export of medicines from Australia](https://www.tga.gov.au/sites/default/files/export-of-medicines-from-australia.pdf), version 1.2, October 2024, and [Export medicines](https://tga.gov.au/node/288014), Therapeutic Goods Administration\n- [Therapeutic Goods Act 1989](https://www.legislation.gov.au/C2004A03952/latest/text), section 3 (export only medicine) and section 26, Federal Register of Legislation\n- [Therapeutic Goods (Standard for Export Only Medicines) (TGO 114) Order 2024](https://legislation.gov.au/F2024L01211/asmade/2024-09-25/text/original/pdf) and its [explanatory statement](https://legislation.gov.au/F2024L01211/asmade/2024-09-25/es/original/pdf), and the [Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026](https://www.legislation.gov.au/F2026L01312/asmade), section 6, Federal Register of Legislation\n- [Therapeutic Goods (Charges) Regulations 2018](https://www.legislation.gov.au/F2018L00774/latest/text), section 7, Federal Register of Legislation\n- [Fees and charges: summary, from 1 July 2026](https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf), Therapeutic Goods Administration\n- [Granting licences and issuing certification](https://www.tga.gov.au/resources/resources/user-guide/australian-manufacturing-licences-and-overseas-gmp-certification/20-granting-licences-and-issuing-certification) and [Determining whether licensing or certification required](https://www.tga.gov.au/node/286068), from the user guide Australian manufacturing licences and overseas GMP certification, and the [Request for certificate, or certified copy of TGA licences and certificates](https://www.tga.gov.au/sites/default/files/2026-07/request-certificate-or-certified-copy-tga-licences-certificates-part-a-copy-conformity-assessment-certificates-part-b.pdf), Therapeutic Goods Administration\n- [China: Complementary Medicine Report](https://www.austrade.gov.au/content/dam/austrade-assets/global/wip/austrade/documents/complementary-medicine-to-china.pdf) and [Complementary Medicine to China](https://www.austrade.gov.au/news/publications/complementary-medicine-to-china), August 2022, and [Consumer trust helps Nature's Way expand into Vietnam](https://www.austrade.gov.au/en/news-and-analysis/news/consumer-trust-helps-natures-way-expand-into-vietnam), May 2026, Austrade\n- [Exporters of non-prescribed goods](https://www.agriculture.gov.au/biosecurity-trade/export/controlled-goods/non-prescribed-goods/exporters) and [Non-prescribed goods](https://agriculture.gov.au/export/controlled-goods/non-prescribed-goods), Department of Agriculture, Fisheries and Forestry","items":[{"text":"Export of medicines from Australia, version 1.2, October 2024, and Export medicines, Therapeutic Goods Administration","links":[{"title":"Export of medicines from Australia","url":"https://www.tga.gov.au/sites/default/files/export-of-medicines-from-australia.pdf"},{"title":"Export medicines","url":"https://tga.gov.au/node/288014"}]},{"text":"Therapeutic Goods Act 1989, section 3 (export only medicine) and section 26, Federal Register of Legislation","links":[{"title":"Therapeutic Goods Act 1989","url":"https://www.legislation.gov.au/C2004A03952/latest/text"}]},{"text":"Therapeutic Goods (Standard for Export Only Medicines) (TGO 114) Order 2024 and its explanatory statement, and the Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026, section 6, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Standard for Export Only Medicines) (TGO 114) Order 2024","url":"https://legislation.gov.au/F2024L01211/asmade/2024-09-25/text/original/pdf"},{"title":"explanatory statement","url":"https://legislation.gov.au/F2024L01211/asmade/2024-09-25/es/original/pdf"},{"title":"Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026","url":"https://www.legislation.gov.au/F2026L01312/asmade"}]},{"text":"Therapeutic Goods (Charges) Regulations 2018, section 7, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Charges) Regulations 2018","url":"https://www.legislation.gov.au/F2018L00774/latest/text"}]},{"text":"Fees and charges: summary, from 1 July 2026, Therapeutic Goods Administration","links":[{"title":"Fees and charges: summary, from 1 July 2026","url":"https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf"}]},{"text":"Granting licences and issuing certification and Determining whether licensing or certification required, from the user guide Australian manufacturing licences and overseas GMP certification, and the Request for certificate, or certified copy of TGA licences and certificates, Therapeutic Goods Administration","links":[{"title":"Granting licences and issuing certification","url":"https://www.tga.gov.au/resources/resources/user-guide/australian-manufacturing-licences-and-overseas-gmp-certification/20-granting-licences-and-issuing-certification"},{"title":"Determining whether licensing or certification required","url":"https://www.tga.gov.au/node/286068"},{"title":"Request for certificate, or certified copy of TGA licences and certificates","url":"https://www.tga.gov.au/sites/default/files/2026-07/request-certificate-or-certified-copy-tga-licences-certificates-part-a-copy-conformity-assessment-certificates-part-b.pdf"}]},{"text":"China: Complementary Medicine Report and Complementary Medicine to China, August 2022, and Consumer trust helps Nature's Way expand into Vietnam, May 2026, Austrade","links":[{"title":"China: Complementary Medicine Report","url":"https://www.austrade.gov.au/content/dam/austrade-assets/global/wip/austrade/documents/complementary-medicine-to-china.pdf"},{"title":"Complementary Medicine to China","url":"https://www.austrade.gov.au/news/publications/complementary-medicine-to-china"},{"title":"Consumer trust helps Nature's Way expand into Vietnam","url":"https://www.austrade.gov.au/en/news-and-analysis/news/consumer-trust-helps-natures-way-expand-into-vietnam"}]},{"text":"Exporters of non-prescribed goods and Non-prescribed goods, Department of Agriculture, Fisheries and Forestry","links":[{"title":"Exporters of non-prescribed goods","url":"https://www.agriculture.gov.au/biosecurity-trade/export/controlled-goods/non-prescribed-goods/exporters"},{"title":"Non-prescribed goods","url":"https://agriculture.gov.au/export/controlled-goods/non-prescribed-goods"}]}]}},{"slug":"beauty-supplements","kind":"guide","url":"/guides/beauty-supplements","title":"Beauty supplements in Australia: why a skin, hair or nail supplement is a medicine","name":"Beauty supplements guide","description":"Why a skin, hair or nail supplement is a TGA-listed medicine in Australia, the claims it can make, collagen and other ingredients, and the advertising rules.","eyebrow":"Guide","lead":"In Australia, a product taken by mouth and labelled or promoted for a cosmetic purpose, such as the look of skin, hair or nails, is a therapeutic good by law. It can't be sold as a food or a cosmetic: it is usually a listed medicine, and its claims come from the TGA's permitted list. This guide covers the declaration, the hair, nail and collagen claims a listed medicine can make and the claims it can't, collagen and other common ingredients, the advertising rules, and the TGA's recent cases.","parent":"/skincare","studies":["vitable-hair-growth-range","pump-haircare-hair-supplement","probiotic-skin-supplement"],"formats":[],"order":75,"updated":"2026-10-23","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- A product taken by mouth that is labelled or promoted for a cosmetic purpose, such as improving the appearance of skin, hair or nails, is declared a therapeutic good. The TGA says such products \"cannot be regulated as foods or cosmetics\".\n- It is usually entered on the ARTG as a listed medicine (AUST L), so its claims must come from the Permissible Indications Determination, and its ingredients from the Permissible Ingredients Determination.\n- The Determination has hair, nail and collagen claims, such as \"Maintain/support hair health\", \"Decrease/reduce hair loss/thinning\", with a label statement, and \"Maintain/support collagen formation\", which needs scientific evidence. Skin claims have a part of their own.\n- Without the TGA's prior evaluation, a listed medicine can't claim skin whitening, and a medicine other than a sunscreen can't claim skin anti-ageing. The TGA has stopped listed products that did.\n- Ads must stay within the claims on the ARTG, and images must not exaggerate the product's efficacy. Paid testimonials aren't allowed, from influencers and brand ambassadors included.","text":"A product taken by mouth that is labelled or promoted for a cosmetic purpose, such as improving the appearance of skin, hair or nails, is declared a therapeutic good. The TGA says such products \"cannot be regulated as foods or cosmetics\". It is usually entered on the ARTG as a listed medicine (AUST L), so its claims must come from the Permissible Indications Determination, and its ingredients from the Permissible Ingredients Determination. The Determination has hair, nail and collagen claims, such as \"Maintain/support hair health\", \"Decrease/reduce hair loss/thinning\", with a label statement, and \"Maintain/support collagen formation\", which needs scientific evidence. Skin claims have a part of their own. Without the TGA's prior evaluation, a listed medicine can't claim skin whitening, and a medicine other than a sunscreen can't claim skin anti-ageing. The TGA has stopped listed products that did. Ads must stay within the claims on the ARTG, and images must not exaggerate the product's efficacy. Paid testimonials aren't allowed, from influencers and brand ambassadors included.","items":[],"tables":[]},{"heading":"Why it's a medicine","anchor":"why-its-a-medicine","markdown":"The Therapeutic Goods (Declared Goods) Order 2019 declares \"goods that are labelled or promoted for cosmetic purposes\" to be therapeutic goods \"when used, advertised or presented for supply for oral consumption\". The TGA says the Order commenced on 22 October 2019. It replaced earlier orders, among them a 1999 order that declared products labelled or promoted for cosmetic purposes to be therapeutic goods when promoted for oral consumption.\n\nIn the TGA's words, oral supplements \"labelled or promoted for cosmetic purposes, such as to improve the appearance of skin, hair and nails, are legally declared to be therapeutic goods\". \"These products cannot be regulated as foods or cosmetics\", and they \"are usually included in the ARTG as low risk listed medicines and can only use claims included in the Therapeutic Goods (Permissible Indications) Determination.\" Food law agrees: in the FSANZ Act, \"food does not include a therapeutic good\".\n\nFor this declaration, the cosmetic purpose and the oral route decide, not the format. The TGA's guidance names tablets, powders and liquids among the ways a product is taken by mouth, and the declaration covers any of them presented for a cosmetic purpose. Without that purpose, the TGA says health claims don't automatically make a product a therapeutic good, \"Nor does the fact that the product comes in capsules or powders, or is labelled as a 'dietary supplement'\". (Some other declarations in the same Order do turn on the dosage form.) Our [food pathway](/pathways/foods) covers where the line falls for products without a cosmetic purpose.","text":"The Therapeutic Goods (Declared Goods) Order 2019 declares \"goods that are labelled or promoted for cosmetic purposes\" to be therapeutic goods \"when used, advertised or presented for supply for oral consumption\". The TGA says the Order commenced on 22 October 2019. It replaced earlier orders, among them a 1999 order that declared products labelled or promoted for cosmetic purposes to be therapeutic goods when promoted for oral consumption. In the TGA's words, oral supplements \"labelled or promoted for cosmetic purposes, such as to improve the appearance of skin, hair and nails, are legally declared to be therapeutic goods\". \"These products cannot be regulated as foods or cosmetics\", and they \"are usually included in the ARTG as low risk listed medicines and can only use claims included in the Therapeutic Goods (Permissible Indications) Determination.\" Food law agrees: in the FSANZ Act, \"food does not include a therapeutic good\". For this declaration, the cosmetic purpose and the oral route decide, not the format. The TGA's guidance names tablets, powders and liquids among the ways a product is taken by mouth, and the declaration covers any of them presented for a cosmetic purpose. Without that purpose, the TGA says health claims don't automatically make a product a therapeutic good, \"Nor does the fact that the product comes in capsules or powders, or is labelled as a 'dietary supplement'\". (Some other declarations in the same Order do turn on the dosage form.) Our food pathway covers where the line falls for products without a cosmetic purpose.","items":[],"tables":[]},{"heading":"What a beauty supplement can claim","anchor":"what-a-beauty-supplement-can-claim","markdown":"As a listed medicine, a beauty supplement can only use the indications in the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025, each backed by the type of evidence it names and meeting any requirement it sets. Among them:\n\n| Indication | Evidence | Requirements |\n| --- | --- | --- |\n| Maintain/support hair health | Scientific or traditional | None |\n| Enhance/improve/promote/increase hair growth | Scientific or traditional | None |\n| Enhance/improve/promote/increase hair strength/thickness | Scientific or traditional | None |\n| Decrease/reduce hair loss/thinning | Scientific or traditional | The label statement \"If symptoms persist, talk to your health professional.\", and a presentation that doesn't imply or refer to serious conditions associated with alopecia |\n| Maintain/support nail health/strength/thickness | Scientific or traditional | None |\n| Decrease/reduce nail brittleness/splitting/chipping | Scientific or traditional | The same label statement |\n| Maintain/support collagen formation | Scientific only | None |\n| Helps enhance/promote collagen formation | Scientific only | None |\n\nThe Determination also has a part of indications relating to skin. The wording can be varied, but it must not \"change the meaning or intent of the indication\", and an indication based on traditional evidence must carry a traditional context qualifier on the label. More in our [claims and indications guide](/guides/permitted-indications), and for hair products, our [hair growth supplements guide](/guides/hair-growth-supplement-development).","text":"As a listed medicine, a beauty supplement can only use the indications in the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025, each backed by the type of evidence it names and meeting any requirement it sets. Among them: Indication: Maintain/support hair health; Evidence: Scientific or traditional; Requirements: None. Indication: Enhance/improve/promote/increase hair growth; Evidence: Scientific or traditional; Requirements: None. Indication: Enhance/improve/promote/increase hair strength/thickness; Evidence: Scientific or traditional; Requirements: None. Indication: Decrease/reduce hair loss/thinning; Evidence: Scientific or traditional; Requirements: The label statement \"If symptoms persist, talk to your health professional.\", and a presentation that doesn't imply or refer to serious conditions associated with alopecia. Indication: Maintain/support nail health/strength/thickness; Evidence: Scientific or traditional; Requirements: None. Indication: Decrease/reduce nail brittleness/splitting/chipping; Evidence: Scientific or traditional; Requirements: The same label statement. Indication: Maintain/support collagen formation; Evidence: Scientific only; Requirements: None. Indication: Helps enhance/promote collagen formation; Evidence: Scientific only; Requirements: None. The Determination also has a part of indications relating to skin. The wording can be varied, but it must not \"change the meaning or intent of the indication\", and an indication based on traditional evidence must carry a traditional context qualifier on the label. More in our claims and indications guide, and for hair products, our hair growth supplements guide.","items":[],"tables":[{"header":["Indication","Evidence","Requirements"],"rows":[["Maintain/support hair health","Scientific or traditional","None"],["Enhance/improve/promote/increase hair growth","Scientific or traditional","None"],["Enhance/improve/promote/increase hair strength/thickness","Scientific or traditional","None"],["Decrease/reduce hair loss/thinning","Scientific or traditional","The label statement \"If symptoms persist, talk to your health professional.\", and a presentation that doesn't imply or refer to serious conditions associated with alopecia"],["Maintain/support nail health/strength/thickness","Scientific or traditional","None"],["Decrease/reduce nail brittleness/splitting/chipping","Scientific or traditional","The same label statement"],["Maintain/support collagen formation","Scientific only","None"],["Helps enhance/promote collagen formation","Scientific only","None"]]}]},{"heading":"Claims a beauty supplement can't make","anchor":"claims-a-beauty-supplement-cant-make","markdown":"- **Anti-ageing.** The TGA says a \"skin anti-ageing\" claim \"is not permitted for non-sunscreen medicines that are available for self-selection without prior evaluation by the TGA\".\n- **Skin whitening.** The TGA has found skin whitening claims \"not permitted for listed medicines without prior evaluation or approval from the TGA\", and has stopped listed medicines that made them.\n- **Anything beyond the permitted list.** A claim that goes further needs the TGA to assess it first, as an [assessed listed medicine](/guides/assessed-listed-medicines) or a registered one.","text":"Anti-ageing. The TGA says a \"skin anti-ageing\" claim \"is not permitted for non-sunscreen medicines that are available for self-selection without prior evaluation by the TGA\". Skin whitening. The TGA has found skin whitening claims \"not permitted for listed medicines without prior evaluation or approval from the TGA\", and has stopped listed medicines that made them. Anything beyond the permitted list. A claim that goes further needs the TGA to assess it first, as an assessed listed medicine or a registered one.","items":[{"lead":"Anti-ageing.","text":"The TGA says a \"skin anti-ageing\" claim \"is not permitted for non-sunscreen medicines that are available for self-selection without prior evaluation by the TGA\"."},{"lead":"Skin whitening.","text":"The TGA has found skin whitening claims \"not permitted for listed medicines without prior evaluation or approval from the TGA\", and has stopped listed medicines that made them."},{"lead":"Anything beyond the permitted list.","text":"A claim that goes further needs the TGA to assess it first, as an assessed listed medicine or a registered one."}],"tables":[]},{"heading":"Collagen and other ingredients","anchor":"collagen-and-other-ingredients","markdown":"Every ingredient in a listed medicine must be in the Therapeutic Goods (Permissible Ingredients) Determination, used only for the purposes it allows: as an active ingredient, an excipient or both, within any limits it sets. For three ingredients common in beauty supplements, the Determination says:\n\n- **Biotin** can be an active ingredient or an excipient.\n- **Hyaluronic acid** itself is \"Only for use as an excipient in topical medicines for dermal application\". Its sodium salt, sodium hyaluronate, has an entry of its own, which a 2021 change opened to use as an active ingredient.\n- **Ingredients of animal origin, such as collagen:** their safety must have been assessed against, and comply with, the principles and requirements of European Pharmacopoeia general monograph 1483. The ARTG includes listed medicines with hydrolysed collagen as an ingredient, such as ARTG entry 346618.\n\nAn ingredient that isn't in the Determination, or one wanted in a role it doesn't allow, needs an application to the TGA first: see our [new ingredients guide](/guides/permissible-ingredients).","text":"Every ingredient in a listed medicine must be in the Therapeutic Goods (Permissible Ingredients) Determination, used only for the purposes it allows: as an active ingredient, an excipient or both, within any limits it sets. For three ingredients common in beauty supplements, the Determination says: Biotin can be an active ingredient or an excipient. Hyaluronic acid itself is \"Only for use as an excipient in topical medicines for dermal application\". Its sodium salt, sodium hyaluronate, has an entry of its own, which a 2021 change opened to use as an active ingredient. Ingredients of animal origin, such as collagen: their safety must have been assessed against, and comply with, the principles and requirements of European Pharmacopoeia general monograph 1483. The ARTG includes listed medicines with hydrolysed collagen as an ingredient, such as ARTG entry 346618. An ingredient that isn't in the Determination, or one wanted in a role it doesn't allow, needs an application to the TGA first: see our new ingredients guide.","items":[{"lead":"Biotin","text":"can be an active ingredient or an excipient."},{"lead":"Hyaluronic acid","text":"itself is \"Only for use as an excipient in topical medicines for dermal application\". Its sodium salt, sodium hyaluronate, has an entry of its own, which a 2021 change opened to use as an active ingredient."},{"lead":"Ingredients of animal origin, such as collagen:","text":"their safety must have been assessed against, and comply with, the principles and requirements of European Pharmacopoeia general monograph 1483. The ARTG includes listed medicines with hydrolysed collagen as an ingredient, such as ARTG entry 346618."}],"tables":[]},{"heading":"Advertising a beauty supplement","anchor":"advertising-a-beauty-supplement","markdown":"The Therapeutic Goods Advertising Code applies to its ads, its website and its social media, as for any medicine:\n\n- **Within the listing.** An ad \"must not be inconsistent with any indication or intended purpose accepted\" for the medicine's ARTG entry, and must be accurate, balanced and substantiated before it is published.\n- **Images count.** An ad must not contain a \"pictorial representation or design\" that exaggerates the product's efficacy or performance. In its guidance on weight-management products, the TGA notes that \"Before and after photos may indicate a claim in the eyes of the consumer\".\n- **Testimonials.** A testimonial's health benefit must be typical of what the product gives, it can't come from anyone engaged in the product's production, marketing or supply, and the advertiser must verify it. Paid testimonials aren't allowed, and the TGA says \"This includes brand ambassadors and social media influencers.\"\n\nMore in our [advertising guide](/guides/tga-advertising).","text":"The Therapeutic Goods Advertising Code applies to its ads, its website and its social media, as for any medicine: Within the listing. An ad \"must not be inconsistent with any indication or intended purpose accepted\" for the medicine's ARTG entry, and must be accurate, balanced and substantiated before it is published. Images count. An ad must not contain a \"pictorial representation or design\" that exaggerates the product's efficacy or performance. In its guidance on weight-management products, the TGA notes that \"Before and after photos may indicate a claim in the eyes of the consumer\". Testimonials. A testimonial's health benefit must be typical of what the product gives, it can't come from anyone engaged in the product's production, marketing or supply, and the advertiser must verify it. Paid testimonials aren't allowed, and the TGA says \"This includes brand ambassadors and social media influencers.\" More in our advertising guide.","items":[{"lead":"Within the listing.","text":"An ad \"must not be inconsistent with any indication or intended purpose accepted\" for the medicine's ARTG entry, and must be accurate, balanced and substantiated before it is published."},{"lead":"Images count.","text":"An ad must not contain a \"pictorial representation or design\" that exaggerates the product's efficacy or performance. In its guidance on weight-management products, the TGA notes that \"Before and after photos may indicate a claim in the eyes of the consumer\"."},{"lead":"Testimonials.","text":"A testimonial's health benefit must be typical of what the product gives, it can't come from anyone engaged in the product's production, marketing or supply, and the advertiser must verify it. Paid testimonials aren't allowed, and the TGA says \"This includes brand ambassadors and social media influencers.\""}],"tables":[]},{"heading":"The TGA's recent cases","anchor":"the-tgas-recent-cases","markdown":"The TGA's compliance reports and safety alerts show how it treats beauty products:\n\n- **Skin whitening.** In September 2023, \"Liver Detox Max Skin White & Light Plus\" (Fairy Wings Pty Ltd): its claims were \"not permitted for listed medicines without prior evaluation or approval from the TGA\", and the medicine was no longer permitted to be supplied. In September 2024, the TGA itself cancelled \"Luxxe White Enhanced Glutathione\" (FR International Australia Pty Ltd), whose name implied skin whitening, and glutathione the product didn't contain.\n- **Anti-ageing.** In June 2024, \"Ultra Nature Skin Anti-Ageing + Energy\" (Selima Pharmaceuticals): its name implied a skin anti-ageing benefit, which isn't permitted, and the sponsor cancelled the listing.\n- **Safety.** The TGA has warned consumers that \"Natures Valley Collagen Builder\" tablets, which it had not assessed, contain \"199.3 milligrams per tablet of an undeclared medicine called sildenafil\".","text":"The TGA's compliance reports and safety alerts show how it treats beauty products: Skin whitening. In September 2023, \"Liver Detox Max Skin White & Light Plus\" (Fairy Wings Pty Ltd): its claims were \"not permitted for listed medicines without prior evaluation or approval from the TGA\", and the medicine was no longer permitted to be supplied. In September 2024, the TGA itself cancelled \"Luxxe White Enhanced Glutathione\" (FR International Australia Pty Ltd), whose name implied skin whitening, and glutathione the product didn't contain. Anti-ageing. In June 2024, \"Ultra Nature Skin Anti-Ageing + Energy\" (Selima Pharmaceuticals): its name implied a skin anti-ageing benefit, which isn't permitted, and the sponsor cancelled the listing. Safety. The TGA has warned consumers that \"Natures Valley Collagen Builder\" tablets, which it had not assessed, contain \"199.3 milligrams per tablet of an undeclared medicine called sildenafil\".","items":[{"lead":"Skin whitening.","text":"In September 2023, \"Liver Detox Max Skin White & Light Plus\" (Fairy Wings Pty Ltd): its claims were \"not permitted for listed medicines without prior evaluation or approval from the TGA\", and the medicine was no longer permitted to be supplied. In September 2024, the TGA itself cancelled \"Luxxe White Enhanced Glutathione\" (FR International Australia Pty Ltd), whose name implied skin whitening, and glutathione the product didn't contain."},{"lead":"Anti-ageing.","text":"In June 2024, \"Ultra Nature Skin Anti-Ageing + Energy\" (Selima Pharmaceuticals): its name implied a skin anti-ageing benefit, which isn't permitted, and the sponsor cancelled the listing."},{"lead":"Safety.","text":"The TGA has warned consumers that \"Natures Valley Collagen Builder\" tablets, which it had not assessed, contain \"199.3 milligrams per tablet of an undeclared medicine called sildenafil\"."}],"tables":[]},{"heading":"Taken by mouth, or put on the skin","anchor":"taken-by-mouth-or-put-on-the-skin","markdown":"The declaration is about what is swallowed. A cream or serum for the skin that makes only cosmetic claims, and has no ingredient in a schedule of the Poisons Standard, is generally regulated as a cosmetic rather than a therapeutic good. So a brand selling a hair capsule and a hair serum sells two products under two sets of rules, as [Vitable's hair range](/work/vitable-hair-growth-range) does. More on the cosmetic side in our [skincare page](/skincare).","text":"The declaration is about what is swallowed. A cream or serum for the skin that makes only cosmetic claims, and has no ingredient in a schedule of the Poisons Standard, is generally regulated as a cosmetic rather than a therapeutic good. So a brand selling a hair capsule and a hair serum sells two products under two sets of rules, as Vitable's hair range does. More on the cosmetic side in our skincare page.","items":[],"tables":[]},{"heading":"Changes in 2026","anchor":"changes-in-2026","markdown":"From 1 July to 12 August 2026 the TGA consulted on changes to the Permissible Indications Determination, among them changing \"Helps reduce occurrence of symptoms of eczema/dermatitis\" to \"Helps reduce occurrence of symptoms of mild eczema/dermatitis\". No outcome had been published by 23 October 2026. Its consultation on improving the Advertising Code ran from 9 July to 3 September 2026: our [advertising guide](/guides/tga-advertising) covers it.","text":"From 1 July to 12 August 2026 the TGA consulted on changes to the Permissible Indications Determination, among them changing \"Helps reduce occurrence of symptoms of eczema/dermatitis\" to \"Helps reduce occurrence of symptoms of mild eczema/dermatitis\". No outcome had been published by 23 October 2026. Its consultation on improving the Advertising Code ran from 9 July to 3 September 2026: our advertising guide covers it.","items":[],"tables":[]},{"heading":"Where we come in","anchor":"where-we-come-in","markdown":"We have taken skin and hair supplements to market for [Pump Haircare](/work/pump-haircare-hair-supplement) (hair growth capsules, a client since 2021), [Vitable](/work/vitable-hair-growth-range) (a hair capsule and matching serum), an Australian skincare brand ([a probiotic skin supplement](/work/probiotic-skin-supplement), from design to production order in 12 weeks) and the skin-check service [Your Skin Scan](/work/your-skin-scan-nicotinamide-tablet) (a nicotinamide tablet). We check the claims at the brief, against the permitted indications, so the formula, the evidence and the label are built around claims the product can make. More on [skincare and cosmetics](/skincare), or [book a call](/contact).","text":"We have taken skin and hair supplements to market for Pump Haircare (hair growth capsules, a client since 2021), Vitable (a hair capsule and matching serum), an Australian skincare brand (a probiotic skin supplement, from design to production order in 12 weeks) and the skin-check service Your Skin Scan (a nicotinamide tablet). We check the claims at the brief, against the permitted indications, so the formula, the evidence and the label are built around claims the product can make. More on skincare and cosmetics, or book a call.","items":[],"tables":[]}],"faqs":[{"q":"Is a collagen supplement a food or a medicine in Australia?","a":"If it is labelled or promoted for a cosmetic purpose, such as the appearance of skin, hair or nails, it is a therapeutic good, whether it is a capsule, a powder or a drink. The TGA says such products can't be regulated as foods or cosmetics; they are usually listed medicines.","md":"If it is labelled or promoted for a cosmetic purpose, such as the appearance of skin, hair or nails, it is a therapeutic good, whether it is a capsule, a powder or a drink. The TGA says such products can't be regulated as foods or cosmetics; they are usually listed medicines."},{"q":"Can a hair supplement claim to reduce hair loss?","a":"Yes, as a listed medicine with the evidence for it: \"Decrease/reduce hair loss/thinning\" is a permitted indication, scientific or traditional. Its label must say \"If symptoms persist, talk to your health professional.\", and its presentation must not imply or refer to serious conditions associated with alopecia, such as autoimmune disease or chemotherapy.","md":"Yes, as a listed medicine with the evidence for it: \"Decrease/reduce hair loss/thinning\" is a permitted indication, scientific or traditional. Its label must say \"If symptoms persist, talk to your health professional.\", and its presentation must not imply or refer to serious conditions associated with alopecia, such as autoimmune disease or chemotherapy."},{"q":"Can a beauty supplement claim to be anti-ageing?","a":"Not without the TGA's prior evaluation. The TGA says a skin anti-ageing claim is not permitted for non-sunscreen medicines available for self-selection without its prior evaluation, and it has acted against a listed medicine whose name implied one.","md":"Not without the TGA's prior evaluation. The TGA says a skin anti-ageing claim is not permitted for non-sunscreen medicines available for self-selection without its prior evaluation, and it has acted against a listed medicine whose name implied one."},{"q":"Can I use hyaluronic acid in a beauty supplement?","a":"Not hyaluronic acid itself: the Permissible Ingredients Determination allows it only as an excipient in topical medicines for dermal application, so it can't be used in a supplement taken by mouth. Sodium hyaluronate has an entry of its own, which a 2021 change opened to use as an active ingredient; its current requirements are in the Determination. An ingredient wanted in a role the Determination doesn't allow needs an application to the TGA first.","md":"Not hyaluronic acid itself: the Permissible Ingredients Determination allows it only as an excipient in topical medicines for dermal application, so it can't be used in a supplement taken by mouth. Sodium hyaluronate has an entry of its own, which a 2021 change opened to use as an active ingredient; its current requirements are in the Determination. An ingredient wanted in a role the Determination doesn't allow needs an application to the TGA first."},{"q":"Can influencers promote a beauty supplement?","a":"Not with a testimonial if they are paid or rewarded in any way: the TGA says the ban on paid testimonials includes brand ambassadors and social media influencers. More in our advertising guide.","md":"Not with a testimonial if they are paid or rewarded in any way: the TGA says the ban on paid testimonials includes brand ambassadors and social media influencers. More in our [advertising guide](/guides/tga-advertising#testimonials-endorsements-and-influencers)."},{"q":"Is a skin serum a medicine too?","a":"Generally not. A cream or serum applied to the skin that makes only cosmetic claims, and has no scheduled ingredient, is regulated as a cosmetic. It is the supplement, taken by mouth for a cosmetic purpose, that the declaration makes a therapeutic good.","md":"Generally not. A cream or serum applied to the skin that makes only cosmetic claims, and has no scheduled ingredient, is regulated as a cosmetic. It is the supplement, taken by mouth for a cosmetic purpose, that the declaration makes a therapeutic good."}],"sources":{"note":"General information, checked against these sources on 23 October 2026. It isn't legal advice or advice on a particular product. Our work is from Take Friday Off's records.","markdown":"General information, checked against these sources on 23 October 2026. It isn't legal advice or advice on a particular product. Our work is from Take Friday Off's records.\n\n- [Therapeutic Goods (Declared Goods) Order 2019](https://legislation.gov.au/F2019L01352/2023-03-01/2023-03-01/text/original/epub/OEBPS/document_1/document_1.html), section 5 and Schedule 1, Part 2, item 1, Federal Register of Legislation, and [New Therapeutic Goods (Declared Goods) Order 2019](https://www.tga.gov.au/node/287922), [Declared goods orders](https://tga.gov.au/node/287260) and [Complementary medicine interface issues](https://www.tga.gov.au/node/452720), Therapeutic Goods Administration\n- [Cosmetics or therapeutic goods: Guidance for advertisers and suppliers](https://www.tga.gov.au/sites/default/files/2024-06/cosmetics-therapeutic-goods-guidance-for-advertisers-suppliers.pdf), version 1.0, June 2024, and [Food and medicine regulation](https://www.tga.gov.au/community-qa/food-and-medicine-regulation), Therapeutic Goods Administration\n- [Food Standards Australia New Zealand Act 1991](https://www.legislation.gov.au/C2004A04193/2024-10-14/2024-10-14/text/original/pdf), section 5, Federal Register of Legislation\n- [Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025](https://www.legislation.gov.au/F2025L00450/asmade/2025-04-02/text/original/epub/OEBPS/document_1/document_1.html), section 6 and Schedule 1, Federal Register of Legislation, and [Permitted indications for listed medicines](https://tga.gov.au/node/289384), Therapeutic Goods Administration\n- [Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026](https://www.legislation.gov.au/F2026L01382/asmade), in force from 16 October 2026, sections 4 and 6 and Schedule 1, the [(No. 2) 2026 Determination](https://www.legislation.gov.au/F2026L00707/asmade/2026-06-11/text/original/pdf/3) it replaced (the hyaluronic acid entry) and the [explanatory statement](https://legislation.gov.au/F2021L01108/asmade/2021-08-13/es/original/pdf) to the (No. 2) 2021 Determination (sodium hyaluronate), Federal Register of Legislation, and [Pure Bastion Beauty Collagen (346618)](https://www.tga.gov.au/node/311296) on the ARTG, Therapeutic Goods Administration\n- [Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021](https://www.legislation.gov.au/F2021L01661/latest), as amended from 30 September 2026, sections 8, 9 and 24, Federal Register of Legislation, and [Testimonials and endorsements in advertising](https://tga.gov.au/node/491816) and [Requirements for weight management claims in advertising](https://www.tga.gov.au/node/491810), Therapeutic Goods Administration\n- Listed medicine compliance reports: [Liver Detox Max Skin White & Light Plus (Fairy Wings Pty Ltd)](https://www.tga.gov.au/resources/listed-medicine-compliance-reports/liver-detox-max-skin-white-light-plus-fairy-wings-pty-ltd), [Ultra Nature Skin Anti-Ageing + Energy (Selima Pharmaceuticals)](https://www.tga.gov.au/node/443284) and [Luxxe White Enhanced Glutathione (FR International Australia Pty Ltd)](https://www.tga.gov.au/node/453015), and the safety alert [Natures Valley Collagen Builder tablets](https://www.tga.gov.au/node/550084), Therapeutic Goods Administration\n- [Cosmetics and therapeutics](https://www.industrialchemicals.gov.au/node/113761), Australian Industrial Chemicals Introduction Scheme\n- [Proposed changes to the Permissible Indications Determination](https://consultations.tga.gov.au/tga/updates-permissible-indications-determination/) and the paper [Changes to the Permissible Indications Determination](https://consultations.tga.gov.au/tga/updates-permissible-indications-determination/user_uploads/consultation-paper---changes-to-the-permissible-indications-determination--no.1--2025--final.pdf), version 1.0, June 2026, Therapeutic Goods Administration","items":[{"text":"Therapeutic Goods (Declared Goods) Order 2019, section 5 and Schedule 1, Part 2, item 1, Federal Register of Legislation, and New Therapeutic Goods (Declared Goods) Order 2019, Declared goods orders and Complementary medicine interface issues, Therapeutic Goods Administration","links":[{"title":"Therapeutic Goods (Declared Goods) Order 2019","url":"https://legislation.gov.au/F2019L01352/2023-03-01/2023-03-01/text/original/epub/OEBPS/document_1/document_1.html"},{"title":"New Therapeutic Goods (Declared Goods) Order 2019","url":"https://www.tga.gov.au/node/287922"},{"title":"Declared goods orders","url":"https://tga.gov.au/node/287260"},{"title":"Complementary medicine interface issues","url":"https://www.tga.gov.au/node/452720"}]},{"text":"Cosmetics or therapeutic goods: Guidance for advertisers and suppliers, version 1.0, June 2024, and Food and medicine regulation, Therapeutic Goods Administration","links":[{"title":"Cosmetics or therapeutic goods: Guidance for advertisers and suppliers","url":"https://www.tga.gov.au/sites/default/files/2024-06/cosmetics-therapeutic-goods-guidance-for-advertisers-suppliers.pdf"},{"title":"Food and medicine regulation","url":"https://www.tga.gov.au/community-qa/food-and-medicine-regulation"}]},{"text":"Food Standards Australia New Zealand Act 1991, section 5, Federal Register of Legislation","links":[{"title":"Food Standards Australia New Zealand Act 1991","url":"https://www.legislation.gov.au/C2004A04193/2024-10-14/2024-10-14/text/original/pdf"}]},{"text":"Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025, section 6 and Schedule 1, Federal Register of Legislation, and Permitted indications for listed medicines, Therapeutic Goods Administration","links":[{"title":"Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025","url":"https://www.legislation.gov.au/F2025L00450/asmade/2025-04-02/text/original/epub/OEBPS/document_1/document_1.html"},{"title":"Permitted indications for listed medicines","url":"https://tga.gov.au/node/289384"}]},{"text":"Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026, in force from 16 October 2026, sections 4 and 6 and Schedule 1, the (No. 2) 2026 Determination it replaced (the hyaluronic acid entry) and the explanatory statement to the (No. 2) 2021 Determination (sodium hyaluronate), Federal Register of Legislation, and Pure Bastion Beauty Collagen (346618) on the ARTG, Therapeutic Goods Administration","links":[{"title":"Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026","url":"https://www.legislation.gov.au/F2026L01382/asmade"},{"title":"(No. 2) 2026 Determination","url":"https://www.legislation.gov.au/F2026L00707/asmade/2026-06-11/text/original/pdf/3"},{"title":"explanatory statement","url":"https://legislation.gov.au/F2021L01108/asmade/2021-08-13/es/original/pdf"},{"title":"Pure Bastion Beauty Collagen (346618)","url":"https://www.tga.gov.au/node/311296"}]},{"text":"Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021, as amended from 30 September 2026, sections 8, 9 and 24, Federal Register of Legislation, and Testimonials and endorsements in advertising and Requirements for weight management claims in advertising, Therapeutic Goods Administration","links":[{"title":"Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021","url":"https://www.legislation.gov.au/F2021L01661/latest"},{"title":"Testimonials and endorsements in advertising","url":"https://tga.gov.au/node/491816"},{"title":"Requirements for weight management claims in advertising","url":"https://www.tga.gov.au/node/491810"}]},{"text":"Listed medicine compliance reports: Liver Detox Max Skin White & Light Plus (Fairy Wings Pty Ltd), Ultra Nature Skin Anti-Ageing + Energy (Selima Pharmaceuticals) and Luxxe White Enhanced Glutathione (FR International Australia Pty Ltd), and the safety alert Natures Valley Collagen Builder tablets, Therapeutic Goods Administration","links":[{"title":"Liver Detox Max Skin White & Light Plus (Fairy Wings Pty Ltd)","url":"https://www.tga.gov.au/resources/listed-medicine-compliance-reports/liver-detox-max-skin-white-light-plus-fairy-wings-pty-ltd"},{"title":"Ultra Nature Skin Anti-Ageing + Energy (Selima Pharmaceuticals)","url":"https://www.tga.gov.au/node/443284"},{"title":"Luxxe White Enhanced Glutathione (FR International Australia Pty Ltd)","url":"https://www.tga.gov.au/node/453015"},{"title":"Natures Valley Collagen Builder tablets","url":"https://www.tga.gov.au/node/550084"}]},{"text":"Cosmetics and therapeutics, Australian Industrial Chemicals Introduction Scheme","links":[{"title":"Cosmetics and therapeutics","url":"https://www.industrialchemicals.gov.au/node/113761"}]},{"text":"Proposed changes to the Permissible Indications Determination and the paper Changes to the Permissible Indications Determination, version 1.0, June 2026, Therapeutic Goods Administration","links":[{"title":"Proposed changes to the Permissible Indications Determination","url":"https://consultations.tga.gov.au/tga/updates-permissible-indications-determination/"},{"title":"Changes to the Permissible Indications Determination","url":"https://consultations.tga.gov.au/tga/updates-permissible-indications-determination/user_uploads/consultation-paper---changes-to-the-permissible-indications-determination--no.1--2025--final.pdf"}]}]}},{"slug":"supplement-labelling","kind":"guide","url":"/guides/supplement-labelling","title":"Labelling a supplement in Australia: what TGO 116 requires","name":"Labelling guide","description":"TGA labelling requirements for supplements under TGO 116: the main label, other required information, text size, warnings, allergens and the transition.","eyebrow":"Guide","lead":"A supplement sold as a listed medicine is labelled to TGO 116, the TGA's standard for the labels of non-prescription medicines, in force since 30 September 2026. This guide covers what the main label must show, everything else the label must carry, the rules on text size and contrast, where the warning statements come from, small containers and blister packs, large tablets and capsules, QR codes, the packaging rules that sit beside TGO 116, and the transition from TGO 92.","parent":"/packaging","studies":["arxi-prenatal-chewable","the-belly-solution-travel-gut-health-powder","your-skin-scan-nicotinamide-tablet"],"formats":[],"order":76,"updated":"2026-10-23","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- Since 30 September 2026, a listed medicine's label follows TGO 116. One released for supply before 1 October 2031 may still follow TGO 92, or TGO 92 with TGO 116's provisions from the order's table swapped in.\n- The main label carries the medicine's name, each active ingredient and its quantity, the dosage form and the quantity in the pack, with the actives and their quantities together as one block below the name. The AUST L number goes on the main label, or on a sticker fixed beside it.\n- The label also carries the batch number, the expiry date, storage conditions, the sponsor's name and contact details, declared substances such as allergens, warning statements, directions for use and the indications.\n- Text must be in English, clearly legible and durable, at least 1.5 mm high unless the order or the Regulations say otherwise, and in a colour that contrasts strongly with its background.\n- Many warning statements come from the Medicines Advisory Statements Specification, which ties each statement to an ingredient, and they sit under a \"Warnings\" heading.\n- The label must not suggest uses beyond the indications on the ARTG, and a QR code can't replace anything the label must say.","text":"Since 30 September 2026, a listed medicine's label follows TGO 116. One released for supply before 1 October 2031 may still follow TGO 92, or TGO 92 with TGO 116's provisions from the order's table swapped in. The main label carries the medicine's name, each active ingredient and its quantity, the dosage form and the quantity in the pack, with the actives and their quantities together as one block below the name. The AUST L number goes on the main label, or on a sticker fixed beside it. The label also carries the batch number, the expiry date, storage conditions, the sponsor's name and contact details, declared substances such as allergens, warning statements, directions for use and the indications. Text must be in English, clearly legible and durable, at least 1.5 mm high unless the order or the Regulations say otherwise, and in a colour that contrasts strongly with its background. Many warning statements come from the Medicines Advisory Statements Specification, which ties each statement to an ingredient, and they sit under a \"Warnings\" heading. The label must not suggest uses beyond the indications on the ARTG, and a QR code can't replace anything the label must say.","items":[],"tables":[]},{"heading":"The main label","anchor":"the-main-label","markdown":"The main label is \"the label, or part of the label, that is most likely to be displayed, presented, shown, or examined under ordinary or customary conditions of display\". On the primary pack and the container it must show:\n\n- the name of the medicine;\n- the name of each active ingredient;\n- the quantity or proportion of each active ingredient;\n- the name of the dosage form; and\n- the quantity of the medicine in the container or pack.\n\nThe name, the active ingredients and their quantities form a \"cohesive unit\": the actives and their quantities sit together on separate lines immediately below the name (or beside it, if that would disrupt or obscure the trade mark), not separated by other text or graphics except as the order allows. Everything the main label must carry runs in the same direction.\n\nTwo allowances suit supplements. A listed medicine with two or more active ingredients (other than a sunscreen) may show them on another part of the label instead, with the same cohesive-unit rules, except that the block needn't include the name or sit on the main label. And a listed medicine's main label may drop the salt, hydrate or solvate from an active's name if the full Australian Approved Name appears elsewhere on the label, the strength isn't based on the salt, hydrate or solvate, and it doesn't matter to safety or efficacy.\n\nThe AUST L number comes from the Therapeutic Goods Regulations rather than TGO 116, as a note to the order explains: it goes on the main label, or on a securely fixed sticker beside it, in characters at least 1 mm high. More on the number in our [ARTG guide](/guides/artg).","text":"The main label is \"the label, or part of the label, that is most likely to be displayed, presented, shown, or examined under ordinary or customary conditions of display\". On the primary pack and the container it must show: the name of the medicine; the name of each active ingredient; the quantity or proportion of each active ingredient; the name of the dosage form; and the quantity of the medicine in the container or pack. The name, the active ingredients and their quantities form a \"cohesive unit\": the actives and their quantities sit together on separate lines immediately below the name (or beside it, if that would disrupt or obscure the trade mark), not separated by other text or graphics except as the order allows. Everything the main label must carry runs in the same direction. Two allowances suit supplements. A listed medicine with two or more active ingredients (other than a sunscreen) may show them on another part of the label instead, with the same cohesive-unit rules, except that the block needn't include the name or sit on the main label. And a listed medicine's main label may drop the salt, hydrate or solvate from an active's name if the full Australian Approved Name appears elsewhere on the label, the strength isn't based on the salt, hydrate or solvate, and it doesn't matter to safety or efficacy. The AUST L number comes from the Therapeutic Goods Regulations rather than TGO 116, as a note to the order explains: it goes on the main label, or on a securely fixed sticker beside it, in characters at least 1 mm high. More on the number in our ARTG guide.","items":[],"tables":[]},{"heading":"Everything else the label must show","anchor":"everything-else-the-label-must-show","markdown":"The label on the container and on the primary pack must also include:\n\n| Information | What TGO 116 says |\n| --- | --- |\n| Batch number | With the batch number identifier |\n| Expiry date | With the expiry date identifier |\n| Storage conditions | For the medicine |\n| The sponsor | Its name and contact details: an Australian phone number or a current email address, or a website that gives one; an address, if given, is the principal place of business in Australia, not a post office (such as a PO box) or other code address |\n| Declared substances | Each Schedule 1 substance the medicine contains, for the routes and thresholds Schedule 1 sets, under the name it gives and with any statement it requires: allergens such as peanuts, tree nuts, milk, egg, fish, crustacea, molluscs, sesame, soya and wheat, and others such as lactose, sugars, sulfites, aspartame, alcohol (with its percentage), propolis and royal jelly |\n| Warning statements | Those that apply to the medicine (below), immediately below the heading \"Warnings\" or straight after the prefix \"Warnings\" |\n| Directions for use | On the label, unless there isn't enough space, in which case they can go on the package or in a package insert, with the label saying where |\n| The indications | What the medicine is for |\n\nSome ingredients bring their own lines. Gluten, or an ingredient from a gluten-containing grain at 20 ppm or more, is declared as \"gluten\". An oral medicine whose sugar alcohols total more than 2 g in the maximum recommended daily dose must state that quantity and, unless the sugar alcohol is glycerol, carry \"Products containing [name of sugar alcohol] may have a laxative effect or cause diarrhoea\", worth checking on a sugar-free [gummy](/formats/gummies). An oral mineral supplement may show the name and quantity of the element it supplies alongside the name and quantity of the active ingredient.","text":"The label on the container and on the primary pack must also include: Information: Batch number; What TGO 116 says: With the batch number identifier. Information: Expiry date; What TGO 116 says: With the expiry date identifier. Information: Storage conditions; What TGO 116 says: For the medicine. Information: The sponsor; What TGO 116 says: Its name and contact details: an Australian phone number or a current email address, or a website that gives one; an address, if given, is the principal place of business in Australia, not a post office (such as a PO box) or other code address. Information: Declared substances; What TGO 116 says: Each Schedule 1 substance the medicine contains, for the routes and thresholds Schedule 1 sets, under the name it gives and with any statement it requires: allergens such as peanuts, tree nuts, milk, egg, fish, crustacea, molluscs, sesame, soya and wheat, and others such as lactose, sugars, sulfites, aspartame, alcohol (with its percentage), propolis and royal jelly. Information: Warning statements; What TGO 116 says: Those that apply to the medicine (below), immediately below the heading \"Warnings\" or straight after the prefix \"Warnings\". Information: Directions for use; What TGO 116 says: On the label, unless there isn't enough space, in which case they can go on the package or in a package insert, with the label saying where. Information: The indications; What TGO 116 says: What the medicine is for. Some ingredients bring their own lines. Gluten, or an ingredient from a gluten-containing grain at 20 ppm or more, is declared as \"gluten\". An oral medicine whose sugar alcohols total more than 2 g in the maximum recommended daily dose must state that quantity and, unless the sugar alcohol is glycerol, carry \"Products containing [name of sugar alcohol] may have a laxative effect or cause diarrhoea\", worth checking on a sugar-free gummy. An oral mineral supplement may show the name and quantity of the element it supplies alongside the name and quantity of the active ingredient.","items":[],"tables":[{"header":["Information","What TGO 116 says"],"rows":[["Batch number","With the batch number identifier"],["Expiry date","With the expiry date identifier"],["Storage conditions","For the medicine"],["The sponsor","Its name and contact details: an Australian phone number or a current email address, or a website that gives one; an address, if given, is the principal place of business in Australia, not a post office (such as a PO box) or other code address"],["Declared substances","Each Schedule 1 substance the medicine contains, for the routes and thresholds Schedule 1 sets, under the name it gives and with any statement it requires: allergens such as peanuts, tree nuts, milk, egg, fish, crustacea, molluscs, sesame, soya and wheat, and others such as lactose, sugars, sulfites, aspartame, alcohol (with its percentage), propolis and royal jelly"],["Warning statements","Those that apply to the medicine (below), immediately below the heading \"Warnings\" or straight after the prefix \"Warnings\""],["Directions for use","On the label, unless there isn't enough space, in which case they can go on the package or in a package insert, with the label saying where"],["The indications","What the medicine is for"]]}]},{"heading":"Text size, contrast and small packs","anchor":"text-size-contrast-and-small-packs","markdown":"Everything the order requires must be in English, clearly legible, durable, in text at least 1.5 mm high unless the order or the Regulations say otherwise, and in a colour that contrasts strongly with the background (an embossed batch number or expiry date is exempt from the colour rule). The larger sizes for active ingredients, and the critical health information panel, apply to registered medicines, not listed ones.\n\n- **Small containers.** A container of 25 mL or less inside a primary pack. Its label must carry, in text at least 1.5 mm high, the name of a listed medicine, the name and quantity of each active, the dosage form, the quantity, the batch number, the expiry date and the sponsor's name as on the primary pack, or a registered trade mark that readily identifies the sponsor.\n- **Blister and strip packs.** They carry the name, the actives and their quantities, the batch, the expiry and the sponsor (or a registered trade mark that readily identifies it). A listed medicine with two or more actives can leave the actives off. Where segments tear off, at least every second segment carries the name, plus the active and its quantity if there is only one active.\n- **Many actives, little space.** Where a listed medicine's actives sit off the main label and it is in a small or medium container, or has 10 or more actives and too little space, they needn't go on separate lines, but their names must be in bold.","text":"Everything the order requires must be in English, clearly legible, durable, in text at least 1.5 mm high unless the order or the Regulations say otherwise, and in a colour that contrasts strongly with the background (an embossed batch number or expiry date is exempt from the colour rule). The larger sizes for active ingredients, and the critical health information panel, apply to registered medicines, not listed ones. Small containers. A container of 25 mL or less inside a primary pack. Its label must carry, in text at least 1.5 mm high, the name of a listed medicine, the name and quantity of each active, the dosage form, the quantity, the batch number, the expiry date and the sponsor's name as on the primary pack, or a registered trade mark that readily identifies the sponsor. Blister and strip packs. They carry the name, the actives and their quantities, the batch, the expiry and the sponsor (or a registered trade mark that readily identifies it). A listed medicine with two or more actives can leave the actives off. Where segments tear off, at least every second segment carries the name, plus the active and its quantity if there is only one active. Many actives, little space. Where a listed medicine's actives sit off the main label and it is in a small or medium container, or has 10 or more actives and too little space, they needn't go on separate lines, but their names must be in bold.","items":[{"lead":"Small containers.","text":"A container of 25 mL or less inside a primary pack. Its label must carry, in text at least 1.5 mm high, the name of a listed medicine, the name and quantity of each active, the dosage form, the quantity, the batch number, the expiry date and the sponsor's name as on the primary pack, or a registered trade mark that readily identifies the sponsor."},{"lead":"Blister and strip packs.","text":"They carry the name, the actives and their quantities, the batch, the expiry and the sponsor (or a registered trade mark that readily identifies it). A listed medicine with two or more actives can leave the actives off. Where segments tear off, at least every second segment carries the name, plus the active and its quantity if there is only one active."},{"lead":"Many actives, little space.","text":"Where a listed medicine's actives sit off the main label and it is in a small or medium container, or has 10 or more actives and too little space, they needn't go on separate lines, but their names must be in bold."}],"tables":[]},{"heading":"Large tablets and capsules","anchor":"large-tablets-and-capsules","markdown":"A capsule more than 24.1 mm long or 9.5 mm wide, a round tablet more than 13 mm across, or a non-round tablet more than 22.4 mm long or 10.5 mm wide is a large dosage form. Its directions must include \"Swallow with water\" or words to that effect. A transparent pack or a medium container instead carries \"Warning: large [name of dosage form]. Swallow with water\". Other packs also need, on the main label or a lid sticker, an image of the tablet or capsule at actual size, with \"actual size\" and \"Warning: large [name of dosage form]\" right beside it. None of this applies if the primary pack is a small container, or if the medicine isn't meant to be swallowed whole, such as a chewable, and its directions say how to take it. It is worth checking before the artwork is locked: a large softgel changes the main label.","text":"A capsule more than 24.1 mm long or 9.5 mm wide, a round tablet more than 13 mm across, or a non-round tablet more than 22.4 mm long or 10.5 mm wide is a large dosage form. Its directions must include \"Swallow with water\" or words to that effect. A transparent pack or a medium container instead carries \"Warning: large [name of dosage form]. Swallow with water\". Other packs also need, on the main label or a lid sticker, an image of the tablet or capsule at actual size, with \"actual size\" and \"Warning: large [name of dosage form]\" right beside it. None of this applies if the primary pack is a small container, or if the medicine isn't meant to be swallowed whole, such as a chewable, and its directions say how to take it. It is worth checking before the artwork is locked: a large softgel changes the main label.","items":[],"tables":[]},{"heading":"Where the warnings come from","anchor":"where-the-warnings-come-from","markdown":"TGO 116's \"warning statements\" gather the statements from several places: any standard that applies to the medicine, those required as a condition of listing, the current Poisons Standard, the instruments that set requirements for ingredients, the statements required for an indication shown on the label, and the advisory statements specified for medicines under the Act.\n\nMany come from the Therapeutic Goods (Medicines Advisory Statements) Specification 2021, in force since 1 January 2022, whose schedule is the Required Advisory Statements for Medicine Labels (RASML No. 6). It ties each statement to an ingredient, in the circumstances it sets, and the wording can be varied only \"in a manner that does not change the intent\". Folic acid in a preparation indicated for reducing the risk of having a child with spina bifida or a neural tube defect, for example, carries \"Do not exceed the stated dose except on medical advice.\" and \"If you have had a baby with a neural tube defect/spina bifida, seek specific medical advice.\"\n\nThe TGA consulted on changes for a RASML No. 7 from 27 July to 4 September 2026; until a new instrument is made, No. 6 applies. For the statements a prenatal carries, see [prenatal and postnatal supplements](/guides/prenatal-supplement-development). A medicine for oral use with an active ingredient in category B1, B2, B3 or C of the TGA's Prescribing medicines in pregnancy database, and no other pregnancy warning, carries \"If pregnant or likely to become pregnant, consult a pharmacist or a doctor before use\" or words to that effect.","text":"TGO 116's \"warning statements\" gather the statements from several places: any standard that applies to the medicine, those required as a condition of listing, the current Poisons Standard, the instruments that set requirements for ingredients, the statements required for an indication shown on the label, and the advisory statements specified for medicines under the Act. Many come from the Therapeutic Goods (Medicines Advisory Statements) Specification 2021, in force since 1 January 2022, whose schedule is the Required Advisory Statements for Medicine Labels (RASML No. 6). It ties each statement to an ingredient, in the circumstances it sets, and the wording can be varied only \"in a manner that does not change the intent\". Folic acid in a preparation indicated for reducing the risk of having a child with spina bifida or a neural tube defect, for example, carries \"Do not exceed the stated dose except on medical advice.\" and \"If you have had a baby with a neural tube defect/spina bifida, seek specific medical advice.\" The TGA consulted on changes for a RASML No. 7 from 27 July to 4 September 2026; until a new instrument is made, No. 6 applies. For the statements a prenatal carries, see prenatal and postnatal supplements. A medicine for oral use with an active ingredient in category B1, B2, B3 or C of the TGA's Prescribing medicines in pregnancy database, and no other pregnancy warning, carries \"If pregnant or likely to become pregnant, consult a pharmacist or a doctor before use\" or words to that effect.","items":[],"tables":[]},{"heading":"What a label can't say","anchor":"what-a-label-cant-say","markdown":"- **Beyond the ARTG.** The TGA counts it as unacceptable presentation where \"statements or pictures suggest that the product has uses or actions different from, or in addition to, the indications for use included in the ARTG\", and a listed medicine with unacceptable presentation can be cancelled from the ARTG.\n- **Advertising rules apply.** The label must comply with all relevant legislation, the TGA says, \"including advertising requirements\": more in our [advertising guide](/guides/tga-advertising).\n- **Websites and QR codes.** A website on a label is acceptable only where its information is consistent with the ARTG entry. A QR code must link to information the sponsor controls, or the TGA's information about the medicine; it must not contradict the label or the medicine's product details, must not ask for a login, personal details or a payment, and can't replace anything the label must carry unless the order allows it.\n- **\"TGA assessed\".** Only an assessed listed medicine, or a registered complementary medicine whose efficacy the TGA assessed before market, can carry it: see our [assessed listed medicines guide](/guides/assessed-listed-medicines#the-tga-assessed-claim).","text":"Beyond the ARTG. The TGA counts it as unacceptable presentation where \"statements or pictures suggest that the product has uses or actions different from, or in addition to, the indications for use included in the ARTG\", and a listed medicine with unacceptable presentation can be cancelled from the ARTG. Advertising rules apply. The label must comply with all relevant legislation, the TGA says, \"including advertising requirements\": more in our advertising guide. Websites and QR codes. A website on a label is acceptable only where its information is consistent with the ARTG entry. A QR code must link to information the sponsor controls, or the TGA's information about the medicine; it must not contradict the label or the medicine's product details, must not ask for a login, personal details or a payment, and can't replace anything the label must carry unless the order allows it. \"TGA assessed\". Only an assessed listed medicine, or a registered complementary medicine whose efficacy the TGA assessed before market, can carry it: see our assessed listed medicines guide.","items":[{"lead":"Beyond the ARTG.","text":"The TGA counts it as unacceptable presentation where \"statements or pictures suggest that the product has uses or actions different from, or in addition to, the indications for use included in the ARTG\", and a listed medicine with unacceptable presentation can be cancelled from the ARTG."},{"lead":"Advertising rules apply.","text":"The label must comply with all relevant legislation, the TGA says, \"including advertising requirements\": more in our advertising guide."},{"lead":"Websites and QR codes.","text":"A website on a label is acceptable only where its information is consistent with the ARTG entry. A QR code must link to information the sponsor controls, or the TGA's information about the medicine; it must not contradict the label or the medicine's product details, must not ask for a login, personal details or a payment, and can't replace anything the label must carry unless the order allows it."},{"lead":"\"TGA assessed\".","text":"Only an assessed listed medicine, or a registered complementary medicine whose efficacy the TGA assessed before market, can carry it: see our assessed listed medicines guide."}],"tables":[]},{"heading":"The packaging rules beside TGO 116","anchor":"the-packaging-rules-beside-tgo-116","markdown":"- **Child-resistant packaging.** TGO 95 requires it for listed and registered medicines containing certain substances in set strengths or pack sizes, and for any medicine whose label or pack says or implies it is child-resistant. Iron is on the list: a pack with more than 250 mg of elemental iron in total, unless each dose unit has 5 mg or less and the iron is combined with other actives. TGO 95 is due to sunset on 1 April 2028.\n- **Tamper evidence.** The TGA's code of practice for tamper-evident packaging isn't mandatory, but some industry associations make it a condition of membership, and goods sold in tamper-evident packaging must say so on the pack.","text":"Child-resistant packaging. TGO 95 requires it for listed and registered medicines containing certain substances in set strengths or pack sizes, and for any medicine whose label or pack says or implies it is child-resistant. Iron is on the list: a pack with more than 250 mg of elemental iron in total, unless each dose unit has 5 mg or less and the iron is combined with other actives. TGO 95 is due to sunset on 1 April 2028. Tamper evidence. The TGA's code of practice for tamper-evident packaging isn't mandatory, but some industry associations make it a condition of membership, and goods sold in tamper-evident packaging must say so on the pack.","items":[{"lead":"Child-resistant packaging.","text":"TGO 95 requires it for listed and registered medicines containing certain substances in set strengths or pack sizes, and for any medicine whose label or pack says or implies it is child-resistant. Iron is on the list: a pack with more than 250 mg of elemental iron in total, unless each dose unit has 5 mg or less and the iron is combined with other actives. TGO 95 is due to sunset on 1 April 2028."},{"lead":"Tamper evidence.","text":"The TGA's code of practice for tamper-evident packaging isn't mandatory, but some industry associations make it a condition of membership, and goods sold in tamper-evident packaging must say so on the pack."}],"tables":[]},{"heading":"The transition","anchor":"the-transition","markdown":"TGO 116 commenced in full on 30 September 2026. A medicine released for supply before 1 October 2031 may follow TGO 92 instead, or TGO 92 with the TGO 116 provisions listed in the order's table in place of their TGO 92 equivalents. From 1 October 2031, every medicine released for supply follows TGO 116 in full. The test is the date of release for supply, not the date of sale.\n\nSo a label in use today can stay as it is for now, and a new label is best written to TGO 116 from the start, to save a second round of artwork before 2031. The TGA's guidance for the TGO 92 route is \"Labelling medicines to comply with TGO 91 and TGO 92\" (version 2.5, December 2024), and it said in August 2026 that it would publish guidance for each new order \"as soon as practicable after registration\".","text":"TGO 116 commenced in full on 30 September 2026. A medicine released for supply before 1 October 2031 may follow TGO 92 instead, or TGO 92 with the TGO 116 provisions listed in the order's table in place of their TGO 92 equivalents. From 1 October 2031, every medicine released for supply follows TGO 116 in full. The test is the date of release for supply, not the date of sale. So a label in use today can stay as it is for now, and a new label is best written to TGO 116 from the start, to save a second round of artwork before 2031. The TGA's guidance for the TGO 92 route is \"Labelling medicines to comply with TGO 91 and TGO 92\" (version 2.5, December 2024), and it said in August 2026 that it would publish guidance for each new order \"as soon as practicable after registration\".","items":[],"tables":[]},{"heading":"Where we come in","anchor":"where-we-come-in","markdown":"We draft and review the label with the listing, from the design brief to print-ready artwork, checking every claim, ingredient and mandatory statement against the labelling order that applies. On [Arxi's prenatal chewable](/work/arxi-prenatal-chewable), our label review caught two errors before print; for [The Belly Solution](/work/the-belly-solution-travel-gut-health-powder) we drafted and reviewed the label of a travel gut-health powder; for [Your Skin Scan](/work/your-skin-scan-nicotinamide-tablet), label compliance came with the listing. More on [packaging and labelling](/packaging), or [book a call](/contact).","text":"We draft and review the label with the listing, from the design brief to print-ready artwork, checking every claim, ingredient and mandatory statement against the labelling order that applies. On Arxi's prenatal chewable, our label review caught two errors before print; for The Belly Solution we drafted and reviewed the label of a travel gut-health powder; for Your Skin Scan, label compliance came with the listing. More on packaging and labelling, or book a call.","items":[],"tables":[]}],"faqs":[{"q":"What must be on a supplement label in Australia?","a":"For a listed medicine, TGO 116 requires the name, each active ingredient and its quantity, the dosage form and the quantity on the main label, then the batch number, the expiry date, storage conditions, the sponsor's name and contact details, declared substances such as allergens, warning statements, directions for use and the indications. The AUST L number goes on the main label, or on a sticker fixed beside it.","md":"For a listed medicine, TGO 116 requires the name, each active ingredient and its quantity, the dosage form and the quantity on the main label, then the batch number, the expiry date, storage conditions, the sponsor's name and contact details, declared substances such as allergens, warning statements, directions for use and the indications. The AUST L number goes on the main label, or on a sticker fixed beside it."},{"q":"How big does the text on a supplement label have to be?","a":"At least 1.5 mm high, unless the order or the Regulations say otherwise, in English, clearly legible, durable and in a colour that contrasts strongly with the background. The AUST L number must be at least 1 mm high.","md":"At least 1.5 mm high, unless the order or the Regulations say otherwise, in English, clearly legible, durable and in a colour that contrasts strongly with the background. The AUST L number must be at least 1 mm high."},{"q":"Do I need to change my TGO 92 label now?","a":"No. A medicine released for supply before 1 October 2031 can still follow TGO 92, or TGO 92 with some TGO 116 provisions swapped in. From 1 October 2031 it must follow TGO 116 in full, so a new label is best written to TGO 116 now.","md":"No. A medicine released for supply before 1 October 2031 can still follow TGO 92, or TGO 92 with some TGO 116 provisions swapped in. From 1 October 2031 it must follow TGO 116 in full, so a new label is best written to TGO 116 now."},{"q":"Does a supplement label need allergen statements?","a":"Yes, where the medicine contains them, for the routes and thresholds TGO 116 sets. Schedule 1 lists the substances to declare, among them peanuts, tree nuts, milk, egg, fish, crustacea, molluscs, sesame, soya, wheat and gluten, as well as lactose, sugars, sulfites, aspartame, alcohol, propolis and royal jelly, with any statement each requires.","md":"Yes, where the medicine contains them, for the routes and thresholds TGO 116 sets. Schedule 1 lists the substances to declare, among them peanuts, tree nuts, milk, egg, fish, crustacea, molluscs, sesame, soya, wheat and gluten, as well as lactose, sugars, sulfites, aspartame, alcohol, propolis and royal jelly, with any statement each requires."},{"q":"Can a supplement label have a QR code?","a":"Yes. What it links to must be in the sponsor's control, or the TGA's information about the medicine, consistent with the label and the product details, and free of logins, personal details and payments. It can't replace anything the label must carry unless the order allows it.","md":"Yes. What it links to must be in the sponsor's control, or the TGA's information about the medicine, consistent with the label and the product details, and free of logins, personal details and payments. It can't replace anything the label must carry unless the order allows it."},{"q":"Does a supplement need child-resistant packaging?","a":"Only if it contains a substance TGO 95 lists, in the strength or pack size it sets, or if its label or pack says or implies it is child-resistant. Iron is on the list: more than 250 mg of elemental iron in a pack, unless each dose unit has 5 mg or less and the iron is combined with other actives.","md":"Only if it contains a substance TGO 95 lists, in the strength or pack size it sets, or if its label or pack says or implies it is child-resistant. Iron is on the list: more than 250 mg of elemental iron in a pack, unless each dose unit has 5 mg or less and the iron is combined with other actives."}],"sources":{"note":"General information, checked against these sources on 23 October 2026. It isn't legal advice or advice on a particular product. Our work is from Take Friday Off's records.","markdown":"General information, checked against these sources on 23 October 2026. It isn't legal advice or advice on a particular product. Our work is from Take Friday Off's records.\n\n- [Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026](https://www.legislation.gov.au/F2026L01312/asmade/2026-09-28/text/original/pdf), sections 2, 4, 6, 8 (and its note on the AUST L number), 9, 11, 12, 13, 15, 17, 27, 32 and 36 and Schedule 1, and its [explanatory statement](https://www.legislation.gov.au/F2026L01312/asmade/2026-09-28/es/original/pdf), Federal Register of Legislation\n- [AUST numbers on medicine labels](https://www.tga.gov.au/products/medicines/labelling-and-advertising/medicines-and-biologicals-labelling-and-packaging/aust-numbers-medicine-labels), Therapeutic Goods Administration\n- [Therapeutic Goods (Medicines Advisory Statements) Specification 2021](https://www.legislation.gov.au/F2021L01888/asmade/2021-12-23/text/original/pdf), Federal Register of Legislation, and [Proposed changes to Required Advisory Statements for Medicine Labels (RASML)](https://consultations.tga.gov.au/tga/proposed-changes-rasml-2026/), Therapeutic Goods Administration, 2026\n- [Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017](https://legislation.gov.au/F2017L01577/asmade/2017-12-04/text/original/pdf), section 6 and Schedule 1, and its [details](https://www.legislation.gov.au/F2017L01577/latest/details), Federal Register of Legislation\n- [Listed medicine presentation and labels](https://tga.gov.au/sites/default/files/listed-medicine-presentation-and-labels.pdf), version 1.1, September 2020, [Using the 'TGA assessed' claim on medicine labels](https://www.tga.gov.au/node/289464) and the [Code of practice for tamper-evident packaging of therapeutic goods](https://www.tga.gov.au/sites/default/files/code-practice-tamper-evident-packaging-therapeutic-goods.pdf), version 2.0, May 2017, Therapeutic Goods Administration\n- [Labelling medicines to comply with TGO 91 and TGO 92](https://tga.gov.au/sites/default/files/2024-12/labelling-medicines-to-comply-with-tgo-91-tgo-92.pdf), version 2.5, December 2024, and [Outcomes of consultation on proposed changes to labelling of medicines supplied in Australia – Non-prescription medicines (replacing TGO 92)](https://consultations.tga.gov.au/medicines-regulation-division/proposed-changes-to-labelling-of-medicines/user_uploads/outcomes-of-consultation-on-changes-to-non-prescription-medicines.pdf), August 2026, Therapeutic Goods Administration","items":[{"text":"Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026, sections 2, 4, 6, 8 (and its note on the AUST L number), 9, 11, 12, 13, 15, 17, 27, 32 and 36 and Schedule 1, and its explanatory statement, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026","url":"https://www.legislation.gov.au/F2026L01312/asmade/2026-09-28/text/original/pdf"},{"title":"explanatory statement","url":"https://www.legislation.gov.au/F2026L01312/asmade/2026-09-28/es/original/pdf"}]},{"text":"AUST numbers on medicine labels, Therapeutic Goods Administration","links":[{"title":"AUST numbers on medicine labels","url":"https://www.tga.gov.au/products/medicines/labelling-and-advertising/medicines-and-biologicals-labelling-and-packaging/aust-numbers-medicine-labels"}]},{"text":"Therapeutic Goods (Medicines Advisory Statements) Specification 2021, Federal Register of Legislation, and Proposed changes to Required Advisory Statements for Medicine Labels (RASML), Therapeutic Goods Administration, 2026","links":[{"title":"Therapeutic Goods (Medicines Advisory Statements) Specification 2021","url":"https://www.legislation.gov.au/F2021L01888/asmade/2021-12-23/text/original/pdf"},{"title":"Proposed changes to Required Advisory Statements for Medicine Labels (RASML)","url":"https://consultations.tga.gov.au/tga/proposed-changes-rasml-2026/"}]},{"text":"Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017, section 6 and Schedule 1, and its details, Federal Register of Legislation","links":[{"title":"Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017","url":"https://legislation.gov.au/F2017L01577/asmade/2017-12-04/text/original/pdf"},{"title":"details","url":"https://www.legislation.gov.au/F2017L01577/latest/details"}]},{"text":"Listed medicine presentation and labels, version 1.1, September 2020, Using the 'TGA assessed' claim on medicine labels and the Code of practice for tamper-evident packaging of therapeutic goods, version 2.0, May 2017, Therapeutic Goods Administration","links":[{"title":"Listed medicine presentation and labels","url":"https://tga.gov.au/sites/default/files/listed-medicine-presentation-and-labels.pdf"},{"title":"Using the 'TGA assessed' claim on medicine labels","url":"https://www.tga.gov.au/node/289464"},{"title":"Code of practice for tamper-evident packaging of therapeutic goods","url":"https://www.tga.gov.au/sites/default/files/code-practice-tamper-evident-packaging-therapeutic-goods.pdf"}]},{"text":"Labelling medicines to comply with TGO 91 and TGO 92, version 2.5, December 2024, and Outcomes of consultation on proposed changes to labelling of medicines supplied in Australia – Non-prescription medicines (replacing TGO 92), August 2026, Therapeutic Goods Administration","links":[{"title":"Labelling medicines to comply with TGO 91 and TGO 92","url":"https://tga.gov.au/sites/default/files/2024-12/labelling-medicines-to-comply-with-tgo-91-tgo-92.pdf"},{"title":"Outcomes of consultation on proposed changes to labelling of medicines supplied in Australia – Non-prescription medicines (replacing TGO 92)","url":"https://consultations.tga.gov.au/medicines-regulation-division/proposed-changes-to-labelling-of-medicines/user_uploads/outcomes-of-consultation-on-changes-to-non-prescription-medicines.pdf"}]}]}},{"slug":"start-a-supplement-brand","kind":"guide","url":"/guides/start-a-supplement-brand","title":"How to start a supplement brand in Australia: the steps from idea to shelf","name":"Starting a supplement brand","description":"Starting a supplement brand in Australia, step by step: the pathway, ingredients and claims, the TGA sponsor, manufacturing, the label, the listing and launch.","eyebrow":"Guide","lead":"Most supplements sold as medicines in Australia are listed medicines, so the TGA's rules set the order of much of the work in starting a supplement brand or business. This guide takes the steps from the idea to the first batch on a shelf: the product's pathway, the ingredients and claims it can use, the sponsor, the formula, the manufacturer, the shelf life, the label, the listing and the launch, with what the TGA charges and how long it has taken in our records.","parent":"/product-development","studies":["everleanbody-saffron-capsule","ashwagandha-capsule-32-days","the-belly-solution-travel-gut-health-powder"],"formats":[],"order":77,"updated":"2026-10-23","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- Most supplements sold as medicines in Australia are listed medicines with an AUST L number, regulated by the TGA. Some powders, drinks, bars and capsules can be sold as foods, and some creams as cosmetics. Settle the product's pathway first: it decides the ingredients you can use, the claims you can make, the label and who regulates you.\n- A medicine can be listed only if it contains only permissible ingredients, used within their requirements, uses permissible indications, isn't required to be sterile and contains no substance in a Poisons Standard schedule. The sponsor holds the evidence for every claim.\n- The sponsor, normally the brand's own Australian company, is legally responsible for the medicine. It needs a TGA Client ID and access to TGA Business Services.\n- Unless a step is exempt, every step of manufacture needs a TGA manufacturing licence in Australia, or, for a site overseas, a TGA GMP clearance that the sponsor holds. A brand doesn't need a factory of its own.\n- The label follows TGO 116 (or TGO 92, for a medicine released for supply before 1 October 2031). Advertising to the public, the label included, follows the Advertising Code, though some of its rules, such as the mandatory statements, don't apply to the label.\n- In 2026–27 the TGA charges $1,063 to list a medicine, then $1,566 a year once it has had turnover. From our records, listed medicines have taken 5.8 to about eight months from brief or formulation to dispatch.","text":"Most supplements sold as medicines in Australia are listed medicines with an AUST L number, regulated by the TGA. Some powders, drinks, bars and capsules can be sold as foods, and some creams as cosmetics. Settle the product's pathway first: it decides the ingredients you can use, the claims you can make, the label and who regulates you. A medicine can be listed only if it contains only permissible ingredients, used within their requirements, uses permissible indications, isn't required to be sterile and contains no substance in a Poisons Standard schedule. The sponsor holds the evidence for every claim. The sponsor, normally the brand's own Australian company, is legally responsible for the medicine. It needs a TGA Client ID and access to TGA Business Services. Unless a step is exempt, every step of manufacture needs a TGA manufacturing licence in Australia, or, for a site overseas, a TGA GMP clearance that the sponsor holds. A brand doesn't need a factory of its own. The label follows TGO 116 (or TGO 92, for a medicine released for supply before 1 October 2031). Advertising to the public, the label included, follows the Advertising Code, though some of its rules, such as the mandatory statements, don't apply to the label. In 2026–27 the TGA charges $1,063 to list a medicine, then $1,566 a year once it has had turnover. From our records, listed medicines have taken 5.8 to about eight months from brief or formulation to dispatch.","items":[],"tables":[]},{"heading":"1. Start with the customer, the claim and the price","anchor":"1-start-with-the-customer-the-claim-and-the-price","markdown":"A supplement brand starts with a brief: who the product is for, what it should do for them, the format they will take it in and the price it has to sell at. Each of those shapes what follows. The claim does most to decide the pathway, and it decides the evidence; the format, the volume and the margin decide the manufacturer; the price sets the budget for the formula.\n\nDesign to the price from the start. As a rule of thumb from our records, divide the retail price by four or five to get the target cost of goods, packaging included, and choose the ingredients, doses and pack to meet it. A formula that can't be made at the price may have to be redesigned. More in our [guide to development costs](/guides/supplement-development-cost).","text":"A supplement brand starts with a brief: who the product is for, what it should do for them, the format they will take it in and the price it has to sell at. Each of those shapes what follows. The claim does most to decide the pathway, and it decides the evidence; the format, the volume and the margin decide the manufacturer; the price sets the budget for the formula. Design to the price from the start. As a rule of thumb from our records, divide the retail price by four or five to get the target cost of goods, packaging included, and choose the ingredients, doses and pack to meet it. A formula that can't be made at the price may have to be redesigned. More in our guide to development costs.","items":[],"tables":[]},{"heading":"2. Settle the pathway: medicine, food or cosmetic","anchor":"2-settle-the-pathway-medicine-food-or-cosmetic","markdown":"In Australia the same capsule or powder can be a listed medicine or a food, and the same cream a listed medicine or a cosmetic. Mostly, presentation decides: the claims, the name, the form, the dose, even where the product is sold. Declared goods, such as beauty supplements, are medicines whatever else applies.\n\nThe pathway decides the ingredients you can use, the claims you can make, the label and who regulates you, so it is settled before the formula. A claim added after the formula is set can move a product from food to medicine, and with it the ingredients, the label and the regulator. Our [pathways page](/pathways) sets out how it is decided, and the [food pathway](/pathways/foods) covers powders, drinks and bars sold as foods.\n\nThe rest of this guide follows a listed medicine, the pathway most supplements sold as medicines take. Foods and cosmetics are [at the end](#foods-and-cosmetics).","text":"In Australia the same capsule or powder can be a listed medicine or a food, and the same cream a listed medicine or a cosmetic. Mostly, presentation decides: the claims, the name, the form, the dose, even where the product is sold. Declared goods, such as beauty supplements, are medicines whatever else applies. The pathway decides the ingredients you can use, the claims you can make, the label and who regulates you, so it is settled before the formula. A claim added after the formula is set can move a product from food to medicine, and with it the ingredients, the label and the regulator. Our pathways page sets out how it is decided, and the food pathway covers powders, drinks and bars sold as foods. The rest of this guide follows a listed medicine, the pathway most supplements sold as medicines take. Foods and cosmetics are at the end.","items":[],"tables":[]},{"heading":"3. Check the product can be listed","anchor":"3-check-the-product-can-be-listed","markdown":"The TGA's checklist for new sponsors says a medicine is eligible for listing if it:\n\n- contains only ingredients in the Permissible Ingredients Determination, and complies with the requirements it sets;\n- uses indications from the Permissible Indications Determination, meeting any requirements they carry;\n- isn't required to be sterile; and\n- contains no substance in a schedule of the Poisons Standard.\n\nCheck every ingredient against the current determination before the formula is final. The third of 2026 commenced on 16 October 2026, and the TGA updates the list at least quarterly. An ingredient that isn't on it, or one wanted at a higher level, by another route or in a new role, needs its own application to the TGA first: in 2026–27 the TGA's fees are $19,826 for an IN1 or IN2 application and $33,696 for IN3 or IN4, and the law allows 40 working days for a preliminary assessment, then 70 to 180 working days for the evaluation. More in our [new ingredients guide](/guides/permissible-ingredients).","text":"The TGA's checklist for new sponsors says a medicine is eligible for listing if it: contains only ingredients in the Permissible Ingredients Determination, and complies with the requirements it sets; uses indications from the Permissible Indications Determination, meeting any requirements they carry; isn't required to be sterile; and contains no substance in a schedule of the Poisons Standard. Check every ingredient against the current determination before the formula is final. The third of 2026 commenced on 16 October 2026, and the TGA updates the list at least quarterly. An ingredient that isn't on it, or one wanted at a higher level, by another route or in a new role, needs its own application to the TGA first: in 2026–27 the TGA's fees are $19,826 for an IN1 or IN2 application and $33,696 for IN3 or IN4, and the law allows 40 working days for a preliminary assessment, then 70 to 180 working days for the evaluation. More in our new ingredients guide.","items":[],"tables":[]},{"heading":"4. Choose claims you can hold evidence for","anchor":"4-choose-claims-you-can-hold-evidence-for","markdown":"A listed medicine can only make therapeutic claims from the TGA's permitted indications, and they are low-level claims: \"relieves throat irritation\", not \"reduces high blood pressure\". Each indication sets the evidence the sponsor must hold, scientific or traditional, and the TGA can ask for it at any time.\n\nChoose the indications with the formula, because the evidence has to match the ingredient, its form and its dose. A stronger claim than the permitted list allows needs another pathway, such as an assessed listed medicine (AUST L(A)) for an intermediate indication. More in our [claims and indications guide](/guides/permitted-indications) and our [guide to assessed listed medicines](/guides/assessed-listed-medicines).","text":"A listed medicine can only make therapeutic claims from the TGA's permitted indications, and they are low-level claims: \"relieves throat irritation\", not \"reduces high blood pressure\". Each indication sets the evidence the sponsor must hold, scientific or traditional, and the TGA can ask for it at any time. Choose the indications with the formula, because the evidence has to match the ingredient, its form and its dose. A stronger claim than the permitted list allows needs another pathway, such as an assessed listed medicine (AUST L(A)) for an intermediate indication. More in our claims and indications guide and our guide to assessed listed medicines.","items":[],"tables":[]},{"heading":"5. Set up as the sponsor","anchor":"5-set-up-as-the-sponsor","markdown":"The sponsor is the person or company that imports, exports or manufactures a medicine, or arranges for it to happen, and is legally responsible for it in Australia. Normally, that is the brand's own company. A sponsor must be an Australian resident, or a company incorporated and doing business in Australia with a representative who lives here, so an overseas brand needs an Australian sponsor.\n\nBecoming a sponsor means a TGA Client ID, through the organisation details form, then access to TGA Business Services, where listings are lodged. The responsibility stays with the sponsor when others do the work, from the formula to the manufacture. More in our [sponsor guide](/guides/tga-sponsor).","text":"The sponsor is the person or company that imports, exports or manufactures a medicine, or arranges for it to happen, and is legally responsible for it in Australia. Normally, that is the brand's own company. A sponsor must be an Australian resident, or a company incorporated and doing business in Australia with a representative who lives here, so an overseas brand needs an Australian sponsor. Becoming a sponsor means a TGA Client ID, through the organisation details form, then access to TGA Business Services, where listings are lodged. The responsibility stays with the sponsor when others do the work, from the formula to the manufacture. More in our sponsor guide.","items":[],"tables":[]},{"heading":"6. Formulate to the claim and the price","anchor":"6-formulate-to-the-claim-and-the-price","markdown":"Formulation turns the brief into three things you can act on: the formulation, its specification and a quote for making it. Every ingredient, form and dose is chosen for the claim the product needs to make, inside the rules of its pathway, and the price it has to sell at. A physical sample is approved before anything goes into production. More on how we do it on our [formulation page](/formulation).","text":"Formulation turns the brief into three things you can act on: the formulation, its specification and a quote for making it. Every ingredient, form and dose is chosen for the claim the product needs to make, inside the rules of its pathway, and the price it has to sell at. A physical sample is approved before anything goes into production. More on how we do it on our formulation page.","items":[],"tables":[]},{"heading":"7. Choose a manufacturer with the right licence or clearance","anchor":"7-choose-a-manufacturer-with-the-right-licence-or-clearance","markdown":"A brand doesn't need a factory of its own: a contract manufacturer can make the product. But unless a step is exempt, every step of manufacture in Australia needs a TGA manufacturing licence, and a site overseas needs a TGA GMP clearance, which the Australian sponsor holds: one for each site, per sponsor, even if the factory already supplies other Australian brands. Only Australian sites can hold a TGA licence. The standard is the PIC/S Guide to GMP, version PE009-17, since 1 September 2025.\n\nChoose the manufacturer for the format, the volume and the cost of goods, and check that its TGA licence covers each step it will carry out in Australia, or, for a site overseas, that the site can be cleared for your product. The desktop routes to a clearance often aren't open to supplement factories overseas, which can mean a TGA inspection first. More in our [guide to choosing a supplement manufacturer](/guides/choosing-a-supplement-manufacturer) and our [GMP clearance guide](/guides/gmp-clearance).","text":"A brand doesn't need a factory of its own: a contract manufacturer can make the product. But unless a step is exempt, every step of manufacture in Australia needs a TGA manufacturing licence, and a site overseas needs a TGA GMP clearance, which the Australian sponsor holds: one for each site, per sponsor, even if the factory already supplies other Australian brands. Only Australian sites can hold a TGA licence. The standard is the PIC/S Guide to GMP, version PE009-17, since 1 September 2025. Choose the manufacturer for the format, the volume and the cost of goods, and check that its TGA licence covers each step it will carry out in Australia, or, for a site overseas, that the site can be cleared for your product. The desktop routes to a clearance often aren't open to supplement factories overseas, which can mean a TGA inspection first. More in our guide to choosing a supplement manufacturer and our GMP clearance guide.","items":[],"tables":[]},{"heading":"8. Support the shelf life","anchor":"8-support-the-shelf-life","markdown":"TGA guidance says a listed medicine's sponsor should hold stability evidence at or before listing, showing the product meets its specifications, stored as its label says, until its expiry date. If full data aren't ready, older TGA guidance allows an interim shelf life supported by evidence. Ongoing stability testing is mandatory and runs in real time after launch: at least one batch from each product group should go on the program each year. Our recent programs run for 24 or 36 months. More in our [stability testing guide](/guides/stability-testing).","text":"TGA guidance says a listed medicine's sponsor should hold stability evidence at or before listing, showing the product meets its specifications, stored as its label says, until its expiry date. If full data aren't ready, older TGA guidance allows an interim shelf life supported by evidence. Ongoing stability testing is mandatory and runs in real time after launch: at least one batch from each product group should go on the program each year. Our recent programs run for 24 or 36 months. More in our stability testing guide.","items":[],"tables":[]},{"heading":"9. Write the label","anchor":"9-write-the-label","markdown":"Since 30 September 2026, a listed medicine's label follows TGO 116. One released for supply before 1 October 2031 may still follow TGO 92, or TGO 92 with some TGO 116 provisions swapped in, so a new label is best written to TGO 116 from the start.\n\nThe main label carries the medicine's name, each active ingredient and its quantity, the dosage form and the quantity in the pack, and the AUST L number goes on the main label or a sticker fixed beside it. A listed medicine with two or more active ingredients, other than a sunscreen, may show them, as one block, on another part of the label instead. The label also carries the batch number, the expiry date, storage conditions, the sponsor's name and contact details, declared substances such as allergens, warning statements, directions for use and the indications. More in our [labelling guide](/guides/supplement-labelling).","text":"Since 30 September 2026, a listed medicine's label follows TGO 116. One released for supply before 1 October 2031 may still follow TGO 92, or TGO 92 with some TGO 116 provisions swapped in, so a new label is best written to TGO 116 from the start. The main label carries the medicine's name, each active ingredient and its quantity, the dosage form and the quantity in the pack, and the AUST L number goes on the main label or a sticker fixed beside it. A listed medicine with two or more active ingredients, other than a sunscreen, may show them, as one block, on another part of the label instead. The label also carries the batch number, the expiry date, storage conditions, the sponsor's name and contact details, declared substances such as allergens, warning statements, directions for use and the indications. More in our labelling guide.","items":[],"tables":[]},{"heading":"10. List the medicine on the ARTG","anchor":"10-list-the-medicine-on-the-artg","markdown":"Each product is its own application, with its own AUST L number. In TGA Business Services the sponsor completes the application and validates it, then certifies that the medicine meets the requirements, submits it and pays the fee: $1,063 in 2026–27. The TGA doesn't evaluate a listed medicine before it is sold: an application that passes the system's validation is listed on the ARTG and given its AUST L number.\n\nThe listing itself is quick. The time goes into the formula, the evidence, GMP manufacturing, stability data and the label before lodging. More in our [TGA listing guide](/guides/tga-approval) and our [guide to the ARTG](/guides/artg).","text":"Each product is its own application, with its own AUST L number. In TGA Business Services the sponsor completes the application and validates it, then certifies that the medicine meets the requirements, submits it and pays the fee: $1,063 in 2026–27. The TGA doesn't evaluate a listed medicine before it is sold: an application that passes the system's validation is listed on the ARTG and given its AUST L number. The listing itself is quick. The time goes into the formula, the evidence, GMP manufacturing, stability data and the label before lodging. More in our TGA listing guide and our guide to the ARTG.","items":[],"tables":[]},{"heading":"11. Make, test and deliver the first batch","anchor":"11-make-test-and-deliver-the-first-batch","markdown":"The first production run is made to the approved specification, release-tested, imported if it was made overseas, and delivered to the brand's warehouse or 3PL. Our minimum run is 3,000 finished retail packs per batch, and a production run takes 12 to 14 weeks once the specification is signed. More on our [manufacturing page](/manufacturing).","text":"The first production run is made to the approved specification, release-tested, imported if it was made overseas, and delivered to the brand's warehouse or 3PL. Our minimum run is 3,000 finished retail packs per batch, and a production run takes 12 to 14 weeks once the specification is signed. More on our manufacturing page.","items":[],"tables":[]},{"heading":"12. Launch within the advertising rules","anchor":"12-launch-within-the-advertising-rules","markdown":"Advertising is any statement, picture or design intended to promote the use or supply of the goods, including on the label and the pack. An ad must be accurate, balanced and not misleading, substantiated before it is published, and not inconsistent with the indications on the ARTG. It can't say \"TGA approved\".\n\nMost ads to the public must carry the medicine's name, at least one accepted indication and \"ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE\". A short-form ad carries \"ALWAYS FOLLOW THE DIRECTIONS FOR USE\" instead, and neither applies to the label itself. Advertising directed only at health professionals, and certain others named in the Act, is outside the Code.\n\nA paid influencer can't give a testimonial, but can endorse a product if the payment is disclosed and they aren't in a group the Code excludes, such as health practitioners. Since 1 July 2020, medicine ads in specified media haven't needed the TGA's approval before they run, though an ad that uses a restricted representation still needs the TGA's approval or permission first. Otherwise the TGA enforces after the fact. More in our [advertising guide](/guides/tga-advertising).","text":"Advertising is any statement, picture or design intended to promote the use or supply of the goods, including on the label and the pack. An ad must be accurate, balanced and not misleading, substantiated before it is published, and not inconsistent with the indications on the ARTG. It can't say \"TGA approved\". Most ads to the public must carry the medicine's name, at least one accepted indication and \"ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE\". A short-form ad carries \"ALWAYS FOLLOW THE DIRECTIONS FOR USE\" instead, and neither applies to the label itself. Advertising directed only at health professionals, and certain others named in the Act, is outside the Code. A paid influencer can't give a testimonial, but can endorse a product if the payment is disclosed and they aren't in a group the Code excludes, such as health practitioners. Since 1 July 2020, medicine ads in specified media haven't needed the TGA's approval before they run, though an ad that uses a restricted representation still needs the TGA's approval or permission first. Otherwise the TGA enforces after the fact. More in our advertising guide.","items":[],"tables":[]},{"heading":"13. After launch","anchor":"13-after-launch","markdown":"A listing comes with duties that last as long as the medicine is on the ARTG, whether or not it is selling, and some records must be kept for years after it comes off. The sponsor keeps the evidence for every claim, makes sure every step of manufacture stays licensed or cleared, keeps records, reports serious adverse reactions within 15 days, runs any recall, answers the TGA's requests and pays its charges. The annual charge, $1,566 in 2026–27, applies every year once the product has had turnover, even in a later year with no sales. Stability testing continues, and reorders follow the sales. More in our [sponsor guide](/guides/tga-sponsor). Then comes the next product ([extending a supplement range](/guides/extending-a-supplement-range)), and sometimes a change to this one ([reformulating a supplement](/guides/reformulating-a-supplement)).","text":"A listing comes with duties that last as long as the medicine is on the ARTG, whether or not it is selling, and some records must be kept for years after it comes off. The sponsor keeps the evidence for every claim, makes sure every step of manufacture stays licensed or cleared, keeps records, reports serious adverse reactions within 15 days, runs any recall, answers the TGA's requests and pays its charges. The annual charge, $1,566 in 2026–27, applies every year once the product has had turnover, even in a later year with no sales. Stability testing continues, and reorders follow the sales. More in our sponsor guide. Then comes the next product (extending a supplement range), and sometimes a change to this one (reformulating a supplement).","items":[],"tables":[]},{"heading":"How long it takes and what it costs","anchor":"how-long-it-takes-and-what-it-costs","markdown":"| Stage or fee | From our records and the TGA's schedule |\n| --- | --- |\n| Design to production order | 32 days to 12 weeks, for listed medicines |\n| Brief or formulation to dispatch | 5.8 to about eight months, for listed medicines |\n| Listing a medicine | $1,063 to apply, in 2026–27 |\n| Each year on the ARTG | $1,566 once the medicine has had turnover, in 2026–27 |\n| A new ingredient, if one is needed | $19,826 to $33,696 in TGA fees; the law allows 40 working days for a preliminary assessment, then 70 to 180 for the evaluation |\n| The first production run | At least 3,000 finished retail packs, priced per unit on a formal quote |\n\nWhat holds a launch up is rarely the listing. It is a formula that won't run, an ingredient that isn't on the TGA's list, a pathway settled late, or a factory overseas without the right clearance. Our [development timeline guide](/guides/supplement-development-timeline) sets out the stages from our records, and our [development costs guide](/guides/supplement-development-cost) what each part of the budget covers.","text":"Stage or fee: Design to production order; From our records and the TGA's schedule: 32 days to 12 weeks, for listed medicines. Stage or fee: Brief or formulation to dispatch; From our records and the TGA's schedule: 5.8 to about eight months, for listed medicines. Stage or fee: Listing a medicine; From our records and the TGA's schedule: $1,063 to apply, in 2026–27. Stage or fee: Each year on the ARTG; From our records and the TGA's schedule: $1,566 once the medicine has had turnover, in 2026–27. Stage or fee: A new ingredient, if one is needed; From our records and the TGA's schedule: $19,826 to $33,696 in TGA fees; the law allows 40 working days for a preliminary assessment, then 70 to 180 for the evaluation. Stage or fee: The first production run; From our records and the TGA's schedule: At least 3,000 finished retail packs, priced per unit on a formal quote. What holds a launch up is rarely the listing. It is a formula that won't run, an ingredient that isn't on the TGA's list, a pathway settled late, or a factory overseas without the right clearance. Our development timeline guide sets out the stages from our records, and our development costs guide what each part of the budget covers.","items":[],"tables":[{"header":["Stage or fee","From our records and the TGA's schedule"],"rows":[["Design to production order","32 days to 12 weeks, for listed medicines"],["Brief or formulation to dispatch","5.8 to about eight months, for listed medicines"],["Listing a medicine","$1,063 to apply, in 2026–27"],["Each year on the ARTG","$1,566 once the medicine has had turnover, in 2026–27"],["A new ingredient, if one is needed","$19,826 to $33,696 in TGA fees; the law allows 40 working days for a preliminary assessment, then 70 to 180 for the evaluation"],["The first production run","At least 3,000 finished retail packs, priced per unit on a formal quote"]]}]},{"heading":"Foods and cosmetics","anchor":"foods-and-cosmetics","markdown":"**A food.** A powder, drink, bar or capsule can be sold as a food unless its presentation, or something else about it, makes it a medicine, or it is declared one. A food meets the Food Standards Code instead of the TGA's rules, and no food may claim to prevent, cure or alleviate a disease. A food for retail sale can't be or contain a novel food, a food without a history of human consumption in Australia or New Zealand whose safety needs assessing, unless it is listed in Schedule 25 of the Code and used within its conditions; a listing takes an application to FSANZ. More on our [food pathway page](/pathways/foods) and in our [novel foods guide](/guides/novel-foods).\n\n**A cosmetic.** A cream, serum or lotion is a cosmetic while its claims stay cosmetic: appearance, cleansing, odour, and protecting the skin or keeping it in good condition. A therapeutic claim, an ingredient from Schedule 2, 3, 4 or 8 of the Poisons Standard, or the way it is used can make it a therapeutic good. A business that imports cosmetics or their ingredients, or manufactures industrial chemicals, must register with AICIS before it does. More on our [skincare page](/skincare) and in our [AICIS guide](/guides/aicis-registration).","text":"A food. A powder, drink, bar or capsule can be sold as a food unless its presentation, or something else about it, makes it a medicine, or it is declared one. A food meets the Food Standards Code instead of the TGA's rules, and no food may claim to prevent, cure or alleviate a disease. A food for retail sale can't be or contain a novel food, a food without a history of human consumption in Australia or New Zealand whose safety needs assessing, unless it is listed in Schedule 25 of the Code and used within its conditions; a listing takes an application to FSANZ. More on our food pathway page and in our novel foods guide. A cosmetic. A cream, serum or lotion is a cosmetic while its claims stay cosmetic: appearance, cleansing, odour, and protecting the skin or keeping it in good condition. A therapeutic claim, an ingredient from Schedule 2, 3, 4 or 8 of the Poisons Standard, or the way it is used can make it a therapeutic good. A business that imports cosmetics or their ingredients, or manufactures industrial chemicals, must register with AICIS before it does. More on our skincare page and in our AICIS guide.","items":[],"tables":[]},{"heading":"Where we come in","anchor":"where-we-come-in","markdown":"We are the product development team a new brand would otherwise have to build: one team carrying the product from the brief and the pathway through the formula, the evidence, the listing and the label to a matched, managed manufacturer and the first batch at your warehouse. We work in five steps, [Friday Launch Engine™](/system), and each stage is a fixed fee for a defined outcome. You can stop at the end of the Design phase with no obligation to have us manage the manufacture, and the formulation is yours to take anywhere.\n\nIf you are working out whether you are ready, the [readiness check](/partner) takes four questions. Weighing a manufacturer, a consultant and a development partner? See [choosing a development partner](/guides/choosing-a-product-development-partner).","text":"We are the product development team a new brand would otherwise have to build: one team carrying the product from the brief and the pathway through the formula, the evidence, the listing and the label to a matched, managed manufacturer and the first batch at your warehouse. We work in five steps, Friday Launch Engine™, and each stage is a fixed fee for a defined outcome. You can stop at the end of the Design phase with no obligation to have us manage the manufacture, and the formulation is yours to take anywhere. If you are working out whether you are ready, the readiness check takes four questions. Weighing a manufacturer, a consultant and a development partner? See choosing a development partner.","items":[],"tables":[]}],"faqs":[{"q":"How do I start a supplement brand in Australia?","a":"Settle the product's pathway first: most supplements sold as medicines are listed medicines. Then check every ingredient and claim against the TGA's permitted lists, set up your company as the TGA sponsor, formulate to the claim and the price, choose a manufacturer licensed, or able to be cleared, for each step, support the shelf life with stability data, write the label to TGO 116, list the medicine on the ARTG and launch within the Advertising Code.","md":"Settle the product's pathway first: most supplements sold as medicines are listed medicines. Then check every ingredient and claim against the TGA's permitted lists, set up your company as the TGA sponsor, formulate to the claim and the price, choose a manufacturer licensed, or able to be cleared, for each step, support the shelf life with stability data, write the label to TGO 116, list the medicine on the ARTG and launch within the Advertising Code."},{"q":"Can I sell supplements in Australia without TGA approval?","a":"Only if the product isn't a therapeutic good, or is exempt. A medicine must be on the ARTG before it is supplied, unless it is exempt, and for most supplements sold as medicines that means an AUST L listing: more in our TGA listing guide. A product that is genuinely a food, presented and sold as one, follows the Food Standards Code instead, and a cosmetic follows the cosmetics rules. A product presented for a therapeutic use is generally a therapeutic good, and a declared good always is; a food covered by a food standard that makes a disease claim stays a food, in breach of the Code.","md":"Only if the product isn't a therapeutic good, or is exempt. A medicine must be on the ARTG before it is supplied, unless it is exempt, and for most supplements sold as medicines that means an AUST L listing: more in our [TGA listing guide](/guides/tga-approval). A product that is genuinely a food, presented and sold as one, follows the Food Standards Code instead, and a cosmetic follows the cosmetics rules. A product presented for a therapeutic use is generally a therapeutic good, and a declared good always is; a food covered by a food standard that makes a disease claim stays a food, in breach of the Code."},{"q":"Do I need my own factory to start a supplement brand?","a":"No. A contract manufacturer can make the product. What matters is that every step of manufacture is covered by a TGA manufacturing licence in Australia, or by a TGA GMP clearance the sponsor holds for each overseas site, unless the step is exempt.","md":"No. A contract manufacturer can make the product. What matters is that every step of manufacture is covered by a TGA manufacturing licence in Australia, or by a TGA GMP clearance the sponsor holds for each overseas site, unless the step is exempt."},{"q":"How much does it cost to start a supplement brand in Australia?","a":"The product side has four parts: the development work, the TGA's fees, the first production run and what continues after launch. In 2026–27 the TGA charges $1,063 to list a medicine and $1,566 a year once it has had turnover. Our minimum first run is 3,000 finished retail packs, priced per unit, and our development work is a fixed fee for each stage. A brand's own costs, such as marketing, sit on top.","md":"The product side has four parts: the development work, the TGA's fees, the first production run and what continues after launch. In 2026–27 the TGA charges $1,063 to list a medicine and $1,566 a year once it has had turnover. Our minimum first run is 3,000 finished retail packs, priced per unit, and our development work is a fixed fee for each stage. A brand's own costs, such as marketing, sit on top."},{"q":"How long does it take to launch a supplement?","a":"From our records, listed medicines have taken 32 days to 12 weeks from design to production order, and 5.8 to about eight months from brief or formulation to dispatch. The TGA's listing step is short; the time goes into the formula, the evidence, stability, the label and manufacturing.","md":"From our records, listed medicines have taken 32 days to 12 weeks from design to production order, and 5.8 to about eight months from brief or formulation to dispatch. The TGA's listing step is short; the time goes into the formula, the evidence, stability, the label and manufacturing."},{"q":"Can an overseas brand sell supplements in Australia?","a":"Yes. As a listed medicine, it needs an Australian sponsor: an Australian resident, or a company incorporated and doing business in Australia with a representative who lives here, and an overseas manufacturer can't be one. A supplement sold as a food needs no TGA sponsor, but must meet the Food Standards Code.","md":"Yes. As a listed medicine, it needs an Australian sponsor: an Australian resident, or a company incorporated and doing business in Australia with a representative who lives here, and an overseas manufacturer can't be one. A supplement sold as a food needs no TGA sponsor, but must meet the Food Standards Code."}],"sources":{"note":"General information, checked against these sources on 23 October 2026. It isn't legal advice or advice on a particular product. Our timelines, minimums, the cost-of-goods rule of thumb and the way we work are from Take Friday Off's records.","markdown":"General information, checked against these sources on 23 October 2026. It isn't legal advice or advice on a particular product. Our timelines, minimums, the cost-of-goods rule of thumb and the way we work are from Take Friday Off's records.\n\n- [Navigating the listed medicines framework: Listed medicines checklist for new sponsors](https://www.tga.gov.au/sites/default/files/2026-05/navigating-listed-medicines-framework-checklist.pdf), version 1.0, May 2026, Therapeutic Goods Administration\n- [Listed medicines](https://www.tga.gov.au/node/520083), [About listed medicines for sponsors](https://www.tga.gov.au/node/546608), [Listed, assessed listed and registered medicines](https://www.tga.gov.au/node/497532) and [The role of the sponsor](https://www.tga.gov.au/how-we-regulate/supply-therapeutic-good/overview-supplying-therapeutic-goods-australia/role-sponsor), Therapeutic Goods Administration\n- [Therapeutic Goods Act 1989](https://www.legislation.gov.au/C2004A03952/latest/text), section 3 (the meanings of advertise and sponsor) and section 26A (listing), Federal Register of Legislation\n- [Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026](https://www.legislation.gov.au/F2026L01382/asmade/versions) and its [explanatory statement](https://www.legislation.gov.au/F2026L01382/asmade/2026-10-13/es/original/pdf), and [Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025](https://www.legislation.gov.au/F2025L00450/latest/versions), Federal Register of Legislation\n- [Updates to listed medicine ingredients](https://www.tga.gov.au/products/medicines/listed-medicines/overview/updates-listed-medicine-ingredients) and [Application requirements for new substances in listed medicines](https://www.tga.gov.au/resources/resource/guidance/application-requirements-new-substances-listed-medicines), Therapeutic Goods Administration\n- [Food-Medicine Interface Guidance Tool](https://www.tga.gov.au/node/287500), [Food and medicine regulation](https://www.tga.gov.au/community-qa/food-and-medicine-regulation) and [Therapeutic Goods (Declared Goods) Order 2019](https://www.legislation.gov.au/F2019L01352/latest/text), Therapeutic Goods Administration and Federal Register of Legislation\n- [Organisation Details: Sponsor, Agent and Manufacturer](https://www.tga.gov.au/sites/default/files/2026-04/form-tga-business-services-organisation-details.pdf), March 2026, and [TGA Business Services: getting started with the TGA](https://www.tga.gov.au/tga-business-services-getting-started-tga), Therapeutic Goods Administration\n- [Manufacturing therapeutic goods](https://www.tga.gov.au/products/regulations-all-products/manufacturing), [Australian manufacturing licences and overseas GMP certification](https://www.tga.gov.au/sites/default/files/australian-manufacturing-licences-and-overseas-gmp-certification.pdf), version 2.2, December 2021, and [The PIC/S Guide to GMP for medicinal products, version 17](https://www.tga.gov.au/node/290180), Therapeutic Goods Administration, and the [Fees and charges summary](https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf), table 28 (GMP clearance per manufacturer, per site, per sponsor)\n- [Stability requirements for listed medicines](https://www.tga.gov.au/stability-requirements-listed-medicines), [Performing ongoing stability testing](https://www.tga.gov.au/node/452227) and [Stability testing of listed complementary medicines](https://www.tga.gov.au/node/497429) (older guidance), Therapeutic Goods Administration\n- [Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026](https://www.legislation.gov.au/F2026L01312/asmade), section 11, and its [explanatory statement](https://www.legislation.gov.au/F2026L01312/asmade/2026-09-28/es/original/pdf), Federal Register of Legislation\n- [Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021](https://www.legislation.gov.au/F2021L01661/latest/versions), Federal Register of Legislation, and the TGA's [Testimonials and endorsements in advertising](https://www.tga.gov.au/node/491816), [Using \"TGA approved\" and other government endorsements](https://www.tga.gov.au/node/491806), [Applying the Advertising Code rules: prominently displayed or communicated information](https://www.tga.gov.au/node/452844) and [Advertising pre-approval ends on 30 June 2020](https://www.tga.gov.au/node/284789)\n- [Fees and charges: summary, from 1 July 2026](https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf), Therapeutic Goods Administration\n- [Pharmacovigilance responsibilities of medicine sponsors](https://www.tga.gov.au/node/286101), version 3.0, Therapeutic Goods Administration\n- [Standard 1.2.7: Nutrition, health and related claims](https://www.legislation.gov.au/F2015L00394/latest/text) and [Standard 1.5.1: Novel foods](https://www.legislation.gov.au/F2015L00403/latest/text), Federal Register of Legislation, and [Novel foods](https://www.foodstandards.gov.au/business/novel), Food Standards Australia New Zealand\n- [Is my product a cosmetic?](https://www.industrialchemicals.gov.au/cosmetics-and-soap/my-product-cosmetic) and [What is registration and who must register?](https://www.industrialchemicals.gov.au/business/getting-started-registration-importing-and-manufacturing/what-registration-and-who-must-register), Australian Industrial Chemicals Introduction Scheme","items":[{"text":"Navigating the listed medicines framework: Listed medicines checklist for new sponsors, version 1.0, May 2026, Therapeutic Goods Administration","links":[{"title":"Navigating the listed medicines framework: Listed medicines checklist for new sponsors","url":"https://www.tga.gov.au/sites/default/files/2026-05/navigating-listed-medicines-framework-checklist.pdf"}]},{"text":"Listed medicines, About listed medicines for sponsors, Listed, assessed listed and registered medicines and The role of the sponsor, Therapeutic Goods Administration","links":[{"title":"Listed medicines","url":"https://www.tga.gov.au/node/520083"},{"title":"About listed medicines for sponsors","url":"https://www.tga.gov.au/node/546608"},{"title":"Listed, assessed listed and registered medicines","url":"https://www.tga.gov.au/node/497532"},{"title":"The role of the sponsor","url":"https://www.tga.gov.au/how-we-regulate/supply-therapeutic-good/overview-supplying-therapeutic-goods-australia/role-sponsor"}]},{"text":"Therapeutic Goods Act 1989, section 3 (the meanings of advertise and sponsor) and section 26A (listing), Federal Register of Legislation","links":[{"title":"Therapeutic Goods Act 1989","url":"https://www.legislation.gov.au/C2004A03952/latest/text"}]},{"text":"Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026 and its explanatory statement, and Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026","url":"https://www.legislation.gov.au/F2026L01382/asmade/versions"},{"title":"explanatory statement","url":"https://www.legislation.gov.au/F2026L01382/asmade/2026-10-13/es/original/pdf"},{"title":"Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025","url":"https://www.legislation.gov.au/F2025L00450/latest/versions"}]},{"text":"Updates to listed medicine ingredients and Application requirements for new substances in listed medicines, Therapeutic Goods Administration","links":[{"title":"Updates to listed medicine ingredients","url":"https://www.tga.gov.au/products/medicines/listed-medicines/overview/updates-listed-medicine-ingredients"},{"title":"Application requirements for new substances in listed medicines","url":"https://www.tga.gov.au/resources/resource/guidance/application-requirements-new-substances-listed-medicines"}]},{"text":"Food-Medicine Interface Guidance Tool, Food and medicine regulation and Therapeutic Goods (Declared Goods) Order 2019, Therapeutic Goods Administration and Federal Register of Legislation","links":[{"title":"Food-Medicine Interface Guidance Tool","url":"https://www.tga.gov.au/node/287500"},{"title":"Food and medicine regulation","url":"https://www.tga.gov.au/community-qa/food-and-medicine-regulation"},{"title":"Therapeutic Goods (Declared Goods) Order 2019","url":"https://www.legislation.gov.au/F2019L01352/latest/text"}]},{"text":"Organisation Details: Sponsor, Agent and Manufacturer, March 2026, and TGA Business Services: getting started with the TGA, Therapeutic Goods Administration","links":[{"title":"Organisation Details: Sponsor, Agent and Manufacturer","url":"https://www.tga.gov.au/sites/default/files/2026-04/form-tga-business-services-organisation-details.pdf"},{"title":"TGA Business Services: getting started with the TGA","url":"https://www.tga.gov.au/tga-business-services-getting-started-tga"}]},{"text":"Manufacturing therapeutic goods, Australian manufacturing licences and overseas GMP certification, version 2.2, December 2021, and The PIC/S Guide to GMP for medicinal products, version 17, Therapeutic Goods Administration, and the Fees and charges summary, table 28 (GMP clearance per manufacturer, per site, per sponsor)","links":[{"title":"Manufacturing therapeutic goods","url":"https://www.tga.gov.au/products/regulations-all-products/manufacturing"},{"title":"Australian manufacturing licences and overseas GMP certification","url":"https://www.tga.gov.au/sites/default/files/australian-manufacturing-licences-and-overseas-gmp-certification.pdf"},{"title":"The PIC/S Guide to GMP for medicinal products, version 17","url":"https://www.tga.gov.au/node/290180"},{"title":"Fees and charges summary","url":"https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf"}]},{"text":"Stability requirements for listed medicines, Performing ongoing stability testing and Stability testing of listed complementary medicines (older guidance), Therapeutic Goods Administration","links":[{"title":"Stability requirements for listed medicines","url":"https://www.tga.gov.au/stability-requirements-listed-medicines"},{"title":"Performing ongoing stability testing","url":"https://www.tga.gov.au/node/452227"},{"title":"Stability testing of listed complementary medicines","url":"https://www.tga.gov.au/node/497429"}]},{"text":"Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026, section 11, and its explanatory statement, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026","url":"https://www.legislation.gov.au/F2026L01312/asmade"},{"title":"explanatory statement","url":"https://www.legislation.gov.au/F2026L01312/asmade/2026-09-28/es/original/pdf"}]},{"text":"Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021, Federal Register of Legislation, and the TGA's Testimonials and endorsements in advertising, Using \"TGA approved\" and other government endorsements, Applying the Advertising Code rules: prominently displayed or communicated information and Advertising pre-approval ends on 30 June 2020","links":[{"title":"Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021","url":"https://www.legislation.gov.au/F2021L01661/latest/versions"},{"title":"Testimonials and endorsements in advertising","url":"https://www.tga.gov.au/node/491816"},{"title":"Using \"TGA approved\" and other government endorsements","url":"https://www.tga.gov.au/node/491806"},{"title":"Applying the Advertising Code rules: prominently displayed or communicated information","url":"https://www.tga.gov.au/node/452844"},{"title":"Advertising pre-approval ends on 30 June 2020","url":"https://www.tga.gov.au/node/284789"}]},{"text":"Fees and charges: summary, from 1 July 2026, Therapeutic Goods Administration","links":[{"title":"Fees and charges: summary, from 1 July 2026","url":"https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf"}]},{"text":"Pharmacovigilance responsibilities of medicine sponsors, version 3.0, Therapeutic Goods Administration","links":[{"title":"Pharmacovigilance responsibilities of medicine sponsors","url":"https://www.tga.gov.au/node/286101"}]},{"text":"Standard 1.2.7: Nutrition, health and related claims and Standard 1.5.1: Novel foods, Federal Register of Legislation, and Novel foods, Food Standards Australia New Zealand","links":[{"title":"Standard 1.2.7: Nutrition, health and related claims","url":"https://www.legislation.gov.au/F2015L00394/latest/text"},{"title":"Standard 1.5.1: Novel foods","url":"https://www.legislation.gov.au/F2015L00403/latest/text"},{"title":"Novel foods","url":"https://www.foodstandards.gov.au/business/novel"}]},{"text":"Is my product a cosmetic? and What is registration and who must register?, Australian Industrial Chemicals Introduction Scheme","links":[{"title":"Is my product a cosmetic?","url":"https://www.industrialchemicals.gov.au/cosmetics-and-soap/my-product-cosmetic"},{"title":"What is registration and who must register?","url":"https://www.industrialchemicals.gov.au/business/getting-started-registration-importing-and-manufacturing/what-registration-and-who-must-register"}]}]}},{"slug":"choosing-a-supplement-manufacturer","kind":"guide","url":"/guides/choosing-a-supplement-manufacturer","title":"How to choose a supplement manufacturer in Australia","name":"Choosing a manufacturer","description":"Choosing a supplement manufacturer in Australia: what a TGA licence covers and how to check it, sites overseas, the GMP agreement and how each batch is tested.","eyebrow":"Guide","lead":"For a supplement sold as a listed medicine, the manufacturer you choose has to be allowed to make it: every step needs a TGA manufacturing licence in Australia, or a TGA GMP clearance for a site overseas, unless the step is exempt. This guide covers what a licence covers and how to check one, the five steps a listing names, release for supply, the written agreement the GMP code requires, the standards every batch is tested to, sites overseas, food and cosmetics manufacturers, and the questions to ask before you sign.","parent":"/manufacturing","studies":["eye-health-tablet-format-rescue","arxi-preconception-supplement","bwellness-practitioner-range"],"formats":[],"order":78,"updated":"2026-10-23","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- In Australia, manufacturing a medicine without a TGA licence is an offence unless the manufacturer or the goods are exempt. \"Manufacture\" includes packaging, labelling, storage, testing and release for supply, not only making the product.\n- A licence names its holder, its sites, and the types of product and steps of manufacture it authorises. Check that it covers your dosage form and every step the manufacturer will carry out: the TGA's public search of licensed Australian manufacturers shows the steps each one is approved for.\n- A listing must name a manufacturer for each of five steps: making the dosage form, packaging and labelling, chemical and physical testing, microbial testing, and release for supply. The listing won't validate unless each manufacturer's licence or clearance matches the step exactly, and the sponsor must make sure it also covers the dosage form.\n- The GMP code requires a written contract between the brand, as sponsor, and its manufacturer, setting out who does what. The TGA calls it a GMP agreement.\n- A listed tablet or capsule must meet TGO 101 throughout its shelf life, a medicine must meet TGO 100's microbiological standards, and no batch may be released before an authorised person certifies it.\n- A site overseas needs a TGA GMP clearance, held by the sponsor, and for a listed medicine it often can't rest on another regulator's inspection. Foods and cosmetics have no TGA licence: a food business notifies or is licensed under state food law.","text":"In Australia, manufacturing a medicine without a TGA licence is an offence unless the manufacturer or the goods are exempt. \"Manufacture\" includes packaging, labelling, storage, testing and release for supply, not only making the product. A licence names its holder, its sites, and the types of product and steps of manufacture it authorises. Check that it covers your dosage form and every step the manufacturer will carry out: the TGA's public search of licensed Australian manufacturers shows the steps each one is approved for. A listing must name a manufacturer for each of five steps: making the dosage form, packaging and labelling, chemical and physical testing, microbial testing, and release for supply. The listing won't validate unless each manufacturer's licence or clearance matches the step exactly, and the sponsor must make sure it also covers the dosage form. The GMP code requires a written contract between the brand, as sponsor, and its manufacturer, setting out who does what. The TGA calls it a GMP agreement. A listed tablet or capsule must meet TGO 101 throughout its shelf life, a medicine must meet TGO 100's microbiological standards, and no batch may be released before an authorised person certifies it. A site overseas needs a TGA GMP clearance, held by the sponsor, and for a listed medicine it often can't rest on another regulator's inspection. Foods and cosmetics have no TGA licence: a food business notifies or is licensed under state food law.","items":[],"tables":[]},{"heading":"Why the licence comes first","anchor":"why-the-licence-comes-first","markdown":"A brand that arranges for another business to make its medicine is, in the law's words, its sponsor, and it is the sponsor's job to make sure every step is made by someone allowed to make it. The TGA puts the rule plainly: it is an offence, carrying heavy penalties, to manufacture therapeutic goods for human use without a licence unless the manufacturer or goods are exempt.\n\nThe law reads \"manufacture\" broadly. It covers producing the goods and any part of the process of bringing them to their final state: processing, assembling, packaging, labelling, storage, testing and releasing for supply. So the business that packs and labels your product, the laboratory that tests your batch and the person who releases it are all manufacturers in the law's sense, and each must hold, or work under, the licence or clearance for what it does.\n\nOnly Australian sites can hold a TGA manufacturing licence. The standard a licensed site making medicines meets is the PIC/S Guide to GMP, version PE009-17, which has applied since 1 September 2025; for manufacturers of non-sterile medicines, the TGA says that update made no material change.","text":"A brand that arranges for another business to make its medicine is, in the law's words, its sponsor, and it is the sponsor's job to make sure every step is made by someone allowed to make it. The TGA puts the rule plainly: it is an offence, carrying heavy penalties, to manufacture therapeutic goods for human use without a licence unless the manufacturer or goods are exempt. The law reads \"manufacture\" broadly. It covers producing the goods and any part of the process of bringing them to their final state: processing, assembling, packaging, labelling, storage, testing and releasing for supply. So the business that packs and labels your product, the laboratory that tests your batch and the person who releases it are all manufacturers in the law's sense, and each must hold, or work under, the licence or clearance for what it does. Only Australian sites can hold a TGA manufacturing licence. The standard a licensed site making medicines meets is the PIC/S Guide to GMP, version PE009-17, which has applied since 1 September 2025; for manufacturers of non-sterile medicines, the TGA says that update made no material change.","items":[],"tables":[]},{"heading":"What a licence covers, and how to check it","anchor":"what-a-licence-covers-and-how-to-check-it","markdown":"A TGA licence to manufacture states its number, its holder, its manufacturing sites and a description of the types of products and manufacturing steps it authorises. A schedule of conditions usually comes with it. A licence has no expiry date: it stays in force until it is revoked or suspended, and once it is, manufacturing, supplying or exporting from that site is an offence.\n\nYou can check a manufacturer yourself. The TGA's Australian Manufacturer search, in TGA Business Services under \"Public TGA Information\", lists the Australian manufacturers that hold a current licence, and the \"Australian Approved Manufacturer\" certificate attached to each result shows the steps it is approved for. Since October 2025 the TGA also publishes its decisions to grant, suspend or revoke licences on its website. Information about overseas manufacturers isn't public.\n\nWhat to check is that the licence covers your dosage form, and that the certificate lists each step the manufacturer will carry out. A factory licensed to make tablets isn't thereby licensed to make softgels, and a factory that makes your capsules may not be the one licensed to release them.\n\nSome goods and manufacturers are exempt from licensing under Schedules 7 and 8 of the Therapeutic Goods Regulations 1990. Herbs and herbal oils used only as starting materials by a licensed manufacturer are one example the TGA gives. Before accepting that a supplier needs no licence, check its exemption against the current Regulations.","text":"A TGA licence to manufacture states its number, its holder, its manufacturing sites and a description of the types of products and manufacturing steps it authorises. A schedule of conditions usually comes with it. A licence has no expiry date: it stays in force until it is revoked or suspended, and once it is, manufacturing, supplying or exporting from that site is an offence. You can check a manufacturer yourself. The TGA's Australian Manufacturer search, in TGA Business Services under \"Public TGA Information\", lists the Australian manufacturers that hold a current licence, and the \"Australian Approved Manufacturer\" certificate attached to each result shows the steps it is approved for. Since October 2025 the TGA also publishes its decisions to grant, suspend or revoke licences on its website. Information about overseas manufacturers isn't public. What to check is that the licence covers your dosage form, and that the certificate lists each step the manufacturer will carry out. A factory licensed to make tablets isn't thereby licensed to make softgels, and a factory that makes your capsules may not be the one licensed to release them. Some goods and manufacturers are exempt from licensing under Schedules 7 and 8 of the Therapeutic Goods Regulations 1990. Herbs and herbal oils used only as starting materials by a licensed manufacturer are one example the TGA gives. Before accepting that a supplier needs no licence, check its exemption against the current Regulations.","items":[],"tables":[]},{"heading":"The five steps every listing names","anchor":"the-five-steps-every-listing-names","markdown":"When a sponsor lists a medicine, it names the manufacturers and the steps each one carries out. Five steps are compulsory, and each must be covered by at least one manufacturer:\n\n1. manufacture of the dosage form;\n2. packaging and labelling;\n3. release for supply;\n4. testing: chemical and physical testing; and\n5. testing: microbial testing.\n\nOne manufacturer can carry out several steps, and a step can be carried out by more than one. The TGA's listing system checks each manufacturer's licence or clearance for an exact match to the step, and won't validate the listing without one; the licence or clearance also designates the dosage form and product category, which the sponsor must check. The sponsor stays responsible for making sure each entry on the ARTG has at least one TGA-approved manufacturer, licensed or holding a current GMP clearance, for every step, release for supply included.\n\nChanging or adding a manufacturer later is a variation of the medicine's ARTG entry.","text":"When a sponsor lists a medicine, it names the manufacturers and the steps each one carries out. Five steps are compulsory, and each must be covered by at least one manufacturer: manufacture of the dosage form; packaging and labelling; release for supply; testing: chemical and physical testing; and testing: microbial testing. One manufacturer can carry out several steps, and a step can be carried out by more than one. The TGA's listing system checks each manufacturer's licence or clearance for an exact match to the step, and won't validate the listing without one; the licence or clearance also designates the dosage form and product category, which the sponsor must check. The sponsor stays responsible for making sure each entry on the ARTG has at least one TGA-approved manufacturer, licensed or holding a current GMP clearance, for every step, release for supply included. Changing or adding a manufacturer later is a variation of the medicine's ARTG entry.","items":[],"tables":[]},{"heading":"Release for supply","anchor":"release-for-supply","markdown":"Release for supply is the step at which a batch is certified for sale. It is a licensable step in Australia, carried out by an authorised person of a TGA-approved manufacturer, who certifies before release that each batch has been made and controlled in line with the medicine's marketing authorisation and the other regulations that apply. Under the GMP code, no batch is released for sale or supply before that certification.\n\nA sponsor that wants to release its own batches must hold a TGA manufacturing licence for the step, be authorised for it in the listing and meet the responsibilities of a release-for-supply manufacturer. Release can be contracted out only to an authorised person who holds, or works under, a licence or a current GMP clearance that includes it. The sponsor still has responsibilities in release: it gives every manufacturer the requirements of the listing, and shares responsibility with them for the ability to recall a batch, the GMP agreements, ongoing stability data and product quality reviews.","text":"Release for supply is the step at which a batch is certified for sale. It is a licensable step in Australia, carried out by an authorised person of a TGA-approved manufacturer, who certifies before release that each batch has been made and controlled in line with the medicine's marketing authorisation and the other regulations that apply. Under the GMP code, no batch is released for sale or supply before that certification. A sponsor that wants to release its own batches must hold a TGA manufacturing licence for the step, be authorised for it in the listing and meet the responsibilities of a release-for-supply manufacturer. Release can be contracted out only to an authorised person who holds, or works under, a licence or a current GMP clearance that includes it. The sponsor still has responsibilities in release: it gives every manufacturer the requirements of the listing, and shares responsibility with them for the ability to recall a batch, the GMP agreements, ongoing stability data and product quality reviews.","items":[],"tables":[]},{"heading":"The GMP agreement","anchor":"the-gmp-agreement","markdown":"The PIC/S Guide to GMP requires a written contract between the business that outsources a GMP activity, the contract giver, and the business that carries it out, the contract acceptor, which clearly sets out each party's roles and responsibilities. The TGA calls it a GMP agreement, and its guidance also speaks of GMP, quality or technical agreements; sponsors and manufacturers are required to have GMP agreements covering every partial manufacturer in the supply chain. Under Chapter 7 of the Guide:\n\n- **Before outsourcing**, the contract giver assesses the legality, suitability and competence of the contract acceptor, and afterwards monitors and reviews its performance.\n- **The contract** says which party is responsible for each step, from purchasing and testing materials to production and quality control, and the technical parts are drawn up by people who know GMP.\n- **The contract acceptor** doesn't subcontract any of the work without the contract giver's prior evaluation and approval, and doesn't make unauthorised changes that could affect quality.\n- **The records**, from manufacturing and analytical records to distribution records and reference samples, are kept by, or available to, the contract giver.\n- **The contract giver can audit** the work, at the contract acceptor and at any subcontractor they have agreed.\n\nFor listed medicines, the TGA's stability guidance says the responsibilities for ongoing stability testing should be written into the GMP agreement, unless one business is the sponsor, the manufacturer and the releaser. In the TGA's words, a sponsor \"cannot delegate responsibilities, but you can delegate certain tasks\", and the tasks should be agreed in writing.","text":"The PIC/S Guide to GMP requires a written contract between the business that outsources a GMP activity, the contract giver, and the business that carries it out, the contract acceptor, which clearly sets out each party's roles and responsibilities. The TGA calls it a GMP agreement, and its guidance also speaks of GMP, quality or technical agreements; sponsors and manufacturers are required to have GMP agreements covering every partial manufacturer in the supply chain. Under Chapter 7 of the Guide: Before outsourcing, the contract giver assesses the legality, suitability and competence of the contract acceptor, and afterwards monitors and reviews its performance. The contract says which party is responsible for each step, from purchasing and testing materials to production and quality control, and the technical parts are drawn up by people who know GMP. The contract acceptor doesn't subcontract any of the work without the contract giver's prior evaluation and approval, and doesn't make unauthorised changes that could affect quality. The records, from manufacturing and analytical records to distribution records and reference samples, are kept by, or available to, the contract giver. The contract giver can audit the work, at the contract acceptor and at any subcontractor they have agreed. For listed medicines, the TGA's stability guidance says the responsibilities for ongoing stability testing should be written into the GMP agreement, unless one business is the sponsor, the manufacturer and the releaser. In the TGA's words, a sponsor \"cannot delegate responsibilities, but you can delegate certain tasks\", and the tasks should be agreed in writing.","items":[{"lead":"Before outsourcing","text":", the contract giver assesses the legality, suitability and competence of the contract acceptor, and afterwards monitors and reviews its performance."},{"lead":"The contract","text":"says which party is responsible for each step, from purchasing and testing materials to production and quality control, and the technical parts are drawn up by people who know GMP."},{"lead":"The contract acceptor","text":"doesn't subcontract any of the work without the contract giver's prior evaluation and approval, and doesn't make unauthorised changes that could affect quality."},{"lead":"The records","text":", from manufacturing and analytical records to distribution records and reference samples, are kept by, or available to, the contract giver."},{"lead":"The contract giver can audit","text":"the work, at the contract acceptor and at any subcontractor they have agreed."}],"tables":[]},{"heading":"The standards each batch meets","anchor":"the-standards-each-batch-meets","markdown":"**TGO 101** is the standard for tablets, capsules and pills. Unless it follows an applicable monograph in the British, European or US pharmacopoeia, a listed tablet or capsule meets the order's own requirements:\n\n- each active ingredient must assay at 90.0 to 120.0% of the content stated on the label, with different limits for vitamins, minerals, enzymes and probiotics;\n- tablets and capsules that aren't chewable must pass a disintegration test, unless the order calls for a dissolution test instead;\n- modified-release products, and most tablets and capsules with 100 micrograms or more of folic acid, have a dissolution test; and\n- the order sets uniformity of weight and limits on elemental impurities.\n\n**TGO 100** sets the microbiological standards medicines must meet, with a few exceptions such as export-only medicines. A complementary medicine taken by mouth that contains raw material of natural origin, animal, vegetable or mineral, must meet the acceptance criteria in its Schedule 1 (a herbal tea made with boiling water meets Schedule 2 instead): limits on total aerobic microbes, yeasts and moulds and bile-tolerant gram-negative bacteria, and no Salmonella, E. coli or Staphylococcus aureus in the amount tested.\n\nA medicine must comply with TGO 101 throughout its shelf life, but the TGA says not every test must be run on every batch: the design of the medicine, its control strategy and its validation or stability data can show the standard will be met. A sponsor may set release specifications tighter than the order.\n\nUnder the GMP code, a finished product's specification sets out its formula, its form and pack, the directions for sampling and testing, the acceptance limits, the storage conditions and the shelf life, and test results are formally assessed against it before a batch is released. A certificate of analysis summarises the results for a batch, with its evaluation against the stated specification. More on shelf life and the stability program in our [stability testing guide](/guides/stability-testing).","text":"TGO 101 is the standard for tablets, capsules and pills. Unless it follows an applicable monograph in the British, European or US pharmacopoeia, a listed tablet or capsule meets the order's own requirements: each active ingredient must assay at 90.0 to 120.0% of the content stated on the label, with different limits for vitamins, minerals, enzymes and probiotics; tablets and capsules that aren't chewable must pass a disintegration test, unless the order calls for a dissolution test instead; modified-release products, and most tablets and capsules with 100 micrograms or more of folic acid, have a dissolution test; and the order sets uniformity of weight and limits on elemental impurities. TGO 100 sets the microbiological standards medicines must meet, with a few exceptions such as export-only medicines. A complementary medicine taken by mouth that contains raw material of natural origin, animal, vegetable or mineral, must meet the acceptance criteria in its Schedule 1 (a herbal tea made with boiling water meets Schedule 2 instead): limits on total aerobic microbes, yeasts and moulds and bile-tolerant gram-negative bacteria, and no Salmonella, E. coli or Staphylococcus aureus in the amount tested. A medicine must comply with TGO 101 throughout its shelf life, but the TGA says not every test must be run on every batch: the design of the medicine, its control strategy and its validation or stability data can show the standard will be met. A sponsor may set release specifications tighter than the order. Under the GMP code, a finished product's specification sets out its formula, its form and pack, the directions for sampling and testing, the acceptance limits, the storage conditions and the shelf life, and test results are formally assessed against it before a batch is released. A certificate of analysis summarises the results for a batch, with its evaluation against the stated specification. More on shelf life and the stability program in our stability testing guide.","items":[],"tables":[]},{"heading":"A manufacturer overseas","anchor":"a-manufacturer-overseas","markdown":"An overseas manufacturer of a medicine supplied in Australia must meet the same standards and practices as an Australian one, but it can't hold a TGA licence. Instead, the Australian sponsor holds a TGA GMP clearance for each overseas site it uses, one per site, per sponsor, and should keep evidence of GMP compliance for each of them. After a successful TGA inspection, the manufacturer receives a GMP certificate, and the sponsor that applied, or contributed to the inspection's costs, receives the clearance.\n\nFor a listed medicine, a clearance often can't rest on another regulator's evidence. The TGA's guidance says this is often not possible for listed medicines, because of differences in regulatory frameworks and GMP standards, and that its reliance routes aren't intended for some complementary and listed medicines, which may not be regulated as medicines in other countries. That can mean a TGA inspection before the first batch. Apply to renew a clearance at least six months before it expires. The routes, the fees and the renewal rules are in our [GMP clearance guide](/guides/gmp-clearance).","text":"An overseas manufacturer of a medicine supplied in Australia must meet the same standards and practices as an Australian one, but it can't hold a TGA licence. Instead, the Australian sponsor holds a TGA GMP clearance for each overseas site it uses, one per site, per sponsor, and should keep evidence of GMP compliance for each of them. After a successful TGA inspection, the manufacturer receives a GMP certificate, and the sponsor that applied, or contributed to the inspection's costs, receives the clearance. For a listed medicine, a clearance often can't rest on another regulator's evidence. The TGA's guidance says this is often not possible for listed medicines, because of differences in regulatory frameworks and GMP standards, and that its reliance routes aren't intended for some complementary and listed medicines, which may not be regulated as medicines in other countries. That can mean a TGA inspection before the first batch. Apply to renew a clearance at least six months before it expires. The routes, the fees and the renewal rules are in our GMP clearance guide.","items":[],"tables":[]},{"heading":"Food and cosmetics manufacturers","anchor":"food-and-cosmetics-manufacturers","markdown":"**A supplement sold as a food** has no TGA licence. Under Standard 3.2.2 of the Food Standards Code, a food business must notify its enforcement agency before it starts handling food, the people who handle food, or supervise its handling, must have skills and knowledge in food safety and hygiene suited to their work, and a manufacturer must have a written system for recalling unsafe food. Beyond that, state law decides: in NSW, a manufacturer whose main activity is manufacturing or wholesaling notifies the NSW Food Authority, unless it is in a sector the Authority licenses, such as dairy or meat, and the Authority sets how often it is inspected by its risk class; in Queensland, a food business that involves the manufacture of food needs a licence. Whether a product can be a food at all is on our [food pathway page](/pathways/foods).\n\n**A cosmetic** has no TGA licence either: the TGA doesn't regulate cosmetics. Cosmetic ingredients and products are controlled through AICIS, the ACCC, which is the primary regulator of cosmetic products, and the Poisons Standard. ISO 22716 is the international standard of good manufacturing practice guidelines for cosmetics, covering production, control, storage and shipment. A business that imports cosmetics or their ingredients, or manufactures industrial chemicals, must register with AICIS before it does; one that buys all its ingredients from Australian suppliers and only blends them doesn't need to. More on our [skincare page](/skincare) and in our [AICIS guide](/guides/aicis-registration).","text":"A supplement sold as a food has no TGA licence. Under Standard 3.2.2 of the Food Standards Code, a food business must notify its enforcement agency before it starts handling food, the people who handle food, or supervise its handling, must have skills and knowledge in food safety and hygiene suited to their work, and a manufacturer must have a written system for recalling unsafe food. Beyond that, state law decides: in NSW, a manufacturer whose main activity is manufacturing or wholesaling notifies the NSW Food Authority, unless it is in a sector the Authority licenses, such as dairy or meat, and the Authority sets how often it is inspected by its risk class; in Queensland, a food business that involves the manufacture of food needs a licence. Whether a product can be a food at all is on our food pathway page. A cosmetic has no TGA licence either: the TGA doesn't regulate cosmetics. Cosmetic ingredients and products are controlled through AICIS, the ACCC, which is the primary regulator of cosmetic products, and the Poisons Standard. ISO 22716 is the international standard of good manufacturing practice guidelines for cosmetics, covering production, control, storage and shipment. A business that imports cosmetics or their ingredients, or manufactures industrial chemicals, must register with AICIS before it does; one that buys all its ingredients from Australian suppliers and only blends them doesn't need to. More on our skincare page and in our AICIS guide.","items":[],"tables":[]},{"heading":"Questions to ask before you sign","anchor":"questions-to-ask-before-you-sign","markdown":"1. Does your TGA licence cover our dosage form and every step you will carry out? May we see the Australian Approved Manufacturer certificate?\n2. Who will carry out each of the five steps the listing needs, and will any step be subcontracted, and to whom?\n3. Who will release each batch for supply, and under which licence?\n4. When was your last TGA inspection, and what was its outcome? The TGA rates a site A1 (good), A2 (satisfactory) or A3 (basic), or unacceptable, and a better rating means a longer interval before the next inspection.\n5. Will you sign a GMP agreement that sets out who does each step, keeps the records available to us and lets us audit?\n6. What is the specification each batch is tested against, which tests run on every batch, and will we receive the certificate of analysis?\n7. Who runs the ongoing stability program, and is it written into the agreement?\n8. How will you tell us about deviations, complaints and anything that could lead to a recall?\n9. For a site overseas: can the site be cleared for a listed medicine, does it need a TGA inspection, and who pays for it?\n10. What are the minimum order, the unit price, the lead time and the payment terms?","text":"Does your TGA licence cover our dosage form and every step you will carry out? May we see the Australian Approved Manufacturer certificate? Who will carry out each of the five steps the listing needs, and will any step be subcontracted, and to whom? Who will release each batch for supply, and under which licence? When was your last TGA inspection, and what was its outcome? The TGA rates a site A1 (good), A2 (satisfactory) or A3 (basic), or unacceptable, and a better rating means a longer interval before the next inspection. Will you sign a GMP agreement that sets out who does each step, keeps the records available to us and lets us audit? What is the specification each batch is tested against, which tests run on every batch, and will we receive the certificate of analysis? Who runs the ongoing stability program, and is it written into the agreement? How will you tell us about deviations, complaints and anything that could lead to a recall? For a site overseas: can the site be cleared for a listed medicine, does it need a TGA inspection, and who pays for it? What are the minimum order, the unit price, the lead time and the payment terms?","items":[],"tables":[]},{"heading":"Where we come in","anchor":"where-we-come-in","markdown":"Take Friday Off is not a contract manufacturer. We develop the product, then manage its manufacture through cGMP partners matched to its format, its volume and the margin it has to make. For a listed medicine, every step is made under the licence or clearance it needs, and every batch is third-party tested before release. From our records:\n\n- **A format that wouldn't run.** An eye-health formula kept failing in encapsulation because the ingredient mix was too wet, and hand-filling would have added one to two more months. We [moved it to a direct-compression tablet](/work/eye-health-tablet-format-rescue).\n- **A first run troubleshot with the maker.** We managed manufacturing for every order of [Arxi's preconception capsule](/work/arxi-preconception-supplement), troubleshooting the first run with the maker, through to delivery.\n- **Reorders.** [BWellness](/work/bwellness-practitioner-range) has had five production batches since 2021, with imported ingredients, customs and freight managed through to its warehouse.\n\nOur minimum run is 3,000 finished retail packs per batch, a production run takes 12 to 14 weeks once the specification is signed, and payment is 50% with the purchase order and 50% before dispatch. More on our [manufacturing page](/manufacturing).","text":"Take Friday Off is not a contract manufacturer. We develop the product, then manage its manufacture through cGMP partners matched to its format, its volume and the margin it has to make. For a listed medicine, every step is made under the licence or clearance it needs, and every batch is third-party tested before release. From our records: A format that wouldn't run. An eye-health formula kept failing in encapsulation because the ingredient mix was too wet, and hand-filling would have added one to two more months. We moved it to a direct-compression tablet. A first run troubleshot with the maker. We managed manufacturing for every order of Arxi's preconception capsule, troubleshooting the first run with the maker, through to delivery. Reorders. BWellness has had five production batches since 2021, with imported ingredients, customs and freight managed through to its warehouse. Our minimum run is 3,000 finished retail packs per batch, a production run takes 12 to 14 weeks once the specification is signed, and payment is 50% with the purchase order and 50% before dispatch. More on our manufacturing page.","items":[{"lead":"A format that wouldn't run.","text":"An eye-health formula kept failing in encapsulation because the ingredient mix was too wet, and hand-filling would have added one to two more months. We moved it to a direct-compression tablet."},{"lead":"A first run troubleshot with the maker.","text":"We managed manufacturing for every order of Arxi's preconception capsule, troubleshooting the first run with the maker, through to delivery."},{"lead":"Reorders.","text":"BWellness has had five production batches since 2021, with imported ingredients, customs and freight managed through to its warehouse."}],"tables":[]}],"faqs":[{"q":"How do I find a TGA licensed manufacturer in Australia?","a":"Use the TGA's Australian Manufacturer search, in TGA Business Services under \"Public TGA Information\". It lists the Australian manufacturers that hold a current licence, and the certificate attached to each result shows the steps it is approved for. Overseas manufacturers aren't listed: their details aren't public.","md":"Use the TGA's Australian Manufacturer search, in TGA Business Services under \"Public TGA Information\". It lists the Australian manufacturers that hold a current licence, and the certificate attached to each result shows the steps it is approved for. Overseas manufacturers aren't listed: their details aren't public."},{"q":"Does a supplement manufacturer need a TGA licence?","a":"For a supplement sold as a listed medicine, yes: every step of manufacture in Australia, including packaging, labelling, testing and release for supply, needs a TGA manufacturing licence unless the manufacturer or the goods are exempt. A supplement sold as a food is made under food law instead, and has no TGA licence.","md":"For a supplement sold as a listed medicine, yes: every step of manufacture in Australia, including packaging, labelling, testing and release for supply, needs a TGA manufacturing licence unless the manufacturer or the goods are exempt. A supplement sold as a food is made under food law instead, and has no TGA licence."},{"q":"Can my supplement be made overseas?","a":"Yes. For a listed medicine, the Australian sponsor needs a TGA GMP clearance for each overseas site that carries out a step of its manufacture, unless the step is exempt, and the clearance often can't rest on another regulator's inspection, which can mean a TGA inspection first. A supplement sold as a food needs no clearance. More in our GMP clearance guide.","md":"Yes. For a listed medicine, the Australian sponsor needs a TGA GMP clearance for each overseas site that carries out a step of its manufacture, unless the step is exempt, and the clearance often can't rest on another regulator's inspection, which can mean a TGA inspection first. A supplement sold as a food needs no clearance. More in our [GMP clearance guide](/guides/gmp-clearance)."},{"q":"What should a contract manufacturing agreement cover?","a":"Under Chapter 7 of the PIC/S Guide to GMP, the written contract sets out which party is responsible for each step, keeps the records available to the sponsor and lets the sponsor audit, and the manufacturer may not subcontract without the sponsor's prior evaluation and approval, or make unauthorised changes. For a listed medicine, the TGA's guidance says the ongoing stability responsibilities should be written in too.","md":"Under Chapter 7 of the PIC/S Guide to GMP, the written contract sets out which party is responsible for each step, keeps the records available to the sponsor and lets the sponsor audit, and the manufacturer may not subcontract without the sponsor's prior evaluation and approval, or make unauthorised changes. For a listed medicine, the TGA's guidance says the ongoing stability responsibilities should be written in too."},{"q":"What tests should each batch of a supplement pass?","a":"Each batch is tested against its finished product specification and certified by an authorised person before it is released for supply. For a listed tablet or capsule, the specification reflects TGO 101: unless it follows a pharmacopoeial monograph, each active ingredient at 90.0 to 120.0% of its stated content, with different limits for vitamins, minerals, enzymes and probiotics. Medicines must also meet TGO 100's microbial standards. Not every test must run on every batch where the design, controls and data show the standard will be met.","md":"Each batch is tested against its finished product specification and certified by an authorised person before it is released for supply. For a listed tablet or capsule, the specification reflects TGO 101: unless it follows a pharmacopoeial monograph, each active ingredient at 90.0 to 120.0% of its stated content, with different limits for vitamins, minerals, enzymes and probiotics. Medicines must also meet TGO 100's microbial standards. Not every test must run on every batch where the design, controls and data show the standard will be met."},{"q":"Can a brand release its own batches?","a":"Only with a TGA manufacturing licence that covers release for supply, and only if the listing authorises it for that step. Otherwise an authorised person of a TGA-approved manufacturer releases each batch, or an independent authorised person who holds, or works under, a licence or GMP clearance that includes the step.","md":"Only with a TGA manufacturing licence that covers release for supply, and only if the listing authorises it for that step. Otherwise an authorised person of a TGA-approved manufacturer releases each batch, or an independent authorised person who holds, or works under, a licence or GMP clearance that includes the step."}],"sources":{"note":"General information, checked against these sources on 23 October 2026. It isn't legal advice or advice on a particular product or manufacturer. Our minimums, timings, payment terms and the way we work are from Take Friday Off's records.","markdown":"General information, checked against these sources on 23 October 2026. It isn't legal advice or advice on a particular product or manufacturer. Our minimums, timings, payment terms and the way we work are from Take Friday Off's records.\n\n- [Therapeutic Goods Act 1989](https://www.legislation.gov.au/C2004A03952/latest/text), section 3 (the meanings of manufacture and sponsor) and Part 3-3 (manufacturing), Federal Register of Legislation\n- [Manufacturing therapeutic goods](https://www.tga.gov.au/products/regulations-all-products/manufacturing) and [Australian manufacturing licences and overseas GMP certification](https://www.tga.gov.au/sites/default/files/australian-manufacturing-licences-and-overseas-gmp-certification.pdf), version 2.2, December 2021, Therapeutic Goods Administration\n- [Therapeutic Goods (Manufacturing Principles) Determination 2020](https://www.legislation.gov.au/F2020L00864/latest/text) and the [PIC/S Guide amendment of 2025](https://www.legislation.gov.au/F2025L00990/asmade/2025-08-28/text/original/epub/OEBPS/document_1/document_1.html), Federal Register of Legislation, and [Complying with the PIC/S Guide to GMP for medicinal products](https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medicine/good-manufacturing-practice-gmp/complying-pics-guide-good-manufacturing-practice-gmp-medicinal-products) and [GMP requirements for medicinal products: PIC/S Guide to GMP PE009-17](https://www.tga.gov.au/resources/guidance/good-manufacturing-practice-gmp-requirements-medicinal-products-pics-guide-gmp-pe009-17), Therapeutic Goods Administration\n- [Australian Manufacturer search](https://www.tga.gov.au/resources/australian-manufacturer-search) and [List of licensed manufacturers in Australia](https://www.tga.gov.au/news/regulatory-decision-notices/list-licensed-manufacturers-australia), Therapeutic Goods Administration\n- [Suspending, revoking and TGA-initiated variation of conditions of a manufacturing licence](https://www.tga.gov.au/sites/default/files/suspending-revoking-and-tga-initiated-variation-conditions-manufacturing-licence.pdf), version 1.2, December 2021, [Responsibilities of manufacturers of medicines and biologicals](https://www.tga.gov.au/responsibilities-manufacturers-medicines-and-biologicals), version 1.0, August 2017, [Manufacturer GMP compliance history](https://www.tga.gov.au/manufacturer-gmp-compliance-history) and [Manufacturer inspections: a risk-based approach to frequency](https://www.tga.gov.au/manufacturer-inspections-risk-based-approach-frequency), Therapeutic Goods Administration\n- [Where does GMP for plants and herbs begin?](https://tga.gov.au/sites/default/files/2025-01/presentation-session-29-gmp-plants-herbs.pdf), Therapeutic Goods Administration, and the [Therapeutic Goods Regulations 1990](https://www.legislation.gov.au/F1996B00406/latest/text), Schedules 7 and 8, Federal Register of Legislation\n- [Listed medicines application and submission user guide](https://www.tga.gov.au/sites/default/files/listed-assessed-listed-medicines-application-submission-user-guide.pdf), version 5.1, July 2021, [Changing a listed or assessed listed medicine: application types and change tables](https://tga.gov.au/sites/default/files/changing-listed-or-assessed-listed-medicine-application-levels-and-change-tables.pdf), version 2.2, March 2022, and [Releasing medicines manufactured at multiple sites](https://www.tga.gov.au/resources/guidance/releasing-medicines-manufactured-multiple-sites-good-manufacturing-practice-gmp), Therapeutic Goods Administration\n- [Release for supply of medicines](https://www.tga.gov.au/sites/default/files/release-supply-medicines.pdf), version 3.0, February 2019, Therapeutic Goods Administration\n- [PIC/S Guide to Good Manufacturing Practice for Medicinal Products, Part I](https://picscheme.org/docview/11332), PE 009-18 (24 September 2026), whose Part I is unchanged from PE 009-17, the version adopted in Australia: paragraphs 1.9, 4.16 and 6.3 and Chapter 7 (outsourced activities), Pharmaceutical Inspection Co-operation Scheme\n- [Ongoing stability testing for listed and complementary medicines](https://www.tga.gov.au/resources/resource/guidance/ongoing-stability-testing-listed-and-complementary-medicines) and [Australian sponsors and GMP](https://www.tga.gov.au/sites/default/files/2023-04/presentation-gmp-australian-sponsors-and-gmp.pdf), Therapeutic Goods Administration\n- [Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019](https://www.legislation.gov.au/F2019L00369/latest/text) and [Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018](https://www.legislation.gov.au/F2018L01685/latest/text), Federal Register of Legislation, and [Complying with quality standards for tablets, capsules and pills](https://www.tga.gov.au/sites/default/files/2025-05/complying-with-quality-standards-for-tablets-capsules-and-pills.pdf), May 2025, Therapeutic Goods Administration\n- [Sponsor responsibilities related to GMP clearance and certification](https://www.tga.gov.au/sponsor-responsibilities-related-gmp-clearance-and-certification), [How to obtain GMP clearance through inspection reliance](https://www.tga.gov.au/gmp-clearance-guidance) and the [GMP clearance application and submission user guide](https://www.tga.gov.au/sites/default/files/2023-12/gmp-clearance-application-submission-user-guide.docx), version 1.1, May 2025, Therapeutic Goods Administration\n- [Standard 3.2.2: Food Safety Practices and General Requirements](https://www.legislation.gov.au/F2008B00576/latest/text), Federal Register of Legislation, [Food business notification requirement](https://www.foodstandards.gov.au/business/safety/factsheets/foodbusinessnotifica100), Food Standards Australia New Zealand, [Licensing and notifying](https://www.foodauthority.nsw.gov.au/help/licensing) and [Manufacturers and wholesalers](https://www.foodauthority.nsw.gov.au/node/1136), NSW Food Authority, and the [Food Act 2006 (Qld)](https://www.legislation.qld.gov.au/view/whole/html/inforce/current/act-2006-003), sections 48 and 49\n- [Determining if your product is a cosmetic or therapeutic good](https://www.tga.gov.au/node/453082) and [What we don't do](https://tga.gov.au/node/287124), Therapeutic Goods Administration, [ISO 22716:2007, Cosmetics: Good Manufacturing Practices](https://www.iso.org/standard/36437.html), International Organization for Standardization, and [Personal care, skincare, make-up and other cosmetic products](https://www.industrialchemicals.gov.au/node/258), Australian Industrial Chemicals Introduction Scheme","items":[{"text":"Therapeutic Goods Act 1989, section 3 (the meanings of manufacture and sponsor) and Part 3-3 (manufacturing), Federal Register of Legislation","links":[{"title":"Therapeutic Goods Act 1989","url":"https://www.legislation.gov.au/C2004A03952/latest/text"}]},{"text":"Manufacturing therapeutic goods and Australian manufacturing licences and overseas GMP certification, version 2.2, December 2021, Therapeutic Goods Administration","links":[{"title":"Manufacturing therapeutic goods","url":"https://www.tga.gov.au/products/regulations-all-products/manufacturing"},{"title":"Australian manufacturing licences and overseas GMP certification","url":"https://www.tga.gov.au/sites/default/files/australian-manufacturing-licences-and-overseas-gmp-certification.pdf"}]},{"text":"Therapeutic Goods (Manufacturing Principles) Determination 2020 and the PIC/S Guide amendment of 2025, Federal Register of Legislation, and Complying with the PIC/S Guide to GMP for medicinal products and GMP requirements for medicinal products: PIC/S Guide to GMP PE009-17, Therapeutic Goods Administration","links":[{"title":"Therapeutic Goods (Manufacturing Principles) Determination 2020","url":"https://www.legislation.gov.au/F2020L00864/latest/text"},{"title":"PIC/S Guide amendment of 2025","url":"https://www.legislation.gov.au/F2025L00990/asmade/2025-08-28/text/original/epub/OEBPS/document_1/document_1.html"},{"title":"Complying with the PIC/S Guide to GMP for medicinal products","url":"https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medicine/good-manufacturing-practice-gmp/complying-pics-guide-good-manufacturing-practice-gmp-medicinal-products"},{"title":"GMP requirements for medicinal products: PIC/S Guide to GMP PE009-17","url":"https://www.tga.gov.au/resources/guidance/good-manufacturing-practice-gmp-requirements-medicinal-products-pics-guide-gmp-pe009-17"}]},{"text":"Australian Manufacturer search and List of licensed manufacturers in Australia, Therapeutic Goods Administration","links":[{"title":"Australian Manufacturer search","url":"https://www.tga.gov.au/resources/australian-manufacturer-search"},{"title":"List of licensed manufacturers in Australia","url":"https://www.tga.gov.au/news/regulatory-decision-notices/list-licensed-manufacturers-australia"}]},{"text":"Suspending, revoking and TGA-initiated variation of conditions of a manufacturing licence, version 1.2, December 2021, Responsibilities of manufacturers of medicines and biologicals, version 1.0, August 2017, Manufacturer GMP compliance history and Manufacturer inspections: a risk-based approach to frequency, Therapeutic Goods Administration","links":[{"title":"Suspending, revoking and TGA-initiated variation of conditions of a manufacturing licence","url":"https://www.tga.gov.au/sites/default/files/suspending-revoking-and-tga-initiated-variation-conditions-manufacturing-licence.pdf"},{"title":"Responsibilities of manufacturers of medicines and biologicals","url":"https://www.tga.gov.au/responsibilities-manufacturers-medicines-and-biologicals"},{"title":"Manufacturer GMP compliance history","url":"https://www.tga.gov.au/manufacturer-gmp-compliance-history"},{"title":"Manufacturer inspections: a risk-based approach to frequency","url":"https://www.tga.gov.au/manufacturer-inspections-risk-based-approach-frequency"}]},{"text":"Where does GMP for plants and herbs begin?, Therapeutic Goods Administration, and the Therapeutic Goods Regulations 1990, Schedules 7 and 8, Federal Register of Legislation","links":[{"title":"Where does GMP for plants and herbs begin?","url":"https://tga.gov.au/sites/default/files/2025-01/presentation-session-29-gmp-plants-herbs.pdf"},{"title":"Therapeutic Goods Regulations 1990","url":"https://www.legislation.gov.au/F1996B00406/latest/text"}]},{"text":"Listed medicines application and submission user guide, version 5.1, July 2021, Changing a listed or assessed listed medicine: application types and change tables, version 2.2, March 2022, and Releasing medicines manufactured at multiple sites, Therapeutic Goods Administration","links":[{"title":"Listed medicines application and submission user guide","url":"https://www.tga.gov.au/sites/default/files/listed-assessed-listed-medicines-application-submission-user-guide.pdf"},{"title":"Changing a listed or assessed listed medicine: application types and change tables","url":"https://tga.gov.au/sites/default/files/changing-listed-or-assessed-listed-medicine-application-levels-and-change-tables.pdf"},{"title":"Releasing medicines manufactured at multiple sites","url":"https://www.tga.gov.au/resources/guidance/releasing-medicines-manufactured-multiple-sites-good-manufacturing-practice-gmp"}]},{"text":"Release for supply of medicines, version 3.0, February 2019, Therapeutic Goods Administration","links":[{"title":"Release for supply of medicines","url":"https://www.tga.gov.au/sites/default/files/release-supply-medicines.pdf"}]},{"text":"PIC/S Guide to Good Manufacturing Practice for Medicinal Products, Part I, PE 009-18 (24 September 2026), whose Part I is unchanged from PE 009-17, the version adopted in Australia: paragraphs 1.9, 4.16 and 6.3 and Chapter 7 (outsourced activities), Pharmaceutical Inspection Co-operation Scheme","links":[{"title":"PIC/S Guide to Good Manufacturing Practice for Medicinal Products, Part I","url":"https://picscheme.org/docview/11332"}]},{"text":"Ongoing stability testing for listed and complementary medicines and Australian sponsors and GMP, Therapeutic Goods Administration","links":[{"title":"Ongoing stability testing for listed and complementary medicines","url":"https://www.tga.gov.au/resources/resource/guidance/ongoing-stability-testing-listed-and-complementary-medicines"},{"title":"Australian sponsors and GMP","url":"https://www.tga.gov.au/sites/default/files/2023-04/presentation-gmp-australian-sponsors-and-gmp.pdf"}]},{"text":"Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019 and Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018, Federal Register of Legislation, and Complying with quality standards for tablets, capsules and pills, May 2025, Therapeutic Goods Administration","links":[{"title":"Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019","url":"https://www.legislation.gov.au/F2019L00369/latest/text"},{"title":"Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018","url":"https://www.legislation.gov.au/F2018L01685/latest/text"},{"title":"Complying with quality standards for tablets, capsules and pills","url":"https://www.tga.gov.au/sites/default/files/2025-05/complying-with-quality-standards-for-tablets-capsules-and-pills.pdf"}]},{"text":"Sponsor responsibilities related to GMP clearance and certification, How to obtain GMP clearance through inspection reliance and the GMP clearance application and submission user guide, version 1.1, May 2025, Therapeutic Goods Administration","links":[{"title":"Sponsor responsibilities related to GMP clearance and certification","url":"https://www.tga.gov.au/sponsor-responsibilities-related-gmp-clearance-and-certification"},{"title":"How to obtain GMP clearance through inspection reliance","url":"https://www.tga.gov.au/gmp-clearance-guidance"},{"title":"GMP clearance application and submission user guide","url":"https://www.tga.gov.au/sites/default/files/2023-12/gmp-clearance-application-submission-user-guide.docx"}]},{"text":"Standard 3.2.2: Food Safety Practices and General Requirements, Federal Register of Legislation, Food business notification requirement, Food Standards Australia New Zealand, Licensing and notifying and Manufacturers and wholesalers, NSW Food Authority, and the Food Act 2006 (Qld), sections 48 and 49","links":[{"title":"Standard 3.2.2: Food Safety Practices and General Requirements","url":"https://www.legislation.gov.au/F2008B00576/latest/text"},{"title":"Food business notification requirement","url":"https://www.foodstandards.gov.au/business/safety/factsheets/foodbusinessnotifica100"},{"title":"Licensing and notifying","url":"https://www.foodauthority.nsw.gov.au/help/licensing"},{"title":"Manufacturers and wholesalers","url":"https://www.foodauthority.nsw.gov.au/node/1136"},{"title":"Food Act 2006 (Qld)","url":"https://www.legislation.qld.gov.au/view/whole/html/inforce/current/act-2006-003"}]},{"text":"Determining if your product is a cosmetic or therapeutic good and What we don't do, Therapeutic Goods Administration, ISO 22716:2007, Cosmetics: Good Manufacturing Practices, International Organization for Standardization, and Personal care, skincare, make-up and other cosmetic products, Australian Industrial Chemicals Introduction Scheme","links":[{"title":"Determining if your product is a cosmetic or therapeutic good","url":"https://www.tga.gov.au/node/453082"},{"title":"What we don't do","url":"https://tga.gov.au/node/287124"},{"title":"ISO 22716:2007, Cosmetics: Good Manufacturing Practices","url":"https://www.iso.org/standard/36437.html"},{"title":"Personal care, skincare, make-up and other cosmetic products","url":"https://www.industrialchemicals.gov.au/node/258"}]}]}},{"slug":"extending-a-supplement-range","kind":"guide","url":"/guides/extending-a-supplement-range","title":"Extending a supplement range: your next product, and the one after","name":"Extending a range","description":"Supplement range extension in Australia: what each new product needs from the TGA, what carries over from your first, and how brands we work with grew.","eyebrow":"Development journey","lead":"Your first product is listed and selling, and the next one starts further along: the brand, the sponsor, the manufacturing partners and the way the evidence is built carry over. The product itself doesn't. Under the TGA's rules, most new products are new medicines with listings of their own. This guide covers what carries over and what starts again, the TGA side of each kind of extension, and how brands we work with grew their ranges.","parent":"/product-development","studies":["bwellness-practitioner-range","everleanbody-saffron-capsule","the-belly-solution-travel-gut-health-powder","arxi-preconception-supplement","eye-health-tablet-format-rescue","vitable-hair-growth-range"],"formats":[],"order":79,"updated":"2026-10-27","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- In the TGA's change tables, a product with a different active ingredient, a different quantity of one or a different dosage form is a new medicine: a new listing, with its own application fee and, once it sells, its own annual charge.\n- A version that differs only in its flavour, colour, fragrance or printing ink is a grouping application instead, charged at the fee for a new product.\n- A listing that has never had turnover stays exempt from the annual charge until sales start, as long as the sponsor declares, between 1 and 22 July each year, that it had none in the year before.\n- What carries over: your sponsor, your manufacturing partners and suppliers, and the way your evidence and labels are built. What starts again: each product's formula, evidence, listing, label and stability program.\n- From our records: nine products for BWellness, a second product for EverLeanBody, and a range of five planned around The Belly Solution's first hero product.","text":"In the TGA's change tables, a product with a different active ingredient, a different quantity of one or a different dosage form is a new medicine: a new listing, with its own application fee and, once it sells, its own annual charge. A version that differs only in its flavour, colour, fragrance or printing ink is a grouping application instead, charged at the fee for a new product. A listing that has never had turnover stays exempt from the annual charge until sales start, as long as the sponsor declares, between 1 and 22 July each year, that it had none in the year before. What carries over: your sponsor, your manufacturing partners and suppliers, and the way your evidence and labels are built. What starts again: each product's formula, evidence, listing, label and stability program. From our records: nine products for BWellness, a second product for EverLeanBody, and a range of five planned around The Belly Solution's first hero product.","items":[],"tables":[]},{"heading":"What carries over, and what starts again","anchor":"what-carries-over-and-what-starts-again","markdown":"| Carries over from your first product | Starts again for each new one |\n| --- | --- |\n| The brand, its customers and its channels | The formula and its specification |\n| The sponsor and its systems | The evidence for every claim |\n| Manufacturing partners already making for you, where their licence or clearance covers the new dosage form and steps | The listing on the ARTG, and its fees |\n| Packaging and ingredient suppliers | The label |\n| How the evidence, the label and the stability program are built | The stability program |","text":"Carries over from your first product: The brand, its customers and its channels; Starts again for each new one: The formula and its specification. Carries over from your first product: The sponsor and its systems; Starts again for each new one: The evidence for every claim. Carries over from your first product: Manufacturing partners already making for you, where their licence or clearance covers the new dosage form and steps; Starts again for each new one: The listing on the ARTG, and its fees. Carries over from your first product: Packaging and ingredient suppliers; Starts again for each new one: The label. Carries over from your first product: How the evidence, the label and the stability program are built; Starts again for each new one: The stability program.","items":[],"tables":[{"header":["Carries over from your first product","Starts again for each new one"],"rows":[["The brand, its customers and its channels","The formula and its specification"],["The sponsor and its systems","The evidence for every claim"],["Manufacturing partners already making for you, where their licence or clearance covers the new dosage form and steps","The listing on the ARTG, and its fees"],["Packaging and ingredient suppliers","The label"],["How the evidence, the label and the stability program are built","The stability program"]]}]},{"heading":"The TGA side of each kind of extension","anchor":"the-tga-side-of-each-kind-of-extension","markdown":"- **A new product.** Adding, replacing or removing an active ingredient, changing an active's quantity or changing the dosage form all make a new medicine in the TGA's change tables: a new listing. What a listing costs is in our [development cost guide](/guides/supplement-development-cost).\n- **A new flavour, colour or fragrance.** A change to flavour, colour, fragrance or printing ink only is a grouping application for a listed medicine, at the same fee as a new product.\n- **A product on another pathway.** A range can cross pathways. Vitable's TGA-listed capsule has a matching serum on the cosmetics pathway, and ATP Science's four listed capsules sit beside a performance powder on the food pathway. Each product follows its own pathway's rules ([medicine, food or cosmetic?](/pathways)).\n- **The same manufacturer.** A manufacturer can make the new product if its TGA licence, or its GMP clearance overseas, covers the new dosage form and every step it will carry out. Adding or changing a manufacturer is an update to the ARTG record, with no fee. More in [choosing a supplement manufacturer](/guides/choosing-a-supplement-manufacturer).\n- **A sample or trial pack.** From our records: a 7-day sample pack for Arxi's preconception capsule, for events and sampling, and a trial pack beside the 60-count pack of an eye-health formula.","text":"A new product. Adding, replacing or removing an active ingredient, changing an active's quantity or changing the dosage form all make a new medicine in the TGA's change tables: a new listing. What a listing costs is in our development cost guide. A new flavour, colour or fragrance. A change to flavour, colour, fragrance or printing ink only is a grouping application for a listed medicine, at the same fee as a new product. A product on another pathway. A range can cross pathways. Vitable's TGA-listed capsule has a matching serum on the cosmetics pathway, and ATP Science's four listed capsules sit beside a performance powder on the food pathway. Each product follows its own pathway's rules (medicine, food or cosmetic?). The same manufacturer. A manufacturer can make the new product if its TGA licence, or its GMP clearance overseas, covers the new dosage form and every step it will carry out. Adding or changing a manufacturer is an update to the ARTG record, with no fee. More in choosing a supplement manufacturer. A sample or trial pack. From our records: a 7-day sample pack for Arxi's preconception capsule, for events and sampling, and a trial pack beside the 60-count pack of an eye-health formula.","items":[{"lead":"A new product.","text":"Adding, replacing or removing an active ingredient, changing an active's quantity or changing the dosage form all make a new medicine in the TGA's change tables: a new listing. What a listing costs is in our development cost guide."},{"lead":"A new flavour, colour or fragrance.","text":"A change to flavour, colour, fragrance or printing ink only is a grouping application for a listed medicine, at the same fee as a new product."},{"lead":"A product on another pathway.","text":"A range can cross pathways. Vitable's TGA-listed capsule has a matching serum on the cosmetics pathway, and ATP Science's four listed capsules sit beside a performance powder on the food pathway. Each product follows its own pathway's rules (medicine, food or cosmetic?)."},{"lead":"The same manufacturer.","text":"A manufacturer can make the new product if its TGA licence, or its GMP clearance overseas, covers the new dosage form and every step it will carry out. Adding or changing a manufacturer is an update to the ARTG record, with no fee. More in choosing a supplement manufacturer."},{"lead":"A sample or trial pack.","text":"From our records: a 7-day sample pack for Arxi's preconception capsule, for events and sampling, and a trial pack beside the 60-count pack of an eye-health formula."}],"tables":[]},{"heading":"Planning the range","anchor":"planning-the-range","markdown":"Plan the range, then build it a product at a time. The Belly Solution started as a new company with a range of five products in mind, and launched one hero product first: a TGA-listed travel gut-health powder that went into a national pharmacy distribution trial, with more than 30 new stockists in its first week. Design each product to its price before the formula is fixed ([design to the price](/guides/supplement-development-cost#design-to-the-price-the-cost-of-goods)), and keep the products already selling in stock: a range grows on its reorders.","text":"Plan the range, then build it a product at a time. The Belly Solution started as a new company with a range of five products in mind, and launched one hero product first: a TGA-listed travel gut-health powder that went into a national pharmacy distribution trial, with more than 30 new stockists in its first week. Design each product to its price before the formula is fixed (design to the price), and keep the products already selling in stock: a range grows on its reorders.","items":[],"tables":[]},{"heading":"From our records","anchor":"from-our-records","markdown":"- [BWellness](/work/bwellness-practitioner-range): nine products for the same practitioner brand, including an immune powder built on Wellmune® and an algal omega-3 capsule built on life's®OMEGA with VitaShine™ vegan vitamin D3. Five production batches from 2021 to 2025, and a sixth order in the pipeline.\n- [EverLeanBody](/work/everleanbody-saffron-capsule): after its first capsule, 5.8 months from signed brief to dispatch, a second product built on Eriomin®, a clinically studied lemon flavonoid extract, now in development with us.\n- [The Belly Solution](/work/the-belly-solution-travel-gut-health-powder): a first hero product from a planned range of five, with a second batch now ordered.\n- [Arxi](/work/arxi-preconception-supplement): a preconception capsule with three production orders since 2024, a 7-day sample pack, then a [prenatal chewable](/work/arxi-prenatal-chewable), in production now.\n- [An eye-health brand](/work/eye-health-tablet-format-rescue): nine products developed and quoted, spanning eye health, omega-3s, probiotics, liver, immune, prostate and more, with three taken into production.\n- [A sports nutrition brand](/work/sports-nutrition-joint-formula): a joint-support formula brought into its range as a TGA-listed medicine, delivered in 2023, alongside further products we scoped for the brand.\n- [An international skincare brand](/work/skincare-brand-regulatory-partner): two supplements and a sunscreen, with stability studies out to 36 months, and its regulatory work on a monthly retainer since 2024.","text":"BWellness: nine products for the same practitioner brand, including an immune powder built on Wellmune® and an algal omega-3 capsule built on life's®OMEGA with VitaShine™ vegan vitamin D3. Five production batches from 2021 to 2025, and a sixth order in the pipeline. EverLeanBody: after its first capsule, 5.8 months from signed brief to dispatch, a second product built on Eriomin®, a clinically studied lemon flavonoid extract, now in development with us. The Belly Solution: a first hero product from a planned range of five, with a second batch now ordered. Arxi: a preconception capsule with three production orders since 2024, a 7-day sample pack, then a prenatal chewable, in production now. An eye-health brand: nine products developed and quoted, spanning eye health, omega-3s, probiotics, liver, immune, prostate and more, with three taken into production. A sports nutrition brand: a joint-support formula brought into its range as a TGA-listed medicine, delivered in 2023, alongside further products we scoped for the brand. An international skincare brand: two supplements and a sunscreen, with stability studies out to 36 months, and its regulatory work on a monthly retainer since 2024.","items":[],"tables":[]}],"faqs":[{"q":"Does each new product need its own TGA listing?","a":"A product with a different active ingredient, a different quantity of one or a different dosage form does: in the TGA's change tables those are new medicines. A version that differs only in flavour, colour, fragrance or printing ink is a grouping application instead, at the same fee as a new product.","md":"A product with a different active ingredient, a different quantity of one or a different dosage form does: in the TGA's change tables those are new medicines. A version that differs only in flavour, colour, fragrance or printing ink is a grouping application instead, at the same fee as a new product."},{"q":"Do we pay the annual charge before a new product sells?","a":"Not while it has never had turnover. A listing stays exempt until sales start, as long as the sponsor declares, between 1 and 22 July each year, that it had none in the year before.","md":"Not while it has never had turnover. A listing stays exempt until sales start, as long as the sponsor declares, between 1 and 22 July each year, that it had none in the year before."},{"q":"Can one range mix medicines, foods and cosmetics?","a":"Yes. Each product follows its own pathway: Vitable's range pairs a TGA-listed capsule with a cosmetic serum, and ATP Science's pairs listed capsules with a food-pathway powder.","md":"Yes. Each product follows its own pathway: Vitable's range pairs a TGA-listed capsule with a cosmetic serum, and ATP Science's pairs listed capsules with a food-pathway powder."},{"q":"Can our current manufacturer make the new product?","a":"If its licence, or its GMP clearance for a site overseas, covers the new product's dosage form and every step it will carry out. If not, we match the product to a partner that is, and adding a manufacturer is an update to the ARTG record, with no fee.","md":"If its licence, or its GMP clearance for a site overseas, covers the new product's dosage form and every step it will carry out. If not, we match the product to a partner that is, and adding a manufacturer is an update to the ARTG record, with no fee."},{"q":"How long does the next product take?","a":"It depends on the formula, the format and the pathway, as the first one did. From our records, listed medicines have taken 32 days to 12 weeks from design to production order. See how long it takes.","md":"It depends on the formula, the format and the pathway, as the first one did. From our records, listed medicines have taken 32 days to 12 weeks from design to production order. See [how long it takes](/guides/supplement-development-timeline)."}],"sources":{"note":"General information, checked against these sources in October 2026: the change tables on 27 October. It isn't advice on a particular product.","markdown":"General information, checked against these sources in October 2026: the change tables on 27 October. It isn't advice on a particular product.\n\n- [Changing a listed or assessed listed medicine: application levels and change tables](https://tga.gov.au/sites/default/files/changing-listed-or-assessed-listed-medicine-application-levels-and-change-tables.pdf), version 2.2, March 2022, Tables A, B and C, Therapeutic Goods Administration\n- [Annual charges](https://www.tga.gov.au/products/regulations-all-products/fees-and-payments/annual-charges), Therapeutic Goods Administration\n- [Australian manufacturing licences and overseas GMP certification](https://www.tga.gov.au/sites/default/files/australian-manufacturing-licences-and-overseas-gmp-certification.pdf), Therapeutic Goods Administration","items":[{"text":"Changing a listed or assessed listed medicine: application levels and change tables, version 2.2, March 2022, Tables A, B and C, Therapeutic Goods Administration","links":[{"title":"Changing a listed or assessed listed medicine: application levels and change tables","url":"https://tga.gov.au/sites/default/files/changing-listed-or-assessed-listed-medicine-application-levels-and-change-tables.pdf"}]},{"text":"Annual charges, Therapeutic Goods Administration","links":[{"title":"Annual charges","url":"https://www.tga.gov.au/products/regulations-all-products/fees-and-payments/annual-charges"}]},{"text":"Australian manufacturing licences and overseas GMP certification, Therapeutic Goods Administration","links":[{"title":"Australian manufacturing licences and overseas GMP certification","url":"https://www.tga.gov.au/sites/default/files/australian-manufacturing-licences-and-overseas-gmp-certification.pdf"}]}]}},{"slug":"reformulating-a-supplement","kind":"guide","url":"/guides/reformulating-a-supplement","title":"Reformulating a supplement: when a product has to change","name":"Reformulating a product","description":"Reformulating a TGA-listed supplement: which changes make a new listing, which update yours, the stability evidence, and reformulations from our records.","eyebrow":"Development journey","lead":"Products change: a better ingredient or dose, a claim the evidence now supports, a format that won't hold, a supplier that can't deliver or a manufacturer that has to change. What decides the cost is how the TGA sees the change. Some changes update the listing you have; others make a new medicine. This guide covers why products are reformulated, what the TGA treats as new, and how the reformulations in our records were run.","parent":"/product-development","studies":["sports-brand-core-range","pump-haircare-hair-supplement","probiotic-skin-supplement","eye-health-tablet-format-rescue","arxi-prenatal-chewable","prenatal-multivitamin-capsule"],"formats":[],"order":80,"updated":"2026-10-27","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- In the TGA's change tables, adding, replacing or removing an active ingredient, changing an active's quantity, changing the dosage form, or changing an excipient for anything other than flavour, colour, fragrance or printing ink makes a new medicine: a new listing.\n- A change to flavour, colour, fragrance or printing ink only, to the indications only or to the name only is a grouping application, at the fee for a new product.\n- Changing or adding a manufacturer, or changing the type of container, is an update to the ARTG record, with no fee.\n- A new formula needs stability evidence of its own: TGA guidance says the sponsor should hold it at or before listing, showing the product meets its specifications until its expiry date.\n- From our records: four ATP Science capsules reformulated from scratch, in a five-product range with reorders on three within a year; Pump Haircare's upgraded formula with a full new listing package, shipped in 2026; and the second version of a probiotic skin supplement, from design to production order in 12 weeks.","text":"In the TGA's change tables, adding, replacing or removing an active ingredient, changing an active's quantity, changing the dosage form, or changing an excipient for anything other than flavour, colour, fragrance or printing ink makes a new medicine: a new listing. A change to flavour, colour, fragrance or printing ink only, to the indications only or to the name only is a grouping application, at the fee for a new product. Changing or adding a manufacturer, or changing the type of container, is an update to the ARTG record, with no fee. A new formula needs stability evidence of its own: TGA guidance says the sponsor should hold it at or before listing, showing the product meets its specifications until its expiry date. From our records: four ATP Science capsules reformulated from scratch, in a five-product range with reorders on three within a year; Pump Haircare's upgraded formula with a full new listing package, shipped in 2026; and the second version of a probiotic skin supplement, from design to production order in 12 weeks.","items":[],"tables":[]},{"heading":"Why products are reformulated","anchor":"why-products-are-reformulated","markdown":"From our records, for seven reasons:\n\n- **Ingredient quality, dose and claims.** Several of ATP Science's best-known formulas had room to improve on ingredient quality, dose and permitted indications. We reformulated four TGA-listed capsules from scratch, one built on Testofen®, a clinically studied fenugreek extract.\n- **A range that grew.** Pump Haircare's first TGA-listed hair growth formula has been reordered since 2021. As the range grew, we built an upgraded version with a full new listing package and stability testing, shipped in 2026 ([hair growth supplements](/guides/hair-growth-supplement-development)).\n- **A new version of a program.** A skin brand's daily supplement, the second version of its formula, with probiotics at its core: a two-a-day product, from design to production order in 12 weeks, shipped in 2025.\n- **A format that won't hold.** An eye-health formula kept failing in encapsulation because the mix was too wet. We moved it to a direct-compression tablet and designed the stability protocol for a three-year expiry.\n- **Taste and stability.** Arxi's prenatal started as a liquid drop that wasn't stable and couldn't have its taste masked. We traced the main odour to one selenium form and removed it, then moved to a two-a-day chewable with Rocoat® coated B vitamins.\n- **Supply.** For a prenatal built on plant powders, we sourced a replacement supply of the formula's lead plant ingredient.\n- **A new dose standard.** An eye-health formula's vitamin E was set to the AREDS2 level before it was built.","text":"From our records, for seven reasons: Ingredient quality, dose and claims. Several of ATP Science's best-known formulas had room to improve on ingredient quality, dose and permitted indications. We reformulated four TGA-listed capsules from scratch, one built on Testofen®, a clinically studied fenugreek extract. A range that grew. Pump Haircare's first TGA-listed hair growth formula has been reordered since 2021. As the range grew, we built an upgraded version with a full new listing package and stability testing, shipped in 2026 (hair growth supplements). A new version of a program. A skin brand's daily supplement, the second version of its formula, with probiotics at its core: a two-a-day product, from design to production order in 12 weeks, shipped in 2025. A format that won't hold. An eye-health formula kept failing in encapsulation because the mix was too wet. We moved it to a direct-compression tablet and designed the stability protocol for a three-year expiry. Taste and stability. Arxi's prenatal started as a liquid drop that wasn't stable and couldn't have its taste masked. We traced the main odour to one selenium form and removed it, then moved to a two-a-day chewable with Rocoat® coated B vitamins. Supply. For a prenatal built on plant powders, we sourced a replacement supply of the formula's lead plant ingredient. A new dose standard. An eye-health formula's vitamin E was set to the AREDS2 level before it was built.","items":[{"lead":"Ingredient quality, dose and claims.","text":"Several of ATP Science's best-known formulas had room to improve on ingredient quality, dose and permitted indications. We reformulated four TGA-listed capsules from scratch, one built on Testofen®, a clinically studied fenugreek extract."},{"lead":"A range that grew.","text":"Pump Haircare's first TGA-listed hair growth formula has been reordered since 2021. As the range grew, we built an upgraded version with a full new listing package and stability testing, shipped in 2026 (hair growth supplements)."},{"lead":"A new version of a program.","text":"A skin brand's daily supplement, the second version of its formula, with probiotics at its core: a two-a-day product, from design to production order in 12 weeks, shipped in 2025."},{"lead":"A format that won't hold.","text":"An eye-health formula kept failing in encapsulation because the mix was too wet. We moved it to a direct-compression tablet and designed the stability protocol for a three-year expiry."},{"lead":"Taste and stability.","text":"Arxi's prenatal started as a liquid drop that wasn't stable and couldn't have its taste masked. We traced the main odour to one selenium form and removed it, then moved to a two-a-day chewable with Rocoat® coated B vitamins."},{"lead":"Supply.","text":"For a prenatal built on plant powders, we sourced a replacement supply of the formula's lead plant ingredient."},{"lead":"A new dose standard.","text":"An eye-health formula's vitamin E was set to the AREDS2 level before it was built."}],"tables":[]},{"heading":"What the TGA treats as a new medicine","anchor":"what-the-tga-treats-as-a-new-medicine","markdown":"The TGA's change tables set out how each change to a listed medicine is made.\n\n| Change to a listed medicine | How it's made |\n| --- | --- |\n| Add, replace or remove an active ingredient | New listing |\n| Change an active ingredient's quantity or concentration | New listing |\n| Change the dosage form, such as a capsule to a tablet | New listing |\n| Change, add or remove an excipient for any purpose other than flavour, colour, fragrance or printing ink | New listing |\n| Change the product name and the indications together | New listing |\n| Change the flavour, colour, fragrance or printing ink only | Grouping, at the fee for a new product |\n| Change the indications only, or the name only | Grouping |\n| Change or add a manufacturer, or the steps it carries out | ARTG record update, no fee |\n| Change the type of container | ARTG record update, no fee |\n\nThe tables are the TGA's guidance, version 2.2 of March 2022. We check the current version, and the product's own entry, before a change is designed.","text":"The TGA's change tables set out how each change to a listed medicine is made. Change to a listed medicine: Add, replace or remove an active ingredient; How it's made: New listing. Change to a listed medicine: Change an active ingredient's quantity or concentration; How it's made: New listing. Change to a listed medicine: Change the dosage form, such as a capsule to a tablet; How it's made: New listing. Change to a listed medicine: Change, add or remove an excipient for any purpose other than flavour, colour, fragrance or printing ink; How it's made: New listing. Change to a listed medicine: Change the product name and the indications together; How it's made: New listing. Change to a listed medicine: Change the flavour, colour, fragrance or printing ink only; How it's made: Grouping, at the fee for a new product. Change to a listed medicine: Change the indications only, or the name only; How it's made: Grouping. Change to a listed medicine: Change or add a manufacturer, or the steps it carries out; How it's made: ARTG record update, no fee. Change to a listed medicine: Change the type of container; How it's made: ARTG record update, no fee. The tables are the TGA's guidance, version 2.2 of March 2022. We check the current version, and the product's own entry, before a change is designed.","items":[],"tables":[{"header":["Change to a listed medicine","How it's made"],"rows":[["Add, replace or remove an active ingredient","New listing"],["Change an active ingredient's quantity or concentration","New listing"],["Change the dosage form, such as a capsule to a tablet","New listing"],["Change, add or remove an excipient for any purpose other than flavour, colour, fragrance or printing ink","New listing"],["Change the product name and the indications together","New listing"],["Change the flavour, colour, fragrance or printing ink only","Grouping, at the fee for a new product"],["Change the indications only, or the name only","Grouping"],["Change or add a manufacturer, or the steps it carries out","ARTG record update, no fee"],["Change the type of container","ARTG record update, no fee"]]}]},{"heading":"What a reformulation involves","anchor":"what-a-reformulation-involves","markdown":"The same work as a new product, built on what you already have: the formula and its specification, the evidence for each claim, the listing (new, grouped or updated), the label, the stability program and the manufacturing run. For Pump Haircare's upgrade, that meant a full new listing package and stability testing. For ATP Science, it meant TGA listings, stability protocols and label review across four capsules, with manufacturing managed through a co-packer delay, then reorders on three of the range's five products within a year.\n\nA changed formula is also a chance to check it against the rules as they stand now. The Permissible Ingredients Determination changes: there have been three determinations in 2026 alone, and each can change an ingredient's limits or required statements ([permissible ingredients](/guides/permissible-ingredients)).","text":"The same work as a new product, built on what you already have: the formula and its specification, the evidence for each claim, the listing (new, grouped or updated), the label, the stability program and the manufacturing run. For Pump Haircare's upgrade, that meant a full new listing package and stability testing. For ATP Science, it meant TGA listings, stability protocols and label review across four capsules, with manufacturing managed through a co-packer delay, then reorders on three of the range's five products within a year. A changed formula is also a chance to check it against the rules as they stand now. The Permissible Ingredients Determination changes: there have been three determinations in 2026 alone, and each can change an ingredient's limits or required statements (permissible ingredients).","items":[],"tables":[]}],"faqs":[{"q":"Does changing a supplement's formula need a new TGA listing?","a":"Usually, if an active ingredient or its quantity changes, the dosage form changes, or an excipient changes for any purpose other than flavour, colour, fragrance or printing ink: in the TGA's change tables, those make a new medicine. A change to flavour, colour, fragrance or printing ink only is a grouping application.","md":"Usually, if an active ingredient or its quantity changes, the dosage form changes, or an excipient changes for any purpose other than flavour, colour, fragrance or printing ink: in the TGA's change tables, those make a new medicine. A change to flavour, colour, fragrance or printing ink only is a grouping application."},{"q":"Can we change manufacturer without a new listing?","a":"Yes. Changing or adding a manufacturer is an update to the ARTG record, with no fee. Every step still has to be made at a site with a TGA licence in Australia, or under a TGA GMP clearance overseas, unless the step is exempt. See choosing a supplement manufacturer.","md":"Yes. Changing or adding a manufacturer is an update to the ARTG record, with no fee. Every step still has to be made at a site with a TGA licence in Australia, or under a TGA GMP clearance overseas, unless the step is exempt. See [choosing a supplement manufacturer](/guides/choosing-a-supplement-manufacturer)."},{"q":"Does a reformulated product need new stability data?","a":"A new formula does. TGA guidance says a listed medicine's sponsor should hold stability evidence at or before listing, showing the product meets its specifications, stored as its label says, until its expiry date. See stability testing.","md":"A new formula does. TGA guidance says a listed medicine's sponsor should hold stability evidence at or before listing, showing the product meets its specifications, stored as its label says, until its expiry date. See [stability testing](/guides/stability-testing)."},{"q":"How long does a reformulation take?","a":"From our records, the second version of a probiotic skin supplement took 12 weeks from design to production order. One that needs a new ingredient approved first takes longer: the law allows 40 working days for the TGA's preliminary assessment, then 70 to 180 working days for the evaluation (new ingredient applications).","md":"From our records, the second version of a probiotic skin supplement took 12 weeks from design to production order. One that needs a new ingredient approved first takes longer: the law allows 40 working days for the TGA's preliminary assessment, then 70 to 180 working days for the evaluation ([new ingredient applications](/new-ingredients))."},{"q":"Can you reformulate a product another company developed?","a":"Yes. ATP Science's capsules were among its best-known existing formulas. We rebuilt them from scratch, then handled the TGA listings, stability protocols and label review, and managed manufacturing.","md":"Yes. ATP Science's capsules were among its best-known existing formulas. We rebuilt them from scratch, then handled the TGA listings, stability protocols and label review, and managed manufacturing."}],"sources":{"note":"General information, checked against these sources in October 2026: the change tables on 27 October. It isn't advice on a particular product.","markdown":"General information, checked against these sources in October 2026: the change tables on 27 October. It isn't advice on a particular product.\n\n- [Changing a listed or assessed listed medicine: application levels and change tables](https://tga.gov.au/sites/default/files/changing-listed-or-assessed-listed-medicine-application-levels-and-change-tables.pdf), version 2.2, March 2022, Tables A, B and C, Therapeutic Goods Administration\n- [Stability requirements for listed medicines](https://www.tga.gov.au/stability-requirements-listed-medicines), Therapeutic Goods Administration\n- [Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026](https://www.legislation.gov.au/F2026L01382/asmade/versions), Federal Register of Legislation","items":[{"text":"Changing a listed or assessed listed medicine: application levels and change tables, version 2.2, March 2022, Tables A, B and C, Therapeutic Goods Administration","links":[{"title":"Changing a listed or assessed listed medicine: application levels and change tables","url":"https://tga.gov.au/sites/default/files/changing-listed-or-assessed-listed-medicine-application-levels-and-change-tables.pdf"}]},{"text":"Stability requirements for listed medicines, Therapeutic Goods Administration","links":[{"title":"Stability requirements for listed medicines","url":"https://www.tga.gov.au/stability-requirements-listed-medicines"}]},{"text":"Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026","url":"https://www.legislation.gov.au/F2026L01382/asmade/versions"}]}]}},{"slug":"bringing-a-supplement-brand-to-australia","kind":"guide","url":"/guides/bringing-a-supplement-brand-to-australia","title":"Bringing a supplement brand to Australia","name":"Bringing a brand to Australia","description":"Selling supplements in Australia as an overseas brand: an Australian sponsor, permitted ingredients and claims, TGA GMP clearance for the maker, and the label.","eyebrow":"Development journey","lead":"A supplement that sells in the US, the UK or Asia can't go on sale in Australia as a medicine as it is. It needs an Australian sponsor, ingredients and claims from Australia's permitted lists, a manufacturer the TGA has cleared and a label to TGO 116, before it is listed on the ARTG. This guide takes an overseas brand through each step, in order, and through the routes for foods and cosmetics.","parent":"/product-development","studies":["skincare-brand-regulatory-partner","deeply-rooted-organic-oil","bwellness-practitioner-range","pump-haircare-hair-supplement"],"formats":[],"order":81,"updated":"2026-10-27","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- Sold in Australia as a listed medicine, a supplement needs an Australian sponsor: an Australian resident, or a company incorporated and doing business in Australia with a representative who lives here. An overseas manufacturer can't be one.\n- Every ingredient has to be in the Permissible Ingredients Determination, within its limits, and every claim has to be a permitted indication the sponsor holds evidence for.\n- Every overseas site that carries out a step of its manufacture needs a TGA GMP clearance, which the Australian sponsor holds. The two desktop routes often aren't open to supplements, because in many countries dietary supplements aren't regulated as medicines.\n- The label follows TGO 116, with the AUST L number on the main label and the sponsor's name and contact details.\n- A product sold as a food complies with the Food Standards Code instead, and gives up therapeutic claims. A cosmetic's chemicals are introduced under AICIS, by a business registered with it.\n- From our records: since 2024, the regulatory work in Australia for an international skincare brand's supplements and sunscreen, and Deeply Rooted's supply chain from its New Zealand maker to Australia.","text":"Sold in Australia as a listed medicine, a supplement needs an Australian sponsor: an Australian resident, or a company incorporated and doing business in Australia with a representative who lives here. An overseas manufacturer can't be one. Every ingredient has to be in the Permissible Ingredients Determination, within its limits, and every claim has to be a permitted indication the sponsor holds evidence for. Every overseas site that carries out a step of its manufacture needs a TGA GMP clearance, which the Australian sponsor holds. The two desktop routes often aren't open to supplements, because in many countries dietary supplements aren't regulated as medicines. The label follows TGO 116, with the AUST L number on the main label and the sponsor's name and contact details. A product sold as a food complies with the Food Standards Code instead, and gives up therapeutic claims. A cosmetic's chemicals are introduced under AICIS, by a business registered with it. From our records: since 2024, the regulatory work in Australia for an international skincare brand's supplements and sunscreen, and Deeply Rooted's supply chain from its New Zealand maker to Australia.","items":[],"tables":[]},{"heading":"1. Settle the pathway","anchor":"1-settle-the-pathway","markdown":"The same product can be a supplement or a food in one country and a medicine in Australia. Here, whether it is a medicine, a food or a cosmetic turns on what it contains and how it is presented, starting with its claims. Most supplements sold as medicines are listed medicines: the TGA doesn't evaluate them before they are sold, and the sponsor certifies that they meet the rules ([TGA listing](/guides/tga-approval)). See [medicine, food or cosmetic?](/pathways)","text":"The same product can be a supplement or a food in one country and a medicine in Australia. Here, whether it is a medicine, a food or a cosmetic turns on what it contains and how it is presented, starting with its claims. Most supplements sold as medicines are listed medicines: the TGA doesn't evaluate them before they are sold, and the sponsor certifies that they meet the rules (TGA listing). See medicine, food or cosmetic?","items":[],"tables":[]},{"heading":"2. Appoint an Australian sponsor","anchor":"2-appoint-an-australian-sponsor","markdown":"Every medicine on the ARTG has a sponsor, the person or company in Australia that is legally responsible for it. The TGA says sponsors must be located in Australia, and that overseas manufacturers can't sponsor medicines for the Australian market. So an overseas brand needs an Australian sponsor: its own Australian company, or an Australian resident or business that agrees to be the sponsor and take on its duties. More in our [TGA sponsor guide](/guides/tga-sponsor).","text":"Every medicine on the ARTG has a sponsor, the person or company in Australia that is legally responsible for it. The TGA says sponsors must be located in Australia, and that overseas manufacturers can't sponsor medicines for the Australian market. So an overseas brand needs an Australian sponsor: its own Australian company, or an Australian resident or business that agrees to be the sponsor and take on its duties. More in our TGA sponsor guide.","items":[],"tables":[]},{"heading":"3. Check the formula and the claims","anchor":"3-check-the-formula-and-the-claims","markdown":"A formula built for another market has to be checked against Australia's lists before anything else is spent.\n\n- **Ingredients.** Each one has to be in the Permissible Ingredients Determination, used for the purposes and within the limits it sets ([permissible ingredients](/guides/permissible-ingredients)). An ingredient that isn't needs its own application first ([new ingredient applications](/new-ingredients)).\n- **Claims.** Each indication has to come from the permitted list, and the sponsor certifies that it holds evidence for every one ([permitted indications](/guides/permitted-indications)). A claim that sells the product elsewhere may not be one a listed medicine can make here.\n\nIf the formula has to change, the change is made before the first listing: see [reformulating a supplement](/guides/reformulating-a-supplement).","text":"A formula built for another market has to be checked against Australia's lists before anything else is spent. Ingredients. Each one has to be in the Permissible Ingredients Determination, used for the purposes and within the limits it sets (permissible ingredients). An ingredient that isn't needs its own application first (new ingredient applications). Claims. Each indication has to come from the permitted list, and the sponsor certifies that it holds evidence for every one (permitted indications). A claim that sells the product elsewhere may not be one a listed medicine can make here. If the formula has to change, the change is made before the first listing: see reformulating a supplement.","items":[{"lead":"Ingredients.","text":"Each one has to be in the Permissible Ingredients Determination, used for the purposes and within the limits it sets (permissible ingredients). An ingredient that isn't needs its own application first (new ingredient applications)."},{"lead":"Claims.","text":"Each indication has to come from the permitted list, and the sponsor certifies that it holds evidence for every one (permitted indications). A claim that sells the product elsewhere may not be one a listed medicine can make here."}],"tables":[]},{"heading":"4. Decide where it's made","anchor":"4-decide-where-its-made","markdown":"- **Keep the overseas maker.** Each overseas site that carries out a step of manufacture recorded on the ARTG entry needs a TGA GMP clearance, unless the step is exempt. The Australian sponsor obtains it: one clearance per site, per sponsor. There are three routes: a desktop evaluation relying on a mutual recognition agreement, a compliance verification desktop evaluation relying on another regulator's inspection, or an inspection by the TGA. The desktop routes rest on an inspection by a recognised regulator for a human medicinal product, so a supplement factory often needs the TGA's own inspection ([GMP clearance](/guides/gmp-clearance)).\n- **Make it in Australia.** Every step at a site with a TGA manufacturing licence that covers the dosage form and the step ([choosing a supplement manufacturer](/guides/choosing-a-supplement-manufacturer)).","text":"Keep the overseas maker. Each overseas site that carries out a step of manufacture recorded on the ARTG entry needs a TGA GMP clearance, unless the step is exempt. The Australian sponsor obtains it: one clearance per site, per sponsor. There are three routes: a desktop evaluation relying on a mutual recognition agreement, a compliance verification desktop evaluation relying on another regulator's inspection, or an inspection by the TGA. The desktop routes rest on an inspection by a recognised regulator for a human medicinal product, so a supplement factory often needs the TGA's own inspection (GMP clearance). Make it in Australia. Every step at a site with a TGA manufacturing licence that covers the dosage form and the step (choosing a supplement manufacturer).","items":[{"lead":"Keep the overseas maker.","text":"Each overseas site that carries out a step of manufacture recorded on the ARTG entry needs a TGA GMP clearance, unless the step is exempt. The Australian sponsor obtains it: one clearance per site, per sponsor. There are three routes: a desktop evaluation relying on a mutual recognition agreement, a compliance verification desktop evaluation relying on another regulator's inspection, or an inspection by the TGA. The desktop routes rest on an inspection by a recognised regulator for a human medicinal product, so a supplement factory often needs the TGA's own inspection (GMP clearance)."},{"lead":"Make it in Australia.","text":"Every step at a site with a TGA manufacturing licence that covers the dosage form and the step (choosing a supplement manufacturer)."}],"tables":[]},{"heading":"5. Make the Australian label","anchor":"5-make-the-australian-label","markdown":"The label follows TGO 116. The main label carries the medicine's name, each active ingredient and its quantity, the dosage form and the quantity in the pack, and the AUST L number goes on it too. The label also carries the batch number, the expiry date, storage conditions, the sponsor's name and contact details, declared substances such as allergens, warning statements, directions for use and the indications. An overseas label won't carry the AUST L number or the Australian sponsor, so the product needs a label of its own here ([supplement labelling](/guides/supplement-labelling)).","text":"The label follows TGO 116. The main label carries the medicine's name, each active ingredient and its quantity, the dosage form and the quantity in the pack, and the AUST L number goes on it too. The label also carries the batch number, the expiry date, storage conditions, the sponsor's name and contact details, declared substances such as allergens, warning statements, directions for use and the indications. An overseas label won't carry the AUST L number or the Australian sponsor, so the product needs a label of its own here (supplement labelling).","items":[],"tables":[]},{"heading":"6. List it, then advertise within the rules","anchor":"6-list-it-then-advertise-within-the-rules","markdown":"The sponsor enters the medicine in TGA Business Services, certifies it and pays the application fee. Once payment is finalised, it goes on the ARTG with its AUST L number, usually showing the next day ([TGA listing](/guides/tga-approval)). From then on, its advertising in Australia follows the Therapeutic Goods Advertising Code, which binds anyone who advertises therapeutic goods, including on social media ([advertising a supplement](/guides/tga-advertising)).","text":"The sponsor enters the medicine in TGA Business Services, certifies it and pays the application fee. Once payment is finalised, it goes on the ARTG with its AUST L number, usually showing the next day (TGA listing). From then on, its advertising in Australia follows the Therapeutic Goods Advertising Code, which binds anyone who advertises therapeutic goods, including on social media (advertising a supplement).","items":[],"tables":[]},{"heading":"Foods and cosmetics","anchor":"foods-and-cosmetics","markdown":"- **A food.** A product on the food pathway doesn't go on the ARTG: it complies with the Food Standards Code instead, and gives up therapeutic claims ([supplements as foods](/pathways/foods)).\n- **A cosmetic.** AICIS regulates the industrial chemicals in cosmetics, and the business that introduces them, by importing or manufacturing, registers with it. The ingredient list follows the Consumer Goods (Cosmetics) Information Standard 2020 ([AICIS registration](/guides/aicis-registration)). A product presented mainly to protect the skin from UV is a primary sunscreen: a therapeutic good, generally listed with an AUST L number ([skincare and cosmetics](/skincare)).","text":"A food. A product on the food pathway doesn't go on the ARTG: it complies with the Food Standards Code instead, and gives up therapeutic claims (supplements as foods). A cosmetic. AICIS regulates the industrial chemicals in cosmetics, and the business that introduces them, by importing or manufacturing, registers with it. The ingredient list follows the Consumer Goods (Cosmetics) Information Standard 2020 (AICIS registration). A product presented mainly to protect the skin from UV is a primary sunscreen: a therapeutic good, generally listed with an AUST L number (skincare and cosmetics).","items":[{"lead":"A food.","text":"A product on the food pathway doesn't go on the ARTG: it complies with the Food Standards Code instead, and gives up therapeutic claims (supplements as foods)."},{"lead":"A cosmetic.","text":"AICIS regulates the industrial chemicals in cosmetics, and the business that introduces them, by importing or manufacturing, registers with it. The ingredient list follows the Consumer Goods (Cosmetics) Information Standard 2020 (AICIS registration). A product presented mainly to protect the skin from UV is a primary sunscreen: a therapeutic good, generally listed with an AUST L number (skincare and cosmetics)."}],"tables":[]},{"heading":"From our records","anchor":"from-our-records","markdown":"- [An international skincare brand](/work/skincare-brand-regulatory-partner): formula and evidence work across three products for Australia, two supplements and a sunscreen, with stability studies out to 36 months. Since 2024 we have run its regulatory work on a monthly retainer.\n- [Deeply Rooted](/work/deeply-rooted-organic-oil): an organic essential oil blend for children, made in New Zealand and sold in Australia, with the whole cross-border supply chain managed, delivered in 2025.\n- [BWellness](/work/bwellness-practitioner-range) and [Pump Haircare](/work/pump-haircare-hair-supplement): production runs with imported ingredients, customs and freight, including air freight, managed through to delivery.","text":"An international skincare brand: formula and evidence work across three products for Australia, two supplements and a sunscreen, with stability studies out to 36 months. Since 2024 we have run its regulatory work on a monthly retainer. Deeply Rooted: an organic essential oil blend for children, made in New Zealand and sold in Australia, with the whole cross-border supply chain managed, delivered in 2025. BWellness and Pump Haircare: production runs with imported ingredients, customs and freight, including air freight, managed through to delivery.","items":[],"tables":[]}],"faqs":[{"q":"Can we sell our supplement in Australia as it is?","a":"Not as a medicine. It needs an Australian sponsor, a listing on the ARTG and a label to TGO 116 with its AUST L number and the sponsor's details, and its ingredients and claims have to fit Australia's permitted lists.","md":"Not as a medicine. It needs an Australian sponsor, a listing on the ARTG and a label to TGO 116 with its AUST L number and the sponsor's details, and its ingredients and claims have to fit Australia's permitted lists."},{"q":"Do we need an Australian company?","a":"You need an Australian sponsor. It can be your own Australian company, or an Australian resident or business that agrees to take on the role and its duties.","md":"You need an Australian sponsor. It can be your own Australian company, or an Australian resident or business that agrees to take on the role and its duties."},{"q":"Can our current manufacturer keep making it?","a":"Yes, if each overseas site that carries out a step holds a TGA GMP clearance, which the Australian sponsor obtains. Because the desktop routes rely on another regulator's inspection of a human medicinal product, a supplement factory often needs a TGA inspection.","md":"Yes, if each overseas site that carries out a step holds a TGA GMP clearance, which the Australian sponsor obtains. Because the desktop routes rely on another regulator's inspection of a human medicinal product, a supplement factory often needs a TGA inspection."},{"q":"Will we have to change the formula?","a":"Only where it doesn't fit: an ingredient that isn't in the Permissible Ingredients Determination, a dose above its limit, or a claim that isn't a permitted indication. We check the formula against the lists before anything else is spent.","md":"Only where it doesn't fit: an ingredient that isn't in the Permissible Ingredients Determination, a dose above its limit, or a claim that isn't a permitted indication. We check the formula against the lists before anything else is spent."},{"q":"Can a consultant be our sponsor?","a":"A consultant can act as the sponsor's agent and do the regulatory work, but the sponsor stays responsible. An overseas manufacturer can't be a sponsor at all.","md":"A consultant can act as the sponsor's agent and do the regulatory work, but the sponsor stays responsible. An overseas manufacturer can't be a sponsor at all."}],"sources":{"note":"General information, drawn from our guides on the sponsor, GMP clearance, labelling and advertising, which were checked against these sources in October 2026. It isn't advice on a particular product.","markdown":"General information, drawn from our guides on the sponsor, GMP clearance, labelling and advertising, which were checked against these sources in October 2026. It isn't advice on a particular product.\n\n- [Therapeutic Goods Act 1989](https://www.legislation.gov.au/C2004A03952/latest/text), section 3 (the meaning of sponsor), Federal Register of Legislation\n- [Determine if you are a sponsor](https://www.tga.gov.au/node/289) and [TGA Business Services: getting started with the TGA](https://www.tga.gov.au/tga-business-services-getting-started-tga), Therapeutic Goods Administration\n- [Australian manufacturing licences and overseas GMP certification](https://www.tga.gov.au/sites/default/files/australian-manufacturing-licences-and-overseas-gmp-certification.pdf), version 2.2, December 2021, and [International agreements and arrangements for GMP clearance](https://www.tga.gov.au/node/287685), Therapeutic Goods Administration\n- [Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026](https://www.legislation.gov.au/F2026L01382/asmade/versions) and [Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025](https://www.legislation.gov.au/F2025L00450/latest/versions), Federal Register of Legislation\n- [Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026](https://www.legislation.gov.au/F2026L01312/asmade/2026-09-28/text/original/pdf), Federal Register of Legislation\n- [Therapeutic Goods Advertising Code](https://www.legislation.gov.au/F2021L01661/latest/text), Federal Register of Legislation\n- [What is registration and who must register?](https://www.industrialchemicals.gov.au/business/getting-started-registration-importing-and-manufacturing/what-registration-and-who-must-register), Australian Industrial Chemicals Introduction Scheme\n- [Cosmetics ingredients labelling mandatory standard](https://www.productsafety.gov.au/business/search-mandatory-standards/cosmetics-ingredients-labelling-mandatory-standard), ACCC Product Safety Australia, and [Sunscreen regulation in Australia](https://www.tga.gov.au/products/medicines/therapeutic-sunscreens/overview/sunscreen-regulation-australia), Therapeutic Goods Administration","items":[{"text":"Therapeutic Goods Act 1989, section 3 (the meaning of sponsor), Federal Register of Legislation","links":[{"title":"Therapeutic Goods Act 1989","url":"https://www.legislation.gov.au/C2004A03952/latest/text"}]},{"text":"Determine if you are a sponsor and TGA Business Services: getting started with the TGA, Therapeutic Goods Administration","links":[{"title":"Determine if you are a sponsor","url":"https://www.tga.gov.au/node/289"},{"title":"TGA Business Services: getting started with the TGA","url":"https://www.tga.gov.au/tga-business-services-getting-started-tga"}]},{"text":"Australian manufacturing licences and overseas GMP certification, version 2.2, December 2021, and International agreements and arrangements for GMP clearance, Therapeutic Goods Administration","links":[{"title":"Australian manufacturing licences and overseas GMP certification","url":"https://www.tga.gov.au/sites/default/files/australian-manufacturing-licences-and-overseas-gmp-certification.pdf"},{"title":"International agreements and arrangements for GMP clearance","url":"https://www.tga.gov.au/node/287685"}]},{"text":"Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026 and Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026","url":"https://www.legislation.gov.au/F2026L01382/asmade/versions"},{"title":"Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025","url":"https://www.legislation.gov.au/F2025L00450/latest/versions"}]},{"text":"Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026","url":"https://www.legislation.gov.au/F2026L01312/asmade/2026-09-28/text/original/pdf"}]},{"text":"Therapeutic Goods Advertising Code, Federal Register of Legislation","links":[{"title":"Therapeutic Goods Advertising Code","url":"https://www.legislation.gov.au/F2021L01661/latest/text"}]},{"text":"What is registration and who must register?, Australian Industrial Chemicals Introduction Scheme","links":[{"title":"What is registration and who must register?","url":"https://www.industrialchemicals.gov.au/business/getting-started-registration-importing-and-manufacturing/what-registration-and-who-must-register"}]},{"text":"Cosmetics ingredients labelling mandatory standard, ACCC Product Safety Australia, and Sunscreen regulation in Australia, Therapeutic Goods Administration","links":[{"title":"Cosmetics ingredients labelling mandatory standard","url":"https://www.productsafety.gov.au/business/search-mandatory-standards/cosmetics-ingredients-labelling-mandatory-standard"},{"title":"Sunscreen regulation in Australia","url":"https://www.tga.gov.au/products/medicines/therapeutic-sunscreens/overview/sunscreen-regulation-australia"}]}]}},{"slug":"branded-ingredients","kind":"guide","url":"/guides/branded-ingredients","title":"Branded ingredients in supplements: what they bring, and what the TGA expects","name":"Branded ingredients guide","description":"Branded, clinically studied ingredients in supplements: why the exact preparation matters to the TGA, what to ask the supplier, the claims, and the ones we use.","eyebrow":"Guide","lead":"A branded ingredient is one supplier's own version of an ingredient: a particular extract, form or strain, made to its specification and sold under its trade mark, often with clinical studies on that exact preparation. Built on well, it gives a formula evidence a generic ingredient can't borrow. This guide covers why the exact preparation matters under the TGA's evidence guidelines, what to ask a supplier for, what the claims and the advertising can say, and the branded ingredients we've built products on.","parent":"/formulation","studies":["everleanbody-saffron-capsule","ashwagandha-capsule-32-days","bwellness-practitioner-range","sports-brand-core-range","vitable-hair-growth-range","arxi-prenatal-chewable"],"formats":[],"order":82,"updated":"2026-10-28","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- A branded ingredient is a specific preparation: one supplier's extract, form or strain, made to a set specification and sold under a trade mark, often with clinical studies on that preparation.\n- The TGA's evidence guidelines expect the evidence to come from the same ingredient preparation and dosage form as the medicine. A herbal extract made a different way needs evidence that its constituent profile isn't substantially different, or a justification. So studies on one branded extract don't carry over to any extract of the same herb.\n- The claim still has to be a permitted indication, backed by evidence the sponsor holds. For a specific indication, the guidelines' minimum is one Category A source, such as a double-blind randomised controlled trial, or one Category B and two Category C sources.\n- In advertising, a scientific or clinical claim must be consistent with the body of evidence. Research an ad refers to must be identified, with the researcher and, where known, who paid for it (section 11 of the Advertising Code). The label itself is exempt from the citing rule.\n- From our records: affron®, KSM-66®, EnXtra®, Wellmune®, Testofen®, life's®OMEGA, VitaShine™, Eriomin®, AnaGain™ under licence, Quatrefolic® and Rocoat®, among others, in products from first launches to nine-product ranges.","text":"A branded ingredient is a specific preparation: one supplier's extract, form or strain, made to a set specification and sold under a trade mark, often with clinical studies on that preparation. The TGA's evidence guidelines expect the evidence to come from the same ingredient preparation and dosage form as the medicine. A herbal extract made a different way needs evidence that its constituent profile isn't substantially different, or a justification. So studies on one branded extract don't carry over to any extract of the same herb. The claim still has to be a permitted indication, backed by evidence the sponsor holds. For a specific indication, the guidelines' minimum is one Category A source, such as a double-blind randomised controlled trial, or one Category B and two Category C sources. In advertising, a scientific or clinical claim must be consistent with the body of evidence. Research an ad refers to must be identified, with the researcher and, where known, who paid for it (section 11 of the Advertising Code). The label itself is exempt from the citing rule. From our records: affron®, KSM-66®, EnXtra®, Wellmune®, Testofen®, life's®OMEGA, VitaShine™, Eriomin®, AnaGain™ under licence, Quatrefolic® and Rocoat®, among others, in products from first launches to nine-product ranges.","items":[],"tables":[]},{"heading":"Why the exact preparation matters","anchor":"why-the-exact-preparation-matters","markdown":"A listed medicine's sponsor certifies that it holds evidence for every indication ([permitted indications](/guides/permitted-indications)). The TGA's Listed medicines evidence guidelines (version 4.0, June 2022) say what makes that evidence relevant to the medicine:\n\n- **The same active ingredients.** The evidence should relate to the whole medicine, or include the same active ingredients. A different dose, dosage form, regimen or route needs a justification.\n- **The same preparation.** The preparations studied should contain the same ingredient preparation and dosage form as the medicine. For a herbal ingredient, a different preparation method needs evidence that the constituent profile isn't substantially different, or a suitable justification. Non-traditional solvents and extraction ratios can change the chemical profile, and standardising to a marker compound doesn't remove every difference. The TGA has separate guidance on the equivalence of herbal extracts.\n- **The same people.** The medicine's target population should be consistent with the population in the studies, unless the extrapolation is justified.\n\nThat's what a branded ingredient is for. When a product uses the studied preparation, at the studied dose, for the studied population, the studies are evidence about the product's own active ingredient. A generic extract of the same herb has to show it's equivalent, or stand on evidence of its own.","text":"A listed medicine's sponsor certifies that it holds evidence for every indication (permitted indications). The TGA's Listed medicines evidence guidelines (version 4.0, June 2022) say what makes that evidence relevant to the medicine: The same active ingredients. The evidence should relate to the whole medicine, or include the same active ingredients. A different dose, dosage form, regimen or route needs a justification. The same preparation. The preparations studied should contain the same ingredient preparation and dosage form as the medicine. For a herbal ingredient, a different preparation method needs evidence that the constituent profile isn't substantially different, or a suitable justification. Non-traditional solvents and extraction ratios can change the chemical profile, and standardising to a marker compound doesn't remove every difference. The TGA has separate guidance on the equivalence of herbal extracts. The same people. The medicine's target population should be consistent with the population in the studies, unless the extrapolation is justified. That's what a branded ingredient is for. When a product uses the studied preparation, at the studied dose, for the studied population, the studies are evidence about the product's own active ingredient. A generic extract of the same herb has to show it's equivalent, or stand on evidence of its own.","items":[{"lead":"The same active ingredients.","text":"The evidence should relate to the whole medicine, or include the same active ingredients. A different dose, dosage form, regimen or route needs a justification."},{"lead":"The same preparation.","text":"The preparations studied should contain the same ingredient preparation and dosage form as the medicine. For a herbal ingredient, a different preparation method needs evidence that the constituent profile isn't substantially different, or a suitable justification. Non-traditional solvents and extraction ratios can change the chemical profile, and standardising to a marker compound doesn't remove every difference. The TGA has separate guidance on the equivalence of herbal extracts."},{"lead":"The same people.","text":"The medicine's target population should be consistent with the population in the studies, unless the extrapolation is justified."}],"tables":[]},{"heading":"What to ask the supplier for","anchor":"what-to-ask-the-supplier-for","markdown":"- **The full studies,** not summaries: the guidelines don't accept abstracts alone, or non-clinical studies on their own, as scientific evidence.\n- **The dose and form studied,** so the formula can use the same, or justify the difference.\n- **The population studied,** to match the customer the product is for.\n- **The specification,** so the preparation in your product is the one in the studies, batch after batch.\n- **The terms for the name.** Whether the brand's name and mark can appear on your label and in your marketing is the supplier's call, set in its terms. AnaGain™, in [Vitable's hair capsule](/work/vitable-hair-growth-range), is under licence.","text":"The full studies, not summaries: the guidelines don't accept abstracts alone, or non-clinical studies on their own, as scientific evidence. The dose and form studied, so the formula can use the same, or justify the difference. The population studied, to match the customer the product is for. The specification, so the preparation in your product is the one in the studies, batch after batch. The terms for the name. Whether the brand's name and mark can appear on your label and in your marketing is the supplier's call, set in its terms. AnaGain™, in Vitable's hair capsule, is under licence.","items":[{"lead":"The full studies,","text":"not summaries: the guidelines don't accept abstracts alone, or non-clinical studies on their own, as scientific evidence."},{"lead":"The dose and form studied,","text":"so the formula can use the same, or justify the difference."},{"lead":"The population studied,","text":"to match the customer the product is for."},{"lead":"The specification,","text":"so the preparation in your product is the one in the studies, batch after batch."},{"lead":"The terms for the name.","text":"Whether the brand's name and mark can appear on your label and in your marketing is the supplier's call, set in its terms. AnaGain™, in Vitable's hair capsule, is under licence."}],"tables":[]},{"heading":"What the claims and the ads can say","anchor":"what-the-claims-and-the-ads-can-say","markdown":"- **On the label and the ARTG entry,** the claims are permitted indications, and the sponsor holds evidence for each one. The guidelines warn against exaggerating the extent, nature or prominence of the effects seen in the studies, and a medicine can't advertise an indication that isn't on its ARTG entry.\n- **In advertising,** a scientific or clinical claim must be consistent with the body of scientific or clinical evidence for the goods. An ad that refers to research has to identify the researcher, the research's financial sponsor where the advertiser knows or ought to know it, and the research itself, by a citation good enough for consumers to find it. More in our [advertising guide](/guides/tga-advertising).\n- **Traditional evidence** can't be dressed as science: an indication supported by traditional evidence mustn't imply efficacy based on scientific evidence, such as \"clinically tested\".","text":"On the label and the ARTG entry, the claims are permitted indications, and the sponsor holds evidence for each one. The guidelines warn against exaggerating the extent, nature or prominence of the effects seen in the studies, and a medicine can't advertise an indication that isn't on its ARTG entry. In advertising, a scientific or clinical claim must be consistent with the body of scientific or clinical evidence for the goods. An ad that refers to research has to identify the researcher, the research's financial sponsor where the advertiser knows or ought to know it, and the research itself, by a citation good enough for consumers to find it. More in our advertising guide. Traditional evidence can't be dressed as science: an indication supported by traditional evidence mustn't imply efficacy based on scientific evidence, such as \"clinically tested\".","items":[{"lead":"On the label and the ARTG entry,","text":"the claims are permitted indications, and the sponsor holds evidence for each one. The guidelines warn against exaggerating the extent, nature or prominence of the effects seen in the studies, and a medicine can't advertise an indication that isn't on its ARTG entry."},{"lead":"In advertising,","text":"a scientific or clinical claim must be consistent with the body of scientific or clinical evidence for the goods. An ad that refers to research has to identify the researcher, the research's financial sponsor where the advertiser knows or ought to know it, and the research itself, by a citation good enough for consumers to find it. More in our advertising guide."},{"lead":"Traditional evidence","text":"can't be dressed as science: an indication supported by traditional evidence mustn't imply efficacy based on scientific evidence, such as \"clinically tested\"."}],"tables":[]},{"heading":"Branded ingredients and the cost of goods","anchor":"branded-ingredients-and-the-cost-of-goods","markdown":"A branded ingredient can cost more than a generic one, and the studied dose sets how much goes into each serve. So the choice is made at the brief, with the price the product has to sell at ([design to the price](/guides/supplement-development-cost#design-to-the-price-the-cost-of-goods)). Sometimes one branded ingredient carries the product, with supporting ingredients around it: EverLeanBody's capsule is built around affron® with L-theanine, lemon balm and active-form B vitamins.","text":"A branded ingredient can cost more than a generic one, and the studied dose sets how much goes into each serve. So the choice is made at the brief, with the price the product has to sell at (design to the price). Sometimes one branded ingredient carries the product, with supporting ingredients around it: EverLeanBody's capsule is built around affron® with L-theanine, lemon balm and active-form B vitamins.","items":[],"tables":[]},{"heading":"From our records","anchor":"from-our-records","markdown":"- [EverLeanBody](/work/everleanbody-saffron-capsule): a four-ingredient capsule built around affron®, a clinically studied saffron extract: 5.8 months from signed brief to dispatch. Its second product, now in development, is built on Eriomin®, a clinically studied lemon flavonoid extract.\n- [A complex herbal capsule](/work/ashwagandha-capsule-32-days) built around KSM-66® ashwagandha, with an evidence package covering more than 13 ingredients: 32 days from design to production order. More in our [sleep and stress guide](/guides/sleep-and-stress-supplement-development).\n- [BWellness](/work/bwellness-practitioner-range): a 60-tablet formula built on EnXtra®, a clinically studied Alpinia galanga extract, and sister products including an immune powder built on Wellmune® and an algal omega-3 capsule built on life's®OMEGA with VitaShine™ vegan vitamin D3.\n- [ATP Science](/work/sports-brand-core-range): four TGA-listed capsules reformulated from scratch, one built on Testofen®, a clinically studied fenugreek extract.\n- [Vitable](/work/vitable-hair-growth-range): a TGA-listed capsule with more than 13 ingredients, including a clinically studied Biota orientalis extract, AnaGain™ under licence and Quatrefolic® active folate.\n- [Arxi](/work/arxi-prenatal-chewable): a two-a-day prenatal chewable with Rocoat® coated B vitamins, to tame the taste.\n- [Ora](/work/ora-practitioner-natural-medicine), our founder's own brand: around 19 natural medicines, on ingredients including affron®, KSM-66® and GutGard®.","text":"EverLeanBody: a four-ingredient capsule built around affron®, a clinically studied saffron extract: 5.8 months from signed brief to dispatch. Its second product, now in development, is built on Eriomin®, a clinically studied lemon flavonoid extract. A complex herbal capsule built around KSM-66® ashwagandha, with an evidence package covering more than 13 ingredients: 32 days from design to production order. More in our sleep and stress guide. BWellness: a 60-tablet formula built on EnXtra®, a clinically studied Alpinia galanga extract, and sister products including an immune powder built on Wellmune® and an algal omega-3 capsule built on life's®OMEGA with VitaShine™ vegan vitamin D3. ATP Science: four TGA-listed capsules reformulated from scratch, one built on Testofen®, a clinically studied fenugreek extract. Vitable: a TGA-listed capsule with more than 13 ingredients, including a clinically studied Biota orientalis extract, AnaGain™ under licence and Quatrefolic® active folate. Arxi: a two-a-day prenatal chewable with Rocoat® coated B vitamins, to tame the taste. Ora, our founder's own brand: around 19 natural medicines, on ingredients including affron®, KSM-66® and GutGard®.","items":[],"tables":[]}],"faqs":[{"q":"Do I need a branded ingredient to make a claim?","a":"No. A listed medicine's evidence can come from any sources that meet the guidelines and are relevant to the product. A branded ingredient brings studies on its own preparation, which makes the evidence for that ingredient straightforward to hold.","md":"No. A listed medicine's evidence can come from any sources that meet the guidelines and are relevant to the product. A branded ingredient brings studies on its own preparation, which makes the evidence for that ingredient straightforward to hold."},{"q":"Can I use the supplier's studies as my product's evidence?","a":"They can be part of it, when your product contains the same ingredient preparation, at a dose and in a form the studies support, for a similar population, and the claim is a permitted indication. The sponsor holds the evidence and certifies it, so we check the studies against the formula before the claims are set.","md":"They can be part of it, when your product contains the same ingredient preparation, at a dose and in a form the studies support, for a similar population, and the claim is a permitted indication. The sponsor holds the evidence and certifies it, so we check the studies against the formula before the claims are set."},{"q":"Can my ads say an ingredient is clinically studied?","a":"Only in line with the body of evidence for the product, and an ad that refers to research has to identify it, the researcher and, where known, who paid for it. If the product's indications rest on traditional evidence, the ads can't imply scientific efficacy at all.","md":"Only in line with the body of evidence for the product, and an ad that refers to research has to identify it, the researcher and, where known, who paid for it. If the product's indications rest on traditional evidence, the ads can't imply scientific efficacy at all."},{"q":"Can I put the ingredient's brand on my label?","a":"That's set by the supplier's terms for its name and trade mark. Some brands are used under licence: AnaGain™ in Vitable's capsule is one.","md":"That's set by the supplier's terms for its name and trade mark. Some brands are used under licence: AnaGain™ in Vitable's capsule is one."},{"q":"Do branded ingredients cost more?","a":"They can, and the studied dose fixes how much goes into each serve, so we cost the formula with them at the brief, against the price the product has to sell at. See what a supplement costs to develop.","md":"They can, and the studied dose fixes how much goes into each serve, so we cost the formula with them at the brief, against the price the product has to sell at. See [what a supplement costs to develop](/guides/supplement-development-cost)."}],"sources":{"note":"General information, checked against these sources on 28 October 2026. It isn't advice on a particular product.","markdown":"General information, checked against these sources on 28 October 2026. It isn't advice on a particular product.\n\n- [Listed medicines evidence guidelines](https://www.tga.gov.au/sites/default/files/evidence-guidelines.pdf), version 4.0, June 2022, sections 3.1 to 3.1.4, Therapeutic Goods Administration\n- [Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021](https://www.legislation.gov.au/F2021L01661/latest/text), section 11, Federal Register of Legislation","items":[{"text":"Listed medicines evidence guidelines, version 4.0, June 2022, sections 3.1 to 3.1.4, Therapeutic Goods Administration","links":[{"title":"Listed medicines evidence guidelines","url":"https://www.tga.gov.au/sites/default/files/evidence-guidelines.pdf"}]},{"text":"Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021, section 11, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021","url":"https://www.legislation.gov.au/F2021L01661/latest/text"}]}]}},{"slug":"prenatal-supplement-development","kind":"guide","url":"/guides/prenatal-supplement-development","title":"Prenatal and postnatal supplements: developing one in Australia","name":"Prenatal and postnatal guide","description":"Working with a prenatal supplement manufacturer: the TGA rules for pregnancy claims and warnings, taste and format, and four prenatals from our records.","eyebrow":"Guide","lead":"A prenatal is held to a higher standard than most supplements. The people taking it are pregnant or trying to be, so the claims, the warnings and the evidence all have to fit them, and the product has to be something they will take every day, often through nausea. This guide covers the rules for pregnancy indications and warnings on a listed medicine, the evidence they need, the taste and format problems prenatals run into, and the preconception, prenatal and postnatal products we've built.","parent":"/product-development","studies":["arxi-preconception-supplement","arxi-prenatal-chewable","prenatal-multivitamin-capsule","mother-daily-postnatal-supplement"],"formats":[],"order":83,"updated":"2026-10-28","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- Most prenatals in our records are TGA-listed medicines, like most of our [women's health supplements](/guides/womens-health-supplement-development): a preconception capsule, a prenatal chewable and a prenatal capsule built on plant powders.\n- Pregnancy indications have their own Part in the Permissible Indications Determination, and can't be combined in a sentence with other indications. The evidence has to come from a population consistent with the product's, or the difference has to be justified.\n- Warnings follow the ingredients. The TGA has counted over 80 ingredients approved for listed medicines that may need a pregnancy warning, set by the Permissible Ingredients Determination and the Poisons Standard. Folic acid, for example, carries its own advisory statements when the product is indicated for reducing the risk of a neural tube defect.\n- The hardest part is often the taste: B vitamins and selenium are bitter and smell strongly. Arxi's prenatal went from a liquid drop to a two-a-day chewable with Rocoat® coated B vitamins.\n- From our records: Arxi's preconception capsule, reordered three times since 2024; Arxi's prenatal chewable, due in late October 2026; a plant-powder prenatal launched in 2025; and Mother Daily's postnatal, six formula versions to a first run of 4,935 units.","text":"Most prenatals in our records are TGA-listed medicines, like most of our women's health supplements: a preconception capsule, a prenatal chewable and a prenatal capsule built on plant powders. Pregnancy indications have their own Part in the Permissible Indications Determination, and can't be combined in a sentence with other indications. The evidence has to come from a population consistent with the product's, or the difference has to be justified. Warnings follow the ingredients. The TGA has counted over 80 ingredients approved for listed medicines that may need a pregnancy warning, set by the Permissible Ingredients Determination and the Poisons Standard. Folic acid, for example, carries its own advisory statements when the product is indicated for reducing the risk of a neural tube defect. The hardest part is often the taste: B vitamins and selenium are bitter and smell strongly. Arxi's prenatal went from a liquid drop to a two-a-day chewable with Rocoat® coated B vitamins. From our records: Arxi's preconception capsule, reordered three times since 2024; Arxi's prenatal chewable, due in late October 2026; a plant-powder prenatal launched in 2025; and Mother Daily's postnatal, six formula versions to a first run of 4,935 units.","items":[],"tables":[]},{"heading":"The rules for pregnancy claims","anchor":"the-rules-for-pregnancy-claims","markdown":"A listed medicine can only carry indications from the TGA's list, the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025 ([permitted indications](/guides/permitted-indications)). Pregnancy indications have their own Part of it, and a pregnancy indication can't be combined in a sentence with other indications.\n\nThe sponsor holds the evidence for each indication. The TGA's Listed medicines evidence guidelines (version 4.0, June 2022) expect the medicine's target population to be consistent with the population studied, unless the difference is justified. For a prenatal, that means studies in people who are pregnant or planning a pregnancy, at the dose and in the form the product uses ([branded ingredients](/guides/branded-ingredients) covers the same test for a single ingredient).","text":"A listed medicine can only carry indications from the TGA's list, the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025 (permitted indications). Pregnancy indications have their own Part of it, and a pregnancy indication can't be combined in a sentence with other indications. The sponsor holds the evidence for each indication. The TGA's Listed medicines evidence guidelines (version 4.0, June 2022) expect the medicine's target population to be consistent with the population studied, unless the difference is justified. For a prenatal, that means studies in people who are pregnant or planning a pregnancy, at the dose and in the form the product uses (branded ingredients covers the same test for a single ingredient).","items":[],"tables":[]},{"heading":"The warnings a prenatal carries","anchor":"the-warnings-a-prenatal-carries","markdown":"Warnings come from the ingredients, and a prenatal has many. In a 2022 review the TGA counted over 80 ingredients approved for listed medicines that may require a warning statement about pregnancy. The requirements are set in the Therapeutic Goods (Permissible Ingredients) Determination, which lists the ingredients a listed medicine can use and the conditions on each, and in the Poisons Standard for some ingredients ([permissible ingredients](/guides/permissible-ingredients)).\n\nOther statements come from the Therapeutic Goods (Medicines Advisory Statements) Specification 2021, whose schedule is the Required Advisory Statements for Medicine Labels (RASML No. 6):\n\n- **Folic acid.** In a preparation indicated for reducing the risk of having a child with spina bifida or a neural tube defect, the label carries \"Do not exceed the stated dose except on medical advice.\" and \"If you have had a baby with a neural tube defect/spina bifida, seek specific medical advice.\"\n- **Pregnancy categories.** A medicine for oral use with an active ingredient in category B1, B2, B3 or C of the TGA's Prescribing medicines in pregnancy database, and no other pregnancy warning, carries \"If pregnant or likely to become pregnant, consult a pharmacist or a doctor before use\" or words to that effect.\n\nThe TGA consulted on changes for a RASML No. 7 from 27 July to 4 September 2026; until a new instrument is made, No. 6 applies. Where each statement goes on the pack is in our [labelling guide](/guides/supplement-labelling).","text":"Warnings come from the ingredients, and a prenatal has many. In a 2022 review the TGA counted over 80 ingredients approved for listed medicines that may require a warning statement about pregnancy. The requirements are set in the Therapeutic Goods (Permissible Ingredients) Determination, which lists the ingredients a listed medicine can use and the conditions on each, and in the Poisons Standard for some ingredients (permissible ingredients). Other statements come from the Therapeutic Goods (Medicines Advisory Statements) Specification 2021, whose schedule is the Required Advisory Statements for Medicine Labels (RASML No. 6): Folic acid. In a preparation indicated for reducing the risk of having a child with spina bifida or a neural tube defect, the label carries \"Do not exceed the stated dose except on medical advice.\" and \"If you have had a baby with a neural tube defect/spina bifida, seek specific medical advice.\" Pregnancy categories. A medicine for oral use with an active ingredient in category B1, B2, B3 or C of the TGA's Prescribing medicines in pregnancy database, and no other pregnancy warning, carries \"If pregnant or likely to become pregnant, consult a pharmacist or a doctor before use\" or words to that effect. The TGA consulted on changes for a RASML No. 7 from 27 July to 4 September 2026; until a new instrument is made, No. 6 applies. Where each statement goes on the pack is in our labelling guide.","items":[{"lead":"Folic acid.","text":"In a preparation indicated for reducing the risk of having a child with spina bifida or a neural tube defect, the label carries \"Do not exceed the stated dose except on medical advice.\" and \"If you have had a baby with a neural tube defect/spina bifida, seek specific medical advice.\""},{"lead":"Pregnancy categories.","text":"A medicine for oral use with an active ingredient in category B1, B2, B3 or C of the TGA's Prescribing medicines in pregnancy database, and no other pregnancy warning, carries \"If pregnant or likely to become pregnant, consult a pharmacist or a doctor before use\" or words to that effect."}],"tables":[]},{"heading":"Taste, format and the daily dose","anchor":"taste-format-and-the-daily-dose","markdown":"A prenatal carries a long list of vitamins and minerals at meaningful doses, for someone who may feel sick at the smell of it. From our records:\n\n- **The smell.** B vitamins and selenium are bitter and smell strongly, and vitamin C fizzes in liquid. For Arxi's prenatal we traced the main odour to one selenium form and removed it.\n- **The format.** Arxi's prenatal started as a liquid drop that trials showed wasn't stable and whose taste couldn't be masked. A liposomal liquid was tested, then the product moved to a two-a-day chewable with Rocoat® coated B vitamins to tame the taste ([capsules, tablets and softgels](/formats/capsules-tablets-softgels)).\n- **The label.** Our label review on the same product caught two errors before print.\n- **Plant powders.** One prenatal was built as much as possible on plant powders, over three versions of the formula, with quotes from three manufacturers. We also sourced a replacement supply of its lead plant ingredient.\n- **Stability.** Arxi's preconception capsule has a 24-month stability program behind it ([stability testing](/guides/stability-testing)).","text":"A prenatal carries a long list of vitamins and minerals at meaningful doses, for someone who may feel sick at the smell of it. From our records: The smell. B vitamins and selenium are bitter and smell strongly, and vitamin C fizzes in liquid. For Arxi's prenatal we traced the main odour to one selenium form and removed it. The format. Arxi's prenatal started as a liquid drop that trials showed wasn't stable and whose taste couldn't be masked. A liposomal liquid was tested, then the product moved to a two-a-day chewable with Rocoat® coated B vitamins to tame the taste (capsules, tablets and softgels). The label. Our label review on the same product caught two errors before print. Plant powders. One prenatal was built as much as possible on plant powders, over three versions of the formula, with quotes from three manufacturers. We also sourced a replacement supply of its lead plant ingredient. Stability. Arxi's preconception capsule has a 24-month stability program behind it (stability testing).","items":[{"lead":"The smell.","text":"B vitamins and selenium are bitter and smell strongly, and vitamin C fizzes in liquid. For Arxi's prenatal we traced the main odour to one selenium form and removed it."},{"lead":"The format.","text":"Arxi's prenatal started as a liquid drop that trials showed wasn't stable and whose taste couldn't be masked. A liposomal liquid was tested, then the product moved to a two-a-day chewable with Rocoat® coated B vitamins to tame the taste (capsules, tablets and softgels)."},{"lead":"The label.","text":"Our label review on the same product caught two errors before print."},{"lead":"Plant powders.","text":"One prenatal was built as much as possible on plant powders, over three versions of the formula, with quotes from three manufacturers. We also sourced a replacement supply of its lead plant ingredient."},{"lead":"Stability.","text":"Arxi's preconception capsule has a 24-month stability program behind it (stability testing)."}],"tables":[]},{"heading":"Evidence for every key ingredient","anchor":"evidence-for-every-key-ingredient","markdown":"A prenatal or postnatal formula is only as strong as the evidence behind each ingredient. Mother Daily's postnatal supplement needed evidence behind every key ingredient, and the first formula wasn't right: it took six versions, with an evidence package covering eight key ingredients. The plant-powder prenatal's evidence package covered 13 or more ingredients.","text":"A prenatal or postnatal formula is only as strong as the evidence behind each ingredient. Mother Daily's postnatal supplement needed evidence behind every key ingredient, and the first formula wasn't right: it took six versions, with an evidence package covering eight key ingredients. The plant-powder prenatal's evidence package covered 13 or more ingredients.","items":[],"tables":[]},{"heading":"From our records","anchor":"from-our-records","markdown":"- [Arxi's preconception supplement](/work/arxi-preconception-supplement): a TGA-listed female preconception capsule, with the claims evidence, the listing, the label and a 24-month stability program. We later added a 7-day sample pack for events and sampling. Three production orders since 2024.\n- [Arxi's prenatal chewable](/work/arxi-prenatal-chewable): a full prenatal vitamin and mineral dose in a two-a-day chewable with Rocoat® coated B vitamins, after a liquid that wouldn't hold. In production, due for dispatch in late October 2026.\n- [A prenatal built on plant powders](/work/prenatal-multivitamin-capsule): a TGA-listed capsule with an evidence package covering 13 or more ingredients, three formula versions and the stability protocol. The brand launched in 2025.\n- [Mother Daily's postnatal supplement](/work/mother-daily-postnatal-supplement): six formula versions, evidence on eight key ingredients, the nutrition panel and label press proofs, and a first production run of 4,935 units, one of our largest, shipped in 2024.","text":"Arxi's preconception supplement: a TGA-listed female preconception capsule, with the claims evidence, the listing, the label and a 24-month stability program. We later added a 7-day sample pack for events and sampling. Three production orders since 2024. Arxi's prenatal chewable: a full prenatal vitamin and mineral dose in a two-a-day chewable with Rocoat® coated B vitamins, after a liquid that wouldn't hold. In production, due for dispatch in late October 2026. A prenatal built on plant powders: a TGA-listed capsule with an evidence package covering 13 or more ingredients, three formula versions and the stability protocol. The brand launched in 2025. Mother Daily's postnatal supplement: six formula versions, evidence on eight key ingredients, the nutrition panel and label press proofs, and a first production run of 4,935 units, one of our largest, shipped in 2024.","items":[],"tables":[]}],"faqs":[{"q":"Is a prenatal a listed medicine?","a":"Most in our records are: three of the four products above are TGA-listed medicines. Which pathway applies depends on the ingredients and the claims, and we settle it at the brief. See listed medicines.","md":"Most in our records are: three of the four products above are TGA-listed medicines. Which pathway applies depends on the ingredients and the claims, and we settle it at the brief. See [listed medicines](/pathways/listed-medicines)."},{"q":"Can a prenatal's label combine pregnancy claims with others?","a":"Not in the same sentence. Pregnancy indications have their own Part in the Permissible Indications Determination and can't be combined in a sentence with other indications.","md":"Not in the same sentence. Pregnancy indications have their own Part in the Permissible Indications Determination and can't be combined in a sentence with other indications."},{"q":"What warnings will my prenatal carry?","a":"That depends on its ingredients and its indications. The Permissible Ingredients Determination and the Poisons Standard set pregnancy warnings for many ingredients, and the Medicines Advisory Statements Specification adds statements such as the two for folic acid in a product indicated for reducing the risk of a neural tube defect. We check every statement against the formula before the label goes to print.","md":"That depends on its ingredients and its indications. The Permissible Ingredients Determination and the Poisons Standard set pregnancy warnings for many ingredients, and the Medicines Advisory Statements Specification adds statements such as the two for folic acid in a product indicated for reducing the risk of a neural tube defect. We check every statement against the formula before the label goes to print."},{"q":"Why are so many prenatals chewables or gummies?","a":"Because people have to take them every day, often through morning sickness. A chewable or a gummy can make a long list of vitamins and minerals easier to take, but the taste of B vitamins and selenium has to be managed. See gummies.","md":"Because people have to take them every day, often through morning sickness. A chewable or a gummy can make a long list of vitamins and minerals easier to take, but the taste of B vitamins and selenium has to be managed. See [gummies](/formats/gummies)."},{"q":"Can you make a sample or trial pack?","a":"Yes. Arxi's preconception capsule has a 7-day sample pack for events and sampling, made alongside its main pack. See sample and trial packs.","md":"Yes. Arxi's preconception capsule has a 7-day sample pack for events and sampling, made alongside its main pack. See [sample and trial packs](/guides/supplement-sample-packs)."}],"sources":{"note":"General information, checked against these sources on 28 October 2026. It isn't advice on a particular product. Our work is from Take Friday Off's records.","markdown":"General information, checked against these sources on 28 October 2026. It isn't advice on a particular product. Our work is from Take Friday Off's records.\n\n- [Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025](https://www.legislation.gov.au/F2025L00450/latest/versions) and its [explanatory statement](https://www.legislation.gov.au/F2025L00450/asmade/2025-04-02/es/original/pdf), Federal Register of Legislation\n- [Listed medicines evidence guidelines](https://www.tga.gov.au/sites/default/files/evidence-guidelines.pdf), version 4.0, June 2022, Therapeutic Goods Administration\n- [Listed medicines requiring pregnancy warning statement](https://www.tga.gov.au/listed-medicines-requiring-pregnancy-warning-statement), Therapeutic Goods Administration, 30 March 2022\n- [Therapeutic Goods (Medicines Advisory Statements) Specification 2021](https://www.legislation.gov.au/F2021L01888/asmade/2021-12-23/text/original/pdf), Federal Register of Legislation, and [Proposed changes to Required Advisory Statements for Medicine Labels (RASML)](https://consultations.tga.gov.au/tga/proposed-changes-rasml-2026/), Therapeutic Goods Administration, 2026","items":[{"text":"Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025 and its explanatory statement, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025","url":"https://www.legislation.gov.au/F2025L00450/latest/versions"},{"title":"explanatory statement","url":"https://www.legislation.gov.au/F2025L00450/asmade/2025-04-02/es/original/pdf"}]},{"text":"Listed medicines evidence guidelines, version 4.0, June 2022, Therapeutic Goods Administration","links":[{"title":"Listed medicines evidence guidelines","url":"https://www.tga.gov.au/sites/default/files/evidence-guidelines.pdf"}]},{"text":"Listed medicines requiring pregnancy warning statement, Therapeutic Goods Administration, 30 March 2022","links":[{"title":"Listed medicines requiring pregnancy warning statement","url":"https://www.tga.gov.au/listed-medicines-requiring-pregnancy-warning-statement"}]},{"text":"Therapeutic Goods (Medicines Advisory Statements) Specification 2021, Federal Register of Legislation, and Proposed changes to Required Advisory Statements for Medicine Labels (RASML), Therapeutic Goods Administration, 2026","links":[{"title":"Therapeutic Goods (Medicines Advisory Statements) Specification 2021","url":"https://www.legislation.gov.au/F2021L01888/asmade/2021-12-23/text/original/pdf"},{"title":"Proposed changes to Required Advisory Statements for Medicine Labels (RASML)","url":"https://consultations.tga.gov.au/tga/proposed-changes-rasml-2026/"}]}]}},{"slug":"probiotic-supplement-development","kind":"guide","url":"/guides/probiotic-supplement-development","title":"Probiotic and gut health supplements: developing one in Australia","name":"Probiotics guide","description":"Working with a probiotic supplement manufacturer: the quality standard, strain names on the label, holding the count to expiry, and our probiotic work.","eyebrow":"Guide","lead":"A probiotic is alive, and that changes the work. The strains have to be identified and controlled, the label has to name them the way the rules allow, and the count on the label has to hold until the last day of the shelf life. This guide covers the quality standard the TGA applies to listed probiotic medicines, how strains are named on the label, what the stability evidence has to show, and the probiotic products we've built.","parent":"/product-development","studies":["the-belly-solution-travel-gut-health-powder","probiotic-skin-supplement","ora-practitioner-natural-medicine"],"formats":[],"order":84,"updated":"2026-10-28","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- The quality standard for a listed probiotic medicine is the European and British Pharmacopoeia's general monograph 3053, Live biotherapeutic products for human use. It applies to all probiotics, multi-strain included, and requires the active ingredients to be controlled at strain level.\n- The TGA's guidelines on demonstrating the quality of listed probiotic medicines aren't mandatory: they show what a TGA delegate considers acceptable.\n- Names: Australian Approved Names for probiotics exist only at species level, while monograph 3053 asks for strains on the label. Until 1 October 2026 a TGA consent let a sponsor follow either, but not mix the two on one label.\n- The stated quantity has to be met until the end of the shelf life, and a total count isn't enough on its own: the TGA wants data showing particular strains aren't out-competing the others.\n- From our records: The Belly Solution's travel gut-health powder, built on *Saccharomyces boulardii*, from formulation to dispatch in about eight months, then a national pharmacy trial; and a skincare brand's probiotic supplement, from design to production order in 12 weeks.","text":"The quality standard for a listed probiotic medicine is the European and British Pharmacopoeia's general monograph 3053, Live biotherapeutic products for human use. It applies to all probiotics, multi-strain included, and requires the active ingredients to be controlled at strain level. The TGA's guidelines on demonstrating the quality of listed probiotic medicines aren't mandatory: they show what a TGA delegate considers acceptable. Names: Australian Approved Names for probiotics exist only at species level, while monograph 3053 asks for strains on the label. Until 1 October 2026 a TGA consent let a sponsor follow either, but not mix the two on one label. The stated quantity has to be met until the end of the shelf life, and a total count isn't enough on its own: the TGA wants data showing particular strains aren't out-competing the others. From our records: The Belly Solution's travel gut-health powder, built on Saccharomyces boulardii, from formulation to dispatch in about eight months, then a national pharmacy trial; and a skincare brand's probiotic supplement, from design to production order in 12 weeks.","items":[],"tables":[]},{"heading":"The quality standard: monograph 3053","anchor":"the-quality-standard-monograph-3053","markdown":"The TGA treats general monograph 3053 of the European and British Pharmacopoeias, Live biotherapeutic products for human use, as the standard most relevant to probiotics. It applies to all probiotics, including multi-strain products, and requires probiotic active ingredients to be controlled at strain level.\n\nControlling at strain level doesn't mean testing every strain to the end of the shelf life. Where the quantity is controlled by what goes in, the TGA's material says strain identity and quantity are controlled earlier, through good manufacturing practice, including qualifying the vendor or supplier. The TGA's guidelines on demonstrating the quality of listed probiotic medicines set out what a delegate would accept, and are not mandatory.\n\nTwo other rules are different for probiotics:\n\n- **Microbial testing.** TGO 100's test methods aren't applicable to medicines containing viable microorganisms, the TGA says; the methods and limits in monograph 3053 are considered more appropriate.\n- **Excipients on the label.** Monograph 3053 asks for the name of any stabilisers and other excipients on the label. Since an amendment to the Exempt Monographs Determination in 2025, that requirement no longer applies to eligible listed medicines in Australia.","text":"The TGA treats general monograph 3053 of the European and British Pharmacopoeias, Live biotherapeutic products for human use, as the standard most relevant to probiotics. It applies to all probiotics, including multi-strain products, and requires probiotic active ingredients to be controlled at strain level. Controlling at strain level doesn't mean testing every strain to the end of the shelf life. Where the quantity is controlled by what goes in, the TGA's material says strain identity and quantity are controlled earlier, through good manufacturing practice, including qualifying the vendor or supplier. The TGA's guidelines on demonstrating the quality of listed probiotic medicines set out what a delegate would accept, and are not mandatory. Two other rules are different for probiotics: Microbial testing. TGO 100's test methods aren't applicable to medicines containing viable microorganisms, the TGA says; the methods and limits in monograph 3053 are considered more appropriate. Excipients on the label. Monograph 3053 asks for the name of any stabilisers and other excipients on the label. Since an amendment to the Exempt Monographs Determination in 2025, that requirement no longer applies to eligible listed medicines in Australia.","items":[{"lead":"Microbial testing.","text":"TGO 100's test methods aren't applicable to medicines containing viable microorganisms, the TGA says; the methods and limits in monograph 3053 are considered more appropriate."},{"lead":"Excipients on the label.","text":"Monograph 3053 asks for the name of any stabilisers and other excipients on the label. Since an amendment to the Exempt Monographs Determination in 2025, that requirement no longer applies to eligible listed medicines in Australia."}],"tables":[]},{"heading":"Strain names on the label","anchor":"strain-names-on-the-label","markdown":"A listed medicine's label names each active ingredient by its Australian Approved Name, and for probiotics those names exist only at species level. Monograph 3053 asks for the strain. A TGA consent under section 14 let sponsors label at species level, under the labelling order, or at strain level, under the monograph, but not mix the two on one label. It ran until 1 October 2026, when TGO 92 ended. Check the TGA's current position before the artwork is final, and see our [labelling guide](/guides/supplement-labelling) for the rest of the label.","text":"A listed medicine's label names each active ingredient by its Australian Approved Name, and for probiotics those names exist only at species level. Monograph 3053 asks for the strain. A TGA consent under section 14 let sponsors label at species level, under the labelling order, or at strain level, under the monograph, but not mix the two on one label. It ran until 1 October 2026, when TGO 92 ended. Check the TGA's current position before the artwork is final, and see our labelling guide for the rest of the label.","items":[],"tables":[]},{"heading":"Holding the count to expiry","anchor":"holding-the-count-to-expiry","markdown":"The quantity on the label has to be there on the last day of the shelf life, not only on the day it was made. Stability studies show each batch keeps at least the labelled quantity. If the evidence relies on a total count for a genus or species over time, the TGA wants additional data showing particular strains aren't out-competing the others, such as stability data for the individual strains and water activity data ([stability testing](/guides/stability-testing)).\n\nThe Belly Solution's powder has a 36-month stability program behind it, designed with the product's formula.","text":"The quantity on the label has to be there on the last day of the shelf life, not only on the day it was made. Stability studies show each batch keeps at least the labelled quantity. If the evidence relies on a total count for a genus or species over time, the TGA wants additional data showing particular strains aren't out-competing the others, such as stability data for the individual strains and water activity data (stability testing). The Belly Solution's powder has a 36-month stability program behind it, designed with the product's formula.","items":[],"tables":[]},{"heading":"Formats","anchor":"formats","markdown":"- **Powders and pouches.** The Belly Solution combines *Saccharomyces boulardii*, a prebiotic and electrolytes in a 14-day pouch ([powders and sachets](/formats/powders-sachets)).\n- **A daily supplement.** A skincare brand's second-version formula put probiotics at the core of a two-a-day product.\n\nWhich format suits a probiotic depends on the strains, the dose and the water in the mix, so we settle it at the brief with the stability plan.","text":"Powders and pouches. The Belly Solution combines Saccharomyces boulardii, a prebiotic and electrolytes in a 14-day pouch (powders and sachets). A daily supplement. A skincare brand's second-version formula put probiotics at the core of a two-a-day product. Which format suits a probiotic depends on the strains, the dose and the water in the mix, so we settle it at the brief with the stability plan.","items":[{"lead":"Powders and pouches.","text":"The Belly Solution combines Saccharomyces boulardii, a prebiotic and electrolytes in a 14-day pouch (powders and sachets)."},{"lead":"A daily supplement.","text":"A skincare brand's second-version formula put probiotics at the core of a two-a-day product."}],"tables":[]},{"heading":"From our records","anchor":"from-our-records","markdown":"- [The Belly Solution](/work/the-belly-solution-travel-gut-health-powder): a TGA-listed travel gut-health powder built on the clinically studied probiotic yeast *Saccharomyces boulardii*, with a prebiotic and electrolytes, in a 14-day pouch. We designed the formula, built the claims evidence, secured the listing, reviewed the label and set up a 36-month stability program. About eight months from formulation to dispatch, then a national pharmacy distribution trial, with more than 30 new stockists in the first week.\n- [A skin program built on probiotics](/work/probiotic-skin-supplement): the second version of a skincare brand's daily supplement, with probiotics at its core, the claims evidence, the TGA listing and a stability program. From design to production order in 12 weeks, shipped in 2025.\n- [Ora](/work/ora-practitioner-natural-medicine), our founder's own brand, has a gut health range among its practitioner medicines.","text":"The Belly Solution: a TGA-listed travel gut-health powder built on the clinically studied probiotic yeast Saccharomyces boulardii, with a prebiotic and electrolytes, in a 14-day pouch. We designed the formula, built the claims evidence, secured the listing, reviewed the label and set up a 36-month stability program. About eight months from formulation to dispatch, then a national pharmacy distribution trial, with more than 30 new stockists in the first week. A skin program built on probiotics: the second version of a skincare brand's daily supplement, with probiotics at its core, the claims evidence, the TGA listing and a stability program. From design to production order in 12 weeks, shipped in 2025. Ora, our founder's own brand, has a gut health range among its practitioner medicines.","items":[],"tables":[]}],"faqs":[{"q":"Do I have to name the strain on the label?","a":"The Australian Approved Names for probiotics are at species level, and monograph 3053 asks for strains. Until 1 October 2026 a TGA consent let sponsors choose one approach or the other, but not both on one label. We check the current position for each product before the artwork is final.","md":"The Australian Approved Names for probiotics are at species level, and monograph 3053 asks for strains. Until 1 October 2026 a TGA consent let sponsors choose one approach or the other, but not both on one label. We check the current position for each product before the artwork is final."},{"q":"Does every strain have to be tested to the end of the shelf life?","a":"Not necessarily. The TGA's material says controlling at strain level throughout the shelf life doesn't equate to testing at strain level throughout it: strain identity and quantity can be controlled earlier, through supplier qualification and manufacturing controls. The stability data still has to show the labelled quantity holds.","md":"Not necessarily. The TGA's material says controlling at strain level throughout the shelf life doesn't equate to testing at strain level throughout it: strain identity and quantity can be controlled earlier, through supplier qualification and manufacturing controls. The stability data still has to show the labelled quantity holds."},{"q":"Is a probiotic a listed medicine or a food?","a":"Which pathway suits a probiotic depends on its ingredients and its claims, and we settle it at the brief. The Belly Solution's powder and the probiotic skin supplement above are TGA-listed medicines. See medicine, food or cosmetic.","md":"Which pathway suits a probiotic depends on its ingredients and its claims, and we settle it at the brief. The Belly Solution's powder and the probiotic skin supplement above are TGA-listed medicines. See [medicine, food or cosmetic](/pathways)."},{"q":"How long does a probiotic take to develop?","a":"From our records: about eight months from formulation to dispatch for The Belly Solution's powder, and 12 weeks from design to production order for the second version of a probiotic skin supplement.","md":"From our records: about eight months from formulation to dispatch for The Belly Solution's powder, and 12 weeks from design to production order for the second version of a probiotic skin supplement."}],"sources":{"note":"General information, checked against these sources on 28 October 2026. It isn't advice on a particular product. Our work is from Take Friday Off's records.","markdown":"General information, checked against these sources on 28 October 2026. It isn't advice on a particular product. Our work is from Take Friday Off's records.\n\n- [Demonstrating the quality of listed probiotic medicines](https://www.tga.gov.au/resources/guidance/demonstrating-quality-listed-probiotic-medicines), Therapeutic Goods Administration\n- [Guidance material: demonstrating the quality of listed probiotic medicines](https://www.tga.gov.au/sites/default/files/2025-05/presentation-guidance-material-demonstrating-quality-listed-probiotic-medicines.pdf), presentation, and the [webinar on the guidance](https://tga.gov.au/node/495729), Therapeutic Goods Administration\n- [Update to monograph requirements for listed probiotic medicines](https://www.tga.gov.au/news/news-articles/update-monograph-requirements-listed-probiotic-medicines), Therapeutic Goods Administration","items":[{"text":"Demonstrating the quality of listed probiotic medicines, Therapeutic Goods Administration","links":[{"title":"Demonstrating the quality of listed probiotic medicines","url":"https://www.tga.gov.au/resources/guidance/demonstrating-quality-listed-probiotic-medicines"}]},{"text":"Guidance material: demonstrating the quality of listed probiotic medicines, presentation, and the webinar on the guidance, Therapeutic Goods Administration","links":[{"title":"Guidance material: demonstrating the quality of listed probiotic medicines","url":"https://www.tga.gov.au/sites/default/files/2025-05/presentation-guidance-material-demonstrating-quality-listed-probiotic-medicines.pdf"},{"title":"webinar on the guidance","url":"https://tga.gov.au/node/495729"}]},{"text":"Update to monograph requirements for listed probiotic medicines, Therapeutic Goods Administration","links":[{"title":"Update to monograph requirements for listed probiotic medicines","url":"https://www.tga.gov.au/news/news-articles/update-monograph-requirements-listed-probiotic-medicines"}]}]}},{"slug":"choosing-a-product-development-partner","kind":"guide","url":"/guides/choosing-a-product-development-partner","title":"Building a TGA-listed supplement brand: who does what, and who to choose","name":"Choosing a development partner","description":"Building a TGA-listed supplement brand in Australia: what a contract manufacturer, a regulatory consultant and a development partner each do, and what to ask.","eyebrow":"Guide","lead":"Building a TGA-listed supplement or wellness brand takes two different kinds of help. One is where you sell: the store, payments, subscriptions and marketing. The other is the product itself: the formula, the evidence, the listing, the label and the manufacture, under the TGA's rules. This guide is about the second: what a contract manufacturer, a regulatory consultant and an end-to-end development partner each do, how to tell which you need, and the questions to ask any of them.","parent":"/product-development","studies":["skincare-brand-regulatory-partner","everleanbody-saffron-capsule","sports-brand-core-range"],"formats":[],"order":85,"updated":"2026-10-28","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- **Two decisions.** Where you sell (your store and marketing) and who builds the product. Settle the product first: its pathway decides the ingredients, the claims and the label you'll be selling with.\n- **A contract manufacturer** makes what it is given. It won't check whether your formula fits its pathway, whether your claims hold up or whether your label is right.\n- **A regulatory consultant** helps with the rules: the TGA calls an agent \"a regulatory affairs consultant offering services, including advice and assistance in relation to regulatory requirements\". The sponsor still answers for the medicine.\n- **An end-to-end development partner** carries the brief, the formula, the evidence, the listing, the label and the packaging, and manages the manufacture. That's what we do.\n- **Whichever you choose,** the sponsor is normally your own company: the business that holds the ARTG entry and is legally responsible for the product.","text":"Two decisions. Where you sell (your store and marketing) and who builds the product. Settle the product first: its pathway decides the ingredients, the claims and the label you'll be selling with. A contract manufacturer makes what it is given. It won't check whether your formula fits its pathway, whether your claims hold up or whether your label is right. A regulatory consultant helps with the rules: the TGA calls an agent \"a regulatory affairs consultant offering services, including advice and assistance in relation to regulatory requirements\". The sponsor still answers for the medicine. An end-to-end development partner carries the brief, the formula, the evidence, the listing, the label and the packaging, and manages the manufacture. That's what we do. Whichever you choose, the sponsor is normally your own company: the business that holds the ARTG entry and is legally responsible for the product.","items":[{"lead":"Two decisions.","text":"Where you sell (your store and marketing) and who builds the product. Settle the product first: its pathway decides the ingredients, the claims and the label you'll be selling with."},{"lead":"A contract manufacturer","text":"makes what it is given. It won't check whether your formula fits its pathway, whether your claims hold up or whether your label is right."},{"lead":"A regulatory consultant","text":"helps with the rules: the TGA calls an agent \"a regulatory affairs consultant offering services, including advice and assistance in relation to regulatory requirements\". The sponsor still answers for the medicine."},{"lead":"An end-to-end development partner","text":"carries the brief, the formula, the evidence, the listing, the label and the packaging, and manages the manufacture. That's what we do."},{"lead":"Whichever you choose,","text":"the sponsor is normally your own company: the business that holds the ARTG entry and is legally responsible for the product."}],"tables":[]},{"heading":"Where you sell, and what you sell","anchor":"where-you-sell-and-what-you-sell","markdown":"Your store, checkout, subscriptions and email are one decision. The product is another, and for a supplement in Australia it comes first: whether it is a listed medicine, a food or a cosmetic decides the ingredients it can use, the claims it can make and the label it carries ([medicine, food or cosmetic](/pathways)). A store can be changed in weeks; a product's pathway can't be changed without remaking it.","text":"Your store, checkout, subscriptions and email are one decision. The product is another, and for a supplement in Australia it comes first: whether it is a listed medicine, a food or a cosmetic decides the ingredients it can use, the claims it can make and the label it carries (medicine, food or cosmetic). A store can be changed in weeks; a product's pathway can't be changed without remaking it.","items":[],"tables":[]},{"heading":"Who builds the product","anchor":"who-builds-the-product","markdown":"### A contract manufacturer\n\nA manufacturer makes what it is given. For a listed medicine it holds a TGA manufacturing licence for the steps it carries out, and makes the batches to the specification. It won't check whether your formula fits its pathway, whether your claims hold up or whether your label is right. That risk sits with you, and it surfaces after launch, when fixing it means relabelling or pulling stock. How to choose one is in our [manufacturer guide](/guides/choosing-a-supplement-manufacturer).\n\n### A regulatory consultant\n\nA sponsor can work through an agent, which the TGA describes as \"a regulatory affairs consultant offering services, including advice and assistance in relation to regulatory requirements\". The agent can do the work, but the sponsor is responsible for the medicine complying ([TGA sponsor](/guides/tga-sponsor)). A consultant suits a brand with its own product team and its own manufacturer, which needs the rules handled.\n\n### An end-to-end development partner\n\nOne team for the whole job: the brief, the formulation, the evidence behind every claim, the listing, the label, the packaging, and managing the manufacture and delivery to your warehouse. You deal with one team; it deals with the factory. This is how we work, through the five steps of the [Friday Launch Engine™](/system).","text":"A contract manufacturer A manufacturer makes what it is given. For a listed medicine it holds a TGA manufacturing licence for the steps it carries out, and makes the batches to the specification. It won't check whether your formula fits its pathway, whether your claims hold up or whether your label is right. That risk sits with you, and it surfaces after launch, when fixing it means relabelling or pulling stock. How to choose one is in our manufacturer guide. A regulatory consultant A sponsor can work through an agent, which the TGA describes as \"a regulatory affairs consultant offering services, including advice and assistance in relation to regulatory requirements\". The agent can do the work, but the sponsor is responsible for the medicine complying (TGA sponsor). A consultant suits a brand with its own product team and its own manufacturer, which needs the rules handled. An end-to-end development partner One team for the whole job: the brief, the formulation, the evidence behind every claim, the listing, the label, the packaging, and managing the manufacture and delivery to your warehouse. You deal with one team; it deals with the factory. This is how we work, through the five steps of the Friday Launch Engine™.","items":[],"tables":[]},{"heading":"How to tell which you need","anchor":"how-to-tell-which-you-need","markdown":"- **You have a finished formula, its evidence and a compliant label:** a manufacturer may be all you need.\n- **You have a product team and a manufacturer, but the rules are slowing you down:** a regulatory consultant or a regulatory retainer.\n- **You have an idea, a brand and a market, and want one team accountable from brief to shelf:** an end-to-end development partner.","text":"You have a finished formula, its evidence and a compliant label: a manufacturer may be all you need. You have a product team and a manufacturer, but the rules are slowing you down: a regulatory consultant or a regulatory retainer. You have an idea, a brand and a market, and want one team accountable from brief to shelf: an end-to-end development partner.","items":[{"lead":"You have a finished formula, its evidence and a compliant label:","text":"a manufacturer may be all you need."},{"lead":"You have a product team and a manufacturer, but the rules are slowing you down:","text":"a regulatory consultant or a regulatory retainer."},{"lead":"You have an idea, a brand and a market, and want one team accountable from brief to shelf:","text":"an end-to-end development partner."}],"tables":[]},{"heading":"Questions to ask any of them","anchor":"questions-to-ask-any-of-them","markdown":"- Which pathway will my product take, and when will that be settled?\n- Who holds the evidence for each claim, and who checks the label against the rules before print?\n- Which parts are fixed fees, and which are priced per unit?\n- Which manufacturer will make it, does it hold the licence for each step, and who manages the batches?\n- What have you built in my format and pathway, and how long did it take?","text":"Which pathway will my product take, and when will that be settled? Who holds the evidence for each claim, and who checks the label against the rules before print? Which parts are fixed fees, and which are priced per unit? Which manufacturer will make it, does it hold the licence for each step, and who manages the batches? What have you built in my format and pathway, and how long did it take?","items":[],"tables":[]},{"heading":"From our records","anchor":"from-our-records","markdown":"- [An international skincare brand](/work/skincare-brand-regulatory-partner): formula and evidence work on two supplements and a sunscreen, and their regulatory work on a monthly retainer since 2024, now in its third year.\n- [EverLeanBody](/work/everleanbody-saffron-capsule): end to end, from the brief workshop to the formula, the evidence, the listing, the label and the stability program: 5.8 months from signed brief to dispatch.\n- [ATP Science](/work/sports-brand-core-range): an established brand's range, four TGA-listed capsules reformulated from scratch.\n- We've run 190 projects since 2020: capsules, tablets, chewables, powders, liquids and creams, as TGA-listed medicines, foods and cosmetics.","text":"An international skincare brand: formula and evidence work on two supplements and a sunscreen, and their regulatory work on a monthly retainer since 2024, now in its third year. EverLeanBody: end to end, from the brief workshop to the formula, the evidence, the listing, the label and the stability program: 5.8 months from signed brief to dispatch. ATP Science: an established brand's range, four TGA-listed capsules reformulated from scratch. We've run 190 projects since 2020: capsules, tablets, chewables, powders, liquids and creams, as TGA-listed medicines, foods and cosmetics.","items":[],"tables":[]}],"faqs":[{"q":"What's the best way to build a TGA-listed supplement brand in Australia?","a":"Settle the product before the store: its pathway, ingredients and claims. Then choose who builds it: a contract manufacturer if you bring a finished formula and its evidence, a regulatory consultant if you have your own team and factory, or an end-to-end development partner such as Take Friday Off if you want one team from brief to shelf. Our guide to starting a supplement brand has the steps.","md":"Settle the product before the store: its pathway, ingredients and claims. Then choose who builds it: a contract manufacturer if you bring a finished formula and its evidence, a regulatory consultant if you have your own team and factory, or an end-to-end development partner such as Take Friday Off if you want one team from brief to shelf. Our guide to [starting a supplement brand](/guides/start-a-supplement-brand) has the steps."},{"q":"Who holds the ARTG listing?","a":"The sponsor, which is normally the brand's own company: the business that holds the ARTG entry and is legally responsible for the product. We prepare the listing, the evidence and the label for the sponsor to certify.","md":"The sponsor, which is normally the brand's own company: the business that holds the ARTG entry and is legally responsible for the product. We prepare the listing, the evidence and the label for the sponsor to certify."},{"q":"Can I put my brand on an existing listed product?","a":"Ask who will be the sponsor, what the existing listing lets you claim, and who controls the formula. If you want your own formula and claims, the product is built and listed for your company.","md":"Ask who will be the sponsor, what the existing listing lets you claim, and who controls the formula. If you want your own formula and claims, the product is built and listed for your company."},{"q":"Is Take Friday Off a manufacturer?","a":"No. We're a product development company in Brookvale, Sydney. We develop the product and make it compliant, then manage its manufacture through audited cGMP partners matched to its format, volume and margin. See supplement product development in Sydney.","md":"No. We're a product development company in Brookvale, Sydney. We develop the product and make it compliant, then manage its manufacture through audited cGMP partners matched to its format, volume and margin. See [supplement product development in Sydney](/supplement-development-sydney)."}],"sources":{"note":"General information, checked against these sources on 28 October 2026. It isn't advice on a particular product. Our work is from Take Friday Off's records.","markdown":"General information, checked against these sources on 28 October 2026. It isn't advice on a particular product. Our work is from Take Friday Off's records.\n\n- [Therapeutic Goods Act 1989](https://www.legislation.gov.au/C2004A03952/latest/text), section 3 (the meanings of manufacture and sponsor) and Part 3-3 (manufacturing), Federal Register of Legislation\n- [Determine if you are a sponsor](https://www.tga.gov.au/node/289) and [Organisation Details: Sponsor, Agent and Manufacturer](https://www.tga.gov.au/sites/default/files/2026-04/form-tga-business-services-organisation-details.pdf), Therapeutic Goods Administration\n- [Manufacturing therapeutic goods](https://www.tga.gov.au/products/regulations-all-products/manufacturing), Therapeutic Goods Administration","items":[{"text":"Therapeutic Goods Act 1989, section 3 (the meanings of manufacture and sponsor) and Part 3-3 (manufacturing), Federal Register of Legislation","links":[{"title":"Therapeutic Goods Act 1989","url":"https://www.legislation.gov.au/C2004A03952/latest/text"}]},{"text":"Determine if you are a sponsor and Organisation Details: Sponsor, Agent and Manufacturer, Therapeutic Goods Administration","links":[{"title":"Determine if you are a sponsor","url":"https://www.tga.gov.au/node/289"},{"title":"Organisation Details: Sponsor, Agent and Manufacturer","url":"https://www.tga.gov.au/sites/default/files/2026-04/form-tga-business-services-organisation-details.pdf"}]},{"text":"Manufacturing therapeutic goods, Therapeutic Goods Administration","links":[{"title":"Manufacturing therapeutic goods","url":"https://www.tga.gov.au/products/regulations-all-products/manufacturing"}]}]}},{"slug":"sports-supplement-development","kind":"guide","url":"/guides/sports-supplement-development","title":"Sports supplements in Australia: food or medicine, and how to build one","name":"Sports supplements guide","description":"Working with a sports supplement manufacturer in Australia: when a sports product is a food or a TGA-listed medicine, the rules for each, and our records.","eyebrow":"Guide","lead":"A sports supplement can be a food or a medicine in Australia, and the line isn't where most founders expect. A protein powder made for sport is usually a food under Standard 2.9.4. The same brand's capsule for recovery or stamina is usually a listed medicine. This guide covers where the line sits, what each pathway allows, the substances that make a sports product a medicine whatever its form, and the sports range we rebuilt from scratch.","parent":"/pathways/foods","studies":["sports-brand-core-range","sports-nutrition-joint-formula","ora-practitioner-natural-medicine"],"formats":[],"order":86,"updated":"2026-10-29","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- A sports product taken by mouth is a food if it only contains ingredients appropriate for food, comes in a traditional food form such as a powder, bar or drink, and meets the Food Standards Code. Standard 2.9.4 covers formulated supplementary sports foods.\n- It is declared a medicine if it is presented for a therapeutic use, such as gaining muscle, increasing focus or stamina, losing fat, or recovering from a workout, and either comes as a tablet, capsule or pill (since 30 November 2023, unless it contains only glucose) or contains certain substances.\n- Those substances include anything in the Poisons Standard, an added substance on the 2023 World Anti-Doping Prohibited List, added dendrobium or methylliberine, or something with the same pharmacological action. Isolated HMB makes a tablet, capsule, pill or powder a medicine whatever its presentation.\n- Since 9 June 2026, Standard 2.9.4 caps caffeine at 200 mg in the amount for one day, as directed on the label, with a transition to 9 June 2028.\n- From our records: a private-equity-backed sports brand's core range, rebuilt as four TGA-listed capsules (one on Testofen®) and a food-pathway performance powder, with three reordered within a year; and a TGA-listed joint formula for an established sports nutrition brand.","text":"A sports product taken by mouth is a food if it only contains ingredients appropriate for food, comes in a traditional food form such as a powder, bar or drink, and meets the Food Standards Code. Standard 2.9.4 covers formulated supplementary sports foods. It is declared a medicine if it is presented for a therapeutic use, such as gaining muscle, increasing focus or stamina, losing fat, or recovering from a workout, and either comes as a tablet, capsule or pill (since 30 November 2023, unless it contains only glucose) or contains certain substances. Those substances include anything in the Poisons Standard, an added substance on the 2023 World Anti-Doping Prohibited List, added dendrobium or methylliberine, or something with the same pharmacological action. Isolated HMB makes a tablet, capsule, pill or powder a medicine whatever its presentation. Since 9 June 2026, Standard 2.9.4 caps caffeine at 200 mg in the amount for one day, as directed on the label, with a transition to 9 June 2028. From our records: a private-equity-backed sports brand's core range, rebuilt as four TGA-listed capsules (one on Testofen®) and a food-pathway performance powder, with three reordered within a year; and a TGA-listed joint formula for an established sports nutrition brand.","items":[],"tables":[]},{"heading":"Food or medicine: where the line sits","anchor":"food-or-medicine-where-the-line-sits","markdown":"Most sports supplements fall on one side of a line the TGA drew in the Therapeutic Goods (Declared Goods) Order 2019. Products taken by mouth and represented as improving or maintaining performance in sport, exercise or recreational activity are declared medicines when they are used, advertised or presented for a therapeutic use, such as gaining muscle, increasing focus or stamina, losing fat, or preparing for or recovering from a workout, or in a way likely to be taken as one, if they:\n\n- contain, or are said to contain, a Poisons Standard substance, an added substance on the 2023 World Anti-Doping Prohibited List, added dendrobium or methylliberine, or a substance with equivalent pharmacological action; or\n- since 30 November 2023, are supplied as a tablet, capsule or pill, unless they contain glucose only.\n\nSome goods are declared by form alone. A tablet, capsule, pill or powder that contains, or is promoted to contain, isolated HMB or its salts is a medicine, whatever its presentation.\n\nOnce declared, a product \"cannot be a food\", the TGA says, even if a food standard covers it. The TGA also says sports supplements \"that only contain ingredients appropriate for food and are presented in a traditional food form\" are not affected, \"e.g. protein powders, nutrition bars and energy drinks\". The full picture is in our guide to [the food pathway](/pathways/foods).","text":"Most sports supplements fall on one side of a line the TGA drew in the Therapeutic Goods (Declared Goods) Order 2019. Products taken by mouth and represented as improving or maintaining performance in sport, exercise or recreational activity are declared medicines when they are used, advertised or presented for a therapeutic use, such as gaining muscle, increasing focus or stamina, losing fat, or preparing for or recovering from a workout, or in a way likely to be taken as one, if they: contain, or are said to contain, a Poisons Standard substance, an added substance on the 2023 World Anti-Doping Prohibited List, added dendrobium or methylliberine, or a substance with equivalent pharmacological action; or since 30 November 2023, are supplied as a tablet, capsule or pill, unless they contain glucose only. Some goods are declared by form alone. A tablet, capsule, pill or powder that contains, or is promoted to contain, isolated HMB or its salts is a medicine, whatever its presentation. Once declared, a product \"cannot be a food\", the TGA says, even if a food standard covers it. The TGA also says sports supplements \"that only contain ingredients appropriate for food and are presented in a traditional food form\" are not affected, \"e.g. protein powders, nutrition bars and energy drinks\". The full picture is in our guide to the food pathway.","items":[],"tables":[]},{"heading":"Building a sports food","anchor":"building-a-sports-food","markdown":"A protein, pre-workout, creatine or electrolyte powder made for sport is usually built as a food under Standard 2.9.4, formulated supplementary sports foods. That standard sets which vitamins, minerals, amino acids and other substances can be added, within its limits, and the statements the label carries. Since 9 June 2026 it also caps caffeine at 200 mg in the amount for one day, as directed on the label, and below 5% of a powder or 1% of a liquid. Until 9 June 2028, a product may follow the Code as it was or as amended.\n\nA food's claims come from the Food Standards Code, not the TGA's list. Sports foods are special purpose foods, so a health claim on one doesn't have to meet the Nutrient Profiling Scoring Criterion that most foods must. How powders are made, packed and costed is in our [powders and sachets](/formats/powders-sachets) guide.","text":"A protein, pre-workout, creatine or electrolyte powder made for sport is usually built as a food under Standard 2.9.4, formulated supplementary sports foods. That standard sets which vitamins, minerals, amino acids and other substances can be added, within its limits, and the statements the label carries. Since 9 June 2026 it also caps caffeine at 200 mg in the amount for one day, as directed on the label, and below 5% of a powder or 1% of a liquid. Until 9 June 2028, a product may follow the Code as it was or as amended. A food's claims come from the Food Standards Code, not the TGA's list. Sports foods are special purpose foods, so a health claim on one doesn't have to meet the Nutrient Profiling Scoring Criterion that most foods must. How powders are made, packed and costed is in our powders and sachets guide.","items":[],"tables":[]},{"heading":"Building a sports medicine","anchor":"building-a-sports-medicine","markdown":"A capsule or tablet for recovery, stamina, joints or performance is a medicine, and usually a listed one. That means three things:\n\n- **Ingredients from the TGA's list.** Every active and excipient must be permitted for listed medicines, with the conditions the Permissible Ingredients Determination sets ([permissible ingredients](/guides/permissible-ingredients)).\n- **Claims from the TGA's list.** Indications come from the Permissible Indications Determination, and the sponsor holds the evidence for each ([permitted indications](/guides/permitted-indications)).\n- **A listing, a label and a stability program.** The product goes on the ARTG with an AUST L number, is labelled to TGO 116 and is made under GMP ([TGA approval](/guides/tga-approval)).\n\nA clinically studied branded ingredient can carry much of the evidence, if the studies match the product's dose and population ([branded ingredients](/guides/branded-ingredients)).","text":"A capsule or tablet for recovery, stamina, joints or performance is a medicine, and usually a listed one. That means three things: Ingredients from the TGA's list. Every active and excipient must be permitted for listed medicines, with the conditions the Permissible Ingredients Determination sets (permissible ingredients). Claims from the TGA's list. Indications come from the Permissible Indications Determination, and the sponsor holds the evidence for each (permitted indications). A listing, a label and a stability program. The product goes on the ARTG with an AUST L number, is labelled to TGO 116 and is made under GMP (TGA approval). A clinically studied branded ingredient can carry much of the evidence, if the studies match the product's dose and population (branded ingredients).","items":[{"lead":"Ingredients from the TGA's list.","text":"Every active and excipient must be permitted for listed medicines, with the conditions the Permissible Ingredients Determination sets (permissible ingredients)."},{"lead":"Claims from the TGA's list.","text":"Indications come from the Permissible Indications Determination, and the sponsor holds the evidence for each (permitted indications)."},{"lead":"A listing, a label and a stability program.","text":"The product goes on the ARTG with an AUST L number, is labelled to TGO 116 and is made under GMP (TGA approval)."}],"tables":[]},{"heading":"One brand, both pathways","anchor":"one-brand-both-pathways","markdown":"A sports range often sits across both pathways. When we rebuilt a sports brand's core range, four products became TGA-listed capsules and a performance powder went to market as a food. Each pathway brought its own ingredients, claims, label and quality system, and we settled which product went where at the brief, before the formulas were written. Ora, our founder's own brand, also spans TGA-listed medicines and premium functional foods.","text":"A sports range often sits across both pathways. When we rebuilt a sports brand's core range, four products became TGA-listed capsules and a performance powder went to market as a food. Each pathway brought its own ingredients, claims, label and quality system, and we settled which product went where at the brief, before the formulas were written. Ora, our founder's own brand, also spans TGA-listed medicines and premium functional foods.","items":[],"tables":[]},{"heading":"From our records","anchor":"from-our-records","markdown":"- [ATP Science's core range](/work/sports-brand-core-range): a private-equity-backed Australian sports and wellness brand, turning over A$24 million a year by 2019 and exporting to New Zealand, the UK and the UAE. Several of its best-known formulas had room to improve on ingredient quality, dose and permitted indications. We reformulated four TGA-listed capsules from scratch, one built on Testofen®, a clinically studied fenugreek extract, plus a food-pathway performance powder. We handled the listings, stability protocols and label review, and managed manufacturing for all five, working through a co-packer delay. Five products in production from late 2023, with reorders on three within a year.\n- [A joint formula for a sports nutrition brand](/work/sports-nutrition-joint-formula): the formula, the claims evidence, the TGA listing, managed production and a later listing update to keep it current. Delivered in 2023.\n- [Ora](/work/ora-practitioner-natural-medicine): our founder's own brand, with TGA-listed medicines and premium functional foods in one range.","text":"ATP Science's core range: a private-equity-backed Australian sports and wellness brand, turning over A$24 million a year by 2019 and exporting to New Zealand, the UK and the UAE. Several of its best-known formulas had room to improve on ingredient quality, dose and permitted indications. We reformulated four TGA-listed capsules from scratch, one built on Testofen®, a clinically studied fenugreek extract, plus a food-pathway performance powder. We handled the listings, stability protocols and label review, and managed manufacturing for all five, working through a co-packer delay. Five products in production from late 2023, with reorders on three within a year. A joint formula for a sports nutrition brand: the formula, the claims evidence, the TGA listing, managed production and a later listing update to keep it current. Delivered in 2023. Ora: our founder's own brand, with TGA-listed medicines and premium functional foods in one range.","items":[],"tables":[]}],"faqs":[{"q":"Is a protein powder a medicine?","a":"Usually not. The TGA says sports supplements that only contain ingredients appropriate for food and come in a traditional food form, such as protein powders, nutrition bars and energy drinks, are not affected by the declaration. A powder becomes a medicine if, for example, it contains a substance the Order names, such as isolated HMB.","md":"Usually not. The TGA says sports supplements that only contain ingredients appropriate for food and come in a traditional food form, such as protein powders, nutrition bars and energy drinks, are not affected by the declaration. A powder becomes a medicine if, for example, it contains a substance the Order names, such as isolated HMB."},{"q":"Can a sports capsule be sold as a food?","a":"Not if it is presented for a therapeutic use such as gaining muscle or recovering from a workout. Since 30 November 2023, a sports supplement in a tablet, capsule or pill presented that way is a medicine, unless it contains glucose only.","md":"Not if it is presented for a therapeutic use such as gaining muscle or recovering from a workout. Since 30 November 2023, a sports supplement in a tablet, capsule or pill presented that way is a medicine, unless it contains glucose only."},{"q":"How much caffeine can a pre-workout contain?","a":"As a sports food under Standard 2.9.4, up to 200 mg in the amount for one day, as directed on the label, and below 5% of a powder or 1% of a liquid, since 9 June 2026, with a transition to 9 June 2028.","md":"As a sports food under Standard 2.9.4, up to 200 mg in the amount for one day, as directed on the label, and below 5% of a powder or 1% of a liquid, since 9 June 2026, with a transition to 9 June 2028."},{"q":"Will my sports supplement be safe for tested athletes?","a":"That depends on every ingredient and on how it is made. A sports supplement presented for a therapeutic use that has an added substance on the 2023 World Anti-Doping Prohibited List is declared a medicine in Australia, so it's worth settling at the brief.","md":"That depends on every ingredient and on how it is made. A sports supplement presented for a therapeutic use that has an added substance on the 2023 World Anti-Doping Prohibited List is declared a medicine in Australia, so it's worth settling at the brief."},{"q":"Can you rebuild an existing sports range?","a":"Yes. We rebuilt a sports brand's core range from scratch: new formulas, listings, stability protocols and labels, and managed manufacturing through to reorders. See reformulating a supplement.","md":"Yes. We rebuilt a sports brand's core range from scratch: new formulas, listings, stability protocols and labels, and managed manufacturing through to reorders. See [reformulating a supplement](/guides/reformulating-a-supplement)."}],"sources":{"note":"General information, checked against these sources between 26 and 29 October 2026. It isn't advice on a particular product. Our work is from Take Friday Off's records.","markdown":"General information, checked against these sources between 26 and 29 October 2026. It isn't advice on a particular product. Our work is from Take Friday Off's records.\n\n- [Therapeutic Goods (Declared Goods) Order 2019](https://www.legislation.gov.au/F2019L01352/latest/text) and the [Therapeutic Goods Act 1989](https://www.legislation.gov.au/C2004A03952/latest/text), section 7, Federal Register of Legislation\n- [Changes to the regulation of sports supplements in Australia](https://www.tga.gov.au/changes-regulation-sports-supplements-australia) and [Food and medicine regulation](https://www.tga.gov.au/community-qa/food-and-medicine-regulation), Therapeutic Goods Administration\n- [Standard 2.9.4: Formulated supplementary sports foods](https://www.legislation.gov.au/F2015L00421/latest/text) and [Standard 1.2.7: Nutrition, health and related claims](https://www.legislation.gov.au/F2015L00394/latest/text), Federal Register of Legislation\n- [The Code variation for Proposal P1056, the caffeine review](https://www.legislation.gov.au/F2026L00700/asmade/text), clause 4, Federal Register of Legislation\n- [Sports foods](https://www.foodstandards.gov.au/consumer/nutrition/sportfood), Food Standards Australia New Zealand","items":[{"text":"Therapeutic Goods (Declared Goods) Order 2019 and the Therapeutic Goods Act 1989, section 7, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Declared Goods) Order 2019","url":"https://www.legislation.gov.au/F2019L01352/latest/text"},{"title":"Therapeutic Goods Act 1989","url":"https://www.legislation.gov.au/C2004A03952/latest/text"}]},{"text":"Changes to the regulation of sports supplements in Australia and Food and medicine regulation, Therapeutic Goods Administration","links":[{"title":"Changes to the regulation of sports supplements in Australia","url":"https://www.tga.gov.au/changes-regulation-sports-supplements-australia"},{"title":"Food and medicine regulation","url":"https://www.tga.gov.au/community-qa/food-and-medicine-regulation"}]},{"text":"Standard 2.9.4: Formulated supplementary sports foods and Standard 1.2.7: Nutrition, health and related claims, Federal Register of Legislation","links":[{"title":"Standard 2.9.4: Formulated supplementary sports foods","url":"https://www.legislation.gov.au/F2015L00421/latest/text"},{"title":"Standard 1.2.7: Nutrition, health and related claims","url":"https://www.legislation.gov.au/F2015L00394/latest/text"}]},{"text":"The Code variation for Proposal P1056, the caffeine review, clause 4, Federal Register of Legislation","links":[{"title":"The Code variation for Proposal P1056, the caffeine review","url":"https://www.legislation.gov.au/F2026L00700/asmade/text"}]},{"text":"Sports foods, Food Standards Australia New Zealand","links":[{"title":"Sports foods","url":"https://www.foodstandards.gov.au/consumer/nutrition/sportfood"}]}]}},{"slug":"womens-health-supplement-development","kind":"guide","url":"/guides/womens-health-supplement-development","title":"Women's health supplements: developing one in Australia","name":"Women's health guide","description":"Working with a women's health supplement manufacturer: the TGA rules for claims, the evidence they need, and what we've built, from preconception to menopause.","eyebrow":"Guide","lead":"Women's health is one of the busiest corners of the supplement market, and one of the most closely watched. A product for a woman's cycle, fertility, pregnancy, recovery after birth or the years around menopause has to make claims the TGA permits, backed by evidence in women like the ones who will take it, without straying into a condition that needs a doctor. This guide covers how the rules apply, where the evidence comes from, and the women's health products we've built across each life stage.","parent":"/product-development","studies":["everleanbody-saffron-capsule","arxi-preconception-supplement","mother-daily-postnatal-supplement","ora-practitioner-natural-medicine"],"formats":[],"order":87,"updated":"2026-10-29","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- Most women's health supplements in our records are TGA-listed medicines. Their claims come from the Permissible Indications Determination, whose tables include the reproductive system (Part 10) and, since 2025, pregnancy in a Part of its own (Part 17).\n- An indication can be qualified by population, and \"In females\" is one of the qualifiers the Determination's explanatory statement gives as an example.\n- No claim may imply the product treats a serious form of a disease, ailment, defect or injury. \"Serious\" takes its meaning from section 28 of the Therapeutic Goods Advertising Code, and a restricted representation needs the TGA's approval.\n- The evidence has to fit the women who will take the product: the TGA expects the population studied to be consistent with the medicine's target population, unless the difference is justified.\n- From our records: EverLeanBody's daily capsule for women 35 and over, signed brief to dispatch in 5.8 months; Arxi's preconception capsule, three production orders since 2024; Mother Daily's postnatal, six formula versions; and the women's hormonal health range in Ora, our founder's own brand.","text":"Most women's health supplements in our records are TGA-listed medicines. Their claims come from the Permissible Indications Determination, whose tables include the reproductive system (Part 10) and, since 2025, pregnancy in a Part of its own (Part 17). An indication can be qualified by population, and \"In females\" is one of the qualifiers the Determination's explanatory statement gives as an example. No claim may imply the product treats a serious form of a disease, ailment, defect or injury. \"Serious\" takes its meaning from section 28 of the Therapeutic Goods Advertising Code, and a restricted representation needs the TGA's approval. The evidence has to fit the women who will take the product: the TGA expects the population studied to be consistent with the medicine's target population, unless the difference is justified. From our records: EverLeanBody's daily capsule for women 35 and over, signed brief to dispatch in 5.8 months; Arxi's preconception capsule, three production orders since 2024; Mother Daily's postnatal, six formula versions; and the women's hormonal health range in Ora, our founder's own brand.","items":[],"tables":[]},{"heading":"The claims a women's health product can make","anchor":"the-claims-a-womens-health-product-can-make","markdown":"A listed medicine can only carry indications from the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025. Its tables are grouped by body system, and two matter most here:\n\n- **The reproductive system (Part 10).** Indications for reproductive health.\n- **Pregnancy (Part 17).** In 2025 the pregnancy indications moved out of the reproductive table into a Part of their own. They can't be combined in a sentence with other indications. Our [prenatal and postnatal guide](/guides/prenatal-supplement-development) covers them, with the warnings a prenatal carries.\n\nIndications can be qualified by population, time of use or tradition, and the explanatory statement gives \"In females\" as one population qualifier. A label can reword or combine indications without changing their meaning, but it can't imply that the product treats a serious form of a disease, ailment, defect or injury, or that it prevents or cures one. More in our guide to [permitted indications](/guides/permitted-indications).","text":"A listed medicine can only carry indications from the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025. Its tables are grouped by body system, and two matter most here: The reproductive system (Part 10). Indications for reproductive health. Pregnancy (Part 17). In 2025 the pregnancy indications moved out of the reproductive table into a Part of their own. They can't be combined in a sentence with other indications. Our prenatal and postnatal guide covers them, with the warnings a prenatal carries. Indications can be qualified by population, time of use or tradition, and the explanatory statement gives \"In females\" as one population qualifier. A label can reword or combine indications without changing their meaning, but it can't imply that the product treats a serious form of a disease, ailment, defect or injury, or that it prevents or cures one. More in our guide to permitted indications.","items":[{"lead":"The reproductive system (Part 10).","text":"Indications for reproductive health."},{"lead":"Pregnancy (Part 17).","text":"In 2025 the pregnancy indications moved out of the reproductive table into a Part of their own. They can't be combined in a sentence with other indications. Our prenatal and postnatal guide covers them, with the warnings a prenatal carries."}],"tables":[]},{"heading":"Where the line on serious conditions sits","anchor":"where-the-line-on-serious-conditions-sits","markdown":"Many women's health conditions are diagnosed and managed by a doctor. A claim that refers to a serious form of a disease, condition, ailment or defect, one that requires \"a health professional to diagnose, follow-up or treat\", is a restricted representation under the Therapeutic Goods Advertising Code. It can only be used with the TGA's prior approval, or under a permission the TGA has granted. So the brief has to place the product clearly: support for normal health in a life stage, not treatment of a condition. Our [TGA advertising guide](/guides/tga-advertising) covers restricted and prohibited representations, and the rules on testimonials and influencers that apply to every women's health brand marketing online.","text":"Many women's health conditions are diagnosed and managed by a doctor. A claim that refers to a serious form of a disease, condition, ailment or defect, one that requires \"a health professional to diagnose, follow-up or treat\", is a restricted representation under the Therapeutic Goods Advertising Code. It can only be used with the TGA's prior approval, or under a permission the TGA has granted. So the brief has to place the product clearly: support for normal health in a life stage, not treatment of a condition. Our TGA advertising guide covers restricted and prohibited representations, and the rules on testimonials and influencers that apply to every women's health brand marketing online.","items":[],"tables":[]},{"heading":"Evidence in the right women","anchor":"evidence-in-the-right-women","markdown":"The sponsor holds the evidence for each indication. The TGA's Listed medicines evidence guidelines expect the medicine's target population to be consistent with the population studied, unless the difference is justified. For a women's health product, that means studies in women of the right age or life stage, at the dose and in the form the product uses. A clinically studied branded ingredient can carry much of that evidence, if its studies match ([branded ingredients](/guides/branded-ingredients)).\n\nEverLeanBody's capsule shows the approach: it is built around affron®, a clinically studied saffron extract, with L-theanine, lemon balm and active-form B vitamins.","text":"The sponsor holds the evidence for each indication. The TGA's Listed medicines evidence guidelines expect the medicine's target population to be consistent with the population studied, unless the difference is justified. For a women's health product, that means studies in women of the right age or life stage, at the dose and in the form the product uses. A clinically studied branded ingredient can carry much of that evidence, if its studies match (branded ingredients). EverLeanBody's capsule shows the approach: it is built around affron®, a clinically studied saffron extract, with L-theanine, lemon balm and active-form B vitamins.","items":[],"tables":[]},{"heading":"Hair, skin and nails","anchor":"hair-skin-and-nails","markdown":"Many women's health ranges include a beauty supplement. A product labelled or promoted for cosmetic purposes, such as improving the appearance of skin, hair or nails, is a declared medicine when it is taken by mouth, so it needs a listing like any other. Our [beauty supplements guide](/guides/beauty-supplements) covers the claims and ingredients.","text":"Many women's health ranges include a beauty supplement. A product labelled or promoted for cosmetic purposes, such as improving the appearance of skin, hair or nails, is a declared medicine when it is taken by mouth, so it needs a listing like any other. Our beauty supplements guide covers the claims and ingredients.","items":[],"tables":[]},{"heading":"Building for every life stage","anchor":"building-for-every-life-stage","markdown":"- **Preconception and fertility.** Arxi's female preconception capsule: the formula, the claims evidence, the TGA listing, the label and a 24-month stability program, with a 7-day sample pack added later.\n- **Pregnancy and after birth.** Prenatal and postnatal formulas, covered in depth in our [prenatal and postnatal guide](/guides/prenatal-supplement-development).\n- **Perimenopause and menopause.** EverLeanBody is a founder-led women's wellness brand for perimenopause and menopause, built around an engaged online community. Its first product is a daily capsule for women 35 and over, built to a set retail price.\n- **Hormonal health across a range.** Ora, our founder's own brand, includes a women's hormonal health range, with every formula therapeutically dosed, plant-based and backed by evidence.","text":"Preconception and fertility. Arxi's female preconception capsule: the formula, the claims evidence, the TGA listing, the label and a 24-month stability program, with a 7-day sample pack added later. Pregnancy and after birth. Prenatal and postnatal formulas, covered in depth in our prenatal and postnatal guide. Perimenopause and menopause. EverLeanBody is a founder-led women's wellness brand for perimenopause and menopause, built around an engaged online community. Its first product is a daily capsule for women 35 and over, built to a set retail price. Hormonal health across a range. Ora, our founder's own brand, includes a women's hormonal health range, with every formula therapeutically dosed, plant-based and backed by evidence.","items":[{"lead":"Preconception and fertility.","text":"Arxi's female preconception capsule: the formula, the claims evidence, the TGA listing, the label and a 24-month stability program, with a 7-day sample pack added later."},{"lead":"Pregnancy and after birth.","text":"Prenatal and postnatal formulas, covered in depth in our prenatal and postnatal guide."},{"lead":"Perimenopause and menopause.","text":"EverLeanBody is a founder-led women's wellness brand for perimenopause and menopause, built around an engaged online community. Its first product is a daily capsule for women 35 and over, built to a set retail price."},{"lead":"Hormonal health across a range.","text":"Ora, our founder's own brand, includes a women's hormonal health range, with every formula therapeutically dosed, plant-based and backed by evidence."}],"tables":[]},{"heading":"From our records","anchor":"from-our-records","markdown":"- [EverLeanBody](/work/everleanbody-saffron-capsule): a four-ingredient capsule built around affron®, a clinically studied saffron extract, with L-theanine, lemon balm and active-form B vitamins. We ran the brief workshop, designed the formula, built the claims evidence, secured the TGA listing, drafted the label and set up a 24-month stability program. 5.8 months from signed brief to dispatch, and a second product, built on Eriomin®, now in development with us.\n- [Arxi's preconception supplement](/work/arxi-preconception-supplement): a TGA-listed female preconception capsule from a fertility brand founded by a fertility dietitian and a clinical nutritionist. Three production orders since 2024.\n- [Mother Daily's postnatal supplement](/work/mother-daily-postnatal-supplement): six formula versions, an evidence package covering eight key ingredients, and one of our largest first production runs.\n- [Ora](/work/ora-practitioner-natural-medicine): around 19 products across healthy longevity, women's hormonal health, gut health, and sleep, stress and recovery, recommended by naturopaths, herbalists and functional medicine practitioners.","text":"EverLeanBody: a four-ingredient capsule built around affron®, a clinically studied saffron extract, with L-theanine, lemon balm and active-form B vitamins. We ran the brief workshop, designed the formula, built the claims evidence, secured the TGA listing, drafted the label and set up a 24-month stability program. 5.8 months from signed brief to dispatch, and a second product, built on Eriomin®, now in development with us. Arxi's preconception supplement: a TGA-listed female preconception capsule from a fertility brand founded by a fertility dietitian and a clinical nutritionist. Three production orders since 2024. Mother Daily's postnatal supplement: six formula versions, an evidence package covering eight key ingredients, and one of our largest first production runs. Ora: around 19 products across healthy longevity, women's hormonal health, gut health, and sleep, stress and recovery, recommended by naturopaths, herbalists and functional medicine practitioners.","items":[],"tables":[]}],"faqs":[{"q":"Is a women's health supplement a listed medicine?","a":"Most in our records are. A capsule, tablet or powder making a health claim is usually a listed medicine, and a beauty supplement taken by mouth is a declared medicine. Some products can be foods. We settle the pathway at the brief. See medicine, food or cosmetic?.","md":"Most in our records are. A capsule, tablet or powder making a health claim is usually a listed medicine, and a beauty supplement taken by mouth is a declared medicine. Some products can be foods. We settle the pathway at the brief. See [medicine, food or cosmetic?](/pathways)."},{"q":"Can a supplement claim to help with menopause?","a":"It can carry the permitted indications that fit its evidence and its population, worded so they don't imply treatment of a serious condition. We choose the indications with the formula, so the evidence is built for them from the start.","md":"It can carry the permitted indications that fit its evidence and its population, worded so they don't imply treatment of a serious condition. We choose the indications with the formula, so the evidence is built for them from the start."},{"q":"Can my label say the product is for women?","a":"Indications can carry a population qualifier, and \"In females\" is one the Determination's explanatory statement gives as an example. The evidence then has to come from women.","md":"Indications can carry a population qualifier, and \"In females\" is one the Determination's explanatory statement gives as an example. The evidence then has to come from women."},{"q":"How long does a women's health product take?","a":"EverLeanBody's capsule went from signed brief to dispatch in 5.8 months. Timing depends on the evidence, the listing and the manufacturer's schedule. See how long it takes to develop a supplement.","md":"EverLeanBody's capsule went from signed brief to dispatch in 5.8 months. Timing depends on the evidence, the listing and the manufacturer's schedule. See [how long it takes to develop a supplement](/guides/supplement-development-timeline)."}],"sources":{"note":"General information, checked against these sources between 26 and 29 October 2026. It isn't advice on a particular product. Our work is from Take Friday Off's records.","markdown":"General information, checked against these sources between 26 and 29 October 2026. It isn't advice on a particular product. Our work is from Take Friday Off's records.\n\n- [Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025](https://www.legislation.gov.au/F2025L00450/latest/versions) and its [explanatory statement](https://www.legislation.gov.au/F2025L00450/asmade/2025-04-02/es/original/pdf), Federal Register of Legislation\n- [Listed medicines evidence guidelines](https://www.tga.gov.au/sites/default/files/evidence-guidelines.pdf), version 4.0, June 2022, Therapeutic Goods Administration\n- [Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021](https://www.legislation.gov.au/F2021L01661/latest/versions), Federal Register of Legislation, and [Restricted and prohibited representations in advertising](https://www.tga.gov.au/node/288050), Therapeutic Goods Administration\n- [Therapeutic Goods (Declared Goods) Order 2019](https://www.legislation.gov.au/F2019L01352/latest/text), Federal Register of Legislation","items":[{"text":"Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025 and its explanatory statement, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025","url":"https://www.legislation.gov.au/F2025L00450/latest/versions"},{"title":"explanatory statement","url":"https://www.legislation.gov.au/F2025L00450/asmade/2025-04-02/es/original/pdf"}]},{"text":"Listed medicines evidence guidelines, version 4.0, June 2022, Therapeutic Goods Administration","links":[{"title":"Listed medicines evidence guidelines","url":"https://www.tga.gov.au/sites/default/files/evidence-guidelines.pdf"}]},{"text":"Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021, Federal Register of Legislation, and Restricted and prohibited representations in advertising, Therapeutic Goods Administration","links":[{"title":"Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021","url":"https://www.legislation.gov.au/F2021L01661/latest/versions"},{"title":"Restricted and prohibited representations in advertising","url":"https://www.tga.gov.au/node/288050"}]},{"text":"Therapeutic Goods (Declared Goods) Order 2019, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Declared Goods) Order 2019","url":"https://www.legislation.gov.au/F2019L01352/latest/text"}]}]}},{"slug":"supplement-sample-packs","kind":"guide","url":"/guides/supplement-sample-packs","title":"Supplement sample and trial packs: sizes, labels and the rules","name":"Sample packs guide","description":"Supplement sample packs, trial packs and travel packs in Australia: label rules for small packs, sampling and advertising, stability and minimums.","eyebrow":"Guide","lead":"A sample or trial pack lets a customer try a product before buying the full size, and gives a brand something to hand out at events, in clinics and in subscriptions. It is still a medicine or a food in its own right, with its own label, its own stability evidence and its own minimum order. This guide covers what a small pack's label must carry, where sampling meets the advertising rules, how a new pack fits the stability program, and the trial and travel packs we've made.","parent":"/packaging","studies":["arxi-preconception-supplement","areds2-eye-health-formula","the-belly-solution-travel-gut-health-powder"],"formats":[],"order":88,"updated":"2026-10-29","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- A sample pack of a listed medicine is labelled to TGO 116 like the full size. A container of 25 mL or less inside a primary pack is a small container, with a shorter list of what its own label must carry.\n- An advertisement can't contain or offer a free sample, except for the goods the Therapeutic Goods Advertising Code allows (section 25). So how and where a sample is given matters as much as the pack.\n- TGA guidance says ongoing stability testing is of the finished packed product, and a different pack may need its own study. A new pack size is planned into the stability program, not added after it.\n- Every pack format has its own minimum. Single-serve sachets typically need around 150,000 sachets, which is why sachets and stick packs suit sampling once a product is established.\n- From our records: a 7-day sample pack for Arxi's preconception capsule, a trial pack made alongside a 60-count eye-health pack in both production runs, and a 14-day travel pouch for The Belly Solution.","text":"A sample pack of a listed medicine is labelled to TGO 116 like the full size. A container of 25 mL or less inside a primary pack is a small container, with a shorter list of what its own label must carry. An advertisement can't contain or offer a free sample, except for the goods the Therapeutic Goods Advertising Code allows (section 25). So how and where a sample is given matters as much as the pack. TGA guidance says ongoing stability testing is of the finished packed product, and a different pack may need its own study. A new pack size is planned into the stability program, not added after it. Every pack format has its own minimum. Single-serve sachets typically need around 150,000 sachets, which is why sachets and stick packs suit sampling once a product is established. From our records: a 7-day sample pack for Arxi's preconception capsule, a trial pack made alongside a 60-count eye-health pack in both production runs, and a 14-day travel pouch for The Belly Solution.","items":[],"tables":[]},{"heading":"What a small pack's label must carry","anchor":"what-a-small-packs-label-must-carry","markdown":"A sample pack of a listed medicine is labelled to TGO 116, the TGA's labelling standard for non-prescription medicines, in force since 30 September 2026. Its main label carries what any main label does: the name, each active ingredient and its quantity, the dosage form and the quantity in the pack. Our [labelling guide](/guides/supplement-labelling) covers the full list.\n\nTwo of TGO 116's rules matter most for small packs:\n\n- **Small containers.** A container of 25 mL or less inside a primary pack. Its label must carry, in text at least 1.5 mm high, the name of a listed medicine, the name and quantity of each active, the dosage form, the quantity, the batch number, the expiry date and the sponsor's name as on the primary pack, or a registered trade mark that readily identifies the sponsor.\n- **Blister and strip packs.** They carry the name, the actives and their quantities, the batch, the expiry and the sponsor (or a registered trade mark that readily identifies it). A listed medicine with two or more actives can leave the actives off. Where segments tear off, at least every second segment carries the name, plus the active and its quantity if there is only one active.\n\nA large tablet or capsule usually needs a \"Swallow with water\" direction and, on many packs, an image at actual size. None of that applies when the primary pack is a small container.","text":"A sample pack of a listed medicine is labelled to TGO 116, the TGA's labelling standard for non-prescription medicines, in force since 30 September 2026. Its main label carries what any main label does: the name, each active ingredient and its quantity, the dosage form and the quantity in the pack. Our labelling guide covers the full list. Two of TGO 116's rules matter most for small packs: Small containers. A container of 25 mL or less inside a primary pack. Its label must carry, in text at least 1.5 mm high, the name of a listed medicine, the name and quantity of each active, the dosage form, the quantity, the batch number, the expiry date and the sponsor's name as on the primary pack, or a registered trade mark that readily identifies the sponsor. Blister and strip packs. They carry the name, the actives and their quantities, the batch, the expiry and the sponsor (or a registered trade mark that readily identifies it). A listed medicine with two or more actives can leave the actives off. Where segments tear off, at least every second segment carries the name, plus the active and its quantity if there is only one active. A large tablet or capsule usually needs a \"Swallow with water\" direction and, on many packs, an image at actual size. None of that applies when the primary pack is a small container.","items":[{"lead":"Small containers.","text":"A container of 25 mL or less inside a primary pack. Its label must carry, in text at least 1.5 mm high, the name of a listed medicine, the name and quantity of each active, the dosage form, the quantity, the batch number, the expiry date and the sponsor's name as on the primary pack, or a registered trade mark that readily identifies the sponsor."},{"lead":"Blister and strip packs.","text":"They carry the name, the actives and their quantities, the batch, the expiry and the sponsor (or a registered trade mark that readily identifies it). A listed medicine with two or more actives can leave the actives off. Where segments tear off, at least every second segment carries the name, plus the active and its quantity if there is only one active."}],"tables":[]},{"heading":"Sampling and the advertising rules","anchor":"sampling-and-the-advertising-rules","markdown":"Advertising a listed medicine is governed by the Therapeutic Goods Advertising Code. Under section 25, an advertisement can't contain or offer a free sample, except for the goods the Code names. Before a sample pack is made, we look at how and where it will be given: at an event, in a practitioner's clinic, with an order, or as a paid trial size. Our [TGA advertising guide](/guides/tga-advertising) covers the Code, including the rules on incentives and influencers.","text":"Advertising a listed medicine is governed by the Therapeutic Goods Advertising Code. Under section 25, an advertisement can't contain or offer a free sample, except for the goods the Code names. Before a sample pack is made, we look at how and where it will be given: at an event, in a practitioner's clinic, with an order, or as a paid trial size. Our TGA advertising guide covers the Code, including the rules on incentives and influencers.","items":[],"tables":[]},{"heading":"The pack in the stability program","anchor":"the-pack-in-the-stability-program","markdown":"The shelf life on a label rests on stability data for the product in its pack. TGA guidance says ongoing stability testing is of the finished packed product, that products grouped in one study should share the same primary packaging materials, and that a change to a product needs a risk assessment to decide whether a new study is needed. A different pack, such as a glass bottle, a particular plastic bottle, a blister or a laminated tube, may need its own study. So a sample pack in a different material from the full size is planned into the stability protocol from the start. More in our [stability testing guide](/guides/stability-testing).","text":"The shelf life on a label rests on stability data for the product in its pack. TGA guidance says ongoing stability testing is of the finished packed product, that products grouped in one study should share the same primary packaging materials, and that a change to a product needs a risk assessment to decide whether a new study is needed. A different pack, such as a glass bottle, a particular plastic bottle, a blister or a laminated tube, may need its own study. So a sample pack in a different material from the full size is planned into the stability protocol from the start. More in our stability testing guide.","items":[],"tables":[]},{"heading":"Child-resistant packaging by pack size","anchor":"child-resistant-packaging-by-pack-size","markdown":"TGO 95 sets child-resistant packaging requirements by substance and, for some, by the total in the pack. Iron, for example, triggers them when a pack holds more than 250 mg of elemental iron, unless it is a divided preparation in which the iron is combined with other actives and each dose has 5 mg or less. Because the thresholds are per pack, each pack size is checked on its own. More in [packaging and labelling](/packaging).","text":"TGO 95 sets child-resistant packaging requirements by substance and, for some, by the total in the pack. Iron, for example, triggers them when a pack holds more than 250 mg of elemental iron, unless it is a divided preparation in which the iron is combined with other actives and each dose has 5 mg or less. Because the thresholds are per pack, each pack size is checked on its own. More in packaging and labelling.","items":[],"tables":[]},{"heading":"Choosing the format","anchor":"choosing-the-format","markdown":"- **A smaller count of the same capsule or tablet.** The simplest trial pack: the same product in a smaller bottle or blister, made in the same run as the full size.\n- **Sachets and stick packs.** One dose each, nothing to measure. They need large minimums from the packaging supplier, typically around 150,000 sachets, so they suit an established product more than a launch ([powders and sachets](/formats/powders-sachets)).\n- **A short-course pouch.** A pouch sized to a course of use, such as a 14-day travel pack.\n\nWe quote the formats side by side, so the choice rests on the cost per pack as well as the customer.","text":"A smaller count of the same capsule or tablet. The simplest trial pack: the same product in a smaller bottle or blister, made in the same run as the full size. Sachets and stick packs. One dose each, nothing to measure. They need large minimums from the packaging supplier, typically around 150,000 sachets, so they suit an established product more than a launch (powders and sachets). A short-course pouch. A pouch sized to a course of use, such as a 14-day travel pack. We quote the formats side by side, so the choice rests on the cost per pack as well as the customer.","items":[{"lead":"A smaller count of the same capsule or tablet.","text":"The simplest trial pack: the same product in a smaller bottle or blister, made in the same run as the full size."},{"lead":"Sachets and stick packs.","text":"One dose each, nothing to measure. They need large minimums from the packaging supplier, typically around 150,000 sachets, so they suit an established product more than a launch (powders and sachets)."},{"lead":"A short-course pouch.","text":"A pouch sized to a course of use, such as a 14-day travel pack."}],"tables":[]},{"heading":"From our records","anchor":"from-our-records","markdown":"- [Arxi's preconception supplement](/work/arxi-preconception-supplement): a TGA-listed preconception capsule. We later added a 7-day sample pack for events and sampling. Three production orders since 2024.\n- [An eye-health formula](/work/areds2-eye-health-formula): a 60-count pack and a trial pack to drive trial, both manufactured in both production runs. Design to production order in under seven weeks, and reordered a year later.\n- [The Belly Solution](/work/the-belly-solution-travel-gut-health-powder): a travel gut-health powder in a 14-day pouch, with a 36-month stability program. More than 30 new pharmacy stockists in the first week of a national distribution trial.","text":"Arxi's preconception supplement: a TGA-listed preconception capsule. We later added a 7-day sample pack for events and sampling. Three production orders since 2024. An eye-health formula: a 60-count pack and a trial pack to drive trial, both manufactured in both production runs. Design to production order in under seven weeks, and reordered a year later. The Belly Solution: a travel gut-health powder in a 14-day pouch, with a 36-month stability program. More than 30 new pharmacy stockists in the first week of a national distribution trial.","items":[],"tables":[]}],"faqs":[{"q":"Does a sample pack need its own listing?","a":"A sample pack is the same medicine in a different pack. Its label follows TGO 116 and its pack is covered by the stability program. What the listing needs for a new pack is worth checking when the pack is planned, not after it's printed.","md":"A sample pack is the same medicine in a different pack. Its label follows TGO 116 and its pack is covered by the stability program. What the listing needs for a new pack is worth checking when the pack is planned, not after it's printed."},{"q":"Can I give away free samples?","a":"An advertisement can't contain or offer a free sample, except for the goods the Advertising Code allows in section 25. How and where a sample is given decides whether the rule applies, so we settle it before the pack is made.","md":"An advertisement can't contain or offer a free sample, except for the goods the Advertising Code allows in section 25. How and where a sample is given decides whether the rule applies, so we settle it before the pack is made."},{"q":"What's the smallest sample pack I can make?","a":"Each pack format has a minimum order from its supplier. Single-serve sachets typically need around 150,000; a smaller count of the same capsule or tablet is usually the easiest place to start.","md":"Each pack format has a minimum order from its supplier. Single-serve sachets typically need around 150,000; a smaller count of the same capsule or tablet is usually the easiest place to start."},{"q":"Can a sample pack be added after launch?","a":"Yes. Arxi's 7-day sample pack was added after launch, for events and sampling.","md":"Yes. Arxi's 7-day sample pack was added after launch, for events and sampling."}],"sources":{"note":"General information, checked against these sources between 26 and 29 October 2026. It isn't advice on a particular product. Our work is from Take Friday Off's records.","markdown":"General information, checked against these sources between 26 and 29 October 2026. It isn't advice on a particular product. Our work is from Take Friday Off's records.\n\n- [Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026](https://www.legislation.gov.au/F2026L01312/asmade), Federal Register of Legislation\n- [Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021](https://www.legislation.gov.au/F2021L01661/latest/versions), section 25, Federal Register of Legislation\n- [Performing ongoing stability testing for listed and complementary medicines](https://www.tga.gov.au/node/452227), Therapeutic Goods Administration\n- [Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017](https://legislation.gov.au/F2017L01577/asmade/2017-12-04/text/original/pdf), section 6 and Schedule 1, Federal Register of Legislation","items":[{"text":"Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026","url":"https://www.legislation.gov.au/F2026L01312/asmade"}]},{"text":"Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021, section 25, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021","url":"https://www.legislation.gov.au/F2021L01661/latest/versions"}]},{"text":"Performing ongoing stability testing for listed and complementary medicines, Therapeutic Goods Administration","links":[{"title":"Performing ongoing stability testing for listed and complementary medicines","url":"https://www.tga.gov.au/node/452227"}]},{"text":"Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017, section 6 and Schedule 1, Federal Register of Legislation","links":[{"title":"Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017","url":"https://legislation.gov.au/F2017L01577/asmade/2017-12-04/text/original/pdf"}]}]}},{"slug":"sustainable-supplement-packaging","kind":"guide","url":"/guides/sustainable-supplement-packaging","title":"Sustainable supplement packaging: recycled bottles and honest claims","name":"Sustainable packaging guide","description":"Sustainable supplement packaging in Australia: recycled PET bottles, what a medicine's pack must still do, and the ACCC's principles for environmental claims.","eyebrow":"Guide","lead":"More brands want their supplement in a recycled or lower-impact pack, and more customers ask about it. A medicine's pack still has to protect the product for its whole shelf life, show it hasn't been opened and, for some formulas, keep children out. Any environmental claim on it has to be true and backed by evidence. This guide covers what changes when a pack changes, the rules a recycled pack still has to meet, the ACCC's principles for green claims, and the recycled PET bottle we sourced for a client.","parent":"/packaging","studies":["vitable-hair-growth-range","the-belly-solution-travel-gut-health-powder","nivari-powder-supplement"],"formats":[],"order":89,"updated":"2026-10-29","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- A recycled or lower-impact pack is possible for a listed medicine. We sourced 100% recycled PET bottles for Vitable's TGA-listed hair capsule and managed the supply through to delivery.\n- The pack is part of the product. TGA guidance says ongoing stability testing is of the finished packed product, and a different pack may need its own study, so a new material is planned into the stability program.\n- Some medicines need child-resistant packaging under TGO 95, and a pack presented as tamper-evident follows the TGA's code of practice for tamper-evident packaging. A new pack has to keep meeting both where they apply.\n- Environmental claims fall under the Australian Consumer Law. The ACCC's guide for business, published in December 2023, sets out eight principles, starting with \"Make accurate and truthful claims\" and \"Have evidence to back up your claims\".\n- The safest claim is a specific, checkable one about the pack itself, worded so it doesn't overstate the benefit.","text":"A recycled or lower-impact pack is possible for a listed medicine. We sourced 100% recycled PET bottles for Vitable's TGA-listed hair capsule and managed the supply through to delivery. The pack is part of the product. TGA guidance says ongoing stability testing is of the finished packed product, and a different pack may need its own study, so a new material is planned into the stability program. Some medicines need child-resistant packaging under TGO 95, and a pack presented as tamper-evident follows the TGA's code of practice for tamper-evident packaging. A new pack has to keep meeting both where they apply. Environmental claims fall under the Australian Consumer Law. The ACCC's guide for business, published in December 2023, sets out eight principles, starting with \"Make accurate and truthful claims\" and \"Have evidence to back up your claims\". The safest claim is a specific, checkable one about the pack itself, worded so it doesn't overstate the benefit.","items":[],"tables":[]},{"heading":"What changes when the pack changes","anchor":"what-changes-when-the-pack-changes","markdown":"A supplement's shelf life rests on stability data for the product in its pack. TGA guidance says ongoing stability testing is of the finished packed product, that products grouped in one study should share the same primary packaging materials, and that a change to a product needs a risk assessment to decide whether a new study is needed. A different pack, such as a glass bottle, a particular plastic bottle, a blister or a laminated tube, may need its own study ([stability testing](/guides/stability-testing)).\n\nSo moving to a recycled bottle, a thinner wall or a compostable pouch starts with the formula. A moisture-sensitive capsule, a probiotic or an oil may behave differently in a new material. We plan the pack into the stability protocol for the shelf life the label will carry, rather than swapping it in after launch.","text":"A supplement's shelf life rests on stability data for the product in its pack. TGA guidance says ongoing stability testing is of the finished packed product, that products grouped in one study should share the same primary packaging materials, and that a change to a product needs a risk assessment to decide whether a new study is needed. A different pack, such as a glass bottle, a particular plastic bottle, a blister or a laminated tube, may need its own study (stability testing). So moving to a recycled bottle, a thinner wall or a compostable pouch starts with the formula. A moisture-sensitive capsule, a probiotic or an oil may behave differently in a new material. We plan the pack into the stability protocol for the shelf life the label will carry, rather than swapping it in after launch.","items":[],"tables":[]},{"heading":"What a medicine's pack still has to do","anchor":"what-a-medicines-pack-still-has-to-do","markdown":"- **Tamper evidence.** The TGA's code of practice for tamper-evident packaging isn't mandatory, but it applies to a pack presented as tamper-evident: at least one tamper-evident feature, two for two-piece capsules, and a statement on the pack describing it.\n- **Child resistance, where required.** Under TGO 95, a listed medicine needs child-resistant packaging if it contains one of the substances the Order lists, in the strength or pack size it sets, such as iron in a pack with more than 250 mg of elemental iron, or if its pack says or implies it is child-resistant. A blister pack generally counts when it seals each tablet or capsule on its own and isn't made of cellulose film or unlaminated paper.\n- **The label.** A listed medicine is labelled to TGO 116, whatever the pack is made of ([supplement labelling](/guides/supplement-labelling)).\n\nThe [packaging and labelling](/packaging) page covers each of these in more detail.","text":"Tamper evidence. The TGA's code of practice for tamper-evident packaging isn't mandatory, but it applies to a pack presented as tamper-evident: at least one tamper-evident feature, two for two-piece capsules, and a statement on the pack describing it. Child resistance, where required. Under TGO 95, a listed medicine needs child-resistant packaging if it contains one of the substances the Order lists, in the strength or pack size it sets, such as iron in a pack with more than 250 mg of elemental iron, or if its pack says or implies it is child-resistant. A blister pack generally counts when it seals each tablet or capsule on its own and isn't made of cellulose film or unlaminated paper. The label. A listed medicine is labelled to TGO 116, whatever the pack is made of (supplement labelling). The packaging and labelling page covers each of these in more detail.","items":[{"lead":"Tamper evidence.","text":"The TGA's code of practice for tamper-evident packaging isn't mandatory, but it applies to a pack presented as tamper-evident: at least one tamper-evident feature, two for two-piece capsules, and a statement on the pack describing it."},{"lead":"Child resistance, where required.","text":"Under TGO 95, a listed medicine needs child-resistant packaging if it contains one of the substances the Order lists, in the strength or pack size it sets, such as iron in a pack with more than 250 mg of elemental iron, or if its pack says or implies it is child-resistant. A blister pack generally counts when it seals each tablet or capsule on its own and isn't made of cellulose film or unlaminated paper."},{"lead":"The label.","text":"A listed medicine is labelled to TGO 116, whatever the pack is made of (supplement labelling)."}],"tables":[]},{"heading":"Making a green claim you can stand behind","anchor":"making-a-green-claim-you-can-stand-behind","markdown":"Environmental claims on a pack or in marketing are covered by the Australian Consumer Law, which the ACCC enforces. Its guide for business, A guide to making environmental claims for business (12 December 2023), sets out eight principles:\n\n1. Make accurate and truthful claims.\n2. Have evidence to back up your claims.\n3. Don't hide or omit important information.\n4. Explain any conditions or qualifications on your claims.\n5. Avoid broad and unqualified claims.\n6. Use clear and easy-to-understand language.\n7. Visual elements should not give the wrong impression.\n8. Be direct and open about your sustainability transition.\n\nThe ACCC notes the guide doesn't yet reflect the higher maximum penalties that took effect on 28 March 2026. In practice, that means saying exactly what is recycled and how much (\"bottle made from 100% recycled PET\"), not a broad word like \"eco-friendly\"; keeping the supplier's evidence for it; and making sure leaves, greens and earth tones don't suggest more than the claim does. A claim about a medicine's health benefits is a different matter, governed by the TGA ([TGA advertising](/guides/tga-advertising)).","text":"Environmental claims on a pack or in marketing are covered by the Australian Consumer Law, which the ACCC enforces. Its guide for business, A guide to making environmental claims for business (12 December 2023), sets out eight principles: Make accurate and truthful claims. Have evidence to back up your claims. Don't hide or omit important information. Explain any conditions or qualifications on your claims. Avoid broad and unqualified claims. Use clear and easy-to-understand language. Visual elements should not give the wrong impression. Be direct and open about your sustainability transition. The ACCC notes the guide doesn't yet reflect the higher maximum penalties that took effect on 28 March 2026. In practice, that means saying exactly what is recycled and how much (\"bottle made from 100% recycled PET\"), not a broad word like \"eco-friendly\"; keeping the supplier's evidence for it; and making sure leaves, greens and earth tones don't suggest more than the claim does. A claim about a medicine's health benefits is a different matter, governed by the TGA (TGA advertising).","items":[],"tables":[]},{"heading":"The formats in our records","anchor":"the-formats-in-our-records","markdown":"Bottles in glass, HDPE and recycled PET; blister packs; sachets in stick, square or rectangular formats; pouches in a range of sizes, materials and closures; and tubs. Each comes with its own minimums, costs and stability questions, and a brand's own pack can be used where it meets the product's needs, as Nivari's own pouch did.","text":"Bottles in glass, HDPE and recycled PET; blister packs; sachets in stick, square or rectangular formats; pouches in a range of sizes, materials and closures; and tubs. Each comes with its own minimums, costs and stability questions, and a brand's own pack can be used where it meets the product's needs, as Nivari's own pouch did.","items":[],"tables":[]},{"heading":"From our records","anchor":"from-our-records","markdown":"- [Vitable](/work/vitable-hair-growth-range): a complex TGA-listed capsule with more than 13 ingredients, including a clinically studied Biota orientalis extract, AnaGain™ under licence and Quatrefolic®, in a 100% recycled PET bottle, beside a matching serum on the cosmetics pathway. We formulated both, managed their manufacture and sourced the recycled bottles. Both delivered in 2024 and 2025.\n- [The Belly Solution](/work/the-belly-solution-travel-gut-health-powder): a travel gut-health powder in a 14-day pouch, with a 36-month stability program.\n- [Nivari](/work/nivari-powder-supplement): a founder's first powder supplement, packed in the brand's own pouch for a mid-August 2026 launch.","text":"Vitable: a complex TGA-listed capsule with more than 13 ingredients, including a clinically studied Biota orientalis extract, AnaGain™ under licence and Quatrefolic®, in a 100% recycled PET bottle, beside a matching serum on the cosmetics pathway. We formulated both, managed their manufacture and sourced the recycled bottles. Both delivered in 2024 and 2025. The Belly Solution: a travel gut-health powder in a 14-day pouch, with a 36-month stability program. Nivari: a founder's first powder supplement, packed in the brand's own pouch for a mid-August 2026 launch.","items":[],"tables":[]}],"faqs":[{"q":"Can a TGA-listed supplement come in a recycled bottle?","a":"Yes. Vitable's TGA-listed hair capsule ships in a 100% recycled PET bottle that we sourced. The bottle is covered by the product's stability program like any other pack.","md":"Yes. Vitable's TGA-listed hair capsule ships in a 100% recycled PET bottle that we sourced. The bottle is covered by the product's stability program like any other pack."},{"q":"Do I need new stability testing if I change to a recycled pack?","a":"Possibly. TGA guidance says a change to a product needs a risk assessment to decide whether a new stability study is needed, and a different pack may need its own study. We plan it with the change.","md":"Possibly. TGA guidance says a change to a product needs a risk assessment to decide whether a new stability study is needed, and a different pack may need its own study. We plan it with the change."},{"q":"Can I call my supplement eco-friendly?","a":"Broad, unqualified claims are the ones the ACCC's principles warn against. A specific claim about the pack, with evidence behind it, is safer: what the material is, how much is recycled, and any conditions.","md":"Broad, unqualified claims are the ones the ACCC's principles warn against. A specific claim about the pack, with evidence behind it, is safer: what the material is, how much is recycled, and any conditions."},{"q":"Is a compostable pouch suitable for a supplement?","a":"It depends on the product. A pouch has to protect the formula for its whole shelf life, and a stability study with the product in that pouch is what shows it can.","md":"It depends on the product. A pouch has to protect the formula for its whole shelf life, and a stability study with the product in that pouch is what shows it can."}],"sources":{"note":"General information, checked against these sources between 26 and 29 October 2026. It isn't advice on a particular product. Our work is from Take Friday Off's records.","markdown":"General information, checked against these sources between 26 and 29 October 2026. It isn't advice on a particular product. Our work is from Take Friday Off's records.\n\n- [A guide to making environmental claims for business](https://www.accc.gov.au/about-us/publications/making-environmental-claims-a-guide-for-business), 12 December 2023, and [ACCC releases eight principles to guide businesses' environmental claims](https://www.accc.gov.au/media-release/accc-releases-eight-principles-to-guide-businesses%E2%80%99-environmental-claims), Australian Competition and Consumer Commission\n- [Performing ongoing stability testing for listed and complementary medicines](https://www.tga.gov.au/node/452227), Therapeutic Goods Administration\n- [Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017](https://legislation.gov.au/F2017L01577/asmade/2017-12-04/text/original/pdf), section 6 and Schedule 1, Federal Register of Legislation\n- [Code of practice for the tamper-evident packaging of therapeutic goods](https://www.tga.gov.au/node/289301), Therapeutic Goods Administration\n- [Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026](https://www.legislation.gov.au/F2026L01312/asmade), Federal Register of Legislation","items":[{"text":"A guide to making environmental claims for business, 12 December 2023, and ACCC releases eight principles to guide businesses' environmental claims, Australian Competition and Consumer Commission","links":[{"title":"A guide to making environmental claims for business","url":"https://www.accc.gov.au/about-us/publications/making-environmental-claims-a-guide-for-business"},{"title":"ACCC releases eight principles to guide businesses' environmental claims","url":"https://www.accc.gov.au/media-release/accc-releases-eight-principles-to-guide-businesses%E2%80%99-environmental-claims"}]},{"text":"Performing ongoing stability testing for listed and complementary medicines, Therapeutic Goods Administration","links":[{"title":"Performing ongoing stability testing for listed and complementary medicines","url":"https://www.tga.gov.au/node/452227"}]},{"text":"Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017, section 6 and Schedule 1, Federal Register of Legislation","links":[{"title":"Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017","url":"https://legislation.gov.au/F2017L01577/asmade/2017-12-04/text/original/pdf"}]},{"text":"Code of practice for the tamper-evident packaging of therapeutic goods, Therapeutic Goods Administration","links":[{"title":"Code of practice for the tamper-evident packaging of therapeutic goods","url":"https://www.tga.gov.au/node/289301"}]},{"text":"Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026","url":"https://www.legislation.gov.au/F2026L01312/asmade"}]}]}},{"slug":"ai","kind":"page","url":"/ai","title":"Take Friday Off in your AI assistant","name":"AI assistants","description":"Connect Claude, ChatGPT, Cursor or VS Code to Take Friday Off's MCP server: search our guides, check a product's pathway, book a call. Free, no account.","eyebrow":"For AI assistants","lead":"Take Friday Off runs a public MCP server at takefridayoff.com/mcp. Connect it to Claude, ChatGPT, Cursor or VS Code, and your assistant can search our guides and case studies, check a product's regulatory pathway, take the readiness check and ask for a call, citing the page behind every answer. Free, with no account.","studies":[],"formats":[],"order":90,"updated":"2026-10-20","author":"Take Friday Off","approved":true,"sections":[{"heading":"What your assistant can do with it","anchor":"what-your-assistant-can-do-with-it","markdown":"- **Search** every guide, case study, question and note on takefridayoff.com, and get the passages that answer the question, each linked to its exact section (`tfo_search`).\n- **Read any page in full**, as clean Markdown with its sources and the date it was last reviewed (`tfo_get_page`).\n- **Plan a launch.** Describe the product and get one plan: the pathway it is likely on, the five steps from brief to shelf with what each delivers and what you decide, how long comparable launches took and what could slow yours, the TGA's fees when it is a medicine, the closest case studies and a link to book a call. Every figure is quoted from the pages it comes from (`tfo_launch_plan`). In assistants that show MCP Apps, the plan is a card with the steps, the fees and a button to book the call.\n- **Check ad and claims copy.** Paste an ad, a product page, a post or the words on the pack and get each line the TGA's advertising rules would question: \"TGA approved\", safe or side-effect free, guaranteed or miraculous, serious diseases, testimonials and excluded endorsements, research claims, and the statement an ad must carry, each with the rule from our [advertising guide](/guides/tga-advertising) and its link. A check of the words, not legal advice (`tfo_claims_check`). In assistants that show MCP Apps, it is a card where you can edit the copy and check it again.\n- **Check a draft label.** Paste the label's text and see what TGO 116 asks it to show and what wasn't found: each active ingredient with its quantity, the dosage form and pack size, the AUST L number, batch and expiry, storage, the sponsor's contact, warnings under their heading, directions and indications, with declared substances and the words a label can't use, each with the rule from our [labelling guide](/guides/supplement-labelling) and its link. A check of the text, not regulatory advice (`tfo_label_check`). In assistants that show MCP Apps, it is a checklist card where you can edit the label and check it again.\n- **Check a product's pathway.** Medicine, food or cosmetic? The check applies the rules on our [pathways page](/pathways), in their order, and quotes the rule that decides it, with what to confirm next (`tfo_pathway_check`). In assistants that show MCP Apps, the answer is a card you can try variations in. It's indicative, not legal or regulatory advice.\n- **Estimate the timeline.** How long a product could take, from our records and the six stages in our [development timeline guide](/guides/supplement-development-timeline), with the hold-ups that apply to it (`tfo_timeline`). Indicative, never a promise.\n- **Add up the TGA's fees** for a plan: listing, the annual charge for each year on the market, variations, new indications, new ingredients, assessed listings and overseas GMP clearances, every amount read from the fee tables in our [TGA listing guide](/guides/tga-approval) and [assessed listed medicines guide](/guides/assessed-listed-medicines) (`tfo_tga_fees`). Fees as at 1 July 2026, for 2026–27. The TGA changes them every 1 July, and the tool reads them from the guide, so it changes when the guide does.\n- **Define a regulatory term,** such as ARTG, AUST L, sponsor or TGO 116, from our [glossary](/glossary), with the guide that covers it in depth (`tfo_define`).\n- **Find case studies** by format, ingredient, pathway or client (`tfo_case_studies`).\n- **Take the readiness check**, the same four questions as our [partner page](/partner), and see whether we're a fit (`tfo_readiness_check`).\n- **Ask for a call** with Gabriel Perera, our founder, and get a link to pick a time. The assistant has to ask you first (`tfo_request_call`).\n- **Send us a product brief.** Your assistant asks about the product, who it's for, the format, what it should do, the ingredients, the price, the volume and the timing, writes the brief we work from with the launch plan attached, and shows it to you. It sends only when you say so (`tfo_send_brief`).\n\nIt also answers questions about who we are, the Friday Launch Engine™ and our founder, and offers ready-made prompts, such as a product brief interview.\n\n### Skills\n\nThe server also carries step-by-step workflows, called skills, that an assistant can follow: a launch brief for a product idea, the medicine, food or cosmetic check, a TGA listing plan, and a check of advertising copy against the TGA's rules. Assistants that support skills over MCP load them from the server. You can also add them to your own assistant with `npx skills add https://takefridayoff.com`.","text":"Search every guide, case study, question and note on takefridayoff.com, and get the passages that answer the question, each linked to its exact section (tfosearch). Read any page in full, as clean Markdown with its sources and the date it was last reviewed (tfogetpage). Plan a launch. Describe the product and get one plan: the pathway it is likely on, the five steps from brief to shelf with what each delivers and what you decide, how long comparable launches took and what could slow yours, the TGA's fees when it is a medicine, the closest case studies and a link to book a call. Every figure is quoted from the pages it comes from (tfolaunchplan). In assistants that show MCP Apps, the plan is a card with the steps, the fees and a button to book the call. Check ad and claims copy. Paste an ad, a product page, a post or the words on the pack and get each line the TGA's advertising rules would question: \"TGA approved\", safe or side-effect free, guaranteed or miraculous, serious diseases, testimonials and excluded endorsements, research claims, and the statement an ad must carry, each with the rule from our advertising guide and its link. A check of the words, not legal advice (tfoclaimscheck). In assistants that show MCP Apps, it is a card where you can edit the copy and check it again. Check a draft label. Paste the label's text and see what TGO 116 asks it to show and what wasn't found: each active ingredient with its quantity, the dosage form and pack size, the AUST L number, batch and expiry, storage, the sponsor's contact, warnings under their heading, directions and indications, with declared substances and the words a label can't use, each with the rule from our labelling guide and its link. A check of the text, not regulatory advice (tfolabelcheck). In assistants that show MCP Apps, it is a checklist card where you can edit the label and check it again. Check a product's pathway. Medicine, food or cosmetic? The check applies the rules on our pathways page, in their order, and quotes the rule that decides it, with what to confirm next (tfopathwaycheck). In assistants that show MCP Apps, the answer is a card you can try variations in. It's indicative, not legal or regulatory advice. Estimate the timeline. How long a product could take, from our records and the six stages in our development timeline guide, with the hold-ups that apply to it (tfotimeline). Indicative, never a promise. Add up the TGA's fees for a plan: listing, the annual charge for each year on the market, variations, new indications, new ingredients, assessed listings and overseas GMP clearances, every amount read from the fee tables in our TGA listing guide and assessed listed medicines guide (tfotgafees). Fees as at 1 July 2026, for 2026–27. The TGA changes them every 1 July, and the tool reads them from the guide, so it changes when the guide does. Define a regulatory term, such as ARTG, AUST L, sponsor or TGO 116, from our glossary, with the guide that covers it in depth (tfodefine). Find case studies by format, ingredient, pathway or client (tfocasestudies). Take the readiness check, the same four questions as our partner page, and see whether we're a fit (tforeadinesscheck). Ask for a call with Gabriel Perera, our founder, and get a link to pick a time. The assistant has to ask you first (tforequestcall). Send us a product brief. Your assistant asks about the product, who it's for, the format, what it should do, the ingredients, the price, the volume and the timing, writes the brief we work from with the launch plan attached, and shows it to you. It sends only when you say so (tfosendbrief). It also answers questions about who we are, the Friday Launch Engine™ and our founder, and offers ready-made prompts, such as a product brief interview. Skills The server also carries step-by-step workflows, called skills, that an assistant can follow: a launch brief for a product idea, the medicine, food or cosmetic check, a TGA listing plan, and a check of advertising copy against the TGA's rules. Assistants that support skills over MCP load them from the server. You can also add them to your own assistant with npx skills add https://takefridayoff.com.","items":[{"lead":"Search","text":"every guide, case study, question and note on takefridayoff.com, and get the passages that answer the question, each linked to its exact section (tfosearch)."},{"lead":"Read any page in full","text":", as clean Markdown with its sources and the date it was last reviewed (tfogetpage)."},{"lead":"Plan a launch.","text":"Describe the product and get one plan: the pathway it is likely on, the five steps from brief to shelf with what each delivers and what you decide, how long comparable launches took and what could slow yours, the TGA's fees when it is a medicine, the closest case studies and a link to book a call. Every figure is quoted from the pages it comes from (tfolaunchplan). In assistants that show MCP Apps, the plan is a card with the steps, the fees and a button to book the call."},{"lead":"Check ad and claims copy.","text":"Paste an ad, a product page, a post or the words on the pack and get each line the TGA's advertising rules would question: \"TGA approved\", safe or side-effect free, guaranteed or miraculous, serious diseases, testimonials and excluded endorsements, research claims, and the statement an ad must carry, each with the rule from our advertising guide and its link. A check of the words, not legal advice (tfoclaimscheck). In assistants that show MCP Apps, it is a card where you can edit the copy and check it again."},{"lead":"Check a draft label.","text":"Paste the label's text and see what TGO 116 asks it to show and what wasn't found: each active ingredient with its quantity, the dosage form and pack size, the AUST L number, batch and expiry, storage, the sponsor's contact, warnings under their heading, directions and indications, with declared substances and the words a label can't use, each with the rule from our labelling guide and its link. A check of the text, not regulatory advice (tfolabelcheck). In assistants that show MCP Apps, it is a checklist card where you can edit the label and check it again."},{"lead":"Check a product's pathway.","text":"Medicine, food or cosmetic? The check applies the rules on our pathways page, in their order, and quotes the rule that decides it, with what to confirm next (tfopathwaycheck). In assistants that show MCP Apps, the answer is a card you can try variations in. It's indicative, not legal or regulatory advice."},{"lead":"Estimate the timeline.","text":"How long a product could take, from our records and the six stages in our development timeline guide, with the hold-ups that apply to it (tfotimeline). Indicative, never a promise."},{"lead":"Add up the TGA's fees","text":"for a plan: listing, the annual charge for each year on the market, variations, new indications, new ingredients, assessed listings and overseas GMP clearances, every amount read from the fee tables in our TGA listing guide and assessed listed medicines guide (tfotgafees). Fees as at 1 July 2026, for 2026–27. The TGA changes them every 1 July, and the tool reads them from the guide, so it changes when the guide does."},{"lead":"Define a regulatory term,","text":"such as ARTG, AUST L, sponsor or TGO 116, from our glossary, with the guide that covers it in depth (tfodefine)."},{"lead":"Find case studies","text":"by format, ingredient, pathway or client (tfocasestudies)."},{"lead":"Take the readiness check","text":", the same four questions as our partner page, and see whether we're a fit (tforeadinesscheck)."},{"lead":"Ask for a call","text":"with Gabriel Perera, our founder, and get a link to pick a time. The assistant has to ask you first (tforequestcall)."},{"lead":"Send us a product brief.","text":"Your assistant asks about the product, who it's for, the format, what it should do, the ingredients, the price, the volume and the timing, writes the brief we work from with the launch plan attached, and shows it to you. It sends only when you say so (tfosendbrief)."}],"tables":[]},{"heading":"Connect it","anchor":"connect-it","markdown":"The address is the same everywhere: `https://takefridayoff.com/mcp`. It needs no account and no authentication.\n\n### Claude\n\nIn Claude, open **Customize**, then **Connectors**. Choose **+ Add**, then **Add custom connector**, enter the address above, choose **No sign in** and **Add**. To use it in a chat, choose **+**, then **Connectors**, and turn it on. On a Team or Enterprise plan, an Owner adds it first under **Organization settings**, then **Connectors**. In Claude Code:\n\n```\nclaude mcp add --transport http takefridayoff \\\n  https://takefridayoff.com/mcp\n```\n\n### ChatGPT\n\nOpen [ChatGPT's plugins](https://chatgpt.com/plugins), choose **+**, then **Add custom MCP server**. Give it a name, enter the address above with no authentication, confirm, and choose **Create as a plugin**. In a chat, type @ and choose it. If your account shows Apps instead, turn on **Developer mode** under **Settings**, **Apps**, **Advanced settings**, then use **Create app**.\n\n### Cursor and VS Code\n\nIn Cursor, `.cursor/mcp.json`:\n\n```json\n{\n  \"mcpServers\": {\n    \"takefridayoff\": { \"url\": \"https://takefridayoff.com/mcp\" }\n  }\n}\n```\n\nIn VS Code, `.vscode/mcp.json`:\n\n```json\n{\n  \"servers\": {\n    \"takefridayoff\": { \"type\": \"http\", \"url\": \"https://takefridayoff.com/mcp\" }\n  }\n}\n```\n\n### On your own machine\n\nFor assistants that start their own servers, the npm package runs the same server over stdio. In Claude Desktop's `claude_desktop_config.json`:\n\n```json\n{\n  \"mcpServers\": {\n    \"takefridayoff\": { \"command\": \"npx\", \"args\": [\"-y\", \"takefridayoff\", \"serve\"] }\n  }\n}\n```","text":"The address is the same everywhere: https://takefridayoff.com/mcp. It needs no account and no authentication. Claude In Claude, open Customize, then Connectors. Choose + Add, then Add custom connector, enter the address above, choose No sign in and Add. To use it in a chat, choose +, then Connectors, and turn it on. On a Team or Enterprise plan, an Owner adds it first under Organization settings, then Connectors. In Claude Code: claude mcp add --transport http takefridayoff \\ https://takefridayoff.com/mcp ChatGPT Open ChatGPT's plugins, choose +, then Add custom MCP server. Give it a name, enter the address above with no authentication, confirm, and choose Create as a plugin. In a chat, type @ and choose it. If your account shows Apps instead, turn on Developer mode under Settings, Apps, Advanced settings, then use Create app. Cursor and VS Code In Cursor, .cursor/mcp.json: json { \"mcpServers\": { \"takefridayoff\": { \"url\": \"https://takefridayoff.com/mcp\" } } } In VS Code, .vscode/mcp.json: json { \"servers\": { \"takefridayoff\": { \"type\": \"http\", \"url\": \"https://takefridayoff.com/mcp\" } } } On your own machine For assistants that start their own servers, the npm package runs the same server over stdio. In Claude Desktop's claudedesktopconfig.json: json { \"mcpServers\": { \"takefridayoff\": { \"command\": \"npx\", \"args\": [\"-y\", \"takefridayoff\", \"serve\"] } } }","items":[],"tables":[]},{"heading":"From a terminal","anchor":"from-a-terminal","markdown":"The same tools, without an assistant. It needs Node.js 18.17 or later and nothing else.\n\n```\nnpx takefridayoff search TGA listing fees\nnpx takefridayoff page /guides/tga-approval\nnpx takefridayoff work capsule\nnpx takefridayoff fit --role product --stage scale --drag capacity --timeline 6\nnpx takefridayoff book --open\n```\n\n`npx takefridayoff help` lists every command; `--json` gives output a script can read.","text":"The same tools, without an assistant. It needs Node.js 18.17 or later and nothing else. npx takefridayoff search TGA listing fees npx takefridayoff page /guides/tga-approval npx takefridayoff work capsule npx takefridayoff fit --role product --stage scale --drag capacity --timeline 6 npx takefridayoff book --open npx takefridayoff help lists every command; --json gives output a script can read.","items":[],"tables":[]},{"heading":"Try asking","anchor":"try-asking","markdown":"- \"How much does it cost to list a supplement with the TGA, and how long does it take?\"\n- \"Is a collagen powder for skin a food or a medicine in Australia?\"\n- \"When can an SPF moisturiser be sold as a cosmetic?\"\n- \"Show me Take Friday Off's case studies for capsule products.\"","text":"\"How much does it cost to list a supplement with the TGA, and how long does it take?\" \"Is a collagen powder for skin a food or a medicine in Australia?\" \"When can an SPF moisturiser be sold as a cosmetic?\" \"Show me Take Friday Off's case studies for capsule products.\"","items":[],"tables":[]},{"heading":"What we record","anchor":"what-we-record","markdown":"When an assistant uses the server, we record which tool it used, what it asked for (a search, a page, a product description), the name of the assistant and the outcome, to learn what people look for. Only Take Friday Off can see these records (Cloudflare stores them for us), they're deleted after three months, and we don't record IP addresses. A product description can be commercially confidential, so describe yours in general terms if you'd rather. We only see a call request or a brief so we can reply to it: it reaches us like a message from our contact form and is kept as our [privacy policy](/privacy) says. The command-line tool reads the site's public content and sends nothing else unless you ask for a call.","text":"When an assistant uses the server, we record which tool it used, what it asked for (a search, a page, a product description), the name of the assistant and the outcome, to learn what people look for. Only Take Friday Off can see these records (Cloudflare stores them for us), they're deleted after three months, and we don't record IP addresses. A product description can be commercially confidential, so describe yours in general terms if you'd rather. We only see a call request or a brief so we can reply to it: it reaches us like a message from our contact form and is kept as our privacy policy says. The command-line tool reads the site's public content and sends nothing else unless you ask for a call.","items":[],"tables":[]},{"heading":"For developers","anchor":"for-developers","markdown":"- **Protocol.** Streamable HTTP, one JSON response per request, no sessions: MCP 2026-07-28 (`server/discover`) and the `initialize` handshake of 2024-11-05 to 2025-11-25.\n- **Discovery.** The server card is at `/mcp/server-card` (and `/.well-known/mcp/server-card.json`); in the official MCP Registry the server is `com.takefridayoff/mcp`.\n- **The pages, for machines.** [llms.txt](/llms.txt) and [llms-full.txt](/llms-full.txt), and every page as Markdown at its address with `.md` on the end.\n- **REST API.** The same tools over plain HTTP, with no key: `GET /api/search?query=TGA+listing+fees`, `/api/page?path=/guides/tga-approval`, `/api/case-studies`, `/api/faq` and the checks. It's described in OpenAPI 3.1 at [/api/openapi.json](/api/openapi.json), and listed with the MCP server at `/.well-known/api-catalog`.\n- **In the browser.** An AI agent working in Chrome gets the same tools through WebMCP, and our contact form fills itself in for you to check and send.","text":"Protocol. Streamable HTTP, one JSON response per request, no sessions: MCP 2026-07-28 (server/discover) and the initialize handshake of 2024-11-05 to 2025-11-25. Discovery. The server card is at /mcp/server-card (and /.well-known/mcp/server-card.json); in the official MCP Registry the server is com.takefridayoff/mcp. The pages, for machines. llms.txt and llms-full.txt, and every page as Markdown at its address with .md on the end. REST API. The same tools over plain HTTP, with no key: GET /api/search?query=TGA+listing+fees, /api/page?path=/guides/tga-approval, /api/case-studies, /api/faq and the checks. It's described in OpenAPI 3.1 at /api/openapi.json, and listed with the MCP server at /.well-known/api-catalog. In the browser. An AI agent working in Chrome gets the same tools through WebMCP, and our contact form fills itself in for you to check and send.","items":[{"lead":"Protocol.","text":"Streamable HTTP, one JSON response per request, no sessions: MCP 2026-07-28 (server/discover) and the initialize handshake of 2024-11-05 to 2025-11-25."},{"lead":"Discovery.","text":"The server card is at /mcp/server-card (and /.well-known/mcp/server-card.json); in the official MCP Registry the server is com.takefridayoff/mcp."},{"lead":"The pages, for machines.","text":"llms.txt and llms-full.txt, and every page as Markdown at its address with .md on the end."},{"lead":"REST API.","text":"The same tools over plain HTTP, with no key: GET /api/search?query=TGA+listing+fees, /api/page?path=/guides/tga-approval, /api/case-studies, /api/faq and the checks. It's described in OpenAPI 3.1 at /api/openapi.json, and listed with the MCP server at /.well-known/api-catalog."},{"lead":"In the browser.","text":"An AI agent working in Chrome gets the same tools through WebMCP, and our contact form fills itself in for you to check and send."}],"tables":[]}],"faqs":[{"q":"Is it free?","a":"Yes. The MCP server, the command-line tool and everything they return are free, with no account or key.","md":"Yes. The MCP server, the command-line tool and everything they return are free, with no account or key."},{"q":"Does it hold any client data?","a":"No. It reads what this website publishes and nothing else. The only things it sends us are a call request or a product brief, when you ask your assistant to send one.","md":"No. It reads what this website publishes and nothing else. The only things it sends us are a call request or a product brief, when you ask your assistant to send one."},{"q":"Is the pathway check legal advice?","a":"No. It applies the rules published on our pathways page to what it's told, and says what it assumed. The Therapeutic Goods Administration and the food regulators decide; check the result with them, or with us, before you rely on it.","md":"No. It applies the rules published on our pathways page to what it's told, and says what it assumed. The Therapeutic Goods Administration and the food regulators decide; check the result with them, or with us, before you rely on it."},{"q":"Which assistants does it work with?","a":"Any that support the Model Context Protocol over HTTP: Claude, ChatGPT (as a custom MCP server), Cursor, VS Code, Claude Code and others. Assistants that only start local servers can use npx -y takefridayoff serve.","md":"Any that support the Model Context Protocol over HTTP: Claude, ChatGPT (as a custom MCP server), Cursor, VS Code, Claude Code and others. Assistants that only start local servers can use `npx -y takefridayoff serve`."}],"sources":null},{"slug":"glossary","kind":"page","url":"/glossary","title":"Glossary: supplement, food and cosmetic regulatory terms","name":"Glossary","description":"Plain definitions of the regulatory terms in our guides: ARTG, AUST L, listed medicine, sponsor, TGO 116, GMP, FSANZ and AICIS, each linked to its guide.","eyebrow":"Glossary","lead":"The terms that come up when a supplement, food or cosmetic is developed for sale in Australia, in plain words: the ARTG and AUST numbers, listed medicines and their sponsors, permitted indications, TGO 116, GMP, the Food Standards Code, AICIS and more. Each entry links to the page that covers it in depth.","studies":[],"formats":[],"order":91,"updated":"2026-10-27","author":"Take Friday Off","approved":true,"sections":[{"heading":"","anchor":"","markdown":"Every definition below is drawn from our guides, which are checked against the regulator pages listed under Sources. Where a term has a long form or another name the regulators use, it is given under the heading. This is general information, not advice on a particular product.","text":"Every definition below is drawn from our guides, which are checked against the regulator pages listed under Sources. Where a term has a long form or another name the regulators use, it is given under the heading. This is general information, not advice on a particular product.","items":[],"tables":[]},{"heading":"ACCC","anchor":"accc","markdown":"*Australian Competition and Consumer Commission*\n\nThe main regulator of cosmetic products in Australia, covering their safety, ingredient labelling and claims. It is responsible for the Consumer Goods (Cosmetics) Information Standard 2020, the mandatory standard a cosmetic's ingredient list follows.\n\nMore in our [AICIS registration guide](/guides/aicis-registration#the-ingredient-label).","text":"Australian Competition and Consumer Commission The main regulator of cosmetic products in Australia, covering their safety, ingredient labelling and claims. It is responsible for the Consumer Goods (Cosmetics) Information Standard 2020, the mandatory standard a cosmetic's ingredient list follows. More in our AICIS registration guide.","items":[],"tables":[]},{"heading":"Advertising to health professionals","anchor":"advertising-to-health-professionals","markdown":"Advertising directed only at health professionals, and the others named in section 42AA of the Therapeutic Goods Act, is outside the Therapeutic Goods Advertising Code. The TGA says the public must not be able to access it, and a brand's public website and social posts count as advertising to the public.\n\nMore on [practitioner-only ranges](/practitioner-ranges).","text":"Advertising directed only at health professionals, and the others named in section 42AA of the Therapeutic Goods Act, is outside the Therapeutic Goods Advertising Code. The TGA says the public must not be able to access it, and a brand's public website and social posts count as advertising to the public. More on practitioner-only ranges.","items":[],"tables":[]},{"heading":"AICIS","anchor":"aicis","markdown":"*Australian Industrial Chemicals Introduction Scheme*\n\nThe regulator of the import and manufacture of industrial chemicals in Australia, which include cosmetic ingredients. It registers the businesses that introduce them, not products or ingredients, and it replaced NICNAS on 1 July 2020.\n\nMore in our [AICIS registration guide](/guides/aicis-registration#what-is-aicis).","text":"Australian Industrial Chemicals Introduction Scheme The regulator of the import and manufacture of industrial chemicals in Australia, which include cosmetic ingredients. It registers the businesses that introduce them, not products or ingredients, and it replaced NICNAS on 1 July 2020. More in our AICIS registration guide.","items":[],"tables":[]},{"heading":"Annual charge","anchor":"annual-charge","markdown":"The fee the TGA charges each financial year for each medicine on the ARTG. For a listed medicine it is $1,566 in 2026–27, and it applies once the product has had turnover: a listing that has never had turnover is exempt until sales start, as long as the sponsor declares each July that it had none in the year before.\n\nMore in our [development costs guide](/guides/supplement-development-cost#the-tgas-fees).","text":"The fee the TGA charges each financial year for each medicine on the ARTG. For a listed medicine it is $1,566 in 2026–27, and it applies once the product has had turnover: a listing that has never had turnover is exempt until sales start, as long as the sponsor declares each July that it had none in the year before. More in our development costs guide.","items":[],"tables":[]},{"heading":"APVMA","anchor":"apvma","markdown":"*Australian Pesticides and Veterinary Medicines Authority*\n\nThe regulator that registers agricultural and veterinary chemical products in Australia under the Agvet Code, including supplements for animals that count as veterinary chemical products. A product for animals isn't regulated by the TGA.\n\nMore in our [pet supplements guide](/guides/pet-supplements#medicine-or-food-where-the-line-falls-for-animals).","text":"Australian Pesticides and Veterinary Medicines Authority The regulator that registers agricultural and veterinary chemical products in Australia under the Agvet Code, including supplements for animals that count as veterinary chemical products. A product for animals isn't regulated by the TGA. More in our pet supplements guide.","items":[],"tables":[]},{"heading":"ARTG","anchor":"artg","markdown":"*Australian Register of Therapeutic Goods*\n\nThe TGA's public database of the therapeutic goods that can be legally supplied in Australia. A medicine on it carries an AUST R, AUST L or AUST L(A) number on its label. An entry means a product can be supplied, not always that the TGA has evaluated it.\n\nMore in our [ARTG guide](/guides/artg#what-is-the-artg).","text":"Australian Register of Therapeutic Goods The TGA's public database of the therapeutic goods that can be legally supplied in Australia. A medicine on it carries an AUST R, AUST L or AUST L(A) number on its label. An entry means a product can be supplied, not always that the TGA has evaluated it. More in our ARTG guide.","items":[],"tables":[]},{"heading":"Assessed listed medicine","anchor":"assessed-listed-medicine","markdown":"A medicine like a listed one, drawing its ingredients from the same pre-approved list, but whose indications the TGA assesses for efficacy before sale. Its label carries AUST L(A), it can make intermediate indications that may name a condition such as tinnitus, and it can say \"TGA assessed\".\n\nMore in our [assessed listed medicines guide](/guides/assessed-listed-medicines).","text":"A medicine like a listed one, drawing its ingredients from the same pre-approved list, but whose indications the TGA assesses for efficacy before sale. Its label carries AUST L(A), it can make intermediate indications that may name a condition such as tinnitus, and it can say \"TGA assessed\". More in our assessed listed medicines guide.","items":[],"tables":[]},{"heading":"AUST L","anchor":"aust-l","markdown":"The number on the label of a listed medicine, the lowest-risk tier of medicine on the ARTG. It shows the medicine uses ingredients from the TGA's pre-approved list and low-level indications, and that its sponsor has certified it meets the rules; the TGA doesn't evaluate a listed medicine before sale.\n\nMore in our [TGA listing guide](/guides/tga-approval#approval-listing-or-registration).","text":"The number on the label of a listed medicine, the lowest-risk tier of medicine on the ARTG. It shows the medicine uses ingredients from the TGA's pre-approved list and low-level indications, and that its sponsor has certified it meets the rules; the TGA doesn't evaluate a listed medicine before sale. More in our TGA listing guide.","items":[],"tables":[]},{"heading":"AUST L(A)","anchor":"aust-la","markdown":"The number on the label of an assessed listed medicine, whose indications the TGA has assessed for efficacy before sale.\n\nMore in our [assessed listed medicines guide](/guides/assessed-listed-medicines#what-an-assessed-listed-medicine-is).","text":"The number on the label of an assessed listed medicine, whose indications the TGA has assessed for efficacy before sale. More in our assessed listed medicines guide.","items":[],"tables":[]},{"heading":"AUST R","anchor":"aust-r","markdown":"The number on the label of a registered medicine, which the TGA fully evaluates before sale, including the indications on its label. Registered medicines are the higher-risk ones: all prescription medicines, most over-the-counter medicines such as pain relief and antihistamines, and higher dose iron supplements.\n\nMore in our [ARTG guide](/guides/artg#what-is-on-the-artg).","text":"The number on the label of a registered medicine, which the TGA fully evaluates before sale, including the indications on its label. Registered medicines are the higher-risk ones: all prescription medicines, most over-the-counter medicines such as pain relief and antihistamines, and higher dose iron supplements. More in our ARTG guide.","items":[],"tables":[]},{"heading":"Certificate of Listed Product","anchor":"certificate-of-listed-product","markdown":"*CLP*\n\nA TGA export certificate for a single listed complementary medicine, noting that it can be legally supplied in Australia. It isn't issued under the World Health Organization's scheme, but the TGA says it is widely accepted in place of a certificate of free sale.\n\nMore in our [export guide](/guides/exporting-supplements#the-tgas-export-certificates).","text":"CLP A TGA export certificate for a single listed complementary medicine, noting that it can be legally supplied in Australia. It isn't issued under the World Health Organization's scheme, but the TGA says it is widely accepted in place of a certificate of free sale. More in our export guide.","items":[],"tables":[]},{"heading":"Certificate of Pharmaceutical Product","anchor":"certificate-of-pharmaceutical-product","markdown":"*CPP*\n\nA TGA export certificate issued under the World Health Organization's certification scheme: it gives a medicine's regulatory status in Australia and confirms that its manufacture conforms to GMP. Australia doesn't require it, but an importing country may.\n\nMore in our [export guide](/guides/exporting-supplements#the-tgas-export-certificates).","text":"CPP A TGA export certificate issued under the World Health Organization's certification scheme: it gives a medicine's regulatory status in Australia and confirms that its manufacture conforms to GMP. Australia doesn't require it, but an importing country may. More in our export guide.","items":[],"tables":[]},{"heading":"Comparable overseas body","anchor":"comparable-overseas-body","markdown":"*COB*\n\nAn overseas regulator on the TGA's list whose evaluation report can support an application to add a new ingredient for listed medicines. With an unredacted report from one, an application can be made at level IN1, IN2 or IN3, with less supporting information and a shorter evaluation than the TGA's own (IN4).\n\nMore in our [new ingredients guide](/guides/permissible-ingredients#the-four-application-levels).","text":"COB An overseas regulator on the TGA's list whose evaluation report can support an application to add a new ingredient for listed medicines. With an unredacted report from one, an application can be made at level IN1, IN2 or IN3, with less supporting information and a shorter evaluation than the TGA's own (IN4). More in our new ingredients guide.","items":[],"tables":[]},{"heading":"Compliance review","anchor":"compliance-review","markdown":"A TGA check of a listed medicine after it is listed, which can come at any time. It can ask for information on the label, quality, safety or efficacy. A medicine that doesn't comply can have its label changed, its listing suspended or cancelled, or be recalled.\n\nMore in our [TGA listing guide](/guides/tga-approval#after-the-listing).","text":"A TGA check of a listed medicine after it is listed, which can come at any time. It can ask for information on the label, quality, safety or efficacy. A medicine that doesn't comply can have its label changed, its listing suspended or cancelled, or be recalled. More in our TGA listing guide.","items":[],"tables":[]},{"heading":"Compliance verification","anchor":"compliance-verification","markdown":"*CV*\n\nOne of the two desktop routes to a TGA GMP clearance for an overseas site, relying on an inspection by a recognised regulator outside its own country or under a cooperative arrangement, such as the US FDA's. It needs the regulator's GMP certificate from an on-site inspection no more than three years old, with the site's documents.\n\nMore in our [GMP clearance guide](/guides/gmp-clearance#three-routes-to-a-clearance).","text":"CV One of the two desktop routes to a TGA GMP clearance for an overseas site, relying on an inspection by a recognised regulator outside its own country or under a cooperative arrangement, such as the US FDA's. It needs the regulator's GMP certificate from an on-site inspection no more than three years old, with the site's documents. More in our GMP clearance guide.","items":[],"tables":[]},{"heading":"Compositional guideline","anchor":"compositional-guideline","markdown":"The specification for an ingredient that no monograph in a default standard covers, set out in an application to add it for listed medicines. The TGA publishes compositional guidelines on its website.\n\nMore in our [new ingredients guide](/guides/permissible-ingredients#what-the-dossier-needs).","text":"The specification for an ingredient that no monograph in a default standard covers, set out in an application to add it for listed medicines. The TGA publishes compositional guidelines on its website. More in our new ingredients guide.","items":[],"tables":[]},{"heading":"Cosmetic","anchor":"cosmetic","markdown":"A product used on an external part of the body, or in the mouth, to change its odour or appearance, cleanse it, keep it in good condition or protect it. A cream, serum or lotion stays a cosmetic while its claims stay there; a claim to treat a condition, an ingredient from Schedule 2, 3, 4 or 8 of the Poisons Standard, or the way it is used can make it a therapeutic good.\n\nMore on [skincare and cosmetics](/skincare#cosmetic-or-medicine-the-claim-decides).","text":"A product used on an external part of the body, or in the mouth, to change its odour or appearance, cleanse it, keep it in good condition or protect it. A cream, serum or lotion stays a cosmetic while its claims stay there; a claim to treat a condition, an ingredient from Schedule 2, 3, 4 or 8 of the Poisons Standard, or the way it is used can make it a therapeutic good. More on skincare and cosmetics.","items":[],"tables":[]},{"heading":"Cost of goods","anchor":"cost-of-goods","markdown":"*COGS*\n\nWhat one finished unit costs to make, packaging included. As a rule of thumb from our records, a target cost of goods is the retail price divided by four or five, which leaves direct-to-consumer brands about 80% gross margin and brands selling through pharmacies and health food stores about 60%.\n\nMore in our [development costs guide](/guides/supplement-development-cost#design-to-the-price-the-cost-of-goods).","text":"COGS What one finished unit costs to make, packaging included. As a rule of thumb from our records, a target cost of goods is the retail price divided by four or five, which leaves direct-to-consumer brands about 80% gross margin and brands selling through pharmacies and health food stores about 60%. More in our development costs guide.","items":[],"tables":[]},{"heading":"Declared goods","anchor":"declared-goods","markdown":"*Declared therapeutic goods*\n\nProducts the Therapeutic Goods (Declared Goods) Order 2019 declares to be therapeutic goods, so the medicines rules apply whatever else does. Some are declared by form alone, such as fibre in tablets, capsules or pills; others by how they are presented, such as beauty supplements, and sports supplements presented for a therapeutic use that contain certain substances or come as a tablet, capsule or pill. Once declared, a product cannot be a food, even if a food standard covers it.\n\nMore on [how the line is drawn](/pathways#how-the-line-is-drawn).","text":"Declared therapeutic goods Products the Therapeutic Goods (Declared Goods) Order 2019 declares to be therapeutic goods, so the medicines rules apply whatever else does. Some are declared by form alone, such as fibre in tablets, capsules or pills; others by how they are presented, such as beauty supplements, and sports supplements presented for a therapeutic use that contain certain substances or come as a tablet, capsule or pill. Once declared, a product cannot be a food, even if a food standard covers it. More on how the line is drawn.","items":[],"tables":[]},{"heading":"Electronic Listing Facility","anchor":"electronic-listing-facility","markdown":"The part of TGA Business Services that validates a listing application. The sponsor then submits it, certifies that the medicine meets every condition of listing and pays the fee. Passing validation doesn't mean the TGA has confirmed the medicine meets all regulatory requirements.\n\nMore in our [TGA listing guide](/guides/tga-approval#the-steps-to-an-aust-l-listing).","text":"The part of TGA Business Services that validates a listing application. The sponsor then submits it, certifies that the medicine meets every condition of listing and pays the fee. Passing validation doesn't mean the TGA has confirmed the medicine meets all regulatory requirements. More in our TGA listing guide.","items":[],"tables":[]},{"heading":"Endorsement","anchor":"endorsement","markdown":"In the TGA's words, \"a form of support, approval or sanction\" for a therapeutic good. Advertising to the public can't carry one from a government body or a hospital, their employees or contractors, a current or former health practitioner, health professional or medical researcher, or anyone who presents as qualified to diagnose or treat disease; a paid endorsement from anyone else must disclose the payment.\n\nMore in our [advertising guide](/guides/tga-advertising#testimonials-endorsements-and-influencers).","text":"In the TGA's words, \"a form of support, approval or sanction\" for a therapeutic good. Advertising to the public can't carry one from a government body or a hospital, their employees or contractors, a current or former health practitioner, health professional or medical researcher, or anyone who presents as qualified to diagnose or treat disease; a paid endorsement from anyone else must disclose the payment. More in our advertising guide.","items":[],"tables":[]},{"heading":"Excluded goods","anchor":"excluded-goods","markdown":"Products the Therapeutic Goods (Excluded Goods) Determination 2018 takes out of the medicines rules, as long as they meet every condition it sets. Examples are an SPF 4 to 15 moisturiser that meets its conditions, and an acne product presented as controlling acne only by cleansing, moisturising, exfoliating or drying the skin, with no Schedule 2, 3, 4 or 8 poisons.\n\nMore on [how the line is drawn](/pathways#how-the-line-is-drawn).","text":"Products the Therapeutic Goods (Excluded Goods) Determination 2018 takes out of the medicines rules, as long as they meet every condition it sets. Examples are an SPF 4 to 15 moisturiser that meets its conditions, and an acne product presented as controlling acne only by cleansing, moisturising, exfoliating or drying the skin, with no Schedule 2, 3, 4 or 8 poisons. More on how the line is drawn.","items":[],"tables":[]},{"heading":"Excluded nutritional or digestive product","anchor":"excluded-nutritional-or-digestive-product","markdown":"*END product*\n\nA feed for livestock or companion animals that the Agvet Code has excluded from APVMA regulation since 5 March 2015, if it is fed to and voluntarily eaten by the animal and meets conditions on its ingredients, manufacturing, labelling and claims. It can make a therapeutic claim only with scientific evidence of a standard suitable for a peer-reviewed journal, or if it is supplied only through the treating veterinarian.\n\nMore in our [pet supplements guide](/guides/pet-supplements#products-the-law-excludes-or-lists).","text":"END product A feed for livestock or companion animals that the Agvet Code has excluded from APVMA regulation since 5 March 2015, if it is fed to and voluntarily eaten by the animal and meets conditions on its ingredients, manufacturing, labelling and claims. It can make a therapeutic claim only with scientific evidence of a standard suitable for a peer-reviewed journal, or if it is supplied only through the treating veterinarian. More in our pet supplements guide.","items":[],"tables":[]},{"heading":"Export only medicine","anchor":"export-only-medicine","markdown":"*export-only medicine*\n\nA medicine made in Australia, or imported, for export only, and listable on the ARTG only for that reason. It can't be supplied in Australia and doesn't follow Australia's labelling order, but it must meet a pharmacopoeia standard under TGO 114 and have at least one step of its manufacture in Australia.\n\nMore in our [export guide](/guides/exporting-supplements#an-export-only-medicine).","text":"export-only medicine A medicine made in Australia, or imported, for export only, and listable on the ARTG only for that reason. It can't be supplied in Australia and doesn't follow Australia's labelling order, but it must meet a pharmacopoeia standard under TGO 114 and have at least one step of its manufacture in Australia. More in our export guide.","items":[],"tables":[]},{"heading":"Food Standards Code","anchor":"food-standards-code","markdown":"*Australia New Zealand Food Standards Code*\n\nThe rules a food sold in Australia must meet. FSANZ writes it, and the states, territories and local councils enforce it. It sets what a food can contain, what it can claim and what its label says, in standards such as 1.2.7 for health claims and 2.9.4 for sports foods.\n\nMore on [the food pathway](/pathways/foods#the-food-standards-that-matter).","text":"Australia New Zealand Food Standards Code The rules a food sold in Australia must meet. FSANZ writes it, and the states, territories and local councils enforce it. It sets what a food can contain, what it can claim and what its label says, in standards such as 1.2.7 for health claims and 2.9.4 for sports foods. More on the food pathway.","items":[],"tables":[]},{"heading":"Food-medicine interface","anchor":"food-medicine-interface","markdown":"The line between a food and a medicine for a product that is swallowed. The TGA says that \"generally a product that is swallowed will be either one form of therapeutic good (a medicine) or a food\"; the Therapeutic Goods Act's definition of a therapeutic good, the declared and excluded goods lists and the food standards decide which, and the TGA's Food-Medicine Interface Guidance Tool walks through the questions.\n\nMore on [how the line is drawn](/pathways#how-the-line-is-drawn).","text":"The line between a food and a medicine for a product that is swallowed. The TGA says that \"generally a product that is swallowed will be either one form of therapeutic good (a medicine) or a food\"; the Therapeutic Goods Act's definition of a therapeutic good, the declared and excluded goods lists and the food standards decide which, and the TGA's Food-Medicine Interface Guidance Tool walks through the questions. More on how the line is drawn.","items":[],"tables":[]},{"heading":"Formulated beverage","anchor":"formulated-beverage","markdown":"One of the foods Schedule 17 of the Food Standards Code lets set vitamins and minerals be added to, within its limits, measured against a 600 mL reference quantity. Fruit and vegetable juices are on the same list. It's how a shot with added vitamins can be sold as a food.\n\nMore on [liquids](/formats/liquids#medicine-or-food).","text":"One of the foods Schedule 17 of the Food Standards Code lets set vitamins and minerals be added to, within its limits, measured against a 600 mL reference quantity. Fruit and vegetable juices are on the same list. It's how a shot with added vitamins can be sold as a food. More on liquids.","items":[],"tables":[]},{"heading":"FSANZ","anchor":"fsanz","markdown":"*Food Standards Australia New Zealand*\n\nThe body that develops and administers the Food Standards Code. It has no enforcement powers: in Australia, state and territory agencies and local councils enforce the Code, and the Department of Agriculture, Fisheries and Forestry enforces it at the border.\n\nMore on [the food pathway](/pathways/foods#who-enforces-the-code).","text":"Food Standards Australia New Zealand The body that develops and administers the Food Standards Code. It has no enforcement powers: in Australia, state and territory agencies and local councils enforce the Code, and the Department of Agriculture, Fisheries and Forestry enforces it at the border. More on the food pathway.","items":[],"tables":[]},{"heading":"GMP","anchor":"gmp","markdown":"*Good manufacturing practice*\n\nThe standard a listed medicine must be made under. In Australia, every manufacturing step needs a TGA manufacturing licence unless it is exempt, including testing, packaging, labelling and release for supply; an overseas site needs a TGA GMP clearance or certification. The standard the TGA holds manufacturers to is the PIC/S Guide to GMP.\n\nMore on [TGA licences and GMP](/manufacturing#tga-licences-and-gmp).","text":"Good manufacturing practice The standard a listed medicine must be made under. In Australia, every manufacturing step needs a TGA manufacturing licence unless it is exempt, including testing, packaging, labelling and release for supply; an overseas site needs a TGA GMP clearance or certification. The standard the TGA holds manufacturers to is the PIC/S Guide to GMP. More on TGA licences and GMP.","items":[],"tables":[]},{"heading":"GMP agreement","anchor":"gmp-agreement","markdown":"*technical agreement*\n\nThe written contract the PIC/S Guide to GMP requires between a business that outsources a GMP activity, such as a brand having its medicine made, and the business that carries it out, setting out each party's roles and responsibilities. It says who does each step, from purchasing and testing materials to production and quality control, keeps the records available to the brand and lets it audit the work. For a listed medicine, the TGA's guidance says the ongoing stability responsibilities should be written into it.\n\nMore in our [guide to choosing a supplement manufacturer](/guides/choosing-a-supplement-manufacturer#the-gmp-agreement).","text":"technical agreement The written contract the PIC/S Guide to GMP requires between a business that outsources a GMP activity, such as a brand having its medicine made, and the business that carries it out, setting out each party's roles and responsibilities. It says who does each step, from purchasing and testing materials to production and quality control, keeps the records available to the brand and lets it audit the work. For a listed medicine, the TGA's guidance says the ongoing stability responsibilities should be written into it. More in our guide to choosing a supplement manufacturer.","items":[],"tables":[]},{"heading":"GMP clearance","anchor":"gmp-clearance","markdown":"*TGA GMP clearance*\n\nWhat an overseas manufacturing site needs before it makes a listed medicine for Australia, since only Australian sites can hold a TGA manufacturing licence. The Australian sponsor, or an agent for it, applies, should hold evidence of GMP compliance for every overseas site, and applies to renew a clearance at least six months before it expires.\n\nMore in our [GMP clearance guide](/guides/gmp-clearance#three-routes-to-a-clearance).","text":"TGA GMP clearance What an overseas manufacturing site needs before it makes a listed medicine for Australia, since only Australian sites can hold a TGA manufacturing licence. The Australian sponsor, or an agent for it, applies, should hold evidence of GMP compliance for every overseas site, and applies to renew a clearance at least six months before it expires. More in our GMP clearance guide.","items":[],"tables":[]},{"heading":"Grouping","anchor":"grouping","markdown":"How some changes to a listed medicine are made without a new listing. In the TGA's change tables, a change to its flavour, colour, fragrance or printing ink only, its indications only or its name only is a grouping application, charged at the fee for a new product. A change to an active ingredient, its quantity or the dosage form needs a new listing instead.\n\nMore in our [reformulation guide](/guides/reformulating-a-supplement#what-the-tga-treats-as-a-new-medicine).","text":"How some changes to a listed medicine are made without a new listing. In the TGA's change tables, a change to its flavour, colour, fragrance or printing ink only, its indications only or its name only is a grouping application, charged at the fee for a new product. A change to an active ingredient, its quantity or the dosage form needs a new listing instead. More in our reformulation guide.","items":[],"tables":[]},{"heading":"Health claim","anchor":"health-claim","markdown":"A claim a food can make only as Standard 1.2.7 of the Food Standards Code permits, at two levels. High level claims refer to a serious disease or a biomarker of one and must rest on a pre-approved relationship; general level claims, such as \"calcium for healthy bones and teeth\", can rest on a pre-approved relationship or on one notified to FSANZ first. No claim on a food may refer to preventing, diagnosing, curing or alleviating a disease, disorder or condition.\n\nMore on [what a food can claim](/pathways/foods#what-a-food-can-and-cant-claim).","text":"A claim a food can make only as Standard 1.2.7 of the Food Standards Code permits, at two levels. High level claims refer to a serious disease or a biomarker of one and must rest on a pre-approved relationship; general level claims, such as \"calcium for healthy bones and teeth\", can rest on a pre-approved relationship or on one notified to FSANZ first. No claim on a food may refer to preventing, diagnosing, curing or alleviating a disease, disorder or condition. More on what a food can claim.","items":[],"tables":[]},{"heading":"Infringement notice","anchor":"infringement-notice","markdown":"One of the TGA's enforcement tools for non-compliant advertising, carrying up to 12 penalty units for an individual and 60 for a company: $4,368 and $21,840 at the $364 penalty unit in force since 1 July 2026. The TGA gave over 75 in the second half of 2025, mostly for alleged unlawful advertising.\n\nMore in our [advertising guide](/guides/tga-advertising#no-pre-approval-what-the-tga-can-do-instead).","text":"One of the TGA's enforcement tools for non-compliant advertising, carrying up to 12 penalty units for an individual and 60 for a company: $4,368 and $21,840 at the $364 penalty unit in force since 1 July 2026. The TGA gave over 75 in the second half of 2025, mostly for alleged unlawful advertising. More in our advertising guide.","items":[],"tables":[]},{"heading":"Intermediate indication","anchor":"intermediate-indication","markdown":"*intermediate level indication*\n\nA claim stronger than the permitted indications a listed medicine can make, but not a high-level one, such as the prevention or alleviation of a non-serious form of a disease. An assessed listed medicine (AUST L(A)) must make at least one, and the TGA assesses the evidence for it before the medicine is sold.\n\nMore in our [assessed listed medicines guide](/guides/assessed-listed-medicines#what-an-intermediate-indication-is).","text":"intermediate level indication A claim stronger than the permitted indications a listed medicine can make, but not a high-level one, such as the prevention or alleviation of a non-serious form of a disease. An assessed listed medicine (AUST L(A)) must make at least one, and the TGA assesses the evidence for it before the medicine is sold. More in our assessed listed medicines guide.","items":[],"tables":[]},{"heading":"Listed medicine","anchor":"listed-medicine","markdown":"The TGA's lowest-risk tier of non-prescription medicine, with an AUST L number on the pack; most complementary medicines sold in Australia, from vitamins to herbal medicines, are listed medicines. It can only use ingredients from the TGA's pre-approved list and make low-level claims from its permitted indications, with evidence held for every claim. The TGA doesn't evaluate it before sale: the Australian sponsor certifies that it meets the rules, and the TGA can review it at any time after.\n\nMore on [the listed-medicines pathway](/pathways/listed-medicines#what-a-listed-medicine-is).","text":"The TGA's lowest-risk tier of non-prescription medicine, with an AUST L number on the pack; most complementary medicines sold in Australia, from vitamins to herbal medicines, are listed medicines. It can only use ingredients from the TGA's pre-approved list and make low-level claims from its permitted indications, with evidence held for every claim. The TGA doesn't evaluate it before sale: the Australian sponsor certifies that it meets the rules, and the TGA can review it at any time after. More on the listed-medicines pathway.","items":[],"tables":[]},{"heading":"Manufacturing licence","anchor":"manufacturing-licence","markdown":"*TGA licence to manufacture*\n\nWhat an Australian manufacturer needs, unless the goods or the manufacturer are exempt, to carry out a step in making a medicine at its site, such as making the dosage form or its ingredients, packaging and labelling, storage, testing, or release for supply. A licence names its holder, its sites and the types of product and steps it authorises, and the TGA's public Australian Manufacturer search shows the steps each licensed manufacturer is approved for. Only Australian sites can hold one; for an overseas site, the sponsor needs a GMP clearance.\n\nMore in our [guide to choosing a supplement manufacturer](/guides/choosing-a-supplement-manufacturer#what-a-licence-covers-and-how-to-check-it).","text":"TGA licence to manufacture What an Australian manufacturer needs, unless the goods or the manufacturer are exempt, to carry out a step in making a medicine at its site, such as making the dosage form or its ingredients, packaging and labelling, storage, testing, or release for supply. A licence names its holder, its sites and the types of product and steps it authorises, and the TGA's public Australian Manufacturer search shows the steps each licensed manufacturer is approved for. Only Australian sites can hold one; for an overseas site, the sponsor needs a GMP clearance. More in our guide to choosing a supplement manufacturer.","items":[],"tables":[]},{"heading":"Minimum order","anchor":"minimum-order","markdown":"*MOQ; minimum order quantity*\n\nThe smallest batch a manufacturer will make in one run. With us it is 3,000 finished retail packs per batch, whatever the format. Packaging has minimums of its own: single-serve sachets typically need around 150,000 sachets.\n\nMore in our [development costs guide](/guides/supplement-development-cost#the-minimum-order).","text":"MOQ; minimum order quantity The smallest batch a manufacturer will make in one run. With us it is 3,000 finished retail packs per batch, whatever the format. Packaging has minimums of its own: single-serve sachets typically need around 150,000 sachets. More in our development costs guide.","items":[],"tables":[]},{"heading":"Mutual recognition agreement","anchor":"mutual-recognition-agreement","markdown":"*MRA*\n\nAn agreement under which the TGA relies on another regulator's GMP inspection of a site within that regulator's own country: the European Union, the United Kingdom, Canada, Singapore, New Zealand and, under a memorandum of understanding, Switzerland. It is the quickest route to a GMP clearance, but often not open to a factory that makes supplements under food rules.\n\nMore in our [GMP clearance guide](/guides/gmp-clearance#three-routes-to-a-clearance).","text":"MRA An agreement under which the TGA relies on another regulator's GMP inspection of a site within that regulator's own country: the European Union, the United Kingdom, Canada, Singapore, New Zealand and, under a memorandum of understanding, Switzerland. It is the quickest route to a GMP clearance, but often not open to a factory that makes supplements under food rules. More in our GMP clearance guide.","items":[],"tables":[]},{"heading":"New ingredient application","anchor":"new-ingredient-application","markdown":"An application to the TGA to add a substance to the Permissible Ingredients Determination, or to change its requirements, such as a higher permitted level, so listed medicines can use it. There are four levels, IN1 to IN4: the more of the safety and quality case that rests on an evaluation by a comparable overseas regulator, or on a published monograph, the less the TGA evaluates itself. A successful applicant for a new ingredient can opt in, when it applies, to two years of exclusive use.\n\nMore in our [permissible ingredients guide](/guides/permissible-ingredients) and on [new ingredient applications](/new-ingredients).","text":"An application to the TGA to add a substance to the Permissible Ingredients Determination, or to change its requirements, such as a higher permitted level, so listed medicines can use it. There are four levels, IN1 to IN4: the more of the safety and quality case that rests on an evaluation by a comparable overseas regulator, or on a published monograph, the less the TGA evaluates itself. A successful applicant for a new ingredient can opt in, when it applies, to two years of exclusive use. More in our permissible ingredients guide and on new ingredient applications.","items":[],"tables":[]},{"heading":"Non-traditional food","anchor":"non-traditional-food","markdown":"Under the Food Standards Code, a food, a substance derived from a food, or any other substance without a history of human consumption in Australia or New Zealand. A non-traditional food that needs an assessment of its public health and safety is a novel food.\n\nMore in our [novel foods guide](/guides/novel-foods#what-makes-a-food-novel).","text":"Under the Food Standards Code, a food, a substance derived from a food, or any other substance without a history of human consumption in Australia or New Zealand. A non-traditional food that needs an assessment of its public health and safety is a novel food. More in our novel foods guide.","items":[],"tables":[]},{"heading":"Novel food","anchor":"novel-food","markdown":"A non-traditional food that needs a safety assessment before it is sold. Under Standard 1.5.1 of the Food Standards Code, a novel food can't be sold at retail unless it is listed in Schedule 25 and used within its conditions, and listing follows a safety assessment by FSANZ.\n\nMore in our [novel foods guide](/guides/novel-foods#what-makes-a-food-novel).","text":"A non-traditional food that needs a safety assessment before it is sold. Under Standard 1.5.1 of the Food Standards Code, a novel food can't be sold at retail unless it is listed in Schedule 25 and used within its conditions, and listing follows a safety assessment by FSANZ. More in our novel foods guide.","items":[],"tables":[]},{"heading":"Permissible Indications Determination","anchor":"permissible-indications-determination","markdown":"*Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025*\n\nThe legal list of the indications a listed medicine can make, in force since 3 April 2025. For each indication it gives the wording, the type of evidence the sponsor must hold, scientific or traditional, and any requirements for using it, such as a label statement.\n\nMore in our [claims and indications guide](/guides/permitted-indications#how-the-permissible-indications-determination-works).","text":"Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025 The legal list of the indications a listed medicine can make, in force since 3 April 2025. For each indication it gives the wording, the type of evidence the sponsor must hold, scientific or traditional, and any requirements for using it, such as a label statement. More in our claims and indications guide.","items":[],"tables":[]},{"heading":"Permissible Ingredients Determination","anchor":"permissible-ingredients-determination","markdown":"*Therapeutic Goods (Permissible Ingredients) Determination*\n\nThe TGA's pre-approved list of the ingredients a listed medicine can use, with the purposes and limits each one is used within. The list changes: there have been three determinations in 2026 alone. An ingredient that isn't on it needs its own application and evaluation before any product using it can be listed.\n\nMore in our [new ingredients guide](/guides/permissible-ingredients#what-needs-an-application).","text":"Therapeutic Goods (Permissible Ingredients) Determination The TGA's pre-approved list of the ingredients a listed medicine can use, with the purposes and limits each one is used within. The list changes: there have been three determinations in 2026 alone. An ingredient that isn't on it needs its own application and evaluation before any product using it can be listed. More in our new ingredients guide.","items":[],"tables":[]},{"heading":"Permitted indications","anchor":"permitted-indications","markdown":"The therapeutic claims a listed medicine is allowed to make, set out in the Permissible Indications Determination. In the TGA's words, indications \"are statements that describe the specific therapeutic use for a medicine\", such as \"relieves coughs\". A listed medicine can make low-level claims only: \"relieves throat irritation\", not \"reduces high blood pressure\".\n\nMore in our [claims and indications guide](/guides/permitted-indications#what-an-indication-is).","text":"The therapeutic claims a listed medicine is allowed to make, set out in the Permissible Indications Determination. In the TGA's words, indications \"are statements that describe the specific therapeutic use for a medicine\", such as \"relieves coughs\". A listed medicine can make low-level claims only: \"relieves throat irritation\", not \"reduces high blood pressure\". More in our claims and indications guide.","items":[],"tables":[]},{"heading":"PIC/S Guide to GMP","anchor":"pics-guide-to-gmp","markdown":"*PIC/S Guide; PE009-17*\n\nThe guide to good manufacturing practice for medicinal products that the TGA applies to medicines through its Manufacturing Principles. Version PE009-17 has applied since 1 September 2025, with its Annexes 4, 5 and 14 not adopted in Australia.\n\nMore in our [GMP clearance guide](/guides/gmp-clearance#the-standard-the-pics-guide-version-17).","text":"PIC/S Guide; PE009-17 The guide to good manufacturing practice for medicinal products that the TGA applies to medicines through its Manufacturing Principles. Version PE009-17 has applied since 1 September 2025, with its Annexes 4, 5 and 14 not adopted in Australia. More in our GMP clearance guide.","items":[],"tables":[]},{"heading":"Primary sunscreen","anchor":"primary-sunscreen","markdown":"A product presented mainly to protect the skin from UV. It is a therapeutic good and must be on the ARTG before it is sold, generally as a listed medicine with an AUST L number on the label.\n\nMore on [sunscreens](/skincare#sunscreens-primary-or-secondary).","text":"A product presented mainly to protect the skin from UV. It is a therapeutic good and must be on the ARTG before it is sold, generally as a listed medicine with an AUST L number on the label. More on sunscreens.","items":[],"tables":[]},{"heading":"Prohibited representation","anchor":"prohibited-representation","markdown":"A claim that advertising for a medicine can't make and that can't be applied for, listed in the Therapeutic Goods Regulations 1990, such as a claim about treating or preventing cancer or mental illness. The TGA can permit one in a specific ad if it is necessary for public health or the appropriate use of the goods.\n\nMore in our [claims and indications guide](/guides/permitted-indications#advertising-the-therapeutic-goods-advertising-code).","text":"A claim that advertising for a medicine can't make and that can't be applied for, listed in the Therapeutic Goods Regulations 1990, such as a claim about treating or preventing cancer or mental illness. The TGA can permit one in a specific ad if it is necessary for public health or the appropriate use of the goods. More in our claims and indications guide.","items":[],"tables":[]},{"heading":"Protected ingredient","anchor":"protected-ingredient","markdown":"A new ingredient its successful applicant opted to keep for its own use: for two calendar years from its inclusion in the Permissible Ingredients Determination, only the owner and the sponsors it authorises, named in the Determination, can use it. After that, any sponsor can.\n\nMore in our [new ingredients guide](/guides/permissible-ingredients#two-years-of-exclusive-use).","text":"A new ingredient its successful applicant opted to keep for its own use: for two calendar years from its inclusion in the Permissible Ingredients Determination, only the owner and the sponsors it authorises, named in the Determination, can use it. After that, any sponsor can. More in our new ingredients guide.","items":[],"tables":[]},{"heading":"Registered medicine","anchor":"registered-medicine","markdown":"The TGA's higher-risk tier of medicine, marked AUST R on the label. The TGA fully evaluates it for safety, quality and efficacy before it goes on sale, including the indications on its label. All prescription medicines are registered, and so are most over-the-counter medicines, such as pain relief and antihistamines, and higher dose iron supplements.\n\nMore in our [TGA listing guide](/guides/tga-approval#approval-listing-or-registration).","text":"The TGA's higher-risk tier of medicine, marked AUST R on the label. The TGA fully evaluates it for safety, quality and efficacy before it goes on sale, including the indications on its label. All prescription medicines are registered, and so are most over-the-counter medicines, such as pain relief and antihistamines, and higher dose iron supplements. More in our TGA listing guide.","items":[],"tables":[]},{"heading":"Release for supply","anchor":"release-for-supply","markdown":"The manufacturing step at which a batch of a medicine is certified by an authorised person before it is supplied. For a listed medicine it needs a TGA manufacturing licence in Australia or a GMP clearance overseas, and TGO 116's transition turns on the date a medicine is released for supply, not the date it is sold.\n\nMore in our [GMP clearance guide](/guides/gmp-clearance#which-steps-need-a-clearance).","text":"The manufacturing step at which a batch of a medicine is certified by an authorised person before it is supplied. For a listed medicine it needs a TGA manufacturing licence in Australia or a GMP clearance overseas, and TGO 116's transition turns on the date a medicine is released for supply, not the date it is sold. More in our GMP clearance guide.","items":[],"tables":[]},{"heading":"Restricted representation","anchor":"restricted-representation","markdown":"A claim in advertising for a medicine that refers to a serious form of a disease, condition, ailment or defect, one that requires \"a health professional to diagnose, follow-up or treat\". It needs the TGA's prior approval or permission, unless it is part of a required health warning.\n\nMore in our [claims and indications guide](/guides/permitted-indications#advertising-the-therapeutic-goods-advertising-code).","text":"A claim in advertising for a medicine that refers to a serious form of a disease, condition, ailment or defect, one that requires \"a health professional to diagnose, follow-up or treat\". It needs the TGA's prior approval or permission, unless it is part of a required health warning. More in our claims and indications guide.","items":[],"tables":[]},{"heading":"Secondary sunscreen","anchor":"secondary-sunscreen","markdown":"A product with an SPF that isn't presented mainly to protect the skin from UV, such as an SPF moisturiser. Most secondary sunscreens are cosmetics, but an SPF moisturiser stays a cosmetic only if it meets every condition of the Excluded Goods Determination, among them SPF 4 to 15, a pack of 300 mL or 300 g or less and no claim of water resistance; above SPF 15 it is a therapeutic sunscreen. A cosmetic sunscreen must still meet the testing and labelling requirements of the Australian sunscreen standard.\n\nMore on [sunscreens](/skincare#sunscreens-primary-or-secondary).","text":"A product with an SPF that isn't presented mainly to protect the skin from UV, such as an SPF moisturiser. Most secondary sunscreens are cosmetics, but an SPF moisturiser stays a cosmetic only if it meets every condition of the Excluded Goods Determination, among them SPF 4 to 15, a pack of 300 mL or 300 g or less and no claim of water resistance; above SPF 15 it is a therapeutic sunscreen. A cosmetic sunscreen must still meet the testing and labelling requirements of the Australian sunscreen standard. More on sunscreens.","items":[],"tables":[]},{"heading":"Shelf life","anchor":"shelf-life","markdown":"How long a product keeps meeting its specifications, stored as its label says: the period to the expiry date on the label. TGA guidance says a listed medicine's sponsor should hold stability evidence for it at or before listing; if full data aren't ready, older TGA guidance allows an interim shelf life supported by evidence, and testing only at expiry isn't acceptable.\n\nMore in our [stability testing guide](/guides/stability-testing#selling-before-the-study-finishes).","text":"How long a product keeps meeting its specifications, stored as its label says: the period to the expiry date on the label. TGA guidance says a listed medicine's sponsor should hold stability evidence for it at or before listing; if full data aren't ready, older TGA guidance allows an interim shelf life supported by evidence, and testing only at expiry isn't acceptable. More in our stability testing guide.","items":[],"tables":[]},{"heading":"Sponsor","anchor":"sponsor","markdown":"The person or company responsible for a therapeutic good in Australia: the one that imports, exports or manufactures it, or arranges for someone else to. A sponsor must be an Australian resident, or a company incorporated and doing business in Australia with a representative who lives here, so an overseas brand needs an Australian sponsor. At listing, the sponsor certifies that the medicine meets every condition of listing and holds the evidence for its claims, and it stays responsible for the medicine meeting every requirement.\n\nMore in our [TGA sponsor guide](/guides/tga-sponsor#who-can-be-a-sponsor).","text":"The person or company responsible for a therapeutic good in Australia: the one that imports, exports or manufactures it, or arranges for someone else to. A sponsor must be an Australian resident, or a company incorporated and doing business in Australia with a representative who lives here, so an overseas brand needs an Australian sponsor. At listing, the sponsor certifies that the medicine meets every condition of listing and holds the evidence for its claims, and it stays responsible for the medicine meeting every requirement. More in our TGA sponsor guide.","items":[],"tables":[]},{"heading":"Sports food","anchor":"sports-food","markdown":"*Formulated supplementary sports food*\n\nIn the Food Standards Code, \"a product that is specifically formulated to assist sports people in achieving specific nutritional or performance goals\". Standard 2.9.4 covers it, allows substances restricted or not permitted in other foods and, since 9 June 2026, permits up to 200 mg of caffeine in a day's amount. A sports supplement presented for a therapeutic use can be a declared medicine instead, for example when it comes as a tablet, capsule or pill.\n\nMore on [the food pathway](/pathways/foods#the-food-standards-that-matter).","text":"Formulated supplementary sports food In the Food Standards Code, \"a product that is specifically formulated to assist sports people in achieving specific nutritional or performance goals\". Standard 2.9.4 covers it, allows substances restricted or not permitted in other foods and, since 9 June 2026, permits up to 200 mg of caffeine in a day's amount. A sports supplement presented for a therapeutic use can be a declared medicine instead, for example when it comes as a tablet, capsule or pill. More on the food pathway.","items":[],"tables":[]},{"heading":"Stability testing","anchor":"stability-testing","markdown":"*Stability studies*\n\nThe studies that prove a product's shelf life: that it meets its specifications, stored as its label says, until its expiry date. Real-time studies store the product at its label's storage conditions, to at least the end of its shelf life; accelerated studies store it above the label's maximum temperature, to predict a shelf life from short-term results. For a listed medicine the ongoing program is mandatory and runs in real time, with at least one batch from each product group going on it each year.\n\nMore in our [stability testing guide](/guides/stability-testing#real-time-and-accelerated-studies).","text":"Stability studies The studies that prove a product's shelf life: that it meets its specifications, stored as its label says, until its expiry date. Real-time studies store the product at its label's storage conditions, to at least the end of its shelf life; accelerated studies store it above the label's maximum temperature, to predict a shelf life from short-term results. For a listed medicine the ongoing program is mandatory and runs in real time, with at least one batch from each product group going on it each year. More in our stability testing guide.","items":[],"tables":[]},{"heading":"Testimonial","anchor":"testimonial","markdown":"In the TGA's words, \"a statement about a therapeutic good made by a person who claims to have used that good personally\", or while caring for someone else. Advertising can't use one from anyone engaged in producing, marketing or supplying the goods, which includes influencers and anyone else paid or rewarded for it, and the advertiser must verify each one.\n\nMore in our [advertising guide](/guides/tga-advertising#testimonials-endorsements-and-influencers).","text":"In the TGA's words, \"a statement about a therapeutic good made by a person who claims to have used that good personally\", or while caring for someone else. Advertising can't use one from anyone engaged in producing, marketing or supplying the goods, which includes influencers and anyone else paid or rewarded for it, and the advertiser must verify each one. More in our advertising guide.","items":[],"tables":[]},{"heading":"TGA","anchor":"tga","markdown":"*Therapeutic Goods Administration*\n\nAustralia's regulator of therapeutic goods, which runs the Therapeutic Goods Act 1989. It keeps the ARTG, sets the lists a listed medicine's ingredients and indications come from, licenses and clears manufacturers, and can review a listed medicine at any time after it is listed.\n\nMore in our [TGA listing guide](/guides/tga-approval#approval-listing-or-registration).","text":"Therapeutic Goods Administration Australia's regulator of therapeutic goods, which runs the Therapeutic Goods Act 1989. It keeps the ARTG, sets the lists a listed medicine's ingredients and indications come from, licenses and clears manufacturers, and can review a listed medicine at any time after it is listed. More in our TGA listing guide.","items":[],"tables":[]},{"heading":"TGA assessed","anchor":"tga-assessed","markdown":"*TGA assessed claim*\n\nThe claim an assessed listed medicine, or a registered complementary medicine, can carry once the TGA authorises it: the statement \"Evidence for the approved indications has been assessed by the TGA.\", with or without the TGA assessed symbol, never the symbol alone. An ad can show it only on the label in a pack shot.\n\nMore in our [assessed listed medicines guide](/guides/assessed-listed-medicines#the-tga-assessed-claim).","text":"TGA assessed claim The claim an assessed listed medicine, or a registered complementary medicine, can carry once the TGA authorises it: the statement \"Evidence for the approved indications has been assessed by the TGA.\", with or without the TGA assessed symbol, never the symbol alone. An ad can show it only on the label in a pack shot. More in our assessed listed medicines guide.","items":[],"tables":[]},{"heading":"TGA Business Services","anchor":"tga-business-services","markdown":"Where a sponsor enters a medicine for listing. The Electronic Listing Facility validates it there, the sponsor submits, certifies and pays the application fee within 14 days, and once the medicine is on the ARTG its listing usually shows there the next day. A new sponsor first gets a Client ID through the TGA's organisation details form.\n\nMore in our [TGA listing guide](/guides/tga-approval#the-steps-to-an-aust-l-listing).","text":"Where a sponsor enters a medicine for listing. The Electronic Listing Facility validates it there, the sponsor submits, certifies and pays the application fee within 14 days, and once the medicine is on the ARTG its listing usually shows there the next day. A new sponsor first gets a Client ID through the TGA's organisation details form. More in our TGA listing guide.","items":[],"tables":[]},{"heading":"TGO 92","anchor":"tgo-92","markdown":"The labelling standard for non-prescription medicines, including listed medicines, until TGO 116 replaced it on 30 September 2026. A medicine released for supply before 1 October 2031 can still follow TGO 92, or a set mix of TGO 116 and TGO 92 provisions.\n\nMore in our [labelling guide](/guides/supplement-labelling#the-transition).","text":"The labelling standard for non-prescription medicines, including listed medicines, until TGO 116 replaced it on 30 September 2026. A medicine released for supply before 1 October 2031 can still follow TGO 92, or a set mix of TGO 116 and TGO 92 provisions. More in our labelling guide.","items":[],"tables":[]},{"heading":"TGO 95","anchor":"tgo-95","markdown":"*Therapeutic Goods Order No. 95 – Child-resistant packaging requirements for medicines 2017*\n\nThe standard that sets which medicines need child-resistant packaging, and the packaging standards it has to meet. For a listed medicine it covers the substances on its list, in the strengths or pack sizes it sets, such as iron when a pack holds more than 250 mg of elemental iron in total, and any medicine whose label or packaging says or implies it's child-resistant.\n\nMore on [gummies](/formats/gummies#the-label) and [liquids](/formats/liquids#making-a-liquid-as-a-medicine).","text":"Therapeutic Goods Order No. 95 – Child-resistant packaging requirements for medicines 2017 The standard that sets which medicines need child-resistant packaging, and the packaging standards it has to meet. For a listed medicine it covers the substances on its list, in the strengths or pack sizes it sets, such as iron when a pack holds more than 250 mg of elemental iron in total, and any medicine whose label or packaging says or implies it's child-resistant. More on gummies and liquids.","items":[],"tables":[]},{"heading":"TGO 100","anchor":"tgo-100","markdown":"*Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018*\n\nThe microbial standard for medicines. A non-sterile medicine has to meet set limits on the microbes it carries, and a water-based medicine in a multidose container also has to pass a pharmacopoeial test of how well its preservative works.\n\nMore on [liquids](/formats/liquids#making-a-liquid-as-a-medicine).","text":"Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018 The microbial standard for medicines. A non-sterile medicine has to meet set limits on the microbes it carries, and a water-based medicine in a multidose container also has to pass a pharmacopoeial test of how well its preservative works. More on liquids.","items":[],"tables":[]},{"heading":"TGO 101","anchor":"tgo-101","markdown":"*Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019*\n\nThe quality standard for tablets, capsules and pills, which TGA guidance says medicines must comply with \"throughout their shelf-lives\". Unless it follows a pharmacopoeial monograph, a listed tablet or capsule must assay at 90.0 to 120.0% of the amount on the label for most active ingredients; vitamins, minerals, enzymes and probiotics have their own limits.\n\nMore in our [stability testing guide](/guides/stability-testing#what-the-tga-expects).","text":"Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019 The quality standard for tablets, capsules and pills, which TGA guidance says medicines must comply with \"throughout their shelf-lives\". Unless it follows a pharmacopoeial monograph, a listed tablet or capsule must assay at 90.0 to 120.0% of the amount on the label for most active ingredients; vitamins, minerals, enzymes and probiotics have their own limits. More in our stability testing guide.","items":[],"tables":[]},{"heading":"TGO 116","anchor":"tgo-116","markdown":"*Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026*\n\nThe labelling standard for non-prescription medicines, including listed medicines, since 30 September 2026, when it replaced TGO 92. The transition runs to 1 October 2031, QR codes are allowed but can't replace what the label must say, and the Therapeutic Goods Advertising Code now refers to it.\n\nMore in our [labelling guide](/guides/supplement-labelling).","text":"Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026 The labelling standard for non-prescription medicines, including listed medicines, since 30 September 2026, when it replaced TGO 92. The transition runs to 1 October 2031, QR codes are allowed but can't replace what the label must say, and the Therapeutic Goods Advertising Code now refers to it. More in our labelling guide.","items":[],"tables":[]},{"heading":"Therapeutic good","anchor":"therapeutic-good","markdown":"A product that is presented as, or likely to be taken to be, for therapeutic use: preventing, curing or alleviating a disease, or \"influencing, inhibiting or modifying a physiological process\". The TGA weighs the name, the claims, the form, dosage instructions, warnings, the advertising and even where it is sold. Declared goods are therapeutic goods whatever else applies; excluded goods are not.\n\nMore on [how the line is drawn](/pathways#how-the-line-is-drawn).","text":"A product that is presented as, or likely to be taken to be, for therapeutic use: preventing, curing or alleviating a disease, or \"influencing, inhibiting or modifying a physiological process\". The TGA weighs the name, the claims, the form, dosage instructions, warnings, the advertising and even where it is sold. Declared goods are therapeutic goods whatever else applies; excluded goods are not. More on how the line is drawn.","items":[],"tables":[]},{"heading":"Therapeutic Goods Advertising Code","anchor":"therapeutic-goods-advertising-code","markdown":"*Advertising Code*\n\nThe rules for advertising therapeutic goods, where advertising includes the label. Advertising must be accurate and balanced, substantiated before it is published and not inconsistent with the indications on the ARTG; most medicine ads must carry \"ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE\", and none can use an endorsement from a current or former health practitioner, health professional or medical researcher. The Code doesn't apply to advertising directed only at health professionals.\n\nMore in our [advertising guide](/guides/tga-advertising#the-codes-core-rules).","text":"Advertising Code The rules for advertising therapeutic goods, where advertising includes the label. Advertising must be accurate and balanced, substantiated before it is published and not inconsistent with the indications on the ARTG; most medicine ads must carry \"ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE\", and none can use an endorsement from a current or former health practitioner, health professional or medical researcher. The Code doesn't apply to advertising directed only at health professionals. More in our advertising guide.","items":[],"tables":[]},{"heading":"Veterinary chemical product","anchor":"veterinary-chemical-product","markdown":"A product represented as suitable for, or supplied or used for, giving to an animal to prevent, diagnose, cure or alleviate a disease or condition, or to modify its physiology in the ways the Agvet Code lists, among other purposes. Unless it is excluded or exempt, the APVMA must register it before it is sold, a listed product through a simpler route; a pet food or feed that makes no therapeutic claim generally needs no registration.\n\nMore in our [pet supplements guide](/guides/pet-supplements#medicine-or-food-where-the-line-falls-for-animals).","text":"A product represented as suitable for, or supplied or used for, giving to an animal to prevent, diagnose, cure or alleviate a disease or condition, or to modify its physiology in the ways the Agvet Code lists, among other purposes. Unless it is excluded or exempt, the APVMA must register it before it is sold, a listed product through a simpler route; a pet food or feed that makes no therapeutic claim generally needs no registration. More in our pet supplements guide.","items":[],"tables":[]}],"faqs":[],"sources":{"note":"General information. Each definition comes from our guides, which were checked against these sources between 19 and 27 October 2026; the minimum order and the cost-of-goods rule of thumb are from Take Friday Off's records. It isn't advice on a particular product.","markdown":"General information. Each definition comes from our guides, which were checked against these sources between 19 and 27 October 2026; the minimum order and the cost-of-goods rule of thumb are from Take Friday Off's records. It isn't advice on a particular product.\n\n- [Therapeutic Goods Act 1989](https://www.legislation.gov.au/C2004A03952/latest/text), section 3 (definitions), section 7, section 9A and section 42AA, Federal Register of Legislation\n- [Advertising to health professionals so consumer rules do not apply](https://www.tga.gov.au/resources/guidance/advertising-health-professionals-so-consumer-rules-do-not-apply), Therapeutic Goods Administration\n- [Food and medicine regulation](https://www.tga.gov.au/community-qa/food-and-medicine-regulation) and the [Food-Medicine Interface Guidance Tool](https://www.tga.gov.au/node/287500), Therapeutic Goods Administration\n- [Therapeutic Goods (Declared Goods) Order 2019](https://www.legislation.gov.au/F2019L01352/latest/text) and [Therapeutic Goods (Excluded Goods) Determination 2018](https://www.legislation.gov.au/F2018L01350/latest/text), Federal Register of Legislation\n- [About the Australian Register of Therapeutic Goods (ARTG)](https://www.tga.gov.au/products/regulations-all-products/about-australian-register-therapeutic-goods-artg), [AUST numbers on medicine labels](https://www.tga.gov.au/products/medicines/labelling-and-advertising/medicines-and-biologicals-labelling-and-packaging/aust-numbers-medicine-labels) and [Listed, assessed listed and registered medicines](https://www.tga.gov.au/node/497532), Therapeutic Goods Administration\n- [About assessed listed medicines](https://www.tga.gov.au/products/medicines/assessed-listed-medicines/overview/about-assessed-listed-medicines), [Assessed listed medicines pathway for complementary medicines](https://tga.gov.au/sites/default/files/assessed-listed-medicines-factsheet.pdf) and [Guidelines for using the TGA assessed claim on medicine labels](https://www.tga.gov.au/sites/default/files/guidelines-using-tga-assessed-claim-medicine-labels.pdf), Therapeutic Goods Administration\n- [About listed medicines](https://www.tga.gov.au/node/520077), [The role of the sponsor](https://www.tga.gov.au/how-we-regulate/supply-therapeutic-good/overview-supplying-therapeutic-goods-australia/role-sponsor) and [General guidance for listed medicines](https://www.tga.gov.au/node/289506), Therapeutic Goods Administration\n- [Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026](https://www.legislation.gov.au/F2026L01382/asmade/versions) and [Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025](https://www.legislation.gov.au/F2025L00450/latest/versions), Federal Register of Legislation\n- [Permitted indications for listed medicines](https://www.tga.gov.au/products/medicines/listed-medicines/application-and-market-authorisation/permitted-indications-listed-medicines) and [Listed medicines evidence guidelines](https://www.tga.gov.au/resources/resource/guidance/evidence-guidelines), Therapeutic Goods Administration\n- [Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026](https://www.legislation.gov.au/F2026L01312/asmade) and [Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019](https://www.legislation.gov.au/F2019L00369/latest/text), Federal Register of Legislation\n- [Complying with quality standards for tablets, capsules and pills](https://www.tga.gov.au/sites/default/files/2025-05/complying-with-quality-standards-for-tablets-capsules-and-pills.pdf), Therapeutic Goods Administration, May 2025\n- [Manufacturing therapeutic goods](https://www.tga.gov.au/products/regulations-all-products/manufacturing) and [Export of medicines from Australia](https://www.tga.gov.au/sites/default/files/export-of-medicines-from-australia.pdf), Therapeutic Goods Administration, and [TGO 114, the standard for export only medicines](https://legislation.gov.au/F2024L01211/asmade/2024-09-25/text/original/pdf), Federal Register of Legislation\n- [Fees and charges: summary, from 1 July 2026](https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf) and [Annual charges](https://www.tga.gov.au/products/regulations-all-products/fees-and-payments/annual-charges), Therapeutic Goods Administration\n- [Stability requirements for listed medicines](https://www.tga.gov.au/stability-requirements-listed-medicines), [Performing ongoing stability testing](https://www.tga.gov.au/node/452227) and [Stability testing of listed complementary medicines](https://www.tga.gov.au/node/497429) (older guidance), Therapeutic Goods Administration\n- [Understanding listed medicines compliance reviews](https://www.tga.gov.au/resources/guidance/understanding-listed-medicines-compliance-reviews), Therapeutic Goods Administration\n- [Therapeutic Goods Advertising Code](https://www.legislation.gov.au/F2021L01661/latest/text), Federal Register of Legislation, and [Restricted and prohibited representations in advertising](https://www.tga.gov.au/node/288050) and [Testimonials and endorsements in advertising](https://www.tga.gov.au/node/491816), Therapeutic Goods Administration\n- [Application requirements for new substances in listed medicines](https://www.tga.gov.au/resources/resource/guidance/application-requirements-new-substances-listed-medicines), Therapeutic Goods Administration\n- [Australian Manufacturer search](https://www.tga.gov.au/resources/australian-manufacturer-search) and [Australian manufacturing licences and overseas GMP certification](https://www.tga.gov.au/sites/default/files/australian-manufacturing-licences-and-overseas-gmp-certification.pdf), version 2.2, December 2021, Therapeutic Goods Administration\n- [PIC/S Guide to Good Manufacturing Practice for Medicinal Products, Part I](https://picscheme.org/docview/11332), PE 009-18 (24 September 2026), whose Part I is unchanged from PE 009-17, the version adopted in Australia: Chapter 7 (outsourced activities), Pharmaceutical Inspection Co-operation Scheme, and [Ongoing stability testing for listed and complementary medicines](https://www.tga.gov.au/resources/resource/guidance/ongoing-stability-testing-listed-and-complementary-medicines), Therapeutic Goods Administration\n- [GMP clearance code tables guidance](https://www.tga.gov.au/sites/default/files/gmp-clearance-code-tables-guidance.pdf), [The PIC/S Guide to GMP, version 17](https://www.tga.gov.au/node/290180) and [Sanctions and penalties for non-compliant advertising](https://tga.gov.au/book-page/sanctions-and-penalties-non-compliant-advertising), Therapeutic Goods Administration\n- [How to obtain GMP clearance through inspection reliance](https://www.tga.gov.au/sites/default/files/2024-11/How-to-obtain-GMP-clearance-through-inspection-reliance.docx) and [International agreements and arrangements for GMP clearance](https://www.tga.gov.au/node/287685), Therapeutic Goods Administration\n- [Agricultural and Veterinary Chemicals Code](https://www.legislation.gov.au/C2004A04723/latest/text), section 5, Federal Register of Legislation, and [guidance on what needs registration](https://apvma.gov.au/node/10606) and [excluded nutritional or digestive products](https://apvma.gov.au/node/13021), Australian Pesticides and Veterinary Medicines Authority\n- [Cosmetics or therapeutic goods: guidance for advertisers and suppliers](https://www.tga.gov.au/sites/default/files/2024-06/cosmetics-therapeutic-goods-guidance-for-advertisers-suppliers.pdf), Therapeutic Goods Administration, June 2024, and [Sunscreen regulation in Australia](https://www.tga.gov.au/products/medicines/therapeutic-sunscreens/overview/sunscreen-regulation-australia), Therapeutic Goods Administration\n- [Standard 1.2.7: Nutrition, health and related claims](https://www.legislation.gov.au/F2015L00394/latest/text), [Standard 1.5.1: Novel foods](https://www.legislation.gov.au/F2015L00403/latest/text) and [Standard 2.9.4: Formulated supplementary sports foods](https://www.legislation.gov.au/F2015L00421/latest/text), Federal Register of Legislation\n- [What we do](https://www.foodstandards.gov.au/about-us/whatwedo), [Nutrition content claims and health claims](https://www.foodstandards.gov.au/consumer/labelling/nutrition), [Novel foods](https://www.foodstandards.gov.au/business/novel) and [Sports foods](https://www.foodstandards.gov.au/consumer/nutrition/sportfood), Food Standards Australia New Zealand\n- [Who we are and what we do](https://www.industrialchemicals.gov.au/about-us/who-we-are-and-what-we-do), [What is registration and who must register?](https://www.industrialchemicals.gov.au/business/getting-started-registration-importing-and-manufacturing/what-registration-and-who-must-register) and [Cosmetics and therapeutics](https://www.industrialchemicals.gov.au/cosmetics-and-soap/cosmetics-and-therapeutics), Australian Industrial Chemicals Introduction Scheme\n- [Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017](https://legislation.gov.au/F2017L01577/asmade/2017-12-04/text/original/pdf) and [Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018](https://www.legislation.gov.au/F2018L01685/latest/text), Federal Register of Legislation\n- [Australia New Zealand Food Standards Code – Schedule 17 – Vitamins and minerals](https://www.legislation.gov.au/F2015L00449/latest), section S17-4, Federal Register of Legislation\n- [Changing a listed or assessed listed medicine: application levels and change tables](https://tga.gov.au/sites/default/files/changing-listed-or-assessed-listed-medicine-application-levels-and-change-tables.pdf), version 2.2, March 2022, Therapeutic Goods Administration\n- [Cosmetics ingredients labelling mandatory standard](https://www.productsafety.gov.au/business/search-mandatory-standards/cosmetics-ingredients-labelling-mandatory-standard), ACCC Product Safety Australia","items":[{"text":"Therapeutic Goods Act 1989, section 3 (definitions), section 7, section 9A and section 42AA, Federal Register of Legislation","links":[{"title":"Therapeutic Goods Act 1989","url":"https://www.legislation.gov.au/C2004A03952/latest/text"}]},{"text":"Advertising to health professionals so consumer rules do not apply, Therapeutic Goods Administration","links":[{"title":"Advertising to health professionals so consumer rules do not apply","url":"https://www.tga.gov.au/resources/guidance/advertising-health-professionals-so-consumer-rules-do-not-apply"}]},{"text":"Food and medicine regulation and the Food-Medicine Interface Guidance Tool, Therapeutic Goods Administration","links":[{"title":"Food and medicine regulation","url":"https://www.tga.gov.au/community-qa/food-and-medicine-regulation"},{"title":"Food-Medicine Interface Guidance Tool","url":"https://www.tga.gov.au/node/287500"}]},{"text":"Therapeutic Goods (Declared Goods) Order 2019 and Therapeutic Goods (Excluded Goods) Determination 2018, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Declared Goods) Order 2019","url":"https://www.legislation.gov.au/F2019L01352/latest/text"},{"title":"Therapeutic Goods (Excluded Goods) Determination 2018","url":"https://www.legislation.gov.au/F2018L01350/latest/text"}]},{"text":"About the Australian Register of Therapeutic Goods (ARTG), AUST numbers on medicine labels and Listed, assessed listed and registered medicines, Therapeutic Goods Administration","links":[{"title":"About the Australian Register of Therapeutic Goods (ARTG)","url":"https://www.tga.gov.au/products/regulations-all-products/about-australian-register-therapeutic-goods-artg"},{"title":"AUST numbers on medicine labels","url":"https://www.tga.gov.au/products/medicines/labelling-and-advertising/medicines-and-biologicals-labelling-and-packaging/aust-numbers-medicine-labels"},{"title":"Listed, assessed listed and registered medicines","url":"https://www.tga.gov.au/node/497532"}]},{"text":"About assessed listed medicines, Assessed listed medicines pathway for complementary medicines and Guidelines for using the TGA assessed claim on medicine labels, Therapeutic Goods Administration","links":[{"title":"About assessed listed medicines","url":"https://www.tga.gov.au/products/medicines/assessed-listed-medicines/overview/about-assessed-listed-medicines"},{"title":"Assessed listed medicines pathway for complementary medicines","url":"https://tga.gov.au/sites/default/files/assessed-listed-medicines-factsheet.pdf"},{"title":"Guidelines for using the TGA assessed claim on medicine labels","url":"https://www.tga.gov.au/sites/default/files/guidelines-using-tga-assessed-claim-medicine-labels.pdf"}]},{"text":"About listed medicines, The role of the sponsor and General guidance for listed medicines, Therapeutic Goods Administration","links":[{"title":"About listed medicines","url":"https://www.tga.gov.au/node/520077"},{"title":"The role of the sponsor","url":"https://www.tga.gov.au/how-we-regulate/supply-therapeutic-good/overview-supplying-therapeutic-goods-australia/role-sponsor"},{"title":"General guidance for listed medicines","url":"https://www.tga.gov.au/node/289506"}]},{"text":"Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026 and Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026","url":"https://www.legislation.gov.au/F2026L01382/asmade/versions"},{"title":"Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025","url":"https://www.legislation.gov.au/F2025L00450/latest/versions"}]},{"text":"Permitted indications for listed medicines and Listed medicines evidence guidelines, Therapeutic Goods Administration","links":[{"title":"Permitted indications for listed medicines","url":"https://www.tga.gov.au/products/medicines/listed-medicines/application-and-market-authorisation/permitted-indications-listed-medicines"},{"title":"Listed medicines evidence guidelines","url":"https://www.tga.gov.au/resources/resource/guidance/evidence-guidelines"}]},{"text":"Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026 and Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026","url":"https://www.legislation.gov.au/F2026L01312/asmade"},{"title":"Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019","url":"https://www.legislation.gov.au/F2019L00369/latest/text"}]},{"text":"Complying with quality standards for tablets, capsules and pills, Therapeutic Goods Administration, May 2025","links":[{"title":"Complying with quality standards for tablets, capsules and pills","url":"https://www.tga.gov.au/sites/default/files/2025-05/complying-with-quality-standards-for-tablets-capsules-and-pills.pdf"}]},{"text":"Manufacturing therapeutic goods and Export of medicines from Australia, Therapeutic Goods Administration, and TGO 114, the standard for export only medicines, Federal Register of Legislation","links":[{"title":"Manufacturing therapeutic goods","url":"https://www.tga.gov.au/products/regulations-all-products/manufacturing"},{"title":"Export of medicines from Australia","url":"https://www.tga.gov.au/sites/default/files/export-of-medicines-from-australia.pdf"},{"title":"TGO 114, the standard for export only medicines","url":"https://legislation.gov.au/F2024L01211/asmade/2024-09-25/text/original/pdf"}]},{"text":"Fees and charges: summary, from 1 July 2026 and Annual charges, Therapeutic Goods Administration","links":[{"title":"Fees and charges: summary, from 1 July 2026","url":"https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf"},{"title":"Annual charges","url":"https://www.tga.gov.au/products/regulations-all-products/fees-and-payments/annual-charges"}]},{"text":"Stability requirements for listed medicines, Performing ongoing stability testing and Stability testing of listed complementary medicines (older guidance), Therapeutic Goods Administration","links":[{"title":"Stability requirements for listed medicines","url":"https://www.tga.gov.au/stability-requirements-listed-medicines"},{"title":"Performing ongoing stability testing","url":"https://www.tga.gov.au/node/452227"},{"title":"Stability testing of listed complementary medicines","url":"https://www.tga.gov.au/node/497429"}]},{"text":"Understanding listed medicines compliance reviews, Therapeutic Goods Administration","links":[{"title":"Understanding listed medicines compliance reviews","url":"https://www.tga.gov.au/resources/guidance/understanding-listed-medicines-compliance-reviews"}]},{"text":"Therapeutic Goods Advertising Code, Federal Register of Legislation, and Restricted and prohibited representations in advertising and Testimonials and endorsements in advertising, Therapeutic Goods Administration","links":[{"title":"Therapeutic Goods Advertising Code","url":"https://www.legislation.gov.au/F2021L01661/latest/text"},{"title":"Restricted and prohibited representations in advertising","url":"https://www.tga.gov.au/node/288050"},{"title":"Testimonials and endorsements in advertising","url":"https://www.tga.gov.au/node/491816"}]},{"text":"Application requirements for new substances in listed medicines, Therapeutic Goods Administration","links":[{"title":"Application requirements for new substances in listed medicines","url":"https://www.tga.gov.au/resources/resource/guidance/application-requirements-new-substances-listed-medicines"}]},{"text":"Australian Manufacturer search and Australian manufacturing licences and overseas GMP certification, version 2.2, December 2021, Therapeutic Goods Administration","links":[{"title":"Australian Manufacturer search","url":"https://www.tga.gov.au/resources/australian-manufacturer-search"},{"title":"Australian manufacturing licences and overseas GMP certification","url":"https://www.tga.gov.au/sites/default/files/australian-manufacturing-licences-and-overseas-gmp-certification.pdf"}]},{"text":"PIC/S Guide to Good Manufacturing Practice for Medicinal Products, Part I, PE 009-18 (24 September 2026), whose Part I is unchanged from PE 009-17, the version adopted in Australia: Chapter 7 (outsourced activities), Pharmaceutical Inspection Co-operation Scheme, and Ongoing stability testing for listed and complementary medicines, Therapeutic Goods Administration","links":[{"title":"PIC/S Guide to Good Manufacturing Practice for Medicinal Products, Part I","url":"https://picscheme.org/docview/11332"},{"title":"Ongoing stability testing for listed and complementary medicines","url":"https://www.tga.gov.au/resources/resource/guidance/ongoing-stability-testing-listed-and-complementary-medicines"}]},{"text":"GMP clearance code tables guidance, The PIC/S Guide to GMP, version 17 and Sanctions and penalties for non-compliant advertising, Therapeutic Goods Administration","links":[{"title":"GMP clearance code tables guidance","url":"https://www.tga.gov.au/sites/default/files/gmp-clearance-code-tables-guidance.pdf"},{"title":"The PIC/S Guide to GMP, version 17","url":"https://www.tga.gov.au/node/290180"},{"title":"Sanctions and penalties for non-compliant advertising","url":"https://tga.gov.au/book-page/sanctions-and-penalties-non-compliant-advertising"}]},{"text":"How to obtain GMP clearance through inspection reliance and International agreements and arrangements for GMP clearance, Therapeutic Goods Administration","links":[{"title":"How to obtain GMP clearance through inspection reliance","url":"https://www.tga.gov.au/sites/default/files/2024-11/How-to-obtain-GMP-clearance-through-inspection-reliance.docx"},{"title":"International agreements and arrangements for GMP clearance","url":"https://www.tga.gov.au/node/287685"}]},{"text":"Agricultural and Veterinary Chemicals Code, section 5, Federal Register of Legislation, and guidance on what needs registration and excluded nutritional or digestive products, Australian Pesticides and Veterinary Medicines Authority","links":[{"title":"Agricultural and Veterinary Chemicals Code","url":"https://www.legislation.gov.au/C2004A04723/latest/text"},{"title":"guidance on what needs registration","url":"https://apvma.gov.au/node/10606"},{"title":"excluded nutritional or digestive products","url":"https://apvma.gov.au/node/13021"}]},{"text":"Cosmetics or therapeutic goods: guidance for advertisers and suppliers, Therapeutic Goods Administration, June 2024, and Sunscreen regulation in Australia, Therapeutic Goods Administration","links":[{"title":"Cosmetics or therapeutic goods: guidance for advertisers and suppliers","url":"https://www.tga.gov.au/sites/default/files/2024-06/cosmetics-therapeutic-goods-guidance-for-advertisers-suppliers.pdf"},{"title":"Sunscreen regulation in Australia","url":"https://www.tga.gov.au/products/medicines/therapeutic-sunscreens/overview/sunscreen-regulation-australia"}]},{"text":"Standard 1.2.7: Nutrition, health and related claims, Standard 1.5.1: Novel foods and Standard 2.9.4: Formulated supplementary sports foods, Federal Register of Legislation","links":[{"title":"Standard 1.2.7: Nutrition, health and related claims","url":"https://www.legislation.gov.au/F2015L00394/latest/text"},{"title":"Standard 1.5.1: Novel foods","url":"https://www.legislation.gov.au/F2015L00403/latest/text"},{"title":"Standard 2.9.4: Formulated supplementary sports foods","url":"https://www.legislation.gov.au/F2015L00421/latest/text"}]},{"text":"What we do, Nutrition content claims and health claims, Novel foods and Sports foods, Food Standards Australia New Zealand","links":[{"title":"What we do","url":"https://www.foodstandards.gov.au/about-us/whatwedo"},{"title":"Nutrition content claims and health claims","url":"https://www.foodstandards.gov.au/consumer/labelling/nutrition"},{"title":"Novel foods","url":"https://www.foodstandards.gov.au/business/novel"},{"title":"Sports foods","url":"https://www.foodstandards.gov.au/consumer/nutrition/sportfood"}]},{"text":"Who we are and what we do, What is registration and who must register? and Cosmetics and therapeutics, Australian Industrial Chemicals Introduction Scheme","links":[{"title":"Who we are and what we do","url":"https://www.industrialchemicals.gov.au/about-us/who-we-are-and-what-we-do"},{"title":"What is registration and who must register?","url":"https://www.industrialchemicals.gov.au/business/getting-started-registration-importing-and-manufacturing/what-registration-and-who-must-register"},{"title":"Cosmetics and therapeutics","url":"https://www.industrialchemicals.gov.au/cosmetics-and-soap/cosmetics-and-therapeutics"}]},{"text":"Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017 and Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018, Federal Register of Legislation","links":[{"title":"Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017","url":"https://legislation.gov.au/F2017L01577/asmade/2017-12-04/text/original/pdf"},{"title":"Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018","url":"https://www.legislation.gov.au/F2018L01685/latest/text"}]},{"text":"Australia New Zealand Food Standards Code – Schedule 17 – Vitamins and minerals, section S17-4, Federal Register of Legislation","links":[{"title":"Australia New Zealand Food Standards Code – Schedule 17 – Vitamins and minerals","url":"https://www.legislation.gov.au/F2015L00449/latest"}]},{"text":"Changing a listed or assessed listed medicine: application levels and change tables, version 2.2, March 2022, Therapeutic Goods Administration","links":[{"title":"Changing a listed or assessed listed medicine: application levels and change tables","url":"https://tga.gov.au/sites/default/files/changing-listed-or-assessed-listed-medicine-application-levels-and-change-tables.pdf"}]},{"text":"Cosmetics ingredients labelling mandatory standard, ACCC Product Safety Australia","links":[{"title":"Cosmetics ingredients labelling mandatory standard","url":"https://www.productsafety.gov.au/business/search-mandatory-standards/cosmetics-ingredients-labelling-mandatory-standard"}]}]}},{"slug":"sleep-and-stress-supplement-development","kind":"guide","url":"/guides/sleep-and-stress-supplement-development","title":"Sleep and stress supplements: developing one in Australia","name":"Sleep and stress guide","description":"Sleep and stress supplement formulation in Australia: the claims a listed medicine can make, melatonin and ashwagandha rules, and the products in our records.","eyebrow":"Guide","lead":"Sleep and stress products are some of the most searched-for supplements, and some of the most crowded. The ones that last are built on clinically studied ingredients at the doses studied, with claims the TGA permits and a label that tells people how to take them safely. This guide covers what a sleep or stress supplement can claim, why melatonin isn't an option for a supplement sold off the shelf, what the TGA has said about ashwagandha, and the products we've built, including a KSM-66® capsule that went from design to production order in 32 days.","parent":"/product-development","studies":["ashwagandha-capsule-32-days","everleanbody-saffron-capsule","ora-practitioner-natural-medicine"],"formats":[],"order":92,"updated":"2026-10-29","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- Most sleep and stress supplements are TGA-listed medicines. Their claims come from the Permissible Indications Determination, whose tables are grouped by body system, with a Part for the nervous system (Part 8).\n- No claim may imply the product treats a serious form of a disease, ailment, defect or injury. A condition that needs a health professional to diagnose or treat stays off the label.\n- Melatonin is a Schedule 4 (prescription) medicine in Australia, apart from one Schedule 3 entry for 2 mg modified-release tablets for short-term use in adults 55 and over. It isn't an ingredient for a supplement sold off the shelf.\n- The TGA has warned of a possible, very rare risk of liver injury with medicines containing Withania somnifera (ashwagandha), and advises people who have or have had liver problems to avoid them.\n- From our records: a complex herbal capsule built around KSM-66® ashwagandha, design to production order in 32 days; EverLeanBody's capsule on affron® saffron with L-theanine and lemon balm; and Ora's sleep, stress and recovery range.","text":"Most sleep and stress supplements are TGA-listed medicines. Their claims come from the Permissible Indications Determination, whose tables are grouped by body system, with a Part for the nervous system (Part 8). No claim may imply the product treats a serious form of a disease, ailment, defect or injury. A condition that needs a health professional to diagnose or treat stays off the label. Melatonin is a Schedule 4 (prescription) medicine in Australia, apart from one Schedule 3 entry for 2 mg modified-release tablets for short-term use in adults 55 and over. It isn't an ingredient for a supplement sold off the shelf. The TGA has warned of a possible, very rare risk of liver injury with medicines containing Withania somnifera (ashwagandha), and advises people who have or have had liver problems to avoid them. From our records: a complex herbal capsule built around KSM-66® ashwagandha, design to production order in 32 days; EverLeanBody's capsule on affron® saffron with L-theanine and lemon balm; and Ora's sleep, stress and recovery range.","items":[],"tables":[]},{"heading":"The claims a sleep or stress product can make","anchor":"the-claims-a-sleep-or-stress-product-can-make","markdown":"A listed medicine can only carry indications from the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025. Its tables are grouped by body system, and nervous system indications sit in Part 8. Indications can be qualified by population, time of use or tradition, and the evidence for each one is held by the sponsor ([permitted indications](/guides/permitted-indications)).\n\nA label can reword or combine indications without changing their meaning, but it can't imply that the product treats a serious form of a disease, ailment, defect or injury, or that it prevents or cures one. \"Serious\" takes its meaning from section 28 of the Therapeutic Goods Advertising Code: a form that needs a health professional to diagnose, follow up or treat. A claim that refers to one is a restricted representation, which needs the TGA's prior approval ([TGA advertising](/guides/tga-advertising)).","text":"A listed medicine can only carry indications from the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025. Its tables are grouped by body system, and nervous system indications sit in Part 8. Indications can be qualified by population, time of use or tradition, and the evidence for each one is held by the sponsor (permitted indications). A label can reword or combine indications without changing their meaning, but it can't imply that the product treats a serious form of a disease, ailment, defect or injury, or that it prevents or cures one. \"Serious\" takes its meaning from section 28 of the Therapeutic Goods Advertising Code: a form that needs a health professional to diagnose, follow up or treat. A claim that refers to one is a restricted representation, which needs the TGA's prior approval (TGA advertising).","items":[],"tables":[]},{"heading":"Why melatonin isn't in supplements here","anchor":"why-melatonin-isnt-in-supplements-here","markdown":"In Australia, melatonin for human use is a Schedule 4 (prescription) medicine. The only exception is a Schedule 3 (pharmacist only) entry, in effect since 1 June 2021: modified-release tablets containing 2 mg or less of melatonin, on its own, for the short-term treatment of primary insomnia characterised by poor quality of sleep in adults aged 55 or over, in packs of no more than 30 tablets. Anything outside that entry stays in Schedule 4. So a sleep product sold as a supplement is built on other ingredients.","text":"In Australia, melatonin for human use is a Schedule 4 (prescription) medicine. The only exception is a Schedule 3 (pharmacist only) entry, in effect since 1 June 2021: modified-release tablets containing 2 mg or less of melatonin, on its own, for the short-term treatment of primary insomnia characterised by poor quality of sleep in adults aged 55 or over, in packs of no more than 30 tablets. Anything outside that entry stays in Schedule 4. So a sleep product sold as a supplement is built on other ingredients.","items":[],"tables":[]},{"heading":"What the TGA has said about ashwagandha","anchor":"what-the-tga-has-said-about-ashwagandha","markdown":"Ashwagandha (Withania somnifera) is one of the most used ingredients in stress products, including our own work. The TGA issued a safety advisory in 2024 about a possible risk of liver injury with medicines containing it. In its update, the TGA said it had received four further adverse event reports suggesting possible liver injury since that advisory, all of which resolved after the product was stopped, none needing hospital.\n\nThe TGA's advice to consumers is to be aware of possible gastrointestinal side effects and, in very rare cases, the possible risk of liver injury; to stop taking the product and seek medical advice if symptoms such as yellowing of the skin or eyes, dark urine, nausea, vomiting, unusual tiredness, weakness, abdominal pain or loss of appetite appear; and for people who have or have had liver problems to avoid medicines and herbal supplements containing it.\n\nFor a brand, that means checking the current conditions on the ingredient in the Permissible Ingredients Determination at the brief ([permissible ingredients](/guides/permissible-ingredients)), choosing a well-characterised extract with studies at the dose used, and keeping the TGA's safety information in view when writing the label and the marketing.","text":"Ashwagandha (Withania somnifera) is one of the most used ingredients in stress products, including our own work. The TGA issued a safety advisory in 2024 about a possible risk of liver injury with medicines containing it. In its update, the TGA said it had received four further adverse event reports suggesting possible liver injury since that advisory, all of which resolved after the product was stopped, none needing hospital. The TGA's advice to consumers is to be aware of possible gastrointestinal side effects and, in very rare cases, the possible risk of liver injury; to stop taking the product and seek medical advice if symptoms such as yellowing of the skin or eyes, dark urine, nausea, vomiting, unusual tiredness, weakness, abdominal pain or loss of appetite appear; and for people who have or have had liver problems to avoid medicines and herbal supplements containing it. For a brand, that means checking the current conditions on the ingredient in the Permissible Ingredients Determination at the brief (permissible ingredients), choosing a well-characterised extract with studies at the dose used, and keeping the TGA's safety information in view when writing the label and the marketing.","items":[],"tables":[]},{"heading":"Building on clinically studied ingredients","anchor":"building-on-clinically-studied-ingredients","markdown":"Branded extracts with their own clinical studies are common in this category: KSM-66® ashwagandha and affron® saffron are two in our records. A branded ingredient can carry much of a product's evidence, if its studies match the product's dose, form and population ([branded ingredients](/guides/branded-ingredients)). A formula with many ingredients needs evidence behind each: the 32-day capsule's evidence package covered more than 13.","text":"Branded extracts with their own clinical studies are common in this category: KSM-66® ashwagandha and affron® saffron are two in our records. A branded ingredient can carry much of a product's evidence, if its studies match the product's dose, form and population (branded ingredients). A formula with many ingredients needs evidence behind each: the 32-day capsule's evidence package covered more than 13.","items":[],"tables":[]},{"heading":"From our records","anchor":"from-our-records","markdown":"- [A KSM-66® ashwagandha capsule in 32 days](/work/ashwagandha-capsule-32-days): a complex herbal formula for a founder-led start-up, built around KSM-66®, a clinically studied ashwagandha extract, on a tight timeline. The formula, an evidence package covering more than 13 ingredients, the TGA listing and a long-term stability program. Design to production order in 32 days.\n- [EverLeanBody](/work/everleanbody-saffron-capsule): a four-ingredient daily capsule for women 35 and over, built around affron®, a clinically studied saffron extract, with L-theanine, lemon balm and active-form B vitamins. 5.8 months from signed brief to dispatch.\n- [Ora](/work/ora-practitioner-natural-medicine): our founder's own brand, with a sleep, stress and recovery range among around 19 products built on ingredients including affron® and KSM-66®.","text":"A KSM-66® ashwagandha capsule in 32 days: a complex herbal formula for a founder-led start-up, built around KSM-66®, a clinically studied ashwagandha extract, on a tight timeline. The formula, an evidence package covering more than 13 ingredients, the TGA listing and a long-term stability program. Design to production order in 32 days. EverLeanBody: a four-ingredient daily capsule for women 35 and over, built around affron®, a clinically studied saffron extract, with L-theanine, lemon balm and active-form B vitamins. 5.8 months from signed brief to dispatch. Ora: our founder's own brand, with a sleep, stress and recovery range among around 19 products built on ingredients including affron® and KSM-66®.","items":[],"tables":[]}],"faqs":[{"q":"Can a supplement contain melatonin in Australia?","a":"Not one sold as a supplement off the shelf. Melatonin is a Schedule 4 (prescription) medicine, with one Schedule 3 entry for 2 mg modified-release tablets for short-term use in adults 55 and over, in packs of no more than 30.","md":"Not one sold as a supplement off the shelf. Melatonin is a Schedule 4 (prescription) medicine, with one Schedule 3 entry for 2 mg modified-release tablets for short-term use in adults 55 and over, in packs of no more than 30."},{"q":"Is ashwagandha still allowed in listed medicines?","a":"Yes: the 32-day capsule in our records, built on KSM-66® ashwagandha, is a TGA-listed medicine. The TGA has also issued safety information about a possible, very rare risk of liver injury. We check the ingredient's current conditions in the Permissible Ingredients Determination at the brief, and the TGA's latest safety information, before it goes into a formula.","md":"Yes: the 32-day capsule in our records, built on KSM-66® ashwagandha, is a TGA-listed medicine. The TGA has also issued safety information about a possible, very rare risk of liver injury. We check the ingredient's current conditions in the Permissible Ingredients Determination at the brief, and the TGA's latest safety information, before it goes into a formula."},{"q":"Can my label say it helps with anxiety or insomnia?","a":"Only within the permitted indications, worded so they don't imply treatment of a serious form of a condition. A claim about a condition that needs a health professional to diagnose or treat is a restricted representation, which needs the TGA's approval.","md":"Only within the permitted indications, worded so they don't imply treatment of a serious form of a condition. A claim about a condition that needs a health professional to diagnose or treat is a restricted representation, which needs the TGA's approval."},{"q":"How fast can a stress supplement be developed?","a":"A complex herbal capsule on KSM-66® went from design to production order in 32 days. Most take longer: see how long it takes to develop a supplement.","md":"A complex herbal capsule on KSM-66® went from design to production order in 32 days. Most take longer: see [how long it takes to develop a supplement](/guides/supplement-development-timeline)."}],"sources":{"note":"General information, checked against these sources between 26 and 29 October 2026. It isn't advice on a particular product. Our work is from Take Friday Off's records.","markdown":"General information, checked against these sources between 26 and 29 October 2026. It isn't advice on a particular product. Our work is from Take Friday Off's records.\n\n- [Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025](https://www.legislation.gov.au/F2025L00450/latest/versions) and its [explanatory statement](https://www.legislation.gov.au/F2025L00450/asmade/2025-04-02/es/original/pdf), Federal Register of Legislation\n- [Notice of final decision to amend the current Poisons Standard in relation to melatonin](https://www.tga.gov.au/resources/publication/scheduling-decisions-final/notice-final-decision-amend-current-poisons-standard-relation-melatonin), Therapeutic Goods Administration\n- [Medicines containing Withania somnifera (withania, ashwagandha)](https://www.tga.gov.au/node/565835), Therapeutic Goods Administration\n- [Restricted and prohibited representations in advertising](https://www.tga.gov.au/node/288050), Therapeutic Goods Administration\n- [Listed medicines evidence guidelines](https://www.tga.gov.au/sites/default/files/evidence-guidelines.pdf), version 4.0, June 2022, Therapeutic Goods Administration","items":[{"text":"Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025 and its explanatory statement, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025","url":"https://www.legislation.gov.au/F2025L00450/latest/versions"},{"title":"explanatory statement","url":"https://www.legislation.gov.au/F2025L00450/asmade/2025-04-02/es/original/pdf"}]},{"text":"Notice of final decision to amend the current Poisons Standard in relation to melatonin, Therapeutic Goods Administration","links":[{"title":"Notice of final decision to amend the current Poisons Standard in relation to melatonin","url":"https://www.tga.gov.au/resources/publication/scheduling-decisions-final/notice-final-decision-amend-current-poisons-standard-relation-melatonin"}]},{"text":"Medicines containing Withania somnifera (withania, ashwagandha), Therapeutic Goods Administration","links":[{"title":"Medicines containing Withania somnifera (withania, ashwagandha)","url":"https://www.tga.gov.au/node/565835"}]},{"text":"Restricted and prohibited representations in advertising, Therapeutic Goods Administration","links":[{"title":"Restricted and prohibited representations in advertising","url":"https://www.tga.gov.au/node/288050"}]},{"text":"Listed medicines evidence guidelines, version 4.0, June 2022, Therapeutic Goods Administration","links":[{"title":"Listed medicines evidence guidelines","url":"https://www.tga.gov.au/sites/default/files/evidence-guidelines.pdf"}]}]}},{"slug":"eye-health-supplement-development","kind":"guide","url":"/guides/eye-health-supplement-development","title":"Eye health supplements: AREDS2 formulas and how to build one","name":"Eye health guide","description":"Eye health supplement formulation in Australia: what the AREDS2 study used and found, the eye indications a listed medicine can carry, and our AREDS2 work.","eyebrow":"Guide","lead":"Eye health supplements are built on one of the best-known nutrition trials there is: the Age-Related Eye Disease Studies, AREDS and AREDS2, run by the US National Eye Institute. Building a product around them takes care at both ends. The formula has to match what the studies used, and the claims have to stay within what a listed medicine can say about the eyes, a long way short of treating eye disease. This guide covers what the studies used and found, the eye indications the TGA permits, the formulation problems these products run into, and two eye-health products from our records.","parent":"/product-development","studies":["areds2-eye-health-formula","eye-health-tablet-format-rescue"],"formats":[],"order":93,"updated":"2026-10-29","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- The AREDS2 formula, as the National Eye Institute sets it out: vitamin C 500 mg, vitamin E 400 IU, lutein 10 mg, zeaxanthin 2 mg, zinc 80 mg and copper (as cupric oxide) 2 mg. The original AREDS formula used beta-carotene 15 mg in place of lutein and zeaxanthin.\n- The NEI says the formulas benefited people with intermediate or late age-related macular degeneration (AMD), with no benefit for people with early AMD or without AMD, and that \"Nutritional supplements cannot prevent AMD.\"\n- A listed medicine's eye claims come from the Permissible Indications Determination, which includes indications such as \"Maintain/support eye health\" and \"Helps maintain/support eye macula health\". It can't claim to treat, prevent or cure AMD.\n- The formulation is demanding: high doses of several nutrients, carotenoids that need protecting, and a mix that may not behave in a capsule.\n- From our records: a TGA-listed AREDS2-level formula, design to production order in under seven weeks, reordered a year later; and an eye-health formula moved from capsule to tablet when it wouldn't encapsulate.","text":"The AREDS2 formula, as the National Eye Institute sets it out: vitamin C 500 mg, vitamin E 400 IU, lutein 10 mg, zeaxanthin 2 mg, zinc 80 mg and copper (as cupric oxide) 2 mg. The original AREDS formula used beta-carotene 15 mg in place of lutein and zeaxanthin. The NEI says the formulas benefited people with intermediate or late age-related macular degeneration (AMD), with no benefit for people with early AMD or without AMD, and that \"Nutritional supplements cannot prevent AMD.\" A listed medicine's eye claims come from the Permissible Indications Determination, which includes indications such as \"Maintain/support eye health\" and \"Helps maintain/support eye macula health\". It can't claim to treat, prevent or cure AMD. The formulation is demanding: high doses of several nutrients, carotenoids that need protecting, and a mix that may not behave in a capsule. From our records: a TGA-listed AREDS2-level formula, design to production order in under seven weeks, reordered a year later; and an eye-health formula moved from capsule to tablet when it wouldn't encapsulate.","items":[],"tables":[]},{"heading":"What the AREDS and AREDS2 studies used","anchor":"what-the-areds-and-areds2-studies-used","markdown":"The National Eye Institute's AREDS/AREDS2 frequently asked questions set out the two formulas:\n\n| Nutrient | AREDS | AREDS2 |\n| --- | --- | --- |\n| Vitamin C | 500 mg | 500 mg |\n| Vitamin E | 400 IU | 400 IU |\n| Beta-carotene | 15 mg | none |\n| Lutein | none | 10 mg |\n| Zeaxanthin | none | 2 mg |\n| Zinc | 80 mg | 80 mg |\n| Copper (cupric oxide) | 2 mg | 2 mg |\n\nAREDS2 replaced beta-carotene with lutein and zeaxanthin. The NEI explains why: among former smokers in AREDS2, lung cancer was found in 2% of those taking beta-carotene against 0.9% of those not taking it, while lutein and zeaxanthin \"have not been associated with increased cancer risk\". The NEI says the original AREDS formula is \"Not recommended for current or former smokers.\"\n\nAREDS2 also tested adding omega-3 fatty acids, which had no additional overall effect on the risk of advanced AMD, and a lower zinc dose. With no placebo group in AREDS2, participants were assigned to 80 mg or a modified formula such as 25 mg zinc, and investigators found no difference between the two doses.","text":"The National Eye Institute's AREDS/AREDS2 frequently asked questions set out the two formulas: Nutrient: Vitamin C; AREDS: 500 mg; AREDS2: 500 mg. Nutrient: Vitamin E; AREDS: 400 IU; AREDS2: 400 IU. Nutrient: Beta-carotene; AREDS: 15 mg; AREDS2: none. Nutrient: Lutein; AREDS: none; AREDS2: 10 mg. Nutrient: Zeaxanthin; AREDS: none; AREDS2: 2 mg. Nutrient: Zinc; AREDS: 80 mg; AREDS2: 80 mg. Nutrient: Copper (cupric oxide); AREDS: 2 mg; AREDS2: 2 mg. AREDS2 replaced beta-carotene with lutein and zeaxanthin. The NEI explains why: among former smokers in AREDS2, lung cancer was found in 2% of those taking beta-carotene against 0.9% of those not taking it, while lutein and zeaxanthin \"have not been associated with increased cancer risk\". The NEI says the original AREDS formula is \"Not recommended for current or former smokers.\" AREDS2 also tested adding omega-3 fatty acids, which had no additional overall effect on the risk of advanced AMD, and a lower zinc dose. With no placebo group in AREDS2, participants were assigned to 80 mg or a modified formula such as 25 mg zinc, and investigators found no difference between the two doses.","items":[],"tables":[{"header":["Nutrient","AREDS","AREDS2"],"rows":[["Vitamin C","500 mg","500 mg"],["Vitamin E","400 IU","400 IU"],["Beta-carotene","15 mg","none"],["Lutein","none","10 mg"],["Zeaxanthin","none","2 mg"],["Zinc","80 mg","80 mg"],["Copper (cupric oxide)","2 mg","2 mg"]]}]},{"heading":"What the studies found, and what they didn't","anchor":"what-the-studies-found-and-what-they-didnt","markdown":"As the NEI puts it, the formulas benefited people with intermediate or late AMD, with \"no benefit for people with early AMD or for people who do not have AMD\". AREDS reduced the risk of advanced AMD by about 25% over five years. In AREDS2, the formula with lutein and zeaxanthin in place of beta-carotene was linked to an 18% lower risk of progressing to advanced AMD than the original formula. The NEI is clear that \"Nutritional supplements cannot prevent AMD\", and that the formulas had no effect on cataract.\n\nThese are the study's findings, about a disease that an eye-care professional diagnoses and manages. They aren't claims a supplement can make for itself.","text":"As the NEI puts it, the formulas benefited people with intermediate or late AMD, with \"no benefit for people with early AMD or for people who do not have AMD\". AREDS reduced the risk of advanced AMD by about 25% over five years. In AREDS2, the formula with lutein and zeaxanthin in place of beta-carotene was linked to an 18% lower risk of progressing to advanced AMD than the original formula. The NEI is clear that \"Nutritional supplements cannot prevent AMD\", and that the formulas had no effect on cataract. These are the study's findings, about a disease that an eye-care professional diagnoses and manages. They aren't claims a supplement can make for itself.","items":[],"tables":[]},{"heading":"The claims a listed eye-health product can make","anchor":"the-claims-a-listed-eye-health-product-can-make","markdown":"A listed medicine can only carry indications from the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025. Among its eye indications are:\n\n- \"Maintain/support eye health\"\n- \"Helps maintain/support eye macula health\"\n- \"Helps maintain/support eye retina health\"\n- \"Maintain/support healthy eyesight/vision\"\n- \"Maintain/support healthy eye function\"\n- \"Decrease/reduce/relieve eye strain\"\n- \"Aids/assists eye adaption to variations in light intensity/night vision\"\n\nThe sponsor holds the evidence for each one, and the label can't imply the product treats a serious form of a disease, or prevents or cures one ([permitted indications](/guides/permitted-indications)). So a claim that the product treats, slows or prevents AMD falls outside what a listed medicine can say, and a claim that refers to a serious form of a disease is a restricted representation, which needs the TGA's approval. How a brand refers to the studies in its marketing is an advertising question, covered in our [TGA advertising guide](/guides/tga-advertising).","text":"A listed medicine can only carry indications from the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025. Among its eye indications are: \"Maintain/support eye health\" \"Helps maintain/support eye macula health\" \"Helps maintain/support eye retina health\" \"Maintain/support healthy eyesight/vision\" \"Maintain/support healthy eye function\" \"Decrease/reduce/relieve eye strain\" \"Aids/assists eye adaption to variations in light intensity/night vision\" The sponsor holds the evidence for each one, and the label can't imply the product treats a serious form of a disease, or prevents or cures one (permitted indications). So a claim that the product treats, slows or prevents AMD falls outside what a listed medicine can say, and a claim that refers to a serious form of a disease is a restricted representation, which needs the TGA's approval. How a brand refers to the studies in its marketing is an advertising question, covered in our TGA advertising guide.","items":[],"tables":[]},{"heading":"Formulating an eye-health product","anchor":"formulating-an-eye-health-product","markdown":"- **Dose and form.** The formula follows the doses the studies used, and each ingredient's form and dose must fit the conditions in the Permissible Ingredients Determination ([permissible ingredients](/guides/permissible-ingredients)). In our AREDS2 work, the formula was updated to the AREDS2 vitamin E level before it was built.\n- **The format.** One eye-health formula in our records kept failing in encapsulation because the ingredient mix was too wet, and hand-filling would have added one to two months. We moved it to a direct-compression tablet ([capsules, tablets and softgels](/formats/capsules-tablets-softgels)).\n- **Stability.** The shelf life rests on stability data for the product in its pack. The tablet's stability protocol was designed to support a three-year expiry, and the AREDS2 formula has a 24-month stability program ([stability testing](/guides/stability-testing)).\n- **Packs.** The AREDS2 formula ships in a 60-count pack and a trial pack, both made in each run ([sample and trial packs](/guides/supplement-sample-packs)).","text":"Dose and form. The formula follows the doses the studies used, and each ingredient's form and dose must fit the conditions in the Permissible Ingredients Determination (permissible ingredients). In our AREDS2 work, the formula was updated to the AREDS2 vitamin E level before it was built. The format. One eye-health formula in our records kept failing in encapsulation because the ingredient mix was too wet, and hand-filling would have added one to two months. We moved it to a direct-compression tablet (capsules, tablets and softgels). Stability. The shelf life rests on stability data for the product in its pack. The tablet's stability protocol was designed to support a three-year expiry, and the AREDS2 formula has a 24-month stability program (stability testing). Packs. The AREDS2 formula ships in a 60-count pack and a trial pack, both made in each run (sample and trial packs).","items":[{"lead":"Dose and form.","text":"The formula follows the doses the studies used, and each ingredient's form and dose must fit the conditions in the Permissible Ingredients Determination (permissible ingredients). In our AREDS2 work, the formula was updated to the AREDS2 vitamin E level before it was built."},{"lead":"The format.","text":"One eye-health formula in our records kept failing in encapsulation because the ingredient mix was too wet, and hand-filling would have added one to two months. We moved it to a direct-compression tablet (capsules, tablets and softgels)."},{"lead":"Stability.","text":"The shelf life rests on stability data for the product in its pack. The tablet's stability protocol was designed to support a three-year expiry, and the AREDS2 formula has a 24-month stability program (stability testing)."},{"lead":"Packs.","text":"The AREDS2 formula ships in a 60-count pack and a trial pack, both made in each run (sample and trial packs)."}],"tables":[]},{"heading":"From our records","anchor":"from-our-records","markdown":"- [An AREDS2 eye-health formula](/work/areds2-eye-health-formula): a premium formula for an established Australian health brand, built on the AREDS2 nutrient levels, with vitamin E brought to the AREDS2 level before build. A 60-count pack and a trial pack, a certification to reach more customers, and a 24-month stability program. Design to production order in under seven weeks, reordered a year later with the certification renewed.\n- [An eye-health tablet rescued from encapsulation](/work/eye-health-tablet-format-rescue): an established natural health company's formula moved to a direct-compression tablet, with a stability protocol for a three-year expiry. Shipped in 2024. Across the relationship we developed and quoted nine products, and a fish oil and a krill oil capsule are also in production.","text":"An AREDS2 eye-health formula: a premium formula for an established Australian health brand, built on the AREDS2 nutrient levels, with vitamin E brought to the AREDS2 level before build. A 60-count pack and a trial pack, a certification to reach more customers, and a 24-month stability program. Design to production order in under seven weeks, reordered a year later with the certification renewed. An eye-health tablet rescued from encapsulation: an established natural health company's formula moved to a direct-compression tablet, with a stability protocol for a three-year expiry. Shipped in 2024. Across the relationship we developed and quoted nine products, and a fish oil and a krill oil capsule are also in production.","items":[],"tables":[]}],"faqs":[{"q":"What is in an AREDS2 supplement?","a":"The National Eye Institute lists vitamin C 500 mg, vitamin E 400 IU, lutein 10 mg, zeaxanthin 2 mg, zinc 80 mg and copper (as cupric oxide) 2 mg.","md":"The National Eye Institute lists vitamin C 500 mg, vitamin E 400 IU, lutein 10 mg, zeaxanthin 2 mg, zinc 80 mg and copper (as cupric oxide) 2 mg."},{"q":"Can an eye supplement claim to prevent macular degeneration?","a":"No. A listed medicine can't claim to prevent or cure a disease, and the NEI itself says \"Nutritional supplements cannot prevent AMD.\" Eye claims come from the permitted indications, such as \"Maintain/support eye health\".","md":"No. A listed medicine can't claim to prevent or cure a disease, and the NEI itself says \"Nutritional supplements cannot prevent AMD.\" Eye claims come from the permitted indications, such as \"Maintain/support eye health\"."},{"q":"Should the formula include omega-3s?","a":"In AREDS2, adding omega-3 fatty acids had no additional overall effect on the risk of advanced AMD. Whether to include them is a product decision, made with the evidence for the claims the product will carry.","md":"In AREDS2, adding omega-3 fatty acids had no additional overall effect on the risk of advanced AMD. Whether to include them is a product decision, made with the evidence for the claims the product will carry."},{"q":"Can an eye-health formula be a capsule?","a":"It can, but the mix doesn't always cooperate. One formula in our records was too wet to encapsulate reliably, so we moved it to a direct-compression tablet.","md":"It can, but the mix doesn't always cooperate. One formula in our records was too wet to encapsulate reliably, so we moved it to a direct-compression tablet."}],"sources":{"note":"General information, checked against these sources between 26 and 29 October 2026. It isn't advice on a particular product. Our work is from Take Friday Off's records.","markdown":"General information, checked against these sources between 26 and 29 October 2026. It isn't advice on a particular product. Our work is from Take Friday Off's records.\n\n- [AREDS/AREDS2 frequently asked questions](https://www.nei.nih.gov/eye-health-information/clinical-trials/age-related-eye-disease-studies-aredsareds2/aredsareds2-frequently-asked-questions), National Eye Institute, last updated 19 November 2020\n- [Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025](https://www.legislation.gov.au/F2025L00450/asmade/2025-04-02/text/original/pdf), Schedule 1, Part 1, and its [explanatory statement](https://www.legislation.gov.au/F2025L00450/asmade/2025-04-02/es/original/pdf), Federal Register of Legislation\n- [Restricted and prohibited representations in advertising](https://www.tga.gov.au/node/288050), Therapeutic Goods Administration\n- [Listed medicines evidence guidelines](https://www.tga.gov.au/sites/default/files/evidence-guidelines.pdf), version 4.0, June 2022, Therapeutic Goods Administration","items":[{"text":"AREDS/AREDS2 frequently asked questions, National Eye Institute, last updated 19 November 2020","links":[{"title":"AREDS/AREDS2 frequently asked questions","url":"https://www.nei.nih.gov/eye-health-information/clinical-trials/age-related-eye-disease-studies-aredsareds2/aredsareds2-frequently-asked-questions"}]},{"text":"Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025, Schedule 1, Part 1, and its explanatory statement, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025","url":"https://www.legislation.gov.au/F2025L00450/asmade/2025-04-02/text/original/pdf"},{"title":"explanatory statement","url":"https://www.legislation.gov.au/F2025L00450/asmade/2025-04-02/es/original/pdf"}]},{"text":"Restricted and prohibited representations in advertising, Therapeutic Goods Administration","links":[{"title":"Restricted and prohibited representations in advertising","url":"https://www.tga.gov.au/node/288050"}]},{"text":"Listed medicines evidence guidelines, version 4.0, June 2022, Therapeutic Goods Administration","links":[{"title":"Listed medicines evidence guidelines","url":"https://www.tga.gov.au/sites/default/files/evidence-guidelines.pdf"}]}]}},{"slug":"press","kind":"page","url":"/press","title":"Take Friday Off in the press: coverage and press kit","name":"Press","description":"Take Friday Off and founder Gabriel Perera in the press, the topics Gabriel comments on, and the press kit: bio, company facts, headshots and logos.","eyebrow":"Press","lead":"Take Friday Off and its founder, Gabriel Perera, have been covered by NutraIngredients on Australia's supplement rules and on Ora's launch. This page lists that coverage, the topics Gabriel can comment on, and a press kit with his bio, the company's facts, headshots and logos.","studies":[],"formats":[],"order":95,"updated":"2026-10-29","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- **Coverage:** NutraIngredients on CBD supplements in Australia (September 2020), the TGA's ingredient listing rules (December 2020) and the launch of Ora (December 2021).\n- **Press kit:** Gabriel's bio in three lengths, the company's facts, five headshots, the logo and the \"Developed with Take Friday Off\" badges, in one download.\n- **Media contact:** Gabriel Perera, hello@takefridayoff.com.","text":"Coverage: NutraIngredients on CBD supplements in Australia (September 2020), the TGA's ingredient listing rules (December 2020) and the launch of Ora (December 2021). Press kit: Gabriel's bio in three lengths, the company's facts, five headshots, the logo and the \"Developed with Take Friday Off\" badges, in one download. Media contact: Gabriel Perera, hello@takefridayoff.com.","items":[{"lead":"Coverage:","text":"NutraIngredients on CBD supplements in Australia (September 2020), the TGA's ingredient listing rules (December 2020) and the launch of Ora (December 2021)."},{"lead":"Press kit:","text":"Gabriel's bio in three lengths, the company's facts, five headshots, the logo and the \"Developed with Take Friday Off\" badges, in one download."},{"lead":"Media contact:","text":"Gabriel Perera, hello@takefridayoff.com."}],"tables":[]},{"heading":"Coverage","anchor":"coverage","markdown":"- [Opportunity or a barrier? CBD supplements for general sale unlikely to go on shelves in Australia soon](https://www.nutraingredients.com/Article/2020/09/21/Opportunity-or-a-barrier-CBD-supplements-for-general-sale-unlikely-to-go-on-shelves-in-Australia-soon/), NutraIngredients, 21 September 2020\n- [Concerns Australia's new ingredient listing rules could cause negative impact for innovative raw material suppliers](https://www.nutraingredients.com/Article/2020/12/08/Concerns-Australia-s-new-ingredient-listing-rules-could-cause-negative-impact-for-innovative-raw-material-suppliers/), NutraIngredients, 8 December 2020\n- [Low to no excipients: New Aussie brand Ora tackles market gaps with organic and vegan offerings](https://www.nutraingredients.com/Article/2021/12/01/Low-to-no-excipients-New-Aussie-brand-Ora-tackles-market-gaps-with-organic-and-vegan-offerings/), NutraIngredients, 1 December 2021\n\nOur own note on the 2020 interview: [our four-pronged approach to the TGA's requirements](/notes/sharing-our-four-pronged-approach-to-tgas-requirements-with-nutraingredients-asia).","text":"Opportunity or a barrier? CBD supplements for general sale unlikely to go on shelves in Australia soon, NutraIngredients, 21 September 2020 Concerns Australia's new ingredient listing rules could cause negative impact for innovative raw material suppliers, NutraIngredients, 8 December 2020 Low to no excipients: New Aussie brand Ora tackles market gaps with organic and vegan offerings, NutraIngredients, 1 December 2021 Our own note on the 2020 interview: our four-pronged approach to the TGA's requirements.","items":[],"tables":[]},{"heading":"What Gabriel comments on","anchor":"what-gabriel-comments-on","markdown":"- Taking a supplement from idea to a TGA-listed product: the pathway, the evidence, the label and the timeline ([TGA approval](/guides/tga-approval))\n- Labels under TGO 116, and what changed from TGO 92 ([supplement labelling](/guides/supplement-labelling))\n- The Therapeutic Goods Advertising Code, influencers and claims ([TGA advertising](/guides/tga-advertising))\n- What a supplement costs to develop, and designing a formula to its retail price ([development cost](/guides/supplement-development-cost))\n- Building and selling a wellness brand, from Ora and Nectar of the Dogs","text":"Taking a supplement from idea to a TGA-listed product: the pathway, the evidence, the label and the timeline (TGA approval) Labels under TGO 116, and what changed from TGO 92 (supplement labelling) The Therapeutic Goods Advertising Code, influencers and claims (TGA advertising) What a supplement costs to develop, and designing a formula to its retail price (development cost) Building and selling a wellness brand, from Ora and Nectar of the Dogs","items":[],"tables":[]},{"heading":"Press kit","anchor":"press-kit","markdown":"- [The full kit](/press-kit/take-friday-off-press-kit.zip): bio, company facts, headshots, logos and badges, in one download\n- [Gabriel's bio](/press-kit/gabriel-perera-bio.txt): one line, about 75 words and about 160 words\n- [Company facts](/press-kit/take-friday-off-company.txt): what we do, the figures from our records, and how to get in touch\n\nPhotographs: please credit \"Take Friday Off\". Wherever \"Take Friday Off\" appears online, please link it to https://takefridayoff.com/.","text":"The full kit: bio, company facts, headshots, logos and badges, in one download Gabriel's bio: one line, about 75 words and about 160 words Company facts: what we do, the figures from our records, and how to get in touch Photographs: please credit \"Take Friday Off\". Wherever \"Take Friday Off\" appears online, please link it to https://takefridayoff.com/.","items":[],"tables":[]},{"heading":"Media contact","anchor":"media-contact","markdown":"Gabriel Perera, Founder and Managing Partner: hello@takefridayoff.com. We reply within one business day.","text":"Gabriel Perera, Founder and Managing Partner: hello@takefridayoff.com. We reply within one business day.","items":[],"tables":[]}],"faqs":[],"sources":null},{"slug":"omega-3-supplement-development","kind":"guide","url":"/guides/omega-3-supplement-development","title":"Omega-3 and fish oil supplements: how to build one","name":"Omega-3 guide","description":"Fish oil supplement manufacturer guide for Australia: the TGA rules for omega-3 fish oil, the heart and brain claims, softgels, stability and our records.","eyebrow":"Guide","lead":"Fish oil and other omega-3 products are among the most familiar supplements on the shelf. Building one well still takes care: the oil has to meet its quality standard, the claims have to stay within the TGA's permitted list, and an oil that oxidises needs a format and a stability program that protect it. This guide covers the ingredient rules, the claims a listed omega-3 product can make, softgels and stability, and the omega-3 products in our records.","parent":"/product-development","studies":["eye-health-tablet-format-rescue","bwellness-practitioner-range","ora-practitioner-natural-medicine"],"formats":[],"order":96,"updated":"2026-11-01","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- Most omega-3 supplements in Australia are TGA-listed medicines. Every ingredient must be in the Permissible Ingredients Determination, and the claims must come from the Permissible Indications Determination.\n- The Determination lists \"Fish oil - rich in omega-3 acids\" as an active ingredient, \"Only for use in oral medicines.\"\n- An ingredient also has to meet its quality standard. Where a default standard applies, such as a European or British Pharmacopoeia monograph, it comes first. A TGA compositional guideline isn't a legal requirement, but the TGA says an ingredient that doesn't meet it may raise safety concerns.\n- Heart and brain claims are available, such as \"Maintain/support heart health\" and \"Maintain/support brain health\", but the product can't imply or refer to serious cardiovascular conditions or mental illnesses.\n- From our records: a fish oil and a krill oil capsule in production for an established natural health company, with the fish oil reordered, and an algal omega-3 capsule built on life's®OMEGA for BWellness.","text":"Most omega-3 supplements in Australia are TGA-listed medicines. Every ingredient must be in the Permissible Ingredients Determination, and the claims must come from the Permissible Indications Determination. The Determination lists \"Fish oil - rich in omega-3 acids\" as an active ingredient, \"Only for use in oral medicines.\" An ingredient also has to meet its quality standard. Where a default standard applies, such as a European or British Pharmacopoeia monograph, it comes first. A TGA compositional guideline isn't a legal requirement, but the TGA says an ingredient that doesn't meet it may raise safety concerns. Heart and brain claims are available, such as \"Maintain/support heart health\" and \"Maintain/support brain health\", but the product can't imply or refer to serious cardiovascular conditions or mental illnesses. From our records: a fish oil and a krill oil capsule in production for an established natural health company, with the fish oil reordered, and an algal omega-3 capsule built on life's®OMEGA for BWellness.","items":[],"tables":[]},{"heading":"The ingredient rules","anchor":"the-ingredient-rules","markdown":"A listed medicine can only contain ingredients in the Therapeutic Goods (Permissible Ingredients) Determination, in the roles it allows and within any limits it sets ([permissible ingredients](/guides/permissible-ingredients)). The current Determination, (No. 3) 2026, has an entry for \"FISH OIL - RICH IN OMEGA-3 ACIDS\". It can be used as an active ingredient, with one requirement: \"Only for use in oral medicines.\"\n\nEach oil in the formula needs its own check. Krill oil, an algal oil and a fish liver oil are different ingredients, and some entries carry conditions of their own. The entry for halibut-liver oil, for example, makes vitamin D and vitamin A mandatory components, caps vitamin D at 25 micrograms a day and requires vitamin A warnings above a set level. We check the entry for every oil and every other ingredient before the formula is fixed.","text":"A listed medicine can only contain ingredients in the Therapeutic Goods (Permissible Ingredients) Determination, in the roles it allows and within any limits it sets (permissible ingredients). The current Determination, (No. 3) 2026, has an entry for \"FISH OIL - RICH IN OMEGA-3 ACIDS\". It can be used as an active ingredient, with one requirement: \"Only for use in oral medicines.\" Each oil in the formula needs its own check. Krill oil, an algal oil and a fish liver oil are different ingredients, and some entries carry conditions of their own. The entry for halibut-liver oil, for example, makes vitamin D and vitamin A mandatory components, caps vitamin D at 25 micrograms a day and requires vitamin A warnings above a set level. We check the entry for every oil and every other ingredient before the formula is fixed.","items":[],"tables":[]},{"heading":"Quality standards for the oil","anchor":"quality-standards-for-the-oil","markdown":"The Determination says what can go in. The quality of the oil itself is set by standards:\n\n- **Default standards come first.** The British Pharmacopoeia, the United States Pharmacopeia-National Formulary and the European Pharmacopoeia are default standards under the Therapeutic Goods Act 1989. If one applies to the ingredient, the ingredient must comply with it.\n- **Compositional guidelines fill gaps.** Where no default standard applies, the TGA may publish a compositional guideline: in its words, \"a summary of descriptions, tests and acceptance criteria\" for the ingredient. The TGA says \"compliance with the compositional guideline is not a legal requirement\", but using an ingredient that doesn't meet it may raise safety concerns.\n\nIn practice, the supplier's specification and certificate of analysis for each batch of oil are checked against the standard that applies before the oil is used.","text":"The Determination says what can go in. The quality of the oil itself is set by standards: Default standards come first. The British Pharmacopoeia, the United States Pharmacopeia-National Formulary and the European Pharmacopoeia are default standards under the Therapeutic Goods Act 1989. If one applies to the ingredient, the ingredient must comply with it. Compositional guidelines fill gaps. Where no default standard applies, the TGA may publish a compositional guideline: in its words, \"a summary of descriptions, tests and acceptance criteria\" for the ingredient. The TGA says \"compliance with the compositional guideline is not a legal requirement\", but using an ingredient that doesn't meet it may raise safety concerns. In practice, the supplier's specification and certificate of analysis for each batch of oil are checked against the standard that applies before the oil is used.","items":[{"lead":"Default standards come first.","text":"The British Pharmacopoeia, the United States Pharmacopeia-National Formulary and the European Pharmacopoeia are default standards under the Therapeutic Goods Act 1989. If one applies to the ingredient, the ingredient must comply with it."},{"lead":"Compositional guidelines fill gaps.","text":"Where no default standard applies, the TGA may publish a compositional guideline: in its words, \"a summary of descriptions, tests and acceptance criteria\" for the ingredient. The TGA says \"compliance with the compositional guideline is not a legal requirement\", but using an ingredient that doesn't meet it may raise safety concerns."}],"tables":[]},{"heading":"The claims an omega-3 product can make","anchor":"the-claims-an-omega-3-product-can-make","markdown":"A listed medicine can only carry indications from the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025, and the sponsor holds the evidence for each one ([permitted indications](/guides/permitted-indications)). There are no omega-3 claims as such. The claims are about the body, and the ones most used for omega-3 products sit in Part 3 (cardiovascular system) and Part 8 (nervous system):\n\n| Indication | Evidence | Requirement |\n| --- | --- | --- |\n| Maintain/support heart health | Scientific or traditional | Must not imply or refer to serious cardiovascular conditions |\n| Maintain/support cardiovascular system health | Scientific or traditional | Must not imply or refer to serious cardiovascular conditions |\n| Helps in the maintenance of healthy blood lipids/blood fats | Scientific only | Must not imply or refer to lowering blood lipids, blood fats and triglycerides |\n| Helps maintain/support healthy cholesterol | Scientific only | Must not imply or refer to lowering or raising blood cholesterol levels from outside the normal healthy range |\n| Maintain/support brain health | Scientific or traditional | Must not imply or refer to mental illnesses, disorders or conditions |\n| Maintain/support brain function | Scientific or traditional | Must not imply or refer to mental illnesses, disorders or conditions |\n\nThe wording of an indication can be varied on the label, but the varied wording must not change its meaning or intent, imply a serious form of a disease, or imply that the medicine prevents or cures a disease. So \"lowers your triglycerides\" or \"protects against heart disease\" is outside what a listed omega-3 product can say. Advertising has to stay within the claims on the ARTG too ([TGA advertising](/guides/tga-advertising)).","text":"A listed medicine can only carry indications from the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025, and the sponsor holds the evidence for each one (permitted indications). There are no omega-3 claims as such. The claims are about the body, and the ones most used for omega-3 products sit in Part 3 (cardiovascular system) and Part 8 (nervous system): Indication: Maintain/support heart health; Evidence: Scientific or traditional; Requirement: Must not imply or refer to serious cardiovascular conditions. Indication: Maintain/support cardiovascular system health; Evidence: Scientific or traditional; Requirement: Must not imply or refer to serious cardiovascular conditions. Indication: Helps in the maintenance of healthy blood lipids/blood fats; Evidence: Scientific only; Requirement: Must not imply or refer to lowering blood lipids, blood fats and triglycerides. Indication: Helps maintain/support healthy cholesterol; Evidence: Scientific only; Requirement: Must not imply or refer to lowering or raising blood cholesterol levels from outside the normal healthy range. Indication: Maintain/support brain health; Evidence: Scientific or traditional; Requirement: Must not imply or refer to mental illnesses, disorders or conditions. Indication: Maintain/support brain function; Evidence: Scientific or traditional; Requirement: Must not imply or refer to mental illnesses, disorders or conditions. The wording of an indication can be varied on the label, but the varied wording must not change its meaning or intent, imply a serious form of a disease, or imply that the medicine prevents or cures a disease. So \"lowers your triglycerides\" or \"protects against heart disease\" is outside what a listed omega-3 product can say. Advertising has to stay within the claims on the ARTG too (TGA advertising).","items":[],"tables":[{"header":["Indication","Evidence","Requirement"],"rows":[["Maintain/support heart health","Scientific or traditional","Must not imply or refer to serious cardiovascular conditions"],["Maintain/support cardiovascular system health","Scientific or traditional","Must not imply or refer to serious cardiovascular conditions"],["Helps in the maintenance of healthy blood lipids/blood fats","Scientific only","Must not imply or refer to lowering blood lipids, blood fats and triglycerides"],["Helps maintain/support healthy cholesterol","Scientific only","Must not imply or refer to lowering or raising blood cholesterol levels from outside the normal healthy range"],["Maintain/support brain health","Scientific or traditional","Must not imply or refer to mental illnesses, disorders or conditions"],["Maintain/support brain function","Scientific or traditional","Must not imply or refer to mental illnesses, disorders or conditions"]]}]},{"heading":"Softgels, capsules and vegan options","anchor":"softgels-capsules-and-vegan-options","markdown":"- **Oils go in softgels.** Fish oil and krill oil are built as softgel capsules. We make bovine and fish gelatin, vegan, chewable and enteric-coated softgels ([capsules, tablets and softgels](/formats/capsules-tablets-softgels)).\n- **Vegan omega-3.** An algal oil gives a plant-based omega-3. In our records, BWellness's omega-3 capsule is built on life's®OMEGA, with VitaShine™ vegan vitamin D3.\n- **Branded oils.** A branded ingredient brings its supplier's research and specification, and the claims still have to fit the permitted list ([branded ingredients](/guides/branded-ingredients)).","text":"Oils go in softgels. Fish oil and krill oil are built as softgel capsules. We make bovine and fish gelatin, vegan, chewable and enteric-coated softgels (capsules, tablets and softgels). Vegan omega-3. An algal oil gives a plant-based omega-3. In our records, BWellness's omega-3 capsule is built on life's®OMEGA, with VitaShine™ vegan vitamin D3. Branded oils. A branded ingredient brings its supplier's research and specification, and the claims still have to fit the permitted list (branded ingredients).","items":[{"lead":"Oils go in softgels.","text":"Fish oil and krill oil are built as softgel capsules. We make bovine and fish gelatin, vegan, chewable and enteric-coated softgels (capsules, tablets and softgels)."},{"lead":"Vegan omega-3.","text":"An algal oil gives a plant-based omega-3. In our records, BWellness's omega-3 capsule is built on life's®OMEGA, with VitaShine™ vegan vitamin D3."},{"lead":"Branded oils.","text":"A branded ingredient brings its supplier's research and specification, and the claims still have to fit the permitted list (branded ingredients)."}],"tables":[]},{"heading":"Stability and the label","anchor":"stability-and-the-label","markdown":"- **Oxidation.** Oils oxidise, and the stability program has to cover it. The shelf life rests on stability data for the product in its final pack ([stability testing](/guides/stability-testing)).\n- **Declared substances.** Under TGO 116, the label declares the Schedule 1 substances the medicine contains, for the routes and thresholds Schedule 1 sets. Fish, crustacea and molluscs are among them, so a marine oil product's label is checked against the schedule ([supplement labelling](/guides/supplement-labelling)).","text":"Oxidation. Oils oxidise, and the stability program has to cover it. The shelf life rests on stability data for the product in its final pack (stability testing). Declared substances. Under TGO 116, the label declares the Schedule 1 substances the medicine contains, for the routes and thresholds Schedule 1 sets. Fish, crustacea and molluscs are among them, so a marine oil product's label is checked against the schedule (supplement labelling).","items":[{"lead":"Oxidation.","text":"Oils oxidise, and the stability program has to cover it. The shelf life rests on stability data for the product in its final pack (stability testing)."},{"lead":"Declared substances.","text":"Under TGO 116, the label declares the Schedule 1 substances the medicine contains, for the routes and thresholds Schedule 1 sets. Fish, crustacea and molluscs are among them, so a marine oil product's label is checked against the schedule (supplement labelling)."}],"tables":[]},{"heading":"From our records","anchor":"from-our-records","markdown":"- [A format rescue, then a range](/work/eye-health-tablet-format-rescue): for an established Australian natural health company, we developed and quoted nine products, spanning eye health, omega-3s, probiotics and more, and took three into production. A fish oil and a krill oil capsule are in production, with the fish oil reordered.\n- [BWellness](/work/bwellness-practitioner-range): nine products for a practitioner-channel brand, including an algal omega-3 capsule built on life's®OMEGA with VitaShine™ vegan vitamin D3.\n- [Ora](/work/ora-practitioner-natural-medicine): our founder's own practitioner brand, with around 19 products built on clinically studied ingredients, life's®OMEGA among them.","text":"A format rescue, then a range: for an established Australian natural health company, we developed and quoted nine products, spanning eye health, omega-3s, probiotics and more, and took three into production. A fish oil and a krill oil capsule are in production, with the fish oil reordered. BWellness: nine products for a practitioner-channel brand, including an algal omega-3 capsule built on life's®OMEGA with VitaShine™ vegan vitamin D3. Ora: our founder's own practitioner brand, with around 19 products built on clinically studied ingredients, life's®OMEGA among them.","items":[],"tables":[]}],"faqs":[{"q":"Is a fish oil supplement a medicine in Australia?","a":"In most cases. A fish oil capsule sold with a health claim is usually a TGA-listed medicine (AUST L), so its ingredients come from the Permissible Ingredients Determination and its claims from the permitted list.","md":"In most cases. A fish oil capsule sold with a health claim is usually a TGA-listed medicine (AUST L), so its ingredients come from the Permissible Ingredients Determination and its claims from the permitted list."},{"q":"Can a fish oil supplement claim to lower cholesterol or triglycerides?","a":"No. The blood lipid and cholesterol indications require that the product doesn't imply or refer to lowering blood lipids, triglycerides or cholesterol. Claims such as \"Maintain/support heart health\" are available, with scientific or traditional evidence.","md":"No. The blood lipid and cholesterol indications require that the product doesn't imply or refer to lowering blood lipids, triglycerides or cholesterol. Claims such as \"Maintain/support heart health\" are available, with scientific or traditional evidence."},{"q":"Can you make a vegan omega-3?","a":"Yes. An algal oil in a vegan softgel or capsule gives a plant-based omega-3. BWellness's omega-3 capsule is built on life's®OMEGA, an algal omega-3.","md":"Yes. An algal oil in a vegan softgel or capsule gives a plant-based omega-3. BWellness's omega-3 capsule is built on life's®OMEGA, an algal omega-3."},{"q":"What format suits fish oil?","a":"A softgel. Fish oil and krill oil are built as softgels, sealed in a shell, with a stability program that covers oxidation.","md":"A softgel. Fish oil and krill oil are built as softgels, sealed in a shell, with a stability program that covers oxidation."}],"sources":{"note":"General information, checked against these sources on 1 November 2026. It isn't advice on a particular product. Our work is from Take Friday Off's records.","markdown":"General information, checked against these sources on 1 November 2026. It isn't advice on a particular product. Our work is from Take Friday Off's records.\n\n- [Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026](https://www.legislation.gov.au/F2026L01382), Schedule 1, items 2228 (fish oil - rich in omega-3 acids) and 2483 (halibut-liver oil), Federal Register of Legislation\n- [Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025](https://www.legislation.gov.au/F2025L00450/asmade/2025-04-02/text/original/epub/OEBPS/document_1/document_1.html), section 6 and Schedule 1, Parts 3 and 8, Federal Register of Legislation\n- [Overview of compositional guidelines and templates](https://www.tga.gov.au/resources/resource/guidance/overview-compositional-guidelines-and-templates), Therapeutic Goods Administration\n- [Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026](https://www.legislation.gov.au/F2026L01312/asmade), Schedule 1, Federal Register of Legislation, as summarised in our [labelling guide](/guides/supplement-labelling)","items":[{"text":"Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026, Schedule 1, items 2228 (fish oil - rich in omega-3 acids) and 2483 (halibut-liver oil), Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026","url":"https://www.legislation.gov.au/F2026L01382"}]},{"text":"Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025, section 6 and Schedule 1, Parts 3 and 8, Federal Register of Legislation","links":[{"title":"Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025","url":"https://www.legislation.gov.au/F2025L00450/asmade/2025-04-02/text/original/epub/OEBPS/document_1/document_1.html"}]},{"text":"Overview of compositional guidelines and templates, Therapeutic Goods Administration","links":[{"title":"Overview of compositional guidelines and templates","url":"https://www.tga.gov.au/resources/resource/guidance/overview-compositional-guidelines-and-templates"}]},{"text":"Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026, Schedule 1, Federal Register of Legislation, as summarised in our labelling guide","links":[{"title":"Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026","url":"https://www.legislation.gov.au/F2026L01312/asmade"},{"title":"labelling guide","url":"/guides/supplement-labelling"}]}]}},{"slug":"hair-growth-supplement-development","kind":"guide","url":"/guides/hair-growth-supplement-development","title":"Hair growth supplements: the rules and how to build one","name":"Hair growth guide","description":"Hair growth supplement manufacturer guide for Australia: why a hair supplement is a TGA-listed medicine, the hair claims it can make, and our hair ranges.","eyebrow":"Guide","lead":"A hair supplement taken by mouth is a medicine by law in Australia, not a food. That shapes everything about building one: the ingredients come from the TGA's permitted list, the hair claims come from the permitted indications, and the ads are held to the Advertising Code. This guide covers why a hair supplement is a medicine, the hair claims a listed medicine can make, a matching topical, formulation and packaging, and two hair ranges from our records.","parent":"/product-development","studies":["pump-haircare-hair-supplement","vitable-hair-growth-range"],"formats":[],"order":97,"updated":"2026-11-01","author":"Take Friday Off","approved":true,"sections":[{"heading":"In short","anchor":"in-short","markdown":"- A product taken by mouth and labelled or promoted for a cosmetic purpose, such as the look of hair, is declared a therapeutic good. It can't be sold as a food or a cosmetic, and it is usually a TGA-listed medicine.\n- The Permissible Indications Determination has hair claims, such as \"Maintain/support hair growth\", \"Maintain/support hair strength/thickness\" and \"Aid/assist/help/maintain healthy hair follicles\", with scientific or traditional evidence.\n- \"Decrease/reduce hair loss/thinning\" needs the label statement \"If symptoms persist, talk to your health professional.\", and the product can't imply or refer to serious conditions associated with alopecia.\n- A matching serum can be a cosmetic, but a claim to promote hair growth will likely make a topical product a therapeutic good unless it is excluded.\n- From our records: Pump Haircare's TGA-listed hair growth capsules, reordered since 2021 and upgraded with a full new listing package in 2026; and Vitable's hair capsule on a clinically studied Biota orientalis extract, with a matching cosmetic serum.","text":"A product taken by mouth and labelled or promoted for a cosmetic purpose, such as the look of hair, is declared a therapeutic good. It can't be sold as a food or a cosmetic, and it is usually a TGA-listed medicine. The Permissible Indications Determination has hair claims, such as \"Maintain/support hair growth\", \"Maintain/support hair strength/thickness\" and \"Aid/assist/help/maintain healthy hair follicles\", with scientific or traditional evidence. \"Decrease/reduce hair loss/thinning\" needs the label statement \"If symptoms persist, talk to your health professional.\", and the product can't imply or refer to serious conditions associated with alopecia. A matching serum can be a cosmetic, but a claim to promote hair growth will likely make a topical product a therapeutic good unless it is excluded. From our records: Pump Haircare's TGA-listed hair growth capsules, reordered since 2021 and upgraded with a full new listing package in 2026; and Vitable's hair capsule on a clinically studied Biota orientalis extract, with a matching cosmetic serum.","items":[],"tables":[]},{"heading":"Why a hair supplement is a medicine","anchor":"why-a-hair-supplement-is-a-medicine","markdown":"The Therapeutic Goods (Declared Goods) Order 2019 declares goods \"labelled or promoted for cosmetic purposes\" to be therapeutic goods \"when used, advertised or presented for supply for oral consumption\". In the TGA's words, oral supplements \"labelled or promoted for cosmetic purposes, such as to improve the appearance of skin, hair and nails, are legally declared to be therapeutic goods\". \"These products cannot be regulated as foods or cosmetics\", and they \"are usually included in the ARTG as low risk listed medicines\".\n\nThe cosmetic purpose and the oral route decide, not the format. A hair capsule, tablet, powder or liquid is covered alike. More in our [beauty supplements guide](/guides/beauty-supplements).","text":"The Therapeutic Goods (Declared Goods) Order 2019 declares goods \"labelled or promoted for cosmetic purposes\" to be therapeutic goods \"when used, advertised or presented for supply for oral consumption\". In the TGA's words, oral supplements \"labelled or promoted for cosmetic purposes, such as to improve the appearance of skin, hair and nails, are legally declared to be therapeutic goods\". \"These products cannot be regulated as foods or cosmetics\", and they \"are usually included in the ARTG as low risk listed medicines\". The cosmetic purpose and the oral route decide, not the format. A hair capsule, tablet, powder or liquid is covered alike. More in our beauty supplements guide.","items":[],"tables":[]},{"heading":"The hair claims a listed medicine can make","anchor":"the-hair-claims-a-listed-medicine-can-make","markdown":"A listed medicine can only carry indications from the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025. The hair indications sit in Part 1, indications relating to general health or body parts:\n\n| Indication | Evidence | Requirements |\n| --- | --- | --- |\n| Maintain/support hair growth | Scientific or traditional | None |\n| Enhance/improve/promote/increase hair growth | Scientific or traditional | None |\n| Maintain/support hair health | Scientific or traditional | None |\n| Maintain/support hair strength/thickness | Scientific or traditional | None |\n| Enhance/improve/promote/increase hair strength/thickness | Scientific or traditional | None |\n| Aid/assist/help/maintain healthy hair follicles | Scientific or traditional | None |\n| Decrease/reduce hair loss/thinning | Scientific or traditional | The label statement \"If symptoms persist, talk to your health professional.\", and a presentation that doesn't imply or refer to serious conditions associated with alopecia |\n\nThe sponsor holds the evidence for each indication the product carries ([permitted indications](/guides/permitted-indications)). The wording can be varied on the label, but the varied wording must not change the meaning or intent of the indication, imply a serious form of a disease, or imply that the medicine prevents or cures one. So a hair capsule can support hair growth, but it can't claim to treat or cure alopecia.","text":"A listed medicine can only carry indications from the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025. The hair indications sit in Part 1, indications relating to general health or body parts: Indication: Maintain/support hair growth; Evidence: Scientific or traditional; Requirements: None. Indication: Enhance/improve/promote/increase hair growth; Evidence: Scientific or traditional; Requirements: None. Indication: Maintain/support hair health; Evidence: Scientific or traditional; Requirements: None. Indication: Maintain/support hair strength/thickness; Evidence: Scientific or traditional; Requirements: None. Indication: Enhance/improve/promote/increase hair strength/thickness; Evidence: Scientific or traditional; Requirements: None. Indication: Aid/assist/help/maintain healthy hair follicles; Evidence: Scientific or traditional; Requirements: None. Indication: Decrease/reduce hair loss/thinning; Evidence: Scientific or traditional; Requirements: The label statement \"If symptoms persist, talk to your health professional.\", and a presentation that doesn't imply or refer to serious conditions associated with alopecia. The sponsor holds the evidence for each indication the product carries (permitted indications). The wording can be varied on the label, but the varied wording must not change the meaning or intent of the indication, imply a serious form of a disease, or imply that the medicine prevents or cures one. So a hair capsule can support hair growth, but it can't claim to treat or cure alopecia.","items":[],"tables":[{"header":["Indication","Evidence","Requirements"],"rows":[["Maintain/support hair growth","Scientific or traditional","None"],["Enhance/improve/promote/increase hair growth","Scientific or traditional","None"],["Maintain/support hair health","Scientific or traditional","None"],["Maintain/support hair strength/thickness","Scientific or traditional","None"],["Enhance/improve/promote/increase hair strength/thickness","Scientific or traditional","None"],["Aid/assist/help/maintain healthy hair follicles","Scientific or traditional","None"],["Decrease/reduce hair loss/thinning","Scientific or traditional","The label statement \"If symptoms persist, talk to your health professional.\", and a presentation that doesn't imply or refer to serious conditions associated with alopecia"]]}]},{"heading":"Advertising a hair supplement","anchor":"advertising-a-hair-supplement","markdown":"The Therapeutic Goods Advertising Code applies to the product's ads, website and social media. An ad must not be inconsistent with the indications accepted for its ARTG entry, and it must not contain a picture or design that exaggerates the product's efficacy. Testimonials must be typical and verified, and paid testimonials aren't allowed, from brand ambassadors and social media influencers included ([TGA advertising](/guides/tga-advertising)). In its guidance on weight-management products, the TGA notes that before and after photos may indicate a claim.","text":"The Therapeutic Goods Advertising Code applies to the product's ads, website and social media. An ad must not be inconsistent with the indications accepted for its ARTG entry, and it must not contain a picture or design that exaggerates the product's efficacy. Testimonials must be typical and verified, and paid testimonials aren't allowed, from brand ambassadors and social media influencers included (TGA advertising). In its guidance on weight-management products, the TGA notes that before and after photos may indicate a claim.","items":[],"tables":[]},{"heading":"A matching serum or topical","anchor":"a-matching-serum-or-topical","markdown":"A hair range often pairs a capsule with something applied to the scalp. The topical has its own pathway. A cosmetic is decided by its claims, its ingredients and how it is used, and a claim to promote hair growth will likely make a product a therapeutic good unless it is excluded. So the serum's claims are written for the cosmetics pathway from the start, and the capsule carries the hair growth indications. Vitable's range works this way: a TGA-listed capsule and a matching serum on the cosmetics pathway ([skincare and topicals](/skincare)).","text":"A hair range often pairs a capsule with something applied to the scalp. The topical has its own pathway. A cosmetic is decided by its claims, its ingredients and how it is used, and a claim to promote hair growth will likely make a product a therapeutic good unless it is excluded. So the serum's claims are written for the cosmetics pathway from the start, and the capsule carries the hair growth indications. Vitable's range works this way: a TGA-listed capsule and a matching serum on the cosmetics pathway (skincare and topicals).","items":[],"tables":[]},{"heading":"Formulating and packing a hair supplement","anchor":"formulating-and-packing-a-hair-supplement","markdown":"- **Ingredients.** Every ingredient must be in the Permissible Ingredients Determination, used only in the roles it allows. Biotin, for example, can be an active ingredient or an excipient ([permissible ingredients](/guides/permissible-ingredients)).\n- **Complex formulas.** Hair formulas often combine a botanical extract with vitamins and minerals. Vitable's capsule has more than 13 ingredients, including a clinically studied Biota orientalis extract, AnaGain™ under licence and Quatrefolic® active folate ([branded ingredients](/guides/branded-ingredients)).\n- **Upgrading a formula.** Changing an active ingredient or its quantity makes a new medicine and a new listing. Pump Haircare's upgraded formula had a full new listing package and stability testing ([reformulating a supplement](/guides/reformulating-a-supplement)).\n- **The pack.** A recycled pack is possible for a listed medicine. Vitable's capsule ships in a 100% recycled PET bottle, covered by the product's stability program like any other pack ([sustainable packaging](/guides/sustainable-supplement-packaging)).","text":"Ingredients. Every ingredient must be in the Permissible Ingredients Determination, used only in the roles it allows. Biotin, for example, can be an active ingredient or an excipient (permissible ingredients). Complex formulas. Hair formulas often combine a botanical extract with vitamins and minerals. Vitable's capsule has more than 13 ingredients, including a clinically studied Biota orientalis extract, AnaGain™ under licence and Quatrefolic® active folate (branded ingredients). Upgrading a formula. Changing an active ingredient or its quantity makes a new medicine and a new listing. Pump Haircare's upgraded formula had a full new listing package and stability testing (reformulating a supplement). The pack. A recycled pack is possible for a listed medicine. Vitable's capsule ships in a 100% recycled PET bottle, covered by the product's stability program like any other pack (sustainable packaging).","items":[{"lead":"Ingredients.","text":"Every ingredient must be in the Permissible Ingredients Determination, used only in the roles it allows. Biotin, for example, can be an active ingredient or an excipient (permissible ingredients)."},{"lead":"Complex formulas.","text":"Hair formulas often combine a botanical extract with vitamins and minerals. Vitable's capsule has more than 13 ingredients, including a clinically studied Biota orientalis extract, AnaGain™ under licence and Quatrefolic® active folate (branded ingredients)."},{"lead":"Upgrading a formula.","text":"Changing an active ingredient or its quantity makes a new medicine and a new listing. Pump Haircare's upgraded formula had a full new listing package and stability testing (reformulating a supplement)."},{"lead":"The pack.","text":"A recycled pack is possible for a listed medicine. Vitable's capsule ships in a 100% recycled PET bottle, covered by the product's stability program like any other pack (sustainable packaging)."}],"tables":[]},{"heading":"From our records","anchor":"from-our-records","markdown":"- [Pump Haircare](/work/pump-haircare-hair-supplement): a hairdresser-founded Australian hair care brand that moved into supplements. We built its TGA-listed hair growth capsules and managed manufacturing, imports and air freight for every order. Working together since 2021, a 2024 reorder ready ahead of schedule, and an upgraded formula with a full new listing package shipped in 2026, with another reorder in the pipeline.\n- [Vitable](/work/vitable-hair-growth-range): a Sydney personalised-vitamin brand's hair range. A TGA-listed capsule with more than 13 ingredients in a 100% recycled PET bottle, and a matching topical serum on the cosmetics pathway. We formulated both, managed their manufacture and sourced the recycled bottles. Both delivered in 2024 and 2025.","text":"Pump Haircare: a hairdresser-founded Australian hair care brand that moved into supplements. We built its TGA-listed hair growth capsules and managed manufacturing, imports and air freight for every order. Working together since 2021, a 2024 reorder ready ahead of schedule, and an upgraded formula with a full new listing package shipped in 2026, with another reorder in the pipeline. Vitable: a Sydney personalised-vitamin brand's hair range. A TGA-listed capsule with more than 13 ingredients in a 100% recycled PET bottle, and a matching topical serum on the cosmetics pathway. We formulated both, managed their manufacture and sourced the recycled bottles. Both delivered in 2024 and 2025.","items":[],"tables":[]}],"faqs":[{"q":"Is a hair growth supplement a medicine in Australia?","a":"Yes, when it is taken by mouth and labelled or promoted for a cosmetic purpose such as the look of hair. It is declared a therapeutic good and is usually a TGA-listed medicine.","md":"Yes, when it is taken by mouth and labelled or promoted for a cosmetic purpose such as the look of hair. It is declared a therapeutic good and is usually a TGA-listed medicine."},{"q":"Can a hair supplement claim to stop hair loss?","a":"It can claim to \"Decrease/reduce hair loss/thinning\", with the label statement \"If symptoms persist, talk to your health professional.\" It can't imply or refer to serious conditions associated with alopecia, or claim to cure them.","md":"It can claim to \"Decrease/reduce hair loss/thinning\", with the label statement \"If symptoms persist, talk to your health professional.\" It can't imply or refer to serious conditions associated with alopecia, or claim to cure them."},{"q":"Can a hair serum claim to grow hair?","a":"A claim to promote hair growth will likely make a topical product a therapeutic good unless it is excluded. A serum sold as a cosmetic keeps its claims cosmetic.","md":"A claim to promote hair growth will likely make a topical product a therapeutic good unless it is excluded. A serum sold as a cosmetic keeps its claims cosmetic."},{"q":"Can a hair supplement and a serum be sold as one range?","a":"Yes. Vitable's range pairs a TGA-listed capsule with a serum on the cosmetics pathway, and we managed manufacturing for both.","md":"Yes. Vitable's range pairs a TGA-listed capsule with a serum on the cosmetics pathway, and we managed manufacturing for both."}],"sources":{"note":"General information, checked against these sources between 23 October and 1 November 2026. It isn't advice on a particular product. Our work is from Take Friday Off's records.","markdown":"General information, checked against these sources between 23 October and 1 November 2026. It isn't advice on a particular product. Our work is from Take Friday Off's records.\n\n- [Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025](https://www.legislation.gov.au/F2025L00450/asmade/2025-04-02/text/original/epub/OEBPS/document_1/document_1.html), section 6 and Schedule 1, Part 1, Federal Register of Legislation (checked 1 November 2026)\n- [Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026](https://www.legislation.gov.au/F2026L01382), Schedule 1 (the biotin entry), Federal Register of Legislation (checked 1 November 2026)\n- [Therapeutic Goods (Declared Goods) Order 2019](https://legislation.gov.au/F2019L01352/2023-03-01/2023-03-01/text/original/epub/OEBPS/document_1/document_1.html), section 5 and Schedule 1, Federal Register of Legislation, and [Complementary medicine interface issues](https://www.tga.gov.au/node/452720), Therapeutic Goods Administration, as set out in our [beauty supplements guide](/guides/beauty-supplements)\n- [Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021](https://www.legislation.gov.au/F2021L01661/latest), and [Testimonials and endorsements in advertising](https://tga.gov.au/node/491816), Therapeutic Goods Administration, as set out in our [beauty supplements guide](/guides/beauty-supplements)\n- [Cosmetics and therapeutics](https://www.industrialchemicals.gov.au/cosmetics-and-soap/cosmetics-and-therapeutics), Australian Industrial Chemicals Introduction Scheme, as set out in our [skincare page](/skincare)","items":[{"text":"Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025, section 6 and Schedule 1, Part 1, Federal Register of Legislation (checked 1 November 2026)","links":[{"title":"Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025","url":"https://www.legislation.gov.au/F2025L00450/asmade/2025-04-02/text/original/epub/OEBPS/document_1/document_1.html"}]},{"text":"Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026, Schedule 1 (the biotin entry), Federal Register of Legislation (checked 1 November 2026)","links":[{"title":"Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026","url":"https://www.legislation.gov.au/F2026L01382"}]},{"text":"Therapeutic Goods (Declared Goods) Order 2019, section 5 and Schedule 1, Federal Register of Legislation, and Complementary medicine interface issues, Therapeutic Goods Administration, as set out in our beauty supplements guide","links":[{"title":"Therapeutic Goods (Declared Goods) Order 2019","url":"https://legislation.gov.au/F2019L01352/2023-03-01/2023-03-01/text/original/epub/OEBPS/document_1/document_1.html"},{"title":"Complementary medicine interface issues","url":"https://www.tga.gov.au/node/452720"},{"title":"beauty supplements guide","url":"/guides/beauty-supplements"}]},{"text":"Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021, and Testimonials and endorsements in advertising, Therapeutic Goods Administration, as set out in our beauty supplements guide","links":[{"title":"Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021","url":"https://www.legislation.gov.au/F2021L01661/latest"},{"title":"Testimonials and endorsements in advertising","url":"https://tga.gov.au/node/491816"},{"title":"beauty supplements guide","url":"/guides/beauty-supplements"}]},{"text":"Cosmetics and therapeutics, Australian Industrial Chemicals Introduction Scheme, as set out in our skincare page","links":[{"title":"Cosmetics and therapeutics","url":"https://www.industrialchemicals.gov.au/cosmetics-and-soap/cosmetics-and-therapeutics"},{"title":"skincare page","url":"/skincare"}]}]}}]}