--- title: "Glossary of Australian regulatory terms | Take Friday Off" 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." url: https://takefridayoff.com/glossary updated: 2026-10-28 --- # Glossary: supplement, food and cosmetic regulatory terms https://takefridayoff.com/glossary · Page · last reviewed 2026-10-27 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. 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. ## ACCC (https://takefridayoff.com/glossary#accc) *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](https://takefridayoff.com/guides/aicis-registration#the-ingredient-label). ## Advertising to health professionals (https://takefridayoff.com/glossary#advertising-to-health-professionals) 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](https://takefridayoff.com/practitioner-ranges). ## AICIS (https://takefridayoff.com/glossary#aicis) *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](https://takefridayoff.com/guides/aicis-registration#what-is-aicis). ## Annual charge (https://takefridayoff.com/glossary#annual-charge) 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](https://takefridayoff.com/guides/supplement-development-cost#the-tgas-fees). ## APVMA (https://takefridayoff.com/glossary#apvma) *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](https://takefridayoff.com/guides/pet-supplements#medicine-or-food-where-the-line-falls-for-animals). ## ARTG (https://takefridayoff.com/glossary#artg) *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](https://takefridayoff.com/guides/artg#what-is-the-artg). ## Assessed listed medicine (https://takefridayoff.com/glossary#assessed-listed-medicine) 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](https://takefridayoff.com/guides/assessed-listed-medicines). ## AUST L (https://takefridayoff.com/glossary#aust-l) 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](https://takefridayoff.com/guides/tga-approval#approval-listing-or-registration). ## AUST L(A) (https://takefridayoff.com/glossary#aust-la) 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](https://takefridayoff.com/guides/assessed-listed-medicines#what-an-assessed-listed-medicine-is). ## AUST R (https://takefridayoff.com/glossary#aust-r) 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](https://takefridayoff.com/guides/artg#what-is-on-the-artg). ## Certificate of Listed Product (https://takefridayoff.com/glossary#certificate-of-listed-product) *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](https://takefridayoff.com/guides/exporting-supplements#the-tgas-export-certificates). ## Certificate of Pharmaceutical Product (https://takefridayoff.com/glossary#certificate-of-pharmaceutical-product) *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](https://takefridayoff.com/guides/exporting-supplements#the-tgas-export-certificates). ## Comparable overseas body (https://takefridayoff.com/glossary#comparable-overseas-body) *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](https://takefridayoff.com/guides/permissible-ingredients#the-four-application-levels). ## Compliance review (https://takefridayoff.com/glossary#compliance-review) 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](https://takefridayoff.com/guides/tga-approval#after-the-listing). ## Compliance verification (https://takefridayoff.com/glossary#compliance-verification) *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](https://takefridayoff.com/guides/gmp-clearance#three-routes-to-a-clearance). ## Compositional guideline (https://takefridayoff.com/glossary#compositional-guideline) 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](https://takefridayoff.com/guides/permissible-ingredients#what-the-dossier-needs). ## Cosmetic (https://takefridayoff.com/glossary#cosmetic) 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](https://takefridayoff.com/skincare#cosmetic-or-medicine-the-claim-decides). ## Cost of goods (https://takefridayoff.com/glossary#cost-of-goods) *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](https://takefridayoff.com/guides/supplement-development-cost#design-to-the-price-the-cost-of-goods). ## Declared goods (https://takefridayoff.com/glossary#declared-goods) *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](https://takefridayoff.com/pathways#how-the-line-is-drawn). ## Electronic Listing Facility (https://takefridayoff.com/glossary#electronic-listing-facility) 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](https://takefridayoff.com/guides/tga-approval#the-steps-to-an-aust-l-listing). ## Endorsement (https://takefridayoff.com/glossary#endorsement) 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](https://takefridayoff.com/guides/tga-advertising#testimonials-endorsements-and-influencers). ## Excluded goods (https://takefridayoff.com/glossary#excluded-goods) 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](https://takefridayoff.com/pathways#how-the-line-is-drawn). ## Excluded nutritional or digestive product (https://takefridayoff.com/glossary#excluded-nutritional-or-digestive-product) *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](https://takefridayoff.com/guides/pet-supplements#products-the-law-excludes-or-lists). ## Export only medicine (https://takefridayoff.com/glossary#export-only-medicine) *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](https://takefridayoff.com/guides/exporting-supplements#an-export-only-medicine). ## Food Standards Code (https://takefridayoff.com/glossary#food-standards-code) *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](https://takefridayoff.com/pathways/foods#the-food-standards-that-matter). ## Food-medicine interface (https://takefridayoff.com/glossary#food-medicine-interface) 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](https://takefridayoff.com/pathways#how-the-line-is-drawn). ## Formulated beverage (https://takefridayoff.com/glossary#formulated-beverage) 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](https://takefridayoff.com/formats/liquids#medicine-or-food). ## FSANZ (https://takefridayoff.com/glossary#fsanz) *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](https://takefridayoff.com/pathways/foods#who-enforces-the-code). ## GMP (https://takefridayoff.com/glossary#gmp) *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](https://takefridayoff.com/manufacturing#tga-licences-and-gmp). ## GMP agreement (https://takefridayoff.com/glossary#gmp-agreement) *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](https://takefridayoff.com/guides/choosing-a-supplement-manufacturer#the-gmp-agreement). ## GMP clearance (https://takefridayoff.com/glossary#gmp-clearance) *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](https://takefridayoff.com/guides/gmp-clearance#three-routes-to-a-clearance). ## Grouping (https://takefridayoff.com/glossary#grouping) 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](https://takefridayoff.com/guides/reformulating-a-supplement#what-the-tga-treats-as-a-new-medicine). ## Health claim (https://takefridayoff.com/glossary#health-claim) 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](https://takefridayoff.com/pathways/foods#what-a-food-can-and-cant-claim). ## Infringement notice (https://takefridayoff.com/glossary#infringement-notice) 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](https://takefridayoff.com/guides/tga-advertising#no-pre-approval-what-the-tga-can-do-instead). ## Intermediate indication (https://takefridayoff.com/glossary#intermediate-indication) *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](https://takefridayoff.com/guides/assessed-listed-medicines#what-an-intermediate-indication-is). ## Listed medicine (https://takefridayoff.com/glossary#listed-medicine) 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](https://takefridayoff.com/pathways/listed-medicines#what-a-listed-medicine-is). ## Manufacturing licence (https://takefridayoff.com/glossary#manufacturing-licence) *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](https://takefridayoff.com/guides/choosing-a-supplement-manufacturer#what-a-licence-covers-and-how-to-check-it). ## Minimum order (https://takefridayoff.com/glossary#minimum-order) *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](https://takefridayoff.com/guides/supplement-development-cost#the-minimum-order). ## Mutual recognition agreement (https://takefridayoff.com/glossary#mutual-recognition-agreement) *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](https://takefridayoff.com/guides/gmp-clearance#three-routes-to-a-clearance). ## New ingredient application (https://takefridayoff.com/glossary#new-ingredient-application) 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](https://takefridayoff.com/guides/permissible-ingredients) and on [new ingredient applications](https://takefridayoff.com/new-ingredients). ## Non-traditional food (https://takefridayoff.com/glossary#non-traditional-food) 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](https://takefridayoff.com/guides/novel-foods#what-makes-a-food-novel). ## Novel food (https://takefridayoff.com/glossary#novel-food) 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](https://takefridayoff.com/guides/novel-foods#what-makes-a-food-novel). ## Permissible Indications Determination (https://takefridayoff.com/glossary#permissible-indications-determination) *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](https://takefridayoff.com/guides/permitted-indications#how-the-permissible-indications-determination-works). ## Permissible Ingredients Determination (https://takefridayoff.com/glossary#permissible-ingredients-determination) *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](https://takefridayoff.com/guides/permissible-ingredients#what-needs-an-application). ## Permitted indications (https://takefridayoff.com/glossary#permitted-indications) 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](https://takefridayoff.com/guides/permitted-indications#what-an-indication-is). ## PIC/S Guide to GMP (https://takefridayoff.com/glossary#pics-guide-to-gmp) *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](https://takefridayoff.com/guides/gmp-clearance#the-standard-the-pics-guide-version-17). ## Primary sunscreen (https://takefridayoff.com/glossary#primary-sunscreen) 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](https://takefridayoff.com/skincare#sunscreens-primary-or-secondary). ## Prohibited representation (https://takefridayoff.com/glossary#prohibited-representation) 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](https://takefridayoff.com/guides/permitted-indications#advertising-the-therapeutic-goods-advertising-code). ## Protected ingredient (https://takefridayoff.com/glossary#protected-ingredient) 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](https://takefridayoff.com/guides/permissible-ingredients#two-years-of-exclusive-use). ## Registered medicine (https://takefridayoff.com/glossary#registered-medicine) 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](https://takefridayoff.com/guides/tga-approval#approval-listing-or-registration). ## Release for supply (https://takefridayoff.com/glossary#release-for-supply) 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](https://takefridayoff.com/guides/gmp-clearance#which-steps-need-a-clearance). ## Restricted representation (https://takefridayoff.com/glossary#restricted-representation) 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](https://takefridayoff.com/guides/permitted-indications#advertising-the-therapeutic-goods-advertising-code). ## Secondary sunscreen (https://takefridayoff.com/glossary#secondary-sunscreen) 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](https://takefridayoff.com/skincare#sunscreens-primary-or-secondary). ## Shelf life (https://takefridayoff.com/glossary#shelf-life) 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](https://takefridayoff.com/guides/stability-testing#selling-before-the-study-finishes). ## Sponsor (https://takefridayoff.com/glossary#sponsor) 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](https://takefridayoff.com/guides/tga-sponsor#who-can-be-a-sponsor). ## Sports food (https://takefridayoff.com/glossary#sports-food) *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](https://takefridayoff.com/pathways/foods#the-food-standards-that-matter). ## Stability testing (https://takefridayoff.com/glossary#stability-testing) *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](https://takefridayoff.com/guides/stability-testing#real-time-and-accelerated-studies). ## Testimonial (https://takefridayoff.com/glossary#testimonial) 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](https://takefridayoff.com/guides/tga-advertising#testimonials-endorsements-and-influencers). ## TGA (https://takefridayoff.com/glossary#tga) *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](https://takefridayoff.com/guides/tga-approval#approval-listing-or-registration). ## TGA assessed (https://takefridayoff.com/glossary#tga-assessed) *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](https://takefridayoff.com/guides/assessed-listed-medicines#the-tga-assessed-claim). ## TGA Business Services (https://takefridayoff.com/glossary#tga-business-services) 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](https://takefridayoff.com/guides/tga-approval#the-steps-to-an-aust-l-listing). ## TGO 92 (https://takefridayoff.com/glossary#tgo-92) 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](https://takefridayoff.com/guides/supplement-labelling#the-transition). ## TGO 95 (https://takefridayoff.com/glossary#tgo-95) *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](https://takefridayoff.com/formats/gummies#the-label) and [liquids](https://takefridayoff.com/formats/liquids#making-a-liquid-as-a-medicine). ## TGO 100 (https://takefridayoff.com/glossary#tgo-100) *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](https://takefridayoff.com/formats/liquids#making-a-liquid-as-a-medicine). ## TGO 101 (https://takefridayoff.com/glossary#tgo-101) *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](https://takefridayoff.com/guides/stability-testing#what-the-tga-expects). ## TGO 116 (https://takefridayoff.com/glossary#tgo-116) *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](https://takefridayoff.com/guides/supplement-labelling). ## Therapeutic good (https://takefridayoff.com/glossary#therapeutic-good) 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](https://takefridayoff.com/pathways#how-the-line-is-drawn). ## Therapeutic Goods Advertising Code (https://takefridayoff.com/glossary#therapeutic-goods-advertising-code) *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](https://takefridayoff.com/guides/tga-advertising#the-codes-core-rules). ## Veterinary chemical product (https://takefridayoff.com/glossary#veterinary-chemical-product) 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](https://takefridayoff.com/guides/pet-supplements#medicine-or-food-where-the-line-falls-for-animals). ## Sources 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. - [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 - [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 - [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 - [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 - [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 - [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 - [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 - [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 - [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 - [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 - [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 - [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 - [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 - [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 - [Understanding listed medicines compliance reviews](https://www.tga.gov.au/resources/guidance/understanding-listed-medicines-compliance-reviews), Therapeutic Goods Administration - [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 - [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 - [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 - [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 - [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 - [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 - [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 - [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 - [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 - [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 - [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 - [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 - [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 - [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 - [Cosmetics ingredients labelling mandatory standard](https://www.productsafety.gov.au/business/search-mandatory-standards/cosmetics-ingredients-labelling-mandatory-standard), ACCC Product Safety Australia