Who can help my brand get a supplement TGA listed?

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.

Can you take over the regulatory work for products already on the market?

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.

Can a powder or a cream be a listed medicine?

Yes. The Belly Solution's travel gut-health powder and a pain relief cream we developed are both TGA-listed medicines.

Do you work with branded clinical ingredients?

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.

How much does it cost to list a medicine with the TGA?

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.

What is an AUST L number?

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.

What evidence does a listed medicine need?

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.

Can I advertise a listed medicine on social media?

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.

How long is the shelf life of a listed medicine?

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.

Do I need a TGA regulatory consultant to list a supplement?

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.

Medicine, food or cosmetic?

Listed medicines: the TGA pathway most supplements take

In short

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.

Guide

TGA listing guide

TGA approval for supplements usually means an AUST L listing on the ARTG: what AUST L means, the steps, the TGO 116 labels and the 2026–27 fees.

Read more Guide

ARTG guide

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.

Read more Guide

Stability testing guide

Shelf life testing for listed medicines: the stability evidence the TGA expects, real-time and accelerated studies, ongoing testing and failed results.

Read more Guide

Claims and indications guide

What a TGA-listed medicine can claim: the permitted indications, the evidence the sponsor must hold, the label statements and the advertising rules.

Read more Guide

New ingredients guide

How a new ingredient gets into the TGA's Permissible Ingredients Determination: IN1 to IN4 applications, the data, 2026–27 fees, timeframes and exclusivity.

Read more Guide

Advertising guide

How the TGA's Advertising Code applies to a supplement: what counts as advertising, required statements, testimonials, influencers, social media and penalties.

Read more Guide

TGA sponsor guide

A TGA sponsor in Australia is legally responsible for a listed medicine: who can be one, what an overseas brand does, how to become one, and the duties.

Read more Guide

Assessed listed medicines guide

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.

Read more Guide

Export guide

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.

What a listed medicine is

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.

What we do on the listed pathway

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.

How long it takes

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.

Questions

: 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.
: 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.
: Yes. The Belly Solution's travel gut-health powder and a pain relief cream we developed are both TGA-listed medicines.
: 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.
: 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.
: 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.
: 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.
: 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.
: 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.
: 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.