TGA approval for supplements: how an AUST L listing works

In short

• 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, usually showing the next day. The time goes into the formula, the evidence, GMP manufacturing, stability data and the label before lodging.

Approval, listing or registration?

The TGA sorts non-prescription medicines into three tiers by risk. Most complementary medicines are listed; few are registered.

Pathway	Listed	Assessed listed	Registered
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

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.

Who can list a medicine

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.

The steps to an AUST L listing

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?
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. Write the label to TGO 116. Below.
8. Lodge and pay. A new sponsor first gets a client number 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.

TGO 92 is now TGO 116

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. 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.
• 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.

What it costs: TGA fees for 2026–27

Fee	Amount
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

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.

How long it takes

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.

After the listing

• 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 claims and indications guide.

Where we come in

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.