Assessed listed medicines: AUST L(A) claims, fees and timeframes

What an assessed listed medicine is

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".

Topic	Listed	Assessed listed	Registered
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

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.

What an intermediate indication is

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.

The "TGA assessed" claim

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.

Applying for an assessed listing

1. A pre-submission meeting. It is free and optional, but the TGA says it is "strongly recommended".
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.

Levels, fees and timeframes for 2026–27

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	Application fee	Evaluation fee	Total	Preliminary assessment	Evaluation
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

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.

Five years of data protection

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.

Listed or assessed listed?

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.

Where we come in

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.