Listed medicines (AUST L) are self-certified by sponsors, not pre-approved by the TGA — and post-market reviews can cancel non-compliant products. Here's what to know.

The AUST L number doesn't mean what many people think

There's a common and comfortable assumption behind every listed medicine on an Australian shelf: that because it carries an AUST L number and sits on the Australian Register of Therapeutic Goods, the TGA has looked at it and approved it. For registered medicines (AUST R) — higher-risk products — that's broadly true. For listed medicines, it isn't.

Listed medicines are self-certified. When you list a complementary medicine, sunscreen, or other low-risk therapeutic good, you — the sponsor — certify to the TGA that the product meets every applicable requirement. The TGA does not assess the product before it goes on the Register. The AUST L number means you have declared compliance, not that the regulator has confirmed it.

That distinction matters enormously, because the check doesn't disappear — it just happens after your product is on the market, and on the TGA's timetable rather than yours.

How the post-market check actually works

The TGA polices listed medicines through compliance reviews. It selects products — some at random, some targeted by risk or complaint — and examines them after they're already being supplied. A review can involve:

  • A desktop audit of your held evidence, indications, formulation and labelling
  • Laboratory testing of product samples bought from the market
  • Scrutiny of your advertising and claims

If the review finds the product doesn't meet requirements, the consequences are real and public: the medicine can be cancelled from the ARTG, recalled, and the outcome published. Cancellation means it can no longer be legally supplied — sometimes at the worst possible commercial moment.

This is not theoretical. In 2026, following SPF testing shortfalls, the TGA cancelled and recalled a group of sunscreens that shared a base formulation — a direct illustration of post-market review turning into product coming off shelves.

The scrutiny is increasing, not easing

The TGA has set out its Compliance Principles for 2026 and 2027, signalling a deliberately proactive, risk-based approach to enforcement across the supply and advertising of therapeutic goods. Listed medicine advertising and sunscreens sit among its stated priority areas. The direction of travel is clear: more active monitoring, not less. A listing that has sat quietly for years is not the safe harbour it might feel like.

Where listed medicines most often come unstuck

In our experience, the issues that surface in a compliance review tend to cluster:

  • Evidence gaps — the sponsor doesn't hold evidence that adequately supports the claims being made, or the evidence no longer stacks up.
  • Indications outside the permitted list — claims that stray beyond the TGA's permitted indications for listed medicines.
  • Formulation and ingredient issues — an ingredient that isn't permitted, is over a limit, or doesn't match what was certified.
  • Labelling and advertising — claims on pack or in marketing that go further than the product is entitled to make.
  • Manufacturing — gaps in GMP evidence for the finished product or its ingredients.

None of these are exotic. They're the routine details that are easy to let slide over the life of a product — especially after a reformulation, a new claim, or a change of staff.

Who should be checking now

You're most exposed if you:

  • Sponsor complementary medicines, supplements or sunscreens listed on the ARTG
  • Are relying on a listing set up years ago that hasn't been revisited
  • Have changed a formulation, ingredient or claim since the product was listed
  • Aren't certain you could produce the evidence for every claim if the TGA asked tomorrow

How Engel Hellyer & Partners can help

The most useful thing a listed medicine sponsor can do is treat a compliance review as a matter of when, not if — and be ready before it lands. We run exactly the checks the TGA would: confirming your indications sit within the permitted list, that the evidence for your claims is held and sufficient, that your formulation and labelling are compliant, and that your certification would stand up to scrutiny.

Finding and fixing a gap on your own terms is far cheaper and less disruptive than having the TGA find it on theirs. If you'd like to know where your listed products stand before a review does, we're happy to take a look.

This article is general information only and does not constitute regulatory advice for any specific product. Requirements change; confirm the current position before acting.

Further reading

Primary guidance from the Therapeutic Goods Administration:

‍

Written by 
Dr Gloria Mao
Has over 15 years of international experience in the food, complementary medicine and cosmetic industries. She received her doctorate from the University of California, Los Angeles in Toxicology and Pharmacology. She received her Masters of Arts in Biochemistry and Molecular Biology from Harvard University and her Bachelors of Science in Biochemistry from the University of Illinois.