Listed or registered: AUST L and AUST R explained

In short. A listed medicine (AUST L) is a lower risk product that the TGA lets onto the Australian Register of Therapeutic Goods (ARTG) without evaluating its efficacy. A registered medicine (AUST R) is higher risk and the TGA evaluates its quality, safety and efficacy before it can be supplied. Which pathway you are on decides what you can say, what evidence you need and how much it costs to stay compliant.

What AUST L means

Most supplements, vitamins, herbal and traditional products sit in the listed pathway. To be listed, a medicine can only contain ingredients permitted for listed medicines, must be made by a manufacturer holding the right GMP licence or certification, and must carry indications chosen from those the TGA allows. The sponsor certifies that the product meets the requirements. The TGA does not review your efficacy evidence before the product is listed, but you must hold that evidence and produce it if asked.

What AUST R means

Registered medicines include prescription medicines and higher risk complementary products. They go through a full TGA evaluation of quality, safety and efficacy, which takes longer and costs more. In return, registered medicines can make stronger therapeutic claims than a listed medicine can.

A third door: listed (assessed)

Some listed medicines go through an additional assessment of the evidence for a specific claim. These carry an AUST L(A) number. If your product depends on a claim that sits outside the standard permitted indications, this pathway is worth understanding.

How the pathway shapes your claims

A listed medicine can only make claims that fit the permitted indications and that you can support with evidence. It cannot make claims about serious diseases or conditions. If your brand story needs claims beyond that, the product may need a different pathway, or the claim may need to change.

The mistakes we see most

Choosing a pathway by price alone. Assuming a listed number means the TGA has approved the claims. Starting product development before checking whether every ingredient is permitted. Each of these is cheaper to fix on paper than after stock is made.

How to choose

Start with the claim you want to make, then work backwards. Confirm the ingredients are permitted, confirm the indication, check you hold or can build the evidence, and only then choose the pathway and the manufacturer.

This article is general information, not legal advice. Check the current TGA guidance for your product.

1. Therapeutic Goods Act 1989 (Cth).
2. Therapeutic Goods (Permissible Ingredients) Determination, as in force.
3. Therapeutic Goods (Permissible Indications) Determination, as in force.
4. TGA, guidance on listed, listed (assessed) and registered complementary medicines: tga.gov.au.