Q.01

What does AUST L mean on a medicine label?

AUST L stands for a listed medicine in Australia. The number is the product's unique listing number on the Australian Register of Therapeutic Goods (ARTG), and it shows the product is a lower-risk medicine that the TGA did not check before it went on sale.

What the TGA says about listed (AUST L) medicines [1]

  • Typical products: vitamins and minerals, traditional Chinese medicines, herbal medicines and some sunscreens.
  • No pre-market evaluation: they are on the ARTG and "can be sold without being checked by the TGA for safety, quality and effectiveness." Instead, the sponsor certifies that the medicine meets all the relevant legal requirements before selling it.
  • Ingredients: listed medicines can only contain ingredients the TGA has assessed as low risk.
  • Claims: indications (therapeutic uses) can only be chosen from a pre-approved list. Any indication on the label, packaging or advertising "must be included in the ARTG entry" and "must be supported by evidence."
  • Checks after sale: the TGA reviews selected listed medicines after they reach the market and publishes the results every quarter in its Listed Medicine Compliance Reports database. For example, the TGA's March 2026 update says 19 sunscreens were cancelled from the ARTG and recalled. They used the same base formulation as a sunscreen (formerly AUST L 332788) whose SPF test results were lower than claimed [2].

AUST R is the other common label number. It marks a registered medicine. For example, the TGA's approval notice for lenacapavir (YEYTUO) gives the products AUST R 489330 and AUST R 489331 [3].

The legal basis is the Therapeutic Goods Act 1989:

  • s 27: when the Secretary includes therapeutic goods in the Register, the Secretary "is to assign a unique registration or listing number to the goods" [4].
  • s 19D(3)-(4): importing or supplying registered or listed goods without the Secretary's written consent is a civil penalty contravention if the registration or listing number is not set out on the label "in the prescribed manner" [5].
  • s 22(1): a person "must not" put a number on a label, container or package that claims to be the goods' registration or listing number if it is not that number [6].

Approach: I searched the current compilation of the Therapeutic Goods Act 1989 and TGA safety and news notices. The detailed rules on how the number must be shown on the label are set in the regulations under the Act, which I did not search here.

Q.02