AUST L meaning and how listed medicines differ from AUST R
AUST L identifies a listed medicine on Australia's ARTG. AUST R marks registration, which involves TGA evaluation rather than sponsor certification.
AUST L on a medicine label identifies a listed medicine in the Australian Register of Therapeutic Goods (ARTG). AUST R identifies a registered medicine. Registration involves TGA evaluation of quality, safety, and efficacy. Ordinary listing uses the sponsor's certificate instead. The two categories sit in different parts of the Register under the Therapeutic Goods Act 1989.
Assessed listed medicines are a third route. They stay listed, but efficacy is evaluated before entry, and that evaluation is not the registration test under section 25. The Act separates the routes in sections 26A, 26AB, 26AE and 25.
What AUST L means for TGA listed medicines
For an ordinary listed medicine, the sponsor certifies that the requirements are met. Section 26A provides for listing without an inquiry into the correctness of that certificate. It is not a TGA finding that the certificate was correct. That is not a premarket efficacy evaluation by TGA, and it doesn't remove the evidence duty or the eligibility limits on ingredients and indications. Those duties sit in section 26A of the Act.
Ingredients must be specified under section 26BB. Indications must be covered by a determination under section 26BF(1)(a). The sponsor must hold evidence supporting those indications. That package is the section 26A certification route, not a TGA efficacy evaluation before listing.
An AUST L number does not prove that TGA individually evaluated the medicine's efficacy before listing. But the sponsor still has to hold that supporting evidence.
AUST R vs AUST L and assessed listing
An AUST R vs AUST L comparison has to include assessed listing. Otherwise the two listing routes get treated as one. Assessed listing remains listing. Its efficacy evaluation is not a full independent evaluation of quality and safety equivalent to registration. The Act puts the tests in separate provisions.
| Medicine category | Basis for entry | What not to infer |
|---|---|---|
| Ordinary listed, associated with AUST L | Sponsor certification under section 26A | That TGA individually evaluated efficacy before listing |
| Assessed listed | Sponsor certification and an efficacy evaluation under sections 26AB and 26AE | That the evaluation matches registration |
| Registered, associated with AUST R | TGA evaluation of quality, safety and efficacy under section 25 | That ordinary listed medicines receive the same evaluation |
Assessed listing also has a different indication pathway. Do not carry ordinary listing's indication rules across unchanged. The distinction is in sections 26AB and 26AF.
What an AUST L number tells you
The number identifies the medicine's register entry. Section 3 defines a listing number as a combination of numbers, symbols and letters assigned under section 27 of the Act.
On a label, or in product copy, keep that identifier separate from assessment claims. An AUST L number alone is a poor basis for wording that implies the evaluation used for registration.
RegAffairs AI's answer on AUST L explains the difference between listed and registered medicines.