WHAT DOES AUST L MEAN?
A simple guide to understanding AUST L numbers on Australian medicine labels.
What is an AUST L number?
If you look at the label of an Australian complementary medicine, you may notice a number beginning with “AUST L”.
This number identifies the medicine on the Australian Register of Therapeutic Goods (ARTG). Medicines included in the ARTG must display the relevant AUST number on their label.
What does “AUST L” tell you?
An AUST L number indicates that the product is a listed medicine in Australia.
Listed medicines are generally lower-risk medicines and may include products such as vitamins, herbal medicines and Traditional Chinese Medicines. They can only use permitted lower-risk ingredients and low-level indications.
Does AUST L mean the TGA has tested the product for effectiveness?
Not necessarily.
AUST L medicines are not individually assessed by the TGA for efficacy before they enter the market.
Instead, the sponsor certifies that the product meets the applicable requirements. The TGA can conduct post-market compliance reviews to check whether listed medicines continue to meet regulatory requirements.
An AUST L number should not be interpreted as TGA pre-market approval of a product’s effectiveness.
AUST L, AUST L(A) and AUST R — what is the difference?
| Number | What it generally means |
|---|---|
| AUST L | Listed medicine |
| AUST L(A) | Assessed listed medicine |
| AUST R | Registered medicine |
AUST L(A) and AUST R medicines have their efficacy assessed to an appropriate standard before they are supplied to the public, while AUST L medicines are not assessed for efficacy prior to market entry.
Where can you find the AUST L number?
The AUST L number is printed on the medicine label or packaging.
When looking at a complementary medicine, you may see something similar to:
AUST L 515470
The number is the product’s ARTG identification number and can be used to identify that specific medicine in the Australian regulatory system.
What should consumers look at besides the AUST L number?
An AUST L number is only one part of the information on a medicine label.
Consumers should also read:
The full label provides important information about how the product is intended to be used. TGA consumer guidance also encourages consumers to use the medicine label to understand key product and regulatory information.
In Simple Terms
AUST L tells you that a medicine is listed on the Australian Register of Therapeutic Goods.
It does not mean the TGA has individually assessed the product for effectiveness before it is supplied.
Always read the full label and follow the directions and warnings provided.
Sources
Therapeutic Goods Administration (TGA)
- AUST numbers on medicine labels
- Listed medicines
- How we regulate medicines