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What are AUST R, AUST L(A), and AUST L Numbers?
All the medicines enlisted in the Australian Register of Therapeutic Goods (ARTG) are allotted an AUST number. The AUST number identifies the product on the ARTG. This is also known as the ARTG ID or registration number, or list number. The AUST number can be either AUST R, AUST L, or AUST L (A).
Medicines with a relevant AUST number on their label ensure that the medicine has been approved (registered or listed) by the Therapeutic Goods Administration (TGA) for supply in Australia.
All registered medicines are always evaluated for efficacy as per their claims before they go for sale. However, not all listed medicines are evaluated for efficacy.
There are different types of AUST numbers, such as:
- AUST L: These are ‘listed’ medicines and have not been assessed for efficacy
- AUST L(A): These are ‘assessed listed’ medicines. These are the ones that have been assessed for efficacy
- AUST R: These are medicines that are assessed for efficacy and are also registered in the ARTG
Comparison Between Different Types of Medicines
Attribute |
Listed |
Assessed Listed |
Registered |
ARTG number |
AUST L |
AUST L(A) |
AUST R |
Pre-market efficacy assessment |
No |
Yes |
Yes |
Ingredients |
From a list of pre-approved ingredients, only |
From a list of pre-approved ingredients, only |
Ingredients are assessed pre-market |
Indications of the medicine |
From a list of pre-approved conditions, only |
From a list of pre-approved conditions, only |
Conditions are assessed pre-market |
Subject to post-market compliance reviews |
Yes |
Yes |
No |
Subject to post-market surveillance |
Yes |
Yes |
Yes |
Available off-the-shelf |
Yes |
Yes |
Some |
Need for a prescription from a health professional |
No |
No |
Some |
Able to use ‘TGA assessed’ claim |
No |
Yes |
Yes, for registered complementary medicines |
Any medicine, whether it is registered or listed in ARTG, must be manufactured in a licensed or approved facility in accordance with the principles of Good Manufacturing Practices (GMP).
To know more about drug registration in Australia and to avail end-to-end Regulatory support, contact Freyr.