What are AUST R, AUST L(A), and AUST L Numbers?

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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.

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Sydney NSW 2000,
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