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AUST numbers on medicine labels

26 February 2021

All medicines included in the Australian Register of Therapeutic Goods (ARTG) must include the relevant AUST number (either AUST R, AUST L or AUST L(A) number) on the label.

What is the AUST number?

The AUST number identifies the product on the ARTG. It is also known as the ARTG ID or the registration or listing number.

The AUST number gives consumers and health professionals confidence that the medicine has been approved (registered or listed) by the TGA for supply in Australia. Medicines with AUST R and AUST L(A) are assessed for efficacy, while those with AUST L are not.

See How we regulate medicines for more information about the different types of medicines and their AUST numbers.

Medicine labels without an AUST number

The TGA administers various pathways that allow access to medicines that are not included in the ARTG (considered 'unapproved'). Medicines accessed under these pathways will not have an AUST R, L or L(A) number on the label.

If a medicine does not have an AUST number on the label and has not been accessed under one of these pathways it may have been supplied illegally. Examples of pathways that may allow supply of products without an AUST number can be found on our Accessing 'unapproved' products webpage.

Outside these access pathways, only in extraordinary circumstances will an ARTG medicine not include the AUST number on the label.

Medicines on the ARTG without the AUST number on the label

Section 19D of the Therapeutic Goods Act 1989 permits the Secretary (or the Secretary's delegate) to consent to the importation or supply of a TGA approved medicine without the relevant AUST number on the primary pack label.

Extraordinary circumstances

Consent for a medicine on the ARTG to be imported or supplied without the AUST number on the label will only be considered in extraordinary circumstances. TGA will inform sponsors where it may be appropriate for consent to be granted.

Consent would only be considered in situations where including the AUST number on the label of a medicine (either by printing or over-stickering) presents an unusual and unexpected challenge and immediate or timely supply of the medicine would address a national public health emergency, such as a pandemic declared by the World Health Organization (WHO).

Consent under section 19D can only be given to an Australian approved product (that is, not an overseas substitute product to address a medicine shortage), limited to a short period of time. Where consent has been provided, the sponsor of the medicine would also need to widely circulate the product's AUST number to health practitioners and consumers.

Note that consent under section 19D of the Act does not remove the need for the medicine to meet other Australian labelling requirements, such as the labelling Therapeutic Goods Orders and requirements under the Poisons Standard.

Legislative basis

Regulation 15 of the Therapeutic Goods Regulations 1990 outlines the requirements for including the AUST number on a medicine label.

Subsections 19D(3) and 19D(4) of the Therapeutic Goods Act 1989 provides civil penalties for importing or supplying registered or listed medicines without the relevant AUST number on the label in the absence of consent.

Where consent is given to import or supply an Australian medicine without the AUST number, details of the decision must be published on the website. If consent is not given under section 19D of the Act, the applicant must be informed within 28 days of the decision to refuse and the reasons for the refusal.

TGA has given consent for the following medicines to be imported or supplied without the AUST number on the label.

COMIRNATY (BNT162b2 [mRNA]) COVID-19 VACCINE 30 micrograms/0.3 mL concentrated suspension for injection vial

AUST number: 346290

Prescription medicine

Sponsor: Pfizer Australia Pty Ltd

Supply/import: Import and supply

Indication

COMIRNATY (BNT162b2[mRNA]) COVID-19 Vaccine has provisional approval for the indication below:

Active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, in individuals 16 years of age and older. The use of this vaccine should be in accordance with official recommendations. The decision has been made on the basis of short term efficacy and safety data. Continued approval depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment.

Duration of consent: All batches of the product imported or supplied until 24 January 2022

Reason for consent: Availability of the product for importation and supply in Australia as soon as possible will assist in the management of the COVID-19 pandemic in Australia, and the preparation and application of labels for the product that set out the registration number would delay the timely availability of the product in Australia for that purpose. Accordingly, this consent will assist in facilitating the timely availability of the product in Australia, and is therefore necessarily in the public interest.

COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection 5mL multidose vial

AUST number: 349072

Prescription medicine

Sponsor: AstraZeneca Pty Ltd

Supply/import: Import and supply

Indication

COVID-19 Vaccine AstraZeneca has provisional approval for the indication:

Active immunisation of individuals ≥ 18 years old for the prevention of coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2. The use of this vaccine should be in accordance with official recommendations. The decision has been made on the basis of short term efficacy and safety data. Continued approval is dependent upon the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment.

Duration of consent: All batches of the product imported or supplied until 15 February 2022

Reason for consent: Availability of the product for importation and supply in Australia as soon as possible will assist in the management of the COVID-19 pandemic in Australia, and the preparation and application of labels for the product that set out the registration number would delay the timely availability of the product in Australia for that purpose. Accordingly, this consent will assist in facilitating the timely availability of the product in Australia, and is therefore necessarily in the public interest.