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Coronavirus (COVID-19): Information on medicines and medical devices

The TGA is publishing the latest information about medicines and medical devices as it relates to COVID-19 on this page.

Please read the information below before contacting the TGA to see if your question is already answered.

5 July 2022

COVID-19 vaccines undergoing evaluation for provisional registration by the TGA

4 July 2022

COVID-19 vaccine batch release information is now available.

30 June 2022
The TGA has granted a number of provisional determinations in relation to COVID-19 vaccines.
30 June 2022
On 28 June 2022 the TGA granted a provisional determination to Pfizer Australia Pty Ltd in relation to its COVID-19 Vaccine, COMIRNATY.
29 June 2022

A list of self-tests that are approved in Australia

22 June 2022
The TGA has issued eight (8) infringement notices totalling $106,560 to Hough Pharma Pty Ltd for allegedly failing to provide information to the TGA to demonstrate the safety and performance of three COVID-19 RATs.
22 June 2022

The TGA is reviewing all laboratory antigen and Rapid Antigen Tests (RATs), including both point-of-care and self-tests, included in the ARTG.

10 June 2022
Update: The ARTG number may not be on the packaging but the Australian sponsor details and/or the manufacturer name and address will be.
3 June 2022
The TGA has issued one infringement notice totalling $2,664 to a Queensland based individual for alleged unlawful advertising of therapeutic goods in relation to COVID-19.
3 June 2022
The TGA has issued four infringement notices totalling $10,664 to an individual for alleged unlawful importation of COVID-19 rapid antigen tests (RATs).

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Further information

Contact TGA Info

Tel: 1800 020 653
Email: info@tga.gov.au

Note: we are currently experiencing a high volume of calls and emails. Please bear with us as we try to respond to queries as quickly as possible.

Department of Health

Coronavirus (COVID-19) health alert — for information and advice not specific to therapeutic goods.

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