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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.

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.
20 June 2022

COVID-19 vaccine batch release information is now available.

10 June 2022

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

27 May 2022

Find information about the supply of COVID-19 rapid antigen self-tests to assist sponsors, manufacturers and consumers. Also includes information about the detection of multiple respiratory targets such as influenza A, influenza B and COVID-19 in a single rapid antigen test format (Combination...

6 May 2022

A list of self-tests that are approved in Australia

2 May 2022

The TGA has provisionally approved a booster dose of the Pfizer Australia Pty Ltd COVID-19 vaccine, COMIRNATY, for individuals 18 years and older.

28 April 2022
The TGA has granted a number of provisional determinations in relation to COVID-19 vaccines.
5 April 2022
The TGA has provisionally approved the Moderna COVID-19 vaccine, SPIKEVAX, for use in individuals aged 6 years and older.
5 April 2022
The Therapeutic Goods Administration (TGA) granted provisional approval to Janssen-Cilag Pty Ltd (known as Johnson & Johnson overseas) for its COVID-19 vaccine Janssen, making it the third COVID-19 vaccine to receive regulatory approval in Australia.
17 March 2022

The TGA is undertaking a post-market review of all Point of Care and Laboratory tests included in the ARTG, which are intended to identify patients with COVID-19, to ensure they can detect the emerging SARS-CoV-2 genetic variants and remain accurate.

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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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