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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.

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28 January 2022
The TGA is undertaking a post-market review of all face masks included in the Australian Register of Therapeutic Goods to ensure the quality and effectiveness of face masks.
28 January 2022
The TGA has provisionally approved the Pfizer Australia Pty Ltd COVID-19 vaccine, COMIRNATY, for use as a booster in individuals aged 16 and 17 years old.
28 January 2022

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

28 January 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.

27 January 2022
The TGA is undertaking a post-market review of face masks included in the ARTG. This page lists all face masks that have been cancelled from the ARTG during the review.
27 January 2022
To enable timely distribution of COVID-19 treatments, international labels may be used during initial supply in Australia.
27 January 2022

Find information about the supply of COVID-19 rapid antigen self-tests to assist sponsors, manufacturers and consumers.

25 January 2022

A list of self-tests that are approved in Australia

24 January 2022

This is current advice relating to the supply of in vitro diagnostic medical devices for the detection of COVID-19/SARS-CoV-2 infections

24 January 2022
Information for sponsors regarding the supply of COVID-19 tests, including advice for those sponsors new to therapeutic goods regulation in Australia.

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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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