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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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29 March 2021
It is alleged the company breached the Therapeutic Goods Act 1989 in relation to the importation of surgical face masks.
26 March 2021

Understand the regulatory process of how a COVID-19 vaccine application is submitted and assessed before a vaccine is approved for supply in Australia.

26 March 2021
The TGA has granted provisional approval to Pfizer Australia Pty Ltd for its COVID-19 vaccine, COMIRNATY, making it the first COVID-19 vaccine to receive regulatory approval in Australia.
26 March 2021
The TGA has granted provisional approval to AstraZeneca Pty Ltd for its COVID-19 vaccine
24 March 2021
In response to the COVID-19 pandemic, the TGA has expedited approvals for inclusion of COVID-19 tests in the Australian Register of Therapeutic Goods (ARTG). The TGA has commenced validation reviews of serology-based COVID-19 point-of-care tests included in the ARTG.
23 March 2021
The Melbourne-manufactured AstraZeneca vaccine is now available for Australians, with the TGA this evening approving the release of the first four batches.
21 March 2021
TGA has approved manufacture of the AstraZeneca COVID-19 Vaccine (ChAdOx1-S) in Australia.
19 March 2021
Update - European and UK reviews find no proven link with blood clots
19 March 2021
Update - Expert review finds no evidence of increased risk of anaphylaxis

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Further information

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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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