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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.

14 September 2021

COVID-19 vaccine batch release information is now available.

10 September 2021

Guidance for sponsors and manufacturers in preparing COVID-19 rapid antigen self-test applications

10 September 2021
General information about rapid antigen point-of-care testing in Australia
9 September 2021

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

9 September 2021
On 9 August 2021 the TGA granted provisional approval to Moderna Australia Pty Ltd for its COVID-19 vaccine - SPIKEVAX (elasomeran) - making it the fourth COVID-19 vaccine to receive regulatory approval in Australia.
8 September 2021
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.
7 September 2021

Guidance and checklist for businesses to understand the requirements for safe implementation of COVID-19 rapid antigen point-of-care testing.

7 September 2021
Answers to frequently asked questions in relation to rapid antigen tests.
6 September 2021
TGA is progressing work that would allow the provision of self-tests for COVID-19 in the future.
27 August 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.

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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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