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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.

23 September 2021
Updated guidance clarifying the interaction between TGA and AHPRA advertising guidelines.
21 September 2021

COVID-19 vaccine batch release information is now available.

20 September 2021
Answers to frequently asked questions in relation to rapid antigen tests.
20 September 2021
General information about rapid antigen point-of-care testing in Australia
17 September 2021
A list of tests approved for inclusion in the Australian Register of Therapeutic Goods (ARTG)
16 September 2021
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.
10 September 2021

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

9 September 2021
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.
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.


Further information

Contact TGA Info

Tel: 1800 020 653

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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