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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.

8 December 2021

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

5 December 2021

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

22 November 2021
The TGA has granted a number of provisional determinations in relation to COVID-19 vaccines.
1 November 2021

COVID-19 vaccine batch release information is now available.

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.
24 August 2021
Where suitable, TGA inspectors will undertake remote and/or hybrid Good Manufacturing Practice (GMP) domestic inspections during the COVID-19 pandemic.
10 August 2021
Guidance to assist manufacturers in choosing appropriate standards and to set out the TGA's expectations for performance testing of respirators, surgical respirators and medical/surgical facemasks, before inclusion on the ARTG.
23 July 2021
The Product Information (PI) used by healthcare professionals for COMIRNATY has been amended to include safety related information on myocarditis and pericarditis
6 July 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.

6 July 2021
At the time of approving a vaccine, the TGA publishes extensive information about the product for both health professionals and the public.

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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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