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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.

20 December 2021
The TGA has granted a number of provisional determinations in relation to COVID-19 vaccines.
17 December 2021
Information about a TGA post-market review of face masks, including guidance for suppliers and users of face masks.
14 December 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.
14 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.

13 December 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 November 2021
Updated guidance clarifying the interaction between TGA and AHPRA advertising guidelines.
5 November 2021

Action in relation to non-compliant face masks will be published on the TGA web site

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.
27 August 2021
The Therapeutic Goods Administration (TGA) granted provisional approval to Janssen-Cilag Pty Ltd (known as Johnson & Johnson overseas) for its COVID-19 vaccine Janssen, making it the third COVID-19 vaccine to receive regulatory approval in Australia.
27 August 2021
The TGA has granted provisional approval to AstraZeneca Pty Ltd for its COVID-19 vaccine

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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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