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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.

9 December 2021
Information relating to face masks and gowns to assist healthcare organisations as they update their operating procedures during the outbreak
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.
2 August 2021

Disinfectants and related products: Regulation of borderline antiviral claims, including in relation to COVID-19

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.

25 June 2021
The 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.
21 May 2021
The TGA granted a provisional determination to GlaxoSmithKline Australia Pty Ltd in relation to the monoclonal antibody treatment, SOTROVIMAB (GSK4182136) on 14 April 2021
12 May 2021
The granting of this determination means that Pfizer is now eligible to apply to vary its provisional registration for the vaccine for use in individuals 12 years of age or older.

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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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