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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.

16 June 2021

COVID-19 vaccine batch release information is now available.

3 June 2021
The TGA has issued two infringement notices to Perth-based company V P & Associates Pty Ltd (V P & Associates), for alleged unlawful advertising of a medical device in relation to SARS-CoV-2 Human Coronavirus.
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
14 May 2021
A list of tests approved for inclusion in the Australian Register of Therapeutic Goods (ARTG)
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.
29 March 2021
It is alleged the company breached the Therapeutic Goods Act 1989 in relation to the importation of surgical face masks.
26 March 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.

26 March 2021
The TGA has granted provisional approval to AstraZeneca Pty Ltd for its COVID-19 vaccine
26 March 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 March 2021
In response to the COVID-19 pandemic, the TGA has expedited approvals for inclusion of COVID-19 tests in the Australian Register of Therapeutic Goods (ARTG). The TGA has commenced validation reviews of serology-based COVID-19 point-of-care tests included in the ARTG.

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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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