You are here

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.

27 August 2021
The TGA has granted provisional approval to AstraZeneca Pty Ltd for its COVID-19 vaccine
23 July 2021
The TGA has issued an infringement notice for $2,664 to an individual from Canberra, for a breach of the Therapeutic Goods Act 1989 in relation to the alleged unlawful advertising of a homoeopathic medicine with COVID-19 claims.
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.
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.
17 June 2021

Find information on complying with the rules around advertising and importing COVID-19 vaccines

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
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.

Pages

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.

Follow us