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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.

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.

2 July 2021
The TGA has issued seven infringement notices totalling $93,240 to Melbourne-based global biopharmaceutical company Starpharma Holdings Limited (Starpharma), for alleged illegal advertising of a nasal spray that is not approved for use 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.
17 June 2021

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

10 June 2021
The TGA has issued two infringement notices totalling $26,640 to Sydney company Aidacare Pty Ltd (Aidacare).
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.
29 March 2021
It is alleged the company breached the Therapeutic Goods Act 1989 in relation to the importation of surgical face masks.
24 March 2021

Information about the post-market review of all approved COVID-19 tests and a post-market evaluation of all approved serology-based COVID point-of-care tests.

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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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