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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.

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.

12 March 2021
In response to the COVID-19 pandemic, the TGA has received a significant number of thermometer applications. This guidance assists thermometer sponsors and manufacturers to meet their regulatory obligations.
11 March 2021
In response to the COVID-19 pandemic, the TGA has expedited the approval (with conditions) of COVID-19 tests including tests intended for laboratory use and those intended for use by specified health professionals at the point of care.
10 March 2021
Information about the TGA's safety monitoring of COVID-19 vaccines
9 March 2021
Due to the unprecedented pressures COVID-19 has placed on the pharmaceutical industry, sponsors of listed medicines and registered over-the-counter (OTC) and complementary medicines (RCM) are eligible to request consent not to comply with TGO 92 labelling requirements for a limited time.
3 March 2021
Information about the TGA's safety monitoring of COVID-19 vaccines
25 February 2021
The TGA has issued four infringement notices to Sydney-based company for the alleged unlawful importation of infrared thermometers, rigid strapping tapes and iodine prep pads.
16 February 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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