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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.

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TGA grants second provisional determination for a COVID-19 vaccine

14 October 2020
The TGA has granted a provisional determination to Pfizer Australia Pty Ltd in relation to its COVID-19 Vaccine, BNT162b2 [mRNA].

TGA grants provisional determination for COVID-19 vaccine

9 October 2020
The TGA has granted a provisional determination to AstraZeneca Pty Ltd in relation to its COVID-19 Vaccine, ChAd0x1-S [recombinant].

Critical medicines supply modelling supports return to elective surgery

3 June 2020
New modelling demonstrates that supply of critical medicines for ventilating patients supports a return to elective surgery.

WA woman fined $2,520 for alleged breaches in relation to COVID-19 test kits

7 May 2020
The TGA has issued an infringement notice for $2,520 to a woman in Western Australia for alleged breaches relating to COVID-19 test kits.

Promedical Equipment fined $63,000 for alleged unlawful advertising of a COVID-19 Rapid Test kit

7 May 2020
The TGA has issued five infringement notices totalling $63,000 to a Queensland company for alleged breaches relating to COVID-19 test kits.

Woman fined $2,520 for alleged breaches in relation to COVID-19 test kits

24 April 2020
The TGA has issued an infringement notice for $2,520 to a woman in Western Australia for alleged breaches relating to COVID-19 test kits.

Labtest Direct issued with a $12,600 infringement notice for alleged advertising of COVID-19 test kits

24 April 2020
The TGA has issued an infringement notice for $12,600 to Labtest Direct for the alleged advertising of COVID-19 Rapid Test kits.

CK Surgitech issued $25,200 in infringement notices for alleged breaches in relation to COVID-19 test kits

24 April 2020
The TGA has issued infringement notices totalling $25,200 to Queensland company CK Surgitech for alleged breaches relating to COVID-19 test kits.

Medical device labelling obligations

16 April 2020
During the COVID-19 pandemic, many businesses are encountering therapeutic goods regulations for the first time. This information explains the labelling requirements for medical devices to help manufacturers and sponsors meet their obligations.

Ventilator for COVID-19 use in Australia

7 April 2020
This new specification details the minimum technical requirements for manufactured invasive ventilators when approved devices are not available during the COVID-19 emergency.

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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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