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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.

22 January 2021
Healthcare professionals and public health authorities will have a central role in discussing vaccination against COVID-19 with their patients.
20 January 2021
The TGA has granted a number of provisional determinations in relation to COVID-19 vaccines.
20 January 2021
The TGA has granted a provisional determination to Biocelect Pty Ltd (on behalf of Novavax Inc.) in relation to the COVID-19 Vaccine, NVX-CoV2373.
17 January 2021
In recent days the TGA has received reports of about 30 deaths in over 40,000 elderly individuals in Norway vaccinated with the Pfizer BioNTech vaccine
13 January 2021
The TGA is undertaking a post-market review of all Point of Care and Laboratory tests included in the ARTG, which are intended to identify patients with COVID-19, to ensure they can detect the emerging SARS-CoV-2 genetic variants and remain accurate.
23 December 2020
The TGA has issued an infringement notice to Melbourne-based company Enviro Tech Holdings Pty Ltd for the alleged unlawful importation of surgical face masks in relation to COVID-19.
23 December 2020
The TGA has issued an infringement notice to Brisbane-based company PPE Direct Pty Ltd, trading as Infinity Biotech for the alleged unlawful advertising of a COVID-19 Rapid Test kit under the Therapeutic Goods Act 1989.
4 December 2020
The medicine regulators from Australia, Canada, Singapore, Switzerland and the United Kingdom have discussed the regulatory evidence requirements for COVID-19 vaccine approvals and considerations for post-market pharmacovigilance.
2 December 2020
The TGA notes the emergency use authorisation related to the COVID-19 vaccine BNT162b2 supplied by Pfizer and BioNTech.
19 November 2020
The TGA has issued an infringement notice for $13,320 to Sydney-based company Nafara Australia Pty Ltd (Nafara Australia) for the alleged unlawful importation of medical face masks in relation to COVID-19.

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Email: info@tga.gov.au

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Department of Health

Coronavirus (COVID-19) health alert — for information and advice not specific to therapeutic goods.

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