WARNING: No special exemptions to import or supply unapproved rapid antigen tests have been granted by TGA

TGA

The Therapeutic Goods Administration (TGA) in collaboration with the Australian Federal Police (AFP) are investigating false documentation allegedly used to support the illegal importation and supply of unapproved rapid antigen tests for COVID-19.

The letter, claimed to have been issued by Minister Hunt, appears to provide a NSW based company with an exemption from the requirement to include their product in the Australian Register of Therapeutic Goods (ARTG) prior to importation and supply in Australia.

No special exemptions to import or supply unapproved rapid antigen tests have been granted by the TGA.

To legally supply COVID-19 test kits in Australia, they must be approved for inclusion in the ARTG.

Permissions or exemptions, should they be granted, are publicly published on the TGA website. They are published on webpages specific to the topic or type of therapeutic good the exemption or permission refers to. No special exemption or permission for the supply of unapproved rapid antigen tests has been granted to date and therefore none have been published.

What COVID-19 test kits are approved for supply in Australia?

All COVID-19 test kits approved by the TGA for inclusion in the ARTG, and therefore for supply in Australia, are listed on the COVID-19 test kit page and are subject to certain conditions.

How can I report concerns about COVID-19 rapid antigen tests?

If you have any concerns about the supply, or advertising, of COVID-19 rapid antigen self-tests, including about how they are being sold in retail outlets, you can report a perceived breach or questionable practice to the TGA. Consumers can contact the ACCC to report concerns regarding excessive pricing of COVID-19 rapid antigen tests.

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