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Individual fined $10,664 for alleged unlawful importation of COVID-19 rapid antigen tests

3 June 2022

The Therapeutic Goods Administration (TGA) has issued four infringement notices totalling $10,664 to an individual for alleged unlawful importation of COVID-19 rapid antigen tests (RATs).

It is alleged that the individual imported 13,500 RATs that were not included in the Australia Register of Therapeutic Goods (ARTG) at the time of importation. The RATs were seized at the border and will not be released.

COVID-19 rapid antigen tests imported into Australia for commercial supply must:

  • be the version manufactured and approved for the Australian market and not a parallel import
  • only be imported by the approved supplier (sponsor), as entered in the ARTG, or their agent
  • be included in the ARTG under the name of the supplier, prior to importation.

The TGA publishes a list of all COVID-19 rapid antigen self-tests that are approved for the Australian market.

Under the Therapeutic Goods Act 1989, products such as RATs must be included in the ARTG before they can be lawfully imported into Australia, unless an exemption applies. No special exemptions to import or supply unapproved rapid antigen tests have been granted by the TGA.

If you suspect non-compliance in relation to therapeutic goods, you can report illegal or questionable practices online to the TGA. The TGA encourages the reporting of suspected non-compliant advertising.