The Therapeutic Goods Administration (TGA) has issued an infringement notice of $13,320 to Victorian-based company TCF Trading Co Pty Ltd for alleged unlawful importation of COVID-19 rapid antigen tests that were seized at the border, resulting in an estimated financial impact to the business of up to $1 million.
It is alleged that TCF Trading Co Pty Ltd imported 70,000 units of COVID-19 rapid antigen tests (RATs) that were not included in the Australia Register of Therapeutic Goods (ARTG) at the time of importation.
The penalty serves as a reminder to businesses unlawfully importing therapeutic goods, that they risk not only fines but loss of the goods, which can be seized at the border.
Under the Therapeutic Goods Act 1989 (the Act), products such as COVID-19 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.
RATs not entered in the ARTG are also subject to biosecurity controls administered by the Department of Agriculture, Water and the Environment.
Importing COVID-19 rapid antigen tests into Australia for commercial supply can only be done by the approved supplier (sponsor), as entered on the ARTG, or their agent.
Any RATs imported for commercial supply must be the version manufactured and approved for the Australian market and not a parallel import. The RATs must be in the ARTG under the name of the supplier, prior to importation.
The TGA website provides a list of all COVID-19 rapid antigen self-tests that are approved in Australia.
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.
