Tuesday, May 17, 2022

Victorian business fined after alleged ‘unlawful’ RATs seized by TGA

A Victorian-based business has been hit with a substantial fine after the Therapeutic Goods Administration seized a shipment of rapid antigen tests (RATs).
TCF Trading Co Pty Ltd has been issued an infringement notice of $13,320 the TGA announced overnight, for the alleged unlawful importation of COVID-19 rapid antigen tests, which were seized at the border.
The TGA says the “estimated financial impact to the business of up to $1 million”.
It’s alleged the company imported 70,000 units of COVID-19 RATs that were not included in the Australia Register of Therapeutic Goods (ARTG) at the time of their importation.
The TGA says products such as COVID-19 RATs must be included in the ARTG before they can be lawfully imported into Australia, unless an exemption applies. However, to-date, no special exemptions to import or supply unapproved rapid antigen tests have been granted by the governing body on therapeutic goods.
They’re requesting anyone who suspects they have bought an unauthorised tests to alert the TGA by reporting illegal or questionable practices online.
“Any RATs imported for commercial supply must be the version manufactured and approved for the Australian market and not a parallel import,” the TGA said in a statement, adding commercial supply can only be done by the approved supplier (sponsor).
“The RATs must be in the ARTG under the name of the supplier, prior to importation.”
The TGA website has a list of all COVID-19 rapid antigen self-tests that are approved in Australia.

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