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The Therapeutic Goods Administration (TGA) has issued two infringement notices totalling $26,640 to a Perth based company G1 Resources Pty Ltd for the alleged unlawful importation and advertising of COVID-19 rapid antigen tests (RATs).
G1 Resources Pty Ltd allegedly imported 600 RATs that were not on the Australian Register of Therapeutic Goods (ARTG) at the time of importation. The RATs were a parallel import of a similar Australian approved product. RATs imported for commercial supply must be the version manufactured and approved for the Australian market. The RATs must be included in the ARTG under the name of the sponsor, prior to importation.
The company also allegedly advertised on its website various pack sizes of a RAT that was not included in the ARTG. The Advertising Permission that relates to the advertising of RATs for COVID-19 sets out conditions for the lawful advertising of test kits, including that the products must be included on the ARTG prior to being advertised.
The TGA website provides a list of all COVID-19 rapid antigen self-tests that are approved in Australia. Only the approved sponsor as entered on the ARTG, or their agent, can import RATs into Australia for commercial supply.
The sale of products that have not been assessed for quality, safety or efficacy poses a risk to consumers as the products purchased could be faulty or ineffective.
The TGA encourages the reporting of suspected non-compliant advertising.