The Therapeutic Goods Administration (TGA), part of the Department of Health, has issued an infringement notice of $13,320 to Queensland-based company CheckMe Pty Ltd for alleged unlawful importation of COVID-19 rapid antigen tests (RATs).
It is alleged that CheckMe Pty Ltd imported approximately 57,000 RATs that were not included in the (ARTG) at the time of importation. The RATs were a parallel import of a similar Australian approved product.
The imported RATs were seized at the Australian border, resulting in an estimated financial impact to the business of $100,000, in addition to the infringement penalty amount.
This matter serves as a reminder to businesses to only purchase stock of therapeutic goods approved for the Australian market. Any RATs imported for commercial supply must be the version manufactured and approved for the Australian market and not a . The RATs must be included in the ARTG under the name of the supplier, prior to importation.
The import and supply to consumers of unregistered, parallel, or counterfeit medical devices has the potential to deliver unreliable results and undermine the integrity of regulatory measures in place to protect consumers.
If you suspect non-compliance in relation to therapeutic goods, you can online to the TGA. The TGA also encourages the .
