The TGA has announced that it has issued a $12,600 infringement notice to Sydney-based company GenesisCare Clinical CRO Pty Ltd for the alleged unlawful importation of KN95 face masks.

The TGA alleges GenesisCare breached a condition of the Therapeutic Goods (Medical Devices—Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020  by importing KN95 face masks that were not included in the Australian Register of Therapeutic Goods (ARTG) and were not being imported for supply to the National Medical Stockpile. The National Medical Stockpile is a strategic reserve of drugs, vaccines, antidotes and personal protective equipment for use in national health emergencies. The government stockpiles these items so Australia is more self-sufficient during an emergency and able to meet high levels of demand.

All therapeutic goods must be entered in the ARTG before they can be lawfully imported into Australia, unless a specific exemption, approval or authority applies. Failure to do this can result in the TGA pursuing civil or criminal penalties.

The TGA notes that it has published guidelines on face masks and respirators that are regulated by the TGA to help people determine when a face mask is a medical device and falls within the TGA’s remit.

The team at Avicenna Consulting has seen a big increase in the number people who want to supply face masks, sanitisers and disinfectants in Australia. It is important that anyone wanting to supply these products comply with the TGA’s requirements or comply with exemptions.

In our experience, the TGA has been highly responsive to enquiries relating to COVID-19 products. However; the TGA has also fined several companies in relation to COVID-19-related breaches. For example, the TGA fined Zafe Zone almost $40,000 for allegedly promoting its disinfectant as effective against coronavirus, without having the necessary approvals from the TGA.

If you have a product you would like to supply, please check out our guide to supplying sanitisers and disinfectants in Australia during the COVID-19 pandemic. If you need help with importing or supplying a surgical face mask or sanitiser, please contact us to find out how we can help you to meet your obligations.

To read more about the fine issued to GenesisCare, read the TGA’s media release.