The Therapeutic Goods Administration (TGA) has commenced proceedings in the Federal Court of Australia against Key Promotional Products Pty Ltd (KPP), and an individual, for allegedly importing and supplying unapproved rapid antigen test kits (RATs).
It is alleged that KPP imported RATs that were intended to be used for humans for the purpose of detecting the COVID-19 antigen. These RATs were not included in the Australian Register of Therapeutic Goods (ARTG) in relation to KPP and there were no other approvals or exemptions in place allowing the company to import them.
It is further alleged that KPP supplied at least 240,000 of these RATs to resellers around Australia, and made false or misleading representations that the RATs were "TGA Approved" or had "TGA Approval" in relation to the company pursuant to their inclusion in the Register.
KPP also allegedly, when in communication with entities looking to purchase the RATs, provided false or misleading representations about the medical devices.
The TGA has also initiated proceedings against Mr Craig Shane Harding, who is the husband of the KPP's registered director. The TGA alleges that Mr Harding was responsible for the day to day running of the company and aided and abetted the contraventions.
Therapeutic goods, including medical devices, must be entered in the ARTG before they can be lawfully imported and supplied, unless a written authority or an exemption applies. This is an important safeguard to help ensure the safety, quality, and performance of products.
