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The Federal Court of Australia has ordered Key Promotional Products Pty Ltd (KPP) to pay $1,750,000 for the unlawful import and supply of over 240,000 units of unapproved COVID-19 detection rapid antigen test kits (RATs) to Australian retailers between January and March 2022.
Additionally, the Court found that KPP made over 2,300 false or misleading representations in claiming that the RATs were 'TGA Approved'.
Mr Craig Shane Harding, the spouse of KPP's registered director, was also ordered to pay $250,000 for his role in aiding and abetting KPP's conduct. Of this amount, $70,000 was suspended on the condition that Mr Harding does not commit any further breaches of the Therapeutic Goods Act 1989 (Cth) (the Act) for 10 years. Mr Harding managed the day-to-day operations of KPP and knowingly aided and abetted the unlawful import and supply of the RATs, as well as the making of the false and misleading representations.
The RATs were not included in the Australian Register of Therapeutic Goods (ARTG) and had no exemptions or approvals that permitted their sale or supply in Australia.
Under the Act, therapeutic goods, including medical devices such as RATs, must be entered in the ARTG before they can be lawfully imported and supplied, unless a written approval or exemption applies.
Professor Anthony Lawler, Deputy Secretary of the Department of Health, Disability and Ageing and head of the TGA, said the outcome highlights the importance of complying with Australia's therapeutic goods regulations.
"Australians expect medical devices to be safe and perform as intended. That assurance comes from robust TGA assessment and approval," Professor Lawler said.
"Attempting to take advantage of a public health emergency for financial gain is unacceptable. The unlawful import and supply of unapproved tests undermines confidence in the regulatory system and may put public health at risk.
"The TGA will continue to take strong compliance and enforcement action where businesses and individuals do not meet their legal obligations," Professor Lawler said.
The TGA reminds businesses that they are responsible for understanding and complying with their regulatory obligations under the Act when importing, supplying and advertising therapeutic goods in Australia.
Consequences for non-compliance may include infringement notices, direction and prevention notices, or civil or criminal proceedings. The TGA takes action where serious non-compliance with the Act is identified, in line with its regulatory compliance framework.
This action reflects the TGA’s ongoing compliance and enforcement activities for therapeutic goods and medical devices, as outlined in the TGA’s Compliance Principles 2026 and 2027.
If you suspect non-compliance in relation to therapeutic goods and medical devices, you can report it to the TGA at any time.
Contact for members of the media:
- Email: news@health.gov.au
- Phone: 02 6289 7400
