The supplier of rapid antigen tests sold in major supermarkets across the country has been hit with colossal fines.
A supplier of rapid Covid-19 antigen tests has been fined $106,560 for “serial” failures to comply with Therapeutic Goods Administration guidelines.
Hough Pharma Pty Ltd has received eight infringement notices for allegedly “failing to provide information” to the TGA to demonstrate the safety and performance of three RATs.
The tests, provided to Coles and Woolworths, would not have provided up-to-date safety and efficacy data or adequate customer support.
Suppliers of TGA-approved medical devices must provide evidence to the agency upon request and within specified time frames, to ensure that the devices are safe and performing to standard.
Additionally, RAT vendors should ensure that they have telephone or online operators available for customer support.
In a statement, the TGA said Hough Pharma Pty Ltd had failed to comply.
“Hough Pharma Pty Ltd has received multiple infringement notices for serial non-compliance,” the statement said.
“In addition to failing to meet deadlines for providing information to the TGA, the lack of customer support has been reported by consumers and verified by TGA surveys.
“The TGA is investigating other sponsors of Covid-19 rapid antigen tests for similar non-compliance. »
Hough Pharma chief executive Jackson Hough told Nine Newspapers that the company has consistently provided data to the TGA.
“Hough Pharma has continuously provided efficacy, safety and variant data to the TGA to demonstrate that our products effectively detect Covid-19 and its variants,” he said.
Read related topics:ColesWoolworths