Pharmacy Daily | TGA issues fake RAT alert

THE Therapeutic Goods Administration (TGA) has issued a formal warning to consumers, urging them to only purchase COVID-19 rapid antigen tests (RATs) which are approved in Australia.

The move is a response to unapproved RATs, which the TGA says are still being sold to Australians.

"The TGA is taking strong enforcement action against unlawful activities resulting in unapproved RATs being imported, sold or advertised in Australia," said TGA Head, John Skerritt.

"We are concerned that some consumers may be relying on RATs that have not been approved in Australia, and subsequently do not work as intended," he said.

Using unapproved, repackaged or repurposed RATs risks poor test performance, Skerritt added.

"Before RATs can be legally supplied in Australia, they must be assessed by the TGA to ensure they have the necessary specificity and sensitivity and meet Australia's other regulatory requirements...once the product has been approved it is entered in the Australian Register of Therapeutic Goods (ARTG)," he said.

While the outer packaging or label of an approved COVID-19 rapid antigen self-test may not include the ARTG number, it should contain the Australian sponsor details and/or the manufacturer name and address, with the TGA regularly updating its list of approved RATs so consumers can compare the details on the outer packaging with those on the official document.

Consumers are advised to report instances of packaging not being in English, or items appearing to have been relabelled or repackaged into single items from a larger pack without all the required parts or instructions for use.

Since the beginning of the year at least six companies and individuals have been collectively fined more than $100,000 for illegally importing unapproved RATs.

Perceived breaches or questionable practices can be reported at tga.gov.au.