The Therapeutic Goods Administration (TGA) has issued an infringement notice of $13,320 to Getafix Café Pty Ltd (the company) for an alleged breach of the Therapeutic Goods Act 1989 (the Act) in relation to the advertising of a COVID-19 rapid antigen test on its website.
It is alleged that the company advertised a rapid antigen test (RAT) on its website without complying with the relevant advertising requirements.
Advertising of RATs must comply with the advertising requirements set out in the Act, which include complying with the Advertising Code and the Therapeutic Goods (Restricted Representations – COVID-19 Rapid Antigen Tests) Permission (No. 2) 2022 (the Advertising Permission). The TGA has published detailed guidance for advertisers of RATs setting out their regulatory obligations.
The TGA contacted the company on multiple occasions, providing detailed guidance on how to comply with the requirements and, in particular, the conditions set out in the Advertising Permission. The company failed to come into compliance.
A recent Federal Court decision expressed that those who intend to undertake business involving therapeutic goods or health services should be aware of the applicable statutory scheme, prohibited conduct, and regulatory requirements from the start. Advertising breaches in relation to RATs are a serious matter and the TGA is taking prompt and appropriate action to ensure compliance with the law.
An infringement notice is an alternative to commencing court proceedings, see Information about infringement notices
