The Therapeutic Goods Administration (TGA), part of the Department of Health, has issued two infringement notices totalling $26,640 to Tianda Pharmaceuticals Australia Pty Ltd (Tianda Pharmaceuticals), for alleged unlawful advertising of a listed medicine in relation to COVID-19.
It is alleged Tianda Pharmaceuticals advertised, on eBay, a listed medicine called ‘Anti-Epidemic Formula 1’ for therapeutic uses in relation to COVID-19. The advertising was allegedly in breach of the Therapeutic Goods Act 1989 (the Act) as claims of therapeutic use for COVID-19 (and related terms) are restricted representations.
In the eBay advertisement, Tianda Pharmaceuticals also allegedly claimed that the medicine was approved by the TGA. Advertisements for therapeutic goods must not make any statement that implies the goods have been recommended or approved by a government, except in very limited circumstances. This includes statements that therapeutic goods have been approved by the TGA or international regulators.
The TGA takes action against sponsors that fail to comply
Sponsors are reminded that at the time of listing a medicine on the Australian Register of Therapeutic Goods (ARTG), they certify that their medicine complies with all relevant requirements under the Act, including those related to advertising. Conduct that undermines this certification-based framework is of significant concern to the TGA, particularly where it has the potential to adversely affect consumer health and safety. In such circumstances, the TGA will not hesitate considering imposing financial penalties.
The TGA is actively monitoring for non-compliance
The TGA conducts post-market compliance reviews of listed medicines and investigates signals of potential non-compliance, including the TGA’s findings from routine monitoring of new or changed listings of medicines on the ARTG. This allows the TGA to determine whether listed medicines comply with relevant regulatory requirements. The infringement notices issued to Tianda Pharmaceuticals stemmed from the TGA’s monitoring of the ARTG and a subsequent investigation.
About infringement notices
The TGA can issue an infringement notice where it has reasonable grounds to believe a person or business has contravened the Act. The payment of an infringement notice is not an admission of guilt or liability.