Australian company PharmaCare has paid penalties of $12,600 after the Therapeutic Goods Administration (TGA) issued an infringement notice for the alleged advertising of a therapeutic good after it had been cancelled from the Australian Register of Therapeutic Goods (ARTG).
In the event of deliberate non-compliance, or the discovery of non-compliant systems, therapeutic goods may be cancelled from the ARTG. Once cancelled, the product can no longer be advertised in Australia.
The product, Sambucol Cold & Flu Kids Liquid, was audited during a routine compliance review. The TGA found that the application to include the medicine on the ARTG was false or misleading, as the scientific evidence PharmaCare held to support some of the indications for the medicine was inadequate. As a result, the TGA cancelled the product from the ARTG in June 2019, however the product was still being advertised on PharmaCare’s website after the cancellation.
The TGA takes action against illegal activity
The TGA oversees the regulation of medicines and medical devices that are used in Australia, and implements a range of compliance and enforcement tools to detect, deter and address the illegal trade of unapproved therapeutic goods. These tools may include criminal or civil court proceedings, which can result in substantial fines or imprisonment.
Businesses and individuals must also comply with the therapeutic goods advertising requirements when advertising medicines and medical devices.
Remember – if you see an ad that breaks the rules, you can make an advertising complaint online. The TGA will investigate and take action.
