Common PV Mistakes Made by Supplement Companies with Products Listed on the ARTG

For many supplement companies, pharmacovigilance is not the first regulatory priority that comes to mind.

The focus is often on getting a product listed on the Australian Register of Therapeutic Goods (ARTG), maintaining manufacturing compliance, managing claims, and ensuring that labels meet regulatory requirements. Once the product is on the market, however, sponsors continue to have important responsibilities for monitoring and managing product safety.

This is where smaller supplement companies can sometimes find themselves exposed.

A product being a listed medicine does not mean that pharmacovigilance can be treated as a formality. Sponsors remain responsible for having appropriate systems in place to identify, assess, document, and report adverse events associated with their products.