IndustriesOTC and Pharmaceuticals
The Department of Health of Australia has published a guidance document intended for complementary medicine products.
This Guidance contains the recommendation to implement a third pathway for sponsors of complementary medicines to enter products in the ARTG. The ‘assessed listed medicines’ pathway sits between the current listed (lower risk) and registered (higher risk) pathways.
A three-year transition period commenced on 5 March 2018 for existing listed medicines to be re-listed.
The first 12 months of the assessed listed medicines pathway will be used as an ‘implementation phase’ where the TGA will work closely with sponsors to ensure the processes, requirements and timeframes for the new pathway are appropriate.