Monitoring and compliance for listed medicines

After your listed medicine is on the market, you have ongoing responsibilities to keep it safe and stay compliant with all applicable legislative requirements.

You must:  

• manage your product’s inclusion in the Australian Register of Therapeutic Goods (ARTG)
• keep your product’s details up to date.
• notify us of any changes through variation processes  
• pay regulatory charges  
• monitor product safety  
• report any issues or adverse events
• provide us any information that we request from you.

Meeting these post-market obligations helps ensure your listed medicine remains safe, effective, and compliant with Australian regulations.  

We monitor medicines on the market and work with you to address safety concerns. Our monitoring and compliance activities protect consumers and maintain product integrity.

You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to listed medicines. You may also have to meet obligations that apply to all medicines and all products.