Amendment: Regulation (EC) No 726/2004 on pharmacovigilance

This procedure aims to update the rules for monitoring the safety of medicines after they have been authorized for use. It focuses on improving the detection of adverse reactions and ensuring that safety information is shared more effectively across the EU to protect patients.

This affects pharmaceutical companies, healthcare providers, and national health agencies. It introduces stricter requirements for safety reporting and monitoring to ensure medicines remain safe throughout their lifecycle.