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Feed/COD2008/0257(COD)Health & Social

Amendment: Pharmacovigilance of medicinal products (Reg 726/2004)

COMCMT1R-EP1R-C2R-EPCNCADO
Updated 190mo ago
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This procedure aims to update the rules for monitoring the safety of medicines after they have been authorized for use. By improving how side effects are reported and analyzed, the EU seeks to identify risks faster and ensure that patients receive the safest possible treatments.

This affects pharmaceutical companies, healthcare providers, and patients. It introduces stricter requirements for drug safety reporting and enhances the coordination of safety alerts across member states.