Documents
Europa English European Commission Initiatives
07.03.2024
Initiative
Performance of pharmacovigilance activities for human medicines ( update of Implementing Regulation (EU) 520/2012)
Targeted amendment to the Commission Implementing Regulation (EU) No 520/2012 harmonising the performance of pharmacovigilance activities by marketing authorisation holders, national competent authorities and the European Medicines Agency. Those activities cover the whole life-cycle managements of medicines with regard to safety.
Targeted amendment to the Commission Implementing Regulation (EU) No 520/2012 harmonising the performance of pharmacovigilance activities by marketing authorisation holders, national competent authorities and the European Medicines Agency. Those activities cover the whole life-cycle managements of medicines with regard to safety.
Errors and omissions excepted. As of: 07.03.2024