Lobbying on Performance of pharmacovigilance activities for human medicines ( update of Implementing Regulation (EU) 520/2012)

Performance of pharmacovigilance activities for human medicines ( update of Implementing Regulation (EU) 520/2012)

Public health

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.

Links

Public consultation

ID: 13195

Lobbying Activity

4 responses

Consultation response

European Federation of Pharmaceutical Industries and Associations, 15 Jan 2025

The European Federation of Pharmaceutical Industries and Associations (EFPIA), representing the biopharmaceutical industry operating in Europe, welcomes the Commissions initiative to update IR_EU_520-2012 and appreciates the opportunity to provide comments. The proposed removal of the MAH's…

Consultation response

Association of the European Self-Care Industry, 15 Jan 2025

The Association of the European Self-Care Industry (AESGP) welcomes the opportunity to provide their comments on the proposed amendments to the Commission Implementing Regulation No (EU) 520/2012 on pharmacovigilance activities. Our comments concerns the proposed updates regarding the conduct of…

Consultation response

Bundesverband der Pharmazeutischen Industrie e.V., 15 Jan 2025

The German Pharmaceutical Industry Association (BPI) represents the common economic interests of its member companies, particularly in the areas of healthcare and location policy, security of supply and pharmaceutical legislation at state and federal level as well as in Europe. With successful…

Consultation response

Shionogi Europe B.V., 14 Jan 2025

Preamble 5: () the requirements for marketing authorisation holders should be clarified (). --Further clarification on what is expected from MAH is welcome. Shall it be expected in a revision of GVP Module IX? Preamble 7: () minimum reporting requirements should apply in all cases --There does not…