25/26 October 2022
A targeted stakeholder consultation on amendments to Commission Implementing Regulation (EU) 520/2012 (IR) on pharmacovigilance activities has been published on the EC website. Comments and proposals received will be published and considered in the work leading to the revision of the IR.
The Commission Implementing Regulation (IR) on the performance of pharmacovigilance activities was adopted in 2012. It outlines the practical details to be followed by marketing authorization holders (MAHs), national competent authorities and the European Medicines Agency (EMA). Since EU inspectors have frequently raised findings in the area of contracts / agreements with third parties performing certain pharmacovigilance services for MAHs, it is considered that it would be beneficial to enhance MAHs' oversight regarding compliance controls of third parties.
The proposed revision focuses on the following sections of the IR:
Stakeholders involved in pharmacovigilance activities are invited to comment on this consultation by 15 October 2021 at the latest. More information is available under Targeted stakeholder consultation on the amendments to Commission Implementing Regulation (EU) 520/2012 published on the EC website.