Date for coming into effect 01 May 2020

This procedure defines the steps in the follow-up of pharmacovigilance inspections and the responsibilities of the parties involved. This includes the process for requesting a CAPA plan in writing from the MAH, CAPA plan review and approval by the inspectors, routine interaction within and between Members States and the Agency, actions to be taken following the identification of inspection findings which may impact the robustness of the benefit-risk profile of medicinal product(s), and reinspection planning. It applies to the follow-up of pharmacovigilance inspections of MAHs with centrally authorised products (CAPs) and nationally authorised products (NAPs), including those authorised via the mutual recognition procedure (MRP) and decentralised procedure (DCP). In addition to inspectors, post-inspection actions may also involve assessors in the Member States, the Agency and other committees such as the Pharmacovigilance Risk Assessment Committee (PRAC).

This procedure does not cover the routine process of exchanging information regarding inspections between Members States, the Agency and the European Commission, including information on the outcome of inspections (covered by the Union procedure on sharing of pharmacovigilance inspection information).


Union procedure on the follow-up of pharmacovigilance inspections