14/15 June 2021
EMA´s Pharmacovigilance Inspectors Working Group adopted a new guideline on the follow-up activities of pharmacovigilance inspections (effective since May 1, 2020). It applies to the follow-up of pharmacovigilance inspections of Marketing Authorization Holders (MAHs) with centrally authorized products (CAPs), nationally authorized products (NAPs), products authorized via the mutual recognition or decentralized procedure (MRP, DCP). The new guideline replaces the EMA document “Union procedure on the management of pharmacovigilance inspection findings which may impact the robustness of the benefit-risk profile of the concerned medicinal products”.
The competent authority
Any non-compliance identified should be rectified by the MAH in a timely manner. The Agency´s procedure includes the following steps:
Post-inspection actions may also involve assessors in the Member States, the Agency and other committees such as the Pharmacovigilance Risk Assessment Committee (PRAC).
According to the Agency, some PV inspections will require significant follow-up and management due to the nature of the findings identified. In addition, the Commission is empowered to impose financial penalties on the MAHs.
More detailed information can be found in "Union procedure on the follow-up of pharmacovigilance inspections" on the EMA website: Pharmacovigilance inspection procedures: human.