EMA: Union procedure on the management of pharmacovigilance inspection findings which may impact the robustness of the benefit-risk profile of the concerned medicinal products

This document applies to the follow-up of pharmacovigilance inspections of MAHs with centrally authorised products (CAPs) and nationally authorised products (NAPs) including those authorised via mutual-recognition procedure (MRP), decentralised procedure (DCP) and national procedure.