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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

10.07.2014
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.

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