Risk management plan (RMP): questions and answers
This page is intended to provide advice to Marketing Authorisation Holders of centrally authorised medicinal productsabout procedural and regulatory aspects to the Risk Management Plan (RMP) lifecycle during the post authorisation phase. It addresses the classification of changes to the RMP, submission requirements and aspects to be considered in the management of parallel procedures affecting RMP. Revised topics are marked 'New' or 'Rev.' upon publication.
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