Risk management plan (RMP): questions and answers

This page is intended to provide advice to Marketing Authorisation Holders of centrally authorised medicinal products about 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.

A PDF version of the entire post-authorisation guidance is available:

It should be read in conjunction with the Guideline on good pharmacovigilance practices – Module V – Risk Management Systems (Rev 1) and the European Commission 'Variations Guidelines' 2013/C 223/01.

MAHs must in all cases comply with the requirements of Community legislation. Provisions that extend to Iceland, Liechtenstein and Norway by virtue of the European Economic Area agreement are outlined in the relevant sections of the text.

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