Spring Intro 2023

03/03/2023

MRP & DCP

MAH

RMS

CMS CMS CMS CMS

Outgoing Mutual Recognition: Agency is Reference Member State (RMS) Incoming Mutual Recognition: Agency is Concerned Member State (CMS)

The Organisation for Professionals in Regulatory Affairs

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● Product has already one National Marketing Authorisation ● Approved within 210 days ● RMS prepares Assessment Report based on Consolidated Dossier (90 days) ● Submit to all EU countries to be involved in the procedure (CMS) ● Validation by the CMSs ● Subsequent approval by the CMSs within 90 days – ‘mutual recognition’ by EU Member States of the initial RMS MA Approval Mutual Recognition Procedure (MRP)

The Organisation for Professionals in Regulatory Affairs

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