CRED 8 Presentations

08/07/2024

Principles MRP and DCP

The Organisation for Professionals in Regulatory Affairs The Organisationfor Professionals in Regulatory Affairs

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General principle MRP

● Applicant selects reference member state (RMS) and files first (national) application

● RMS assesses the dossier and clarifies open issues

● RMS grants marketing authorisationand issues assessment report

● Selected concerned member states (CMS) evaluate the assessment report, clarify open questions with information provided in the dossier, and are supposed to recognise the RMS marketing authorisation – unless there is a serious risk to public health (90 days).

The Organisation for Professionals in Regulatory Affairs The Organisationfor Professionals in Regulatory Affairs

14