CRED 8 Presentations

08/07/2024

Registration Strategy MRP –Repeat Use

● This procedure can be used in following cases: – Application for a new CMS not involved in the first MRP or DCP – Reapplication to CMS withdrawn from the first application

● There is no limit to the number of Repeat Use procedure(s) until all Member States are involved in the procedure.

● No additional updates can be proposed to the approved dossier as part of the Repeat-use MRP.

● 90 days procedure

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

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MRP/DCP offers flexibility (1/2)

● Applicant can choose RMS

● Tradename can be different in each MS → (exception: generics of centrally authorised reference product)

● Number of CMS can vary from 1 to 30 → A lot of companies do not sell their products in all MS in Europe, very often only regional business

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

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