CRED ERP 25

01/07/2025

MRP/DCP - Practical Tips Pre-submission activities/Building a story

Develop realistic timelines ● Understand deliverables from each functional areas ● Plan your pre- submission meeting (legal basis, dossier content…) and implement its feedback ● Tradename selection? ATC code? Pediatric Requirements? ● Confirmation of your RMS

Building your application

“Tell me the story, and I will tell you if I agree” ● Presentation of clear, easy, consistent, synthetic dossier ● Proactive vs Reactive ● Preparation of a Table of Content and a Risk Register

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

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MRP/DCP - Practical Tips Validation Phase

In theory, resolution within 14 days of submission

● Administrative check to ensure application is valid, complete and contains all appropriate documentation

In practice, can be a lot longer

● Between 6 to ~100 days depending on the issues – Application not received/modules are missing – Proposed MAH not established in the EEA – Missing/incorrect fee ● Role of RMS pre-submission meeting + Discussion with RMS prior to submission to limit the impact

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

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