CRED ERP 25
01/07/2025
Key milestones in procedures
• All 3 procedures more or less same milestones for applicants:
• Submission/validation (before day 0)
• List of questions/preparation of responses (clock off period)
• Possible further questions/finalisation procedure
• In case of possible refusal: possibility of oral hearing
So time tables of different procedures important!
The Organisation for Professionals in Regulatory Affairs
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Main contact during procedure
• National applications: different per MS. In case of application to MEB: casemanager (no direct contact with assessors) • MRP/DCP applications: different per MS. In case of application to MEB: casemanager (no direct contact with assessors)
• Applications via centralised procedure: P(roduct)L(ead) EMA
The Organisation for Professionals in Regulatory Affairs
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