CRED 8 Presentations
08/07/2024
Initial Registration Strategy Decentralised Procedure
• No existing national license required
Day 0
• RMS manages timetable and leads assessment
Day 70 : RMS Comments Day 100 : CMS Comments
• Submission to RMS + 1 or more CMS
CLOCKSTOP
• RMS prepares assessment report
• CMS requested to recognise RMS conclusion
Day 106
• Clock-stop period for response preparation
Day 120 : RMS Comments Day 145-150 : CMS comments
• Procedure concludes by Day 210 (or sooner)
• National phase follows procedure conclusion
Day 160 : Applicant Response
• National HAs grant licenses on a local basis
Day 180 : RMS Comments Day 195-200 : CMS comments
MA Grant - 1 month > 1 year depending on the Member State
Day 210
The Organisation for Professionals in Regulatory Affairs The Organisationfor Professionals in Regulatory Affairs
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Registration Strategy Disagreement at end of MRP/DCP
CMDh referral : Outstanding major issues at Day 90(MRP) or Day 210 (DCP)
Applicant response accepted at CMDh
• Procedure concludes and national phase begins
No agreement at CMDh – Arbitration
• Referral to coordination group • Referral to CHMP for scientific evaluation • CHMP opinion 90 days + clock stop • Commission Decision • Single outcome binding all MSs in MRP/DCP • MSs need to implement EC Decision within 30 days
The Organisation for Professionals in Regulatory Affairs The Organisationfor Professionals in Regulatory Affairs
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