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

21

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

22