CRED 8 Presentations

01/07/2024

TIMELINES

The Organisation for Professionals in Regulatory Affairs

29

Comparative Timelines (without clock stop)

CP

MRP

DCP

Assessment

CHMP

National Competent Authorities

Timeline/ Duration

210 days: Opinion + 67 days to Commission Decision

+90d AR +90dMRP (+ 60d referral to CMDh) + 30d national MA 210 days at best

105/120/150/210 days

(+ 60d referral to CMDh) + 30d national MA 135 days at best 300 days at worst

Total

277 days

The Organisation for Professionals in Regulatory Affairs

30