reference medicinal product - TOPRA

Which procedure is quickest? (on paper)
MRP DCP CP
National Application:
210 days
RMS issues Assessment
Report: 90 days
CMS Validation: 10 days
Validation: 14 days
DCP Phases:
120 days to 210 days
(Pre-submission: - 7
months)
Validation: 30 days
CHMP assessment:
120 to 210 days
MR-phase: 90 days Clock-stop: 90 days Clock stop: 120 days
National MA grant:
30 days
National MA grant:
30 days
Commission Decision:
30 days
Total: 420 days Total: 240 days Total: 270 days
When CMDh referral: add 60 days +
50