reference medicinal product - TOPRA

Which procedure is quickest? (in practice)
MRP DCP CP
National Application:
6 months to 3 years
RMS issues Assessment
Report: 3 to 18 months
CMS Validation:
upto 6 months
Getting a slot:
6-month delay?
Validation: 6 months
DCP Phases: majority run
to Day 210 (7 months)
Agreeing submission time:
3-6 months
Validation: 30 days
CHMP assessment:
210 days
MR-Phase: 90+ days Clock-stop: 3 to 12 months Clock-stop: 120 days +
National MA grant:
1 month to 2 yrs +
Total: 5 yrs +
National MA grant:
1 month to 2 yrs +
Total: 18 months
+ National Phase
Commission Decision:
30 days
Total: approx 18 months
When CMDh referral: add 60 days +
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