Spring Intro 2023

16/02/2023

European Framework for Assessment & Approval

Central

National

Single

MRP/DCP

1+ EEA-MS

Only 1 EU MS

All EU MS

Reviewed by:

EMA (CHMP and PRAC*) *Safety

RMS w/CMSs or PRAC* *Safety

NCA

Approval

• CHMP opinion • EC decision

• RMS • CMDh can help mediate

NCA

Appeal

CHMP – re-examination CMDh (breakout)

Per local regulations

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General Process

Agency review Validation Submission Pre-submission

MRP/DCP:

CP:

PRAC / RMS + CMS

PRAC/CHMP

30/60/90d

Meeting / Arbitration Agency review MAH response Questions

PRAC / RMS + CMS

Break-out session / CMDh referral

SAG / OE / Re examination

If complex!

Opinion / Approval

RMS

CHMP

MAH/EMA agreed Linguistic Review

Implementation Translation

PRAC / RMS + CMS NCA – within 2m

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