Spring Intro 2023

03/03/2023

What are the Current Regulatory Procedures for the Approval of Products in Europe?

• Centralised Procedure (CP) – All or nothing ● Single application, single evaluation, ● single EU community authorisation • Decentralised Procedure (DCP)/Mutual Recognition Procedure (MRP) ● All EU agencies are equal and hence they should all recognise each others’ approvals ● One agency should be able to perform the review for the whole of the EU • National Procedures ● Older products, Switzerland, UK (bar NI) post Brexit Procedures will be discussed in detail on Day 3

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EU Regulatory Decision Makers

CVMP

PRAC

CAT

EMA

COMP

HMPC

PDCO

CHMP

SAWP, QWP, EWP, BWP, etc.

SAG, iNRG

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