CRED 8 Presentations
01/07/2024
Marketing authorisation routes in EU
Centralised procedure (CP): one marketing authorisation (MA) granted by European Commission for Europe Other (than CP) marketing authorisation application (MAA) procedures Purely national procedure: MA in one Member State (MS) Mutual recognition procedure (MRP): MA in more than one Member State Decentralised procedure: MA in more than one Member State
These 3 procedures concern all national MAAs resulting in national MAs but procedure differs and for MRP/DCP result is harmonised!
See also pre-read documents
5
The Organisation for Professionals in Regulatory Affairs
5
Legal provisions Centralised Procedure (CP)
Regulation 726/2004/EC: laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
One new marketing authorisation application submissionto EMA
Assessment by Rapporteur/co Rapporteur
Assessment Risk Management Plan by PRAC
Scientific discussion and final opinion by CHMP
One EU MA for EU issuedby European Commission
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The Organisation for Professionals in Regulatory Affairs
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