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

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The Organisation for Professionals in Regulatory Affairs

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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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