CRED ERP 25

01/07/2025

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

The Organisation for Professionals in Regulatory Affairs 5

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 applicationsubmission to EMA

➢ Assessment byRapporteur/co Rapporteur

➢ Assessment Risk Management Plan by PRAC

➢ Scientific discussion and final opinion by CHMP

➢ One EU MA for EU issued by European Commission

6

The Organisation for Professionals in Regulatory Affairs

6