CRED ERP 25

01/07/2025

⚫ A brief outline of the Centralised and Mutual Recognition /Decentralised procedures (see also pre-read documentation)

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Marketing authorisation routes Legislative governance

The EU governance of new marketing authorisation applications is laid down in

⚫ Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (MRP/DCP and purely national applications) ⚫ 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 (applications via centralise procedure)

NB: Draft proposal for revision of Directive and Regulation published in April 2023!

See also pre-read documents and next 4 slides for more information

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