CRED ERP 25

01/07/2025

CMDh (article 27 of Directive 2001/83/EC (2/2) …….

● Harmonisation of MAs in the Union – annual lists for SmPC harmonisation

● Ensure consistency of standards and good quality decision making across EU • One representative per EU MS (+IS, NO, LI), MS may appoint an alternate, CMDh secretariat provided by EMA • CMDh is an independent legal body, not a working group of HMA nor an EMA committee

• No systematic discussion on all ongoing MRP/DCP applications!

• CMDh advice: see CMDh website under Q&As and Advice from CMDh

• CMDh minutes/agenda’s and monthly press release published on CMDh website

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The Organisation for Professionals in Regulatory Affairs

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National EU-Competent Authorities

Products

Activities

MRP/ DCP/ purely national

• Assessment of applications and authorisation

All

• Authorisation and supervision of clinical trials • Conduct of Inspections (GMP, GLP, GCP, PhV) • Manufacturing authorisations • Supervision of distribution • Testing of samples • Supervision of advertising and promotion • Etc.

ANSM : Agence Nationale de sécurité du Médicament et des produits de santé

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The Organisation for Professionals in Regulatory Affairs 34

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