CRED 8 Presentations

01/07/2024

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 is 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

31

The Organisation for Professionals in Regulatory Affairs

31

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.

32

The Organisation for Professionals in Regulatory Affairs 32

32