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
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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.
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The Organisation for Professionals in Regulatory Affairs 32
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