Questions & Answers

Questions on regulatory matters may be asked to CMDv. Please use the following email address: CMDvnoSpam@noSpamema.europanoSpam.eu

Best Practice Guide for advice from CMDv on regulatory matters

Summary of questions to CMDv

Including:

• General questions
• Questions on generics and data protection
• Naming of VMPs
• Product literature
• Post authorisation

Q&A - List for the submission of variations according to Regulation (EU) 2019/6

CMDh-CMDv Q&A on Active Substance Master Files (ASMF)

CMDh-CMDv Q&A on QP Declaration