CRED Managing Variations Effectively

grouping …../ctd Disadvantages • Excludes Extension applications  use DCP • Increased bureaucracy  Justification for WS  discussions at CMD and working groups  CA for national procedures • 4-6 weeks consultation timeline (?)  60-day Type II procedure impractical for associated Type IA/Bs  all changes delayed in case of discussions/referrals Consider: do the advantages outweigh the disadvantages

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