CRED Managing Variations Effectively

Worksharing strategy: Advantages • One submission; one data package • Applicable to > 1 global MA • CMD endorses the WS proposal ∴ avoids invalidation by CMS • CMDh does not check/agree the variation Type or Grouping proposal – this remains the responsibility of the RMS at validation  NATIONAL: WS can include purely national MAs (all or selected) • after CMDh agreement, all MS proposed for WS of purely national MAs should accept the submission • not possible for a single MS to refuse to participate  Harmonisation of dossier or SmPC is not a prerequisite • when part of the SmPC has been harmonised for a purely national MA as part of worksharing, this should remain harmonised. • One assessment  harmonised regulatory outcome • Reduced costs (fees), admin burden (?) • Less red tape for WS procedure if same RMS….. • Company can nominate their preferred Reference Authority • If multiple RMS or CA (but not if one of the products is a Centralised)

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