CRED Managing Variations Effectively

Annex III Cases for grouping: Article 7(2)(b) 14 cases listed for grouping Extension / II / IB e.g. Single or mixed categories are possible e.g. • Type II + consequential Type II • Type II + consequential Type IB + IA Administrative changes to SPC/label/PIL Changes to ASMF, VAMF or PMF “Project changes” to improve the manufacturing process • Product or active Changes to the Pharmacovigilance system Changes consequential to PSUR, SO, FUM, USR Other cases as agreed – see CMD website for acceptable groupings also CA/RMS/EMA

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