CRED Managing Variations Effectively

Chapter C – Most commonly used scope categories

Changes to SmPC (and Package Leaflet): • affecting indication: C.I.6 (and C.I.2 for generics) • non-indication changes at MAH’s initiative: C.I.4 • non-indication changes at regulator recommendation (PASS or paediatric art 45 or 46): C.I.3 (from signal assessment: C.I.z ) No changes to SmPC • Changes to RMP (and other conditions): C.I.11 • Submission of final study results: C.I.13

Introduction to Classification of CMC (Quality) / Clinical / PhV Variations

64