CRED Managing Variations Effectively

Chapter C – Pointers on most commonly used scope categories

Changes to SmPC (and Package Leaflet): • C.I.6 : additional submission requirements (see next slide) • C.I.4 : number of scopes equals number of changes • C.I.3 : copy of prior assessment to be included in submission No changes to SmPC

• C.I.11 : minor changes qualifying as IA/IB scopes if submitted alone can be included as minor changes in a type II variation, clinical overview expected • C.I.13 : number of scopes equals number of studies submitted, clinical overview expected and clinical summary updates expected if relevant

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

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