CRED Managing Variations Effectively

Chapter C – 1 st example cont.

C.I.4 Change(s) in the Summary of Product Characteristics, Labelling or Package Leaflet due to new quality, preclinical, clinical or pharmacovigilance data.

Conditions to be fulfilled

Documentation to be supplied

Procedure type

II

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