CRED Managing Variations Effectively

Chapter C – 2 nd example cont.

C.I.6 Change(s) to therapeutic indication(s)

Conditions to be fulfilled

Documentation to be supplied

Procedure type

a) Addition of a new therapeutic indication or modification of an approved one b) Deletion of a therapeutic indication

II

IB Note: Where the change takes place in the context of the implementation of the outcome of a referral procedure, or -for a generic/hybrid/biosimilar product- when the same change has been done for the reference product, variations C.I.1 and C.I.2 apply, respectively

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