CRED Managing Variations Effectively

How are variations classified?

• Extensions [changes to active substance, new strength/pharm form/route of administration, addition of food-producing target species (vet area)]* • Major variation of type II, i.e. with significant impact on quality, safety and efficacy • Minor variation of type IA, i.e. no or minimal impact on quality, safety and efficacy • Minor variation of type IB, i.e. minor impact on quality, safety and efficacy a variation, as defined in the Classification Guideline. Also: • Variation that is neither a type IA nor a type II (default variation for unforeseen variations); • Type IA variation where at least one of the conditions is not met.

* Refer to Annex I of the Variations Regulation

Introduction to Classification of CMC (Quality) / Clinical / PhV Variations 36