CRED Managing Variations Effectively

C. Safety, Efficacy, Pharmacovigilance

I. Human and Veterinary medicinal products II. Veterinary medicinal product – specific changes  Changes affecting Modules 4/5 of the CTD for human medicinal products  Part III (Safety) or Part IV (Efficacy) of the dossier for veterinary products in analogy

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