CRED Managing Variations Effectively

Chapter A - Remarks (I)

• Changes in section A are of administrative nature. • Scope A.1

 Changes of address of MAH (e.g. relocation, change of name of street/post code)  Change of the name of MAH but the MAH remains the same legal entity (e.g. “Generics Pharma B.V.” to “Generics B.V.”) If the legal entity changes (i.e. the marketing authorisation of the medicinal product is transferred from MAH1 to MAH2), this variation does not apply. In this case, a “MAH transfer” procedure applies, which is not a variation procedure.

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