CRED Managing Variations Effectively
A. Administrative Changes
These involve: • Change in the name and/or address of the marketing authorisation holder, manufacturers of active substance/finished product • Change in the (invented) name of the medicinal product / active substance /excipient • Change in ATC Code / ATC Vet Code • Deletion of manufacturers
Introduction to Classification of CMC (Quality) / Clinical / PhV Variations 43
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