CRED Managing Variations Effectively

Glossary

ATC= Anatomical Therapeutic Chemical (drug classification system) CEP= Certificate of suitability CMC= Chemical, Manufacturing and Controls

CTD= Common Technical Document MAH= Marketing Authorisation Holder

PHV= Pharmacovigilance PMF= Plasma Master File TSE=Transmissible Spongiform Encephalopathy VAMF= Vaccine Antigen Master File

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