EMA: European Medicines Agency standard operating procedure (SOPs) on: Type IA variations to centralised marketing authorisations (medcines for human use)

The purpose of this SOP is to describe the procedure for handling of Type IA variations to centrally authorized medicinal product for human use. It applies to the Quality of Medicines and Safety and Efficacy of Medicines Sectors in the Human Medicines Development and Evaluation Unit, the Compliance an Inspection Sector in the Patient Health Protection Unit, and Product Data Management Sector in the Veterinary Medicines and Product Data Management Unit.