Europe – Product Management Service (PMS) – Implementation of International Organization for Standardization (ISO) standards for the Identification of Medicinal Products (IDMP) in Europe : Chapter 1

In accordance with the obligations laid down by the Commission Implementing Regulation (EU) No 520/2012 (articles 25 and 26) the European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organization for Standardization (ISO) for the Identification of Medicinal Products (IDMP). The European Union (EU) Member States, marketing authorisation holders (MAHs) and EMA are required to make use of the ISO IDMP standards to support the exchange of medicinal product information in standardised manner.
EMA is implementing the standards in a phased programme based on the four domains of master data in pharmaceutical regulatory processes: Substance, Product, Organisation and Referential (SPOR) master data…