EVS-EN ISO 11615:2012

This International Standard establishes definitions and concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicinal Products. Taken together, the standards listed in the introduction define, characterize and uniquely identify regulated Medicinal Products for human use during their entire life cycle, i.e. from development to authorization, postmarketing and renewal or withdrawal from the market, where applicable. Furthermore, to support successful information exchange in relation to the unique identification and characterization of Medicinal Products, the use of other normative IDMP messaging standards is included, which are to be applied in the context of this International Standard.