BS EN ISO 11615:2017

1   Scope This document 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, characterise and uniquely identify regulated Medicinal Products for human use during their entire life cycle, i.e. from development to authorisation, post-marketing and renewal or withdrawal from the market, where applicable. Furthermore, to support successful information exchange in relation to the unique identification and characterisation of Medicinal Products , the use of other normative IDMP messaging standards is included, which are to be applied in the context of this document.