Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information
Abstract
ISO 11615:2017 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 ISO 11615:2017.
Begin
2023-12-05
WI
00251410
Planned document number
DIN EN ISO 11615 rev
Project number
17600056
Responsible national committee
Responsible european committee
CEN/TC 251 - Health informatics
Responsible international committee
ISO/TC 215/WG 6 - Pharmacy and medicines business
