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ISO 11615:2017

Current Revision

Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information

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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.


SDO ISO: International Organization for Standardization
Document Number ISO 11615
Publication Date Not Available
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 215
Publish Date Document Id Type View
Not Available ISO 11615:2017 Revision