SS-EN-ISO-11615 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO 11615:2017)

SS-EN-ISO-11615 - 2017 EDITION - CURRENT
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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.

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Designation Name

SS-EN ISO 11615:2017

Revision Level

2017 EDITION

Status

Current

Publication Date

Dec. 13, 2017

Language(s)

English

Page Count

96

International Equivalent

EN ISO 11615:2017(IDT); ISO 11615:2017(IDT)