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ISO 11615

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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Organization: ISO
Publication Date: 1 October 2017
Status: active
Page Count: 88
ICS Code (IT applications in health care technology): 35.240.80
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.

Document History

ISO 11615
October 1, 2017
Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information
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...
November 1, 2012
Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information
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...

References

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