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  • BSI
    BS EN ISO 11615:2017 Health informatics. Identification of medicinal products. Data elements and structures for the unique identification and exchange of regulated medicinal product information
    Edition: 2018
    $569.57
    / user per year

Description of BS EN ISO 11615:2017 2018

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.



Standard NumberBS EN ISO 11615:2017
TitleHealth informatics. Identification of medicinal products. Data elements and structures for the unique identification and exchange of regulated medicinal product information
StatusWithdrawn
Publication Date2018-01-09
Withdrawn Date2022-09-28
Identical National Standard OfEN ISO 11615:2017, ISO 11615:2017
DescriptorsData elements, Structures, Identification methods, Drugs, Technical regulations, Exchange, Product information
ICS35.240.80 IT applications in health care technology
CommitteeIST/35
ISBN978 0 580 94880 0
PublisherBSI
Pages90

The following editions for this book are also available...

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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