NF EN ISO 11615

NF EN ISO 11615

February 2018
Standard Current

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

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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Main informations

Collections

National standards and national normative documents

Publication date

February 2018

Number of pages

91 p.

Reference

NF EN ISO 11615

ICS Codes

35.240.80   IT applications in health care technology

Classification index

S95-615

Print number

1

International kinship

ISO 11615:2017

European kinship

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

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.

Replaced standards (1)
NF EN ISO 11615
February 2013
Standard Cancelled
Health Informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information

<p>ISO 11615:2012 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.</p>

Table of contents
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  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes, définitions et abréviations
  • 4 Format d'échange de messages
  • 5 Terminologie relative à la conformité et contexte en lien avec les normes ISO IDMP et les spécifications techniques IDMP correspondantes
  • 6 Concepts requis pour l'identification unique de médicaments
  • 7 Description des principes et des pratiques de modélisation des informations
  • 8 Caractéristiques d'identification pour les médicaments autorisés
  • 9 Informations concernant un médicament autorisé
  • 10 Caractéristiques d'identification pour médicaments de recherche
  • 11 Informations concernant un médicament de recherche
  • Annexe A (normative) Modèle complet - Schéma détaillé des médicaments autorisés
  • Annexe B (normative) Modèle complet - Schéma détaillé des médicaments de recherche
  • Bibliographie
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