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ISO 11615 : 2017

M00024264

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ISO 11615 : 2017

HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED MEDICINAL PRODUCT INFORMATION

International Organization for Standardization

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Table of Contents

Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and abbreviated
   terms
4 Message exchange format
5 Conformance terminology and context
   as it relates to the ISO IDMP standards
   and corresponding IDMP technical
   specifications
6 Concepts required for the unique
   identification of Medicinal Products
7 Description of the information modelling
   principles and practices
8 Identifying characteristics for authorised
   Medicinal Products
9 Information for an authorised Medicinal
   Product
10 Identifying characteristics for Investigational
   Medicinal Products
11 Information for an Investigational
    Medicinal Product
Annex A (normative) - Full model - Authorised
        Medicinal Products detailed diagram
Annex B (normative) - Full model - Investigational
        Medicinal Products detailed diagram
Bibliography

Abstract

Specifies 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.

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Document Type Standard
Status Current
Publisher International Organization for Standardization
Committee TC 215
Supersedes
  • ISO/DIS 11615 : 60.00 (2017)