M00024264
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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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Availability date: 11/05/2021
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
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.
Published | |
Document Type | Standard |
Status | Current |
Publisher | International Organization for Standardization |
Pages | |
ISBN | |
Committee | TC 215 |
Supersedes |
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