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BS EN ISO 11239:2012

$167.15

Health informatics. Identification of medicinal products. Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging

Published By Publication Date Number of Pages
BSI 2012 40
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This International Standard specifies:

  • the data elements, structures and relationships between the data elements required for the exchange of information, which uniquely and with certainty identify pharmaceutical dose forms, units of presentation, routes of administration and packaging items (containers, closures and administration devices) related to medicinal products;

  • a mechanism for the association of translations of a single concept into different languages, which is an integral part of the information exchange;

  • a mechanism for the versioning of the concepts in order to track their evolution;

  • rules to allow regional authorities to map existing regional terms to the terms created using this International Standard, in a harmonized and meaningful way.

In addition, to support the successful application of this International Standard, references to standards concerned with identification of medicinal products (IDMP) and messaging for medicinal product information are provided as required.

PDF Catalog

PDF Pages PDF Title
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
3 Terms, definitions and abbreviations
3.1 Terms and definitions
13 3.2 Abbreviations
14 4 Requirements
4.1 General requirements for controlled vocabularies
15 4.2 Requirements for use within the IDMP set of standards
5 Schema
5.1 General
16 5.2 Conceptual modelsĀ ā€” Supporting concepts
18 5.3 Conceptual modelsĀ ā€” High-level concepts
25 AnnexĀ A
(informative)

Examples of controlled vocabularies

31 AnnexĀ B
(informative)

Examples of controlled vocabularies to describe medicinal products

36 Bibliography
BS EN ISO 11239:2012
$167.15