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BS EN ISO 11239:2023

BS EN ISO 11239:2023

$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 2023 38
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This document 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 help regional authorities to map existing regional terms to the terms created using this document, in a harmonized and meaningful way.

PDF Catalog

PDF Pages PDF Title
2 undefined
4 European foreword
Endorsement notice
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
3 Terms, definitions and abbreviated terms
3.1 Terms and definitions
14 3.2 Abbreviated terms
15 4 Requirements
4.1 General information regarding controlled vocabularies
4.2 Requirements for use
5 Schema
5.1 General
16 5.2 Conceptual models — Supporting concepts
5.2.1 General
5.2.2 Terms and codes
19 5.3 Conceptual models — High-level concepts
5.3.1 General
5.3.2 Pharmaceutical dose form
23 5.3.3 Unit of presentation
24 5.3.4 Route of administration
25 5.3.5 Packaging
26 Annex A (informative) Examples of controlled vocabularies
32 Annex B (informative) Examples of controlled vocabularies to describe medicinal products
37 Bibliography

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BS EN ISO 11239:2023
$167.15