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Description of BS EN ISO 11239:2023 2024This 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.
About BSIBSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses. |
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