EN ISO 11239:2023

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 (ISO 11239:2023)

Publication date:   Sep 19, 2023

General information

60.60 Standard published   Jun 14, 2023

CEN

CEN/TC 251 Health informatics

European Norm

35.240.80   IT applications in health care technology

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 11239:2012

NOW

PUBLISHED
EN ISO 11239:2023
60.60 Standard published
Jun 14, 2023