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naSRPS EN ISO 11239:2020

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/DIS 11239:2022)

General information

40.20     Sep 29, 2022

40.60    Nov 28, 2022

ISS

I215

European Norm

35.240.80  

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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 allow regional authorities to map existing regional terms to the terms created using this document, in a harmonised and meaningful way.
In addition, to support the successful application of this document, references to documents concerned with identification of medicinal products (IDMP) and messaging for medicinal product information are provided as required.

Life cycle

PREVIOUSLY

Replaces
SRPS EN ISO 11239:2014

NOW

PROJECT
naSRPS EN ISO 11239:2020
40.20 DIS ballot initiated: 12 weeks
Sep 29, 2022

Related project

Adopted from prEN ISO 11239

Adopted from ISO/DIS 11239 IDENTICAL

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