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Normas DIN – AENOR
DIN EN ISO 11616:2018-04

DIN EN ISO 11616:2018-04

Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information (ISO 11616:2017); German version EN ISO 11616:2017

Informatique de santé - Identification des médicaments - Éléments de données et structures pour l'identification unique et l'échange d'informations réglementées sur les produits pharmaceutiques (ISO 11616:2017); Version allemande EN ISO 11616:2017

Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und Strukturen zur eindeutigen Identifikation und zum Austausch von vorgeschriebenen pharmazeutischen Produktkennzeichen (ISO 11616:2017); Deutsche Fassung EN ISO 11616:2017

Fecha:
2018-04 /Active
Equivalencias internacionales:

EN ISO 11616 (2017-12)

ISO 11616 (2017-10)

Relación con otras normas DIN:
Resumen:
This document is intended to provide specific levels of information relevant to the identification of a Medicinal Product or group of Medicinal Products. It defines the data elements, structures and relationships between data elements that are required for the exchange of regulated information, in order to uniquely identify pharmaceutical products. This identification is to be applied throughout the product lifecycle to support pharmacovigilance, regulatory and other activities worldwide. In addition, this document is essential to ensure that pharmaceutical product information is assembled in a structured format with transmission between a diverse set of stakeholders for both regulatory and clinical (e. g. e-prescribing, clinical decision support) purposes. This ensures interoperability and compatibility for both the sender and the recipient.
Keywords:
Compatibility, Data elements, Data structures, Definitions, Identification, Information exchange, Information interchange, Information models, Interoperability, Medical devices, Medical informatics, Medical products, Medical sciences, Medicaments, Medicine, Pharmacy, Product information, Products documentation
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