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Normas DIN – AENOR
DIN EN ISO 11616:2016-09

DIN EN ISO 11616:2016-09

Health informatics - Identification of medicinal products - Data elements and structures for the Unique Identification and Exchange of regulated Pharmaceutical Product Information (ISO/DIS 11616:2016); German and English version prEN ISO 11616:2016 / Note: Date of issue 2016-08-19

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/DIS 11616:2016); Version allemande et anglaise prEN ISO 11616:2016 / Attention: Date de parution 2016-08-19

Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und -strukturen zur Identifikation und zum Austausch von pharmazeutischen Produktkennzeichen (ISO/DIS 11616:2016); Deutsche und Englische Fassung prEN ISO 11616:2016 / Achtung: Erscheinungsdatum 2016-08-19

Fecha Anulación:
2018-04 /Withdrawn
Equivalencias internacionales:

ISO/DIS 11616 (2016-08)

prEN ISO 11616 (2016-08)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 11616:2018-04

Resumen:
This International Standard defines data elements, structures, and relationships between data elements required for the exchange of regulated information to uniquely identify pharmaceutical medicinal products. This international standard is applicable to regulatory and pharmacovigilance activities worldwide. This standard shall establish definitions and concepts and specify data elements and their structural relationships for the detailed description and unique identification of pharmaceutical products. Reference to other normative IDMP and messaging standards for pharmaceutical product information is included and shall be applied in the context of this standard. Medicinal products for veterinary use are out of scope of this standard. The purpose of this standard is to present the data elements, structures, and their relationships to uniquely identify and exchange regulated pharmaceutical product information. This standard shall provide an accurate and consistent mechanism to fully represent the relationship of Pharmaceutical Product Identifier(s) (PhPID) with the following: Medicinal Product Identifier(s) (MPIDs); Investigational Medicinal Product Identifier(s) (IMPIDs).
Keywords:
Compatibility, Data elements, Data structures, Definitions, Identification, Information exchange, Information interchange, Information models, Interoperability, Medical informatics, Medical products, Medical sciences, Medicaments, Medicine, Pharmacy, Product information, Products documentation
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