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 / Note: To be replaced by DIN EN ISO 11616 (2025-11).
| Fecha edición: |
2018-04-01
En Vigor
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|---|---|
| Idiomas disponibles: | Inglés, Alemán |
| 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 |
| ICS: | 35.240.80 - Aplicaciones de las tecnologías de la información en la sanidad |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 11616:2017 Idéntica ISO 11616:2017 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 11616:2013-03 Reemplaza a DIN EN ISO 11616:2016-09 |
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