DIN EN ISO 11615:2025-10
Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO/DIS 11615:2025); German and English version prEN ISO 11615:2025 / Note: Date of issue 2025-09-12
| Fecha edición: |
2026-06-01
En Vigor
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| Idiomas disponibles: | Alemán, Inglés |
| Resumen: | This document establishes definitions and concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of medicinal products. Taken together, the standards listed in the Introduction define, characterise and uniquely identify regulated medicinal products for human use during their entire life cycle, i.e. from development to authorisation, post-marketing and renewal or withdrawal from the market, where applicable. Furthermore, to support successful information exchange in relation to the unique identification and characterisation of medicinal products, the use of other non-normative IDMP messaging standards is included, which are to be applied in the context of this document. |
| Keywords: | Approval|Concepts|Data communication|Data elements|Data exchange|Data structures|Definitions|Descriptions|Drugs|Exchange|Food additives|Human medicine|Identification|Information|Information exchange|Information interchange|Information models|Marking|Medical devices|Medical informatics|Medical products|Medical sciences|Medicaments|Medicine|Product approval|Product data|Product descriptions|Product information|Products|Substances|Vocabulary |
| ICS: | 35.240.80 - Aplicaciones de las tecnologías de la información en la sanidad |
| CTN: | |
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Reemplazo Normas |
Es reemplazada por DIN EN ISO 11615:2026-06 |
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