Aktivní norma | Vydána: 30.04.2026

ISO/TS 20451:2026-ed.2.0

Health informatics — Identification of medicinal products — Implementation for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information
(Informatique de santé — Identification des médicaments — Implémentation des éléments de données et structures ISO 11616 pour l’identification unique et l’échange d’informations réglementées sur les produits pharmaceutiques)

Dostupné jazyky: Anglicky

Dostupné provedení: Elektronické PDF, Tištěné

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Podrobné informace

Označení: ISO/TS 20451:2026-ed.2.0

Datum vydání: 30.04.2026

Stran: 66

Země: Mezinárodní technická norma

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Anotace

Description / Abstract: This document provides requirements and recommendations related to the concepts required to associate pharmaceutical products or groups of pharmaceutical products with an appropriate set of PhPID(s) in accordance with ISO 11616. Pharmaceutical product identifiers and the related elements are intended to represent pharmaceutical products as defined within a medicinal product by a medicines regulatory authority. While the ISO standards on IDMP can be applied to off-label usage of medicinal products, such applications are currently outside of the scope of this document. Reference to ISO 11238, ISO 11239, ISO 11240, ISO 11615, HL7 V3 messaging standards (HL7 Reference Information Model (RIM)[8], HL7 Common Product Model (CPM)[9] and HL7 V3 Structured Product Labelling (SPL)[10], and HL7 FHIR[11] can be applied for pharmaceutical product information in the context of this document.

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