UNE-CEN ISO/TS 20451:2026

This document provides requirements and recommendations related to the concepts required to associatepharmaceutical products or groups of pharmaceutical products with an appropriate set of PhPID(s) inaccordance with ISO 11616 [2].Pharmaceutical product identifiers and the related elements are intended to represent pharmaceuticalproducts as defined within a medicinal product by a medicines regulatory authority. While the ISO standardson IDMP can be applied to off-label usage of medicinal products, such applications are currently outside ofthe scope of this document.Reference to ISO 11238 [4], ISO 11239 [5], ISO 11240 [6], ISO 11615 [3], HL7 V3 messaging standards (HL7Reference Information Model (RIM)[8], HL7 Common Product Model (CPM)[9] and HL7 V3 Structured ProductLabelling (SPL)[10], and HL7 FHIR[11] can be applied for pharmaceutical product information in the context ofthis document.