PD CEN ISO/TS 21405:2026 PDF

1 Scope This document describes a standardized methodology and framework for the development and representation of an ontology that supports a global, open-source approach to implementing the ISO standards on the identification of medicinal products (IDMP) ( ISO 11615 , ISO/TS 20443, ISO/TS 20451 , ISO 11238 ; ISO/TS 19844 , ISO 11239 , ISO/TS 20440 , and ISO 11240 ). Realization of the full potential of IDMP requires fully self-describing data. For this purpose, this document describes a methodology and framework that complements the existing conceptual and logical models in the ISO documents on IDMP with an IDMP ontology that enables deep, semantic interoperability based on findable, accessible, interoperable and reusable (FAIR) data principles. This methodology and framework enhance the usage of the IDMP data model as the foundation of medicinal product identification and will ultimately enable collaboration towards drug safety and overall operational efficiency.