ČSN P CEN ISO/TS 21405

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. This document also describes a methodology for the agile adaptation of the ISO documents on IDMP in connection with cross-jurisdictional IDMP-related legislation and initiatives. This document is intended to be complementary to and independent from formal regulatory guidance. Thus, it enables cross-jurisdictional consistency and supports stakeholders in their regional implementations of IDMP standards. This document does not mandate any specific ontology as an implementation tool, nor is it an instructional guideline on how to build ontologies, which is out of scope of this document. This document includes key use cases described in the ISO documents on IDMP ISO 11615, ISO 11238 and ISO/TS 19844, as well as further use cases arising from the comprehensive deployment of the ISO documents on IDMP via an ontological framework. Thus, an ontology that represents the IDMP standards aims to cover the complete collection of ISO standards on IDMP regarding key interoperability issues that implementing stakeholders are facing.