本文件描述了一种用于开发和表示本体的标准化方法和框架，该本体支持采用全球开源方法来实施ISO药品鉴定标准（IDMP）（ISO 11615、ISO/TS 20443、ISO/TS 20451、ISO 11238；ISO/TS 19844、ISO 11239、ISO/TS 20440和ISO 11240）。实现IDMP的全部潜力需要完全自我描述的数据。为此，本文档描述了一种方法和框架，该方法和框架用IDMP本体补充了ISO IDMP文档中现有的概念和逻辑模型，该本体支持基于可查找、可访问、可互操作和可重用（FAIR）数据原则的深度语义互操作性。该方法和框架增强了IDMP数据模型作为药品识别基础的使用，并最终将实现药物安全和整体运营效率的协作。本文件还描述了一种方法，用于根据跨管辖区的IDMP相关立法和倡议灵活调整ISO IDMP文件。本文件旨在补充和独立于正式的监管指南。因此，它实现了跨辖区的一致性，并支持利益相关者在区域内实施IDMP标准。本文档没有强制要求任何特定的本体作为实现工具，也不是关于如何构建本体的指导性指南，这超出了本文档的范围。 本文档包括关于IDMP ISO 11615、ISO 11238和ISO/TS 19844的ISO文档中描述的关键用例，以及通过本体框架全面部署关于IDMP的ISO文档所产生的进一步用例。因此，代表IDMP标准的本体旨在涵盖关于IDMP的ISO标准的完整集合，这些标准涉及实现涉众所面临的关键互操作性问题。

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.