标准摘要
[中文适用范围]: 本文件规定了: — 信息交换所需的数据元素、结构和数据元素之间的关系,这些信息元素、结构和关系可以唯一且确定地识别药品剂型、给药单位、给药途径和与药品相关的包装物品(容器、封盖和给药设备); — 将单一概念翻译关联到不同语言的机制,这是信息交换不可分割的一部分; — 对概念进行版本控制的机制,以追踪其发展; — 帮助区域主管部门以协调且有意义的方式将现有的区域术语映射到使用本文件创建的术语的规则。 [外文原描述]: This document specifies: — the data elements, structures and relationships between the data elements required for the exchange of information, which uniquely and with certainty identify pharmaceutical dose forms, units of presentation, routes of administration and packaging items (containers, closures and administration devices) related to medicinal products; — a mechanism for the association of translations of a single concept into different languages, which is an integral part of the information exchange; — a mechanism for the versioning of the concepts in order to track their evolution; — rules to help regional authorities to map existing regional terms to the terms created using this document, in a harmonized and meaningful way.
英文名称Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging