标准摘要
[中文适用范围]： 本文件旨在提供与药品或药品组的识别相关的特定级别的信息。 它定义了监管信息交换所需的数据元素、结构和数据元素之间的关系，以便唯一地标识药品。 该标识将应用于整个产品生命周期，以支持全球的药物警戒、监管和其他活动。 此外，该文件对于确保药品信息以结构化格式组装并在不同利益相关者之间传输以实现监管和临床（例如电子处方、临床决策支持）目的至关重要。 这确保了发送者和接收者的互操作性和兼容性。 本文件无意对药品进行科学分类。 相反，它是按规定组合分类的特定数据元素的正式关联，并在信息的分级程度不完整时唯一标识。 这使得药品能够在全球范围内得到明确的识别。 第 2 条中包含对其他规范性 IDMP 和药品信息消息传递标准的引用，适用于本文件的上下文。 兽用药品不属于本文件的范围。 [外文原描述]： ISO 11616:2017 is intended to provide specific levels of information relevant to the identification of a Medicinal Product or group of Medicinal Products. It defines the data elements, structures and relationships between data elements that are required for the exchange of regulated information, in order to uniquely identify pharmaceutical products. This identification is to be applied throughout the product lifecycle to support pharmacovigilance, regulatory and other activities worldwide. In addition, ISO 11616:2017 is essential to ensure that pharmaceutical product information is assembled in a structured format with transmission between a diverse set of stakeholders for both regulatory and clinical (e.g. e-prescribing, clinical decision support) purposes. This ensures interoperability and compatibility for both the sender and the recipient. ISO 11616:2017 is not intended to be a scientific classification for pharmaceutical products. Rather, it is a formal association of particular data elements categorised in prescribed combinations and uniquely identified when levelling degrees of information are incomplete. This allows for Medicinal Products to be unequivocally identified on a global level. References to other normative IDMP and messaging standards for pharmaceutical product information are included in Clause 2, to be applied in the context of ISO 11616:2017. Medicinal products for veterinary use are out of scope of ISO 11616:2017.
英文名称Health informatics — Identification of medicinal products — Data elements and structures for unique identification and exchange of regulated pharmaceutical product information