ISO 11616:2017旨在提供与药品或药品组标识相关的特定级别的信息。它定义了交换受监管信息所需的数据元素、结构和数据元素之间的关系，以便唯一地识别药品。该标识将应用于整个产品生命周期，以支持全球范围内的药物警戒、监管和其他活动。此外，ISO 11616:2017对于确保药品信息以结构化格式进行组装，并在不同利益相关者之间进行传输，以达到监管和临床（如电子处方、临床决策支持）的目的至关重要。这确保了发送方和接收方的互操作性和兼容性。 ISO 11616:2017不是药品的科学分类。相反，它是特定数据元素的正式关联，这些数据元素按规定的组合进行分类，并在信息水平不完整时唯一识别。这使得医药产品能够在全球范围内得到明确的识别。 第2条包含了药品信息的其他规范性IDMP和消息传递标准的参考，将在ISO 11616:2017的背景下应用。 兽医用医药产品不在ISO 11616:2017的范围内。

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.