Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO 11615:2017)

This International Standard: — specifies rules for the usage and coded representation of units of measurement for the purpose of exchanging information about quantitative medicinal product characteristics that require units of measurement (e.g. strength) in the human medicine domain; — establishes requirements for units in order to provide traceability to international metrological standards; — provides rules for the standardized and machine-readable documentation of quantitative composition and strength of medicinal products, specifically in the context of medicinal product identification; — defines the requirements for the representation of units of measurement in coded form; — provides structures and rules for mapping between different unit vocabularies and language translations to support the implementation of this International Standard, taking into account that existing systems, dictionaries and repositories use a variety of terms and codes for the representation of units. The scope of this International Standard is limited to the representation of units of measurement for data interchange between computer applications.

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.

This document provides an information model to define and identify substances within medicinal products or substances used for medicinal purposes, including dietary supplements, foods and cosmetics. The information model can be used in the human and veterinary domain since the principles are transferrable. Other standards and external terminological resources are referenced that are applicable to this document.

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.