DANSK DSF/PREN ISO 11239 PDF

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 allow regional authorities to map existing regional terms to the terms created using this document, in a harmonised and meaningful way. In addition, to support the successful application of this document, references to documents concerned with identification of medicinal products (IDMP) and messaging for medicinal product information are provided as required.