ČSN EN ISO 11239

This document specifies: - the data elements, structures and relationships between the data elements required for the exchange of in-formation, 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 in-tegral 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.