ISO 11239:2012 specifies: · the 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 related to medicinal products; · a mechanism for the association of translations of a single concept into different languages; · 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 ISO 11239:2012 in a harmonized and meaningful way.