This document describes data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging. Based on the principles outlined in this document, harmonised controlled terminologies will be developed according to an agreed maintenance process, allowing users to consult the terminologies and locate the appropriate terms for the concepts that they wish to describe. Provisions to allow for the mapping of existing regional terminologies to the harmonised controlled terminologies will also be developed in order to facilitate the identification of the appropriate terms. The codes provided for the terms can then be used in the relevant fields in the PhPID, PCID and MPID in order to identify those concepts. This document is intended for use by: any organisation that might be responsible for developing and maintaining such controlled vocabularies; any regional authorities or software vendors who wish to use the controlled vocabularies in their own systems and need to understand how they are created; owners of databases who want to map their own terms to a standardised list of controlled vocabularies; other users who want to understand the hierarchy of the controlled vocabularies in order to help identify the most appropriate term to describe a particular concept. This document does not specify a particular terminology for the implementation of ISO 11239.