ONR CEN ISO/TS 20440

This Technical Specification 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 Technical Specification, 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 Technical Specification 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 wish to map their own terms to a central list of controlled vocabularies; - other users who wish to understand the hierarchy of the controlled vocabularies in order to help identify the most appropriate term to describe a particular concept. The terminology to be applied in the context of this Technical Specification and set out in ISO 11239 is under development. All codes, terms and definitions used as examples in this Technical Specification are provided for illustration purposes only, and are not intended to represent the final terminology.