BS PD CEN ISO/TS 20440:2016

BS PD CEN ISO/TS 20440:2016 describes data elements and structures for the unique identification andexchange of regulated information on pharmaceutical dose forms, units of presentation, routes ofadministration and packaging.Based on the principles outlined in this Technical Specification, harmonised controlled terminologieswill be developed according to an agreed maintenance process, allowing users to consult theterminologies and locate the appropriate terms for the concepts that they wish to describe. Provisionsto allow for the mapping of existing regional terminologies to the harmonised controlled terminologieswill also be developed in order to facilitate the identification of the appropriate terms. The codesprovided for the terms can then be used in the relevant fields in the PhPID, PCID and MPID in order toidentify those concepts.This Technical Specification is intended for use by:

• any organisation that might be responsible for developing and maintaining such controlledvocabularies;
• any regional authorities or software vendors who wish to use the controlled vocabularies in theirown 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 helpidentify 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 isunder development. All codes, terms and definitions used as examples in this Technical Specificationare provided for illustration purposes only, and are not intended to represent the final terminology.Cross References:ISO 639-1ISO 3166-1ISO 8601ISO/TR 14872ISO 11239:2012