Health informatics. Identification of medicinal products. Implementation guidelines for ISO 11239 data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of…
1 Scope
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 organization that might be responsible for developing and maintaining such controlled
vocabularies;
— any regional authorities or software vendors who want 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 standardized list of controlled
vocabularies;
— other users who want to understand the hierarchy of th...