ISO/TS 20440:2023
(Main)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 presentation, routes of administration and packaging
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 presentation, routes of administration and packaging
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 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.
Informatique de santé — Identification des produits médicaux — Guide de mise en œuvre des éléments de données et structures pour l'identification unique et l'échange d'informations réglementées sur les formes des doses pharmaceutiques, les unités de présentation, les voies d'administration et les emballages de l'ISO 11239
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Standards Content (Sample)
TECHNICAL ISO/TS
SPECIFICATION 20440
Second edition
2023-03
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
presentation, routes of administration
and packaging
Informatique de santé — Identification des produits médicaux —
Guide de mise en œuvre des éléments de données et structures pour
l'identification unique et l'échange d'informations réglementées sur
les formes des doses pharmaceutiques, les unités de présentation, les
voies d'administration et les emballages de l'ISO 11239
Reference number
© ISO 2023
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Published in Switzerland
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Organization of controlled terms . 2
4.1 General . 2
4.2 Code-term pair and coded concept . 2
4.2.1 General . 2
4.2.2 Code-term pair . 2
4.2.3 Coded concept . 5
4.3 Versioning . 7
4.3.1 Versioning of the term . 7
4.3.2 Versioning of the terminology . 10
5 Terminologies .10
5.1 General . 10
5.2 Pharmaceutical dose form . 10
5.2.1 Pharmaceutical dose form overview . 10
5.2.2 Pharmaceutical dose form schema . 11
5.2.3 Pharmaceutical dose form example: Prolonged-release tablet . 17
5.2.4 Using pharmaceutical dose form attributes directly .22
5.3 Combined pharmaceutical dose form . 23
5.3.1 Combined pharmaceutical dose form overview .23
5.3.2 Combined pharmaceutical dose form schema . 24
5.3.3 Combined pharmaceutical dose form example: Powder and solvent for
solution for injection . 25
5.3.4 Other authorised combinations of terms — Combined terms and
combination packs . 26
5.4 Unit of presentation .28
5.4.1 Unit of presentation overview .28
5.4.2 Unit of presentation schema .28
5.4.3 Unit of presentation example: Tablet .29
5.5 Route of administration . 30
5.5.1 Route of administration overview .30
5.5.2 Route of administration schema .30
5.5.3 Route of administration example: Intravenous use . 31
5.6 Packaging . 31
5.6.1 Packaging overview . 31
5.6.2 Packaging schema . 31
5.6.3 Packaging example: Ampoule (Packaging category: Container) .33
5.6.4 Packaging example: Screw cap (Packaging category: Closure) .34
5.6.5 Packaging example: Oral syringe (Packaging category: Administration
device) . 36
5.6.6 Packaging concept summaries. 37
6 Mapping of regional terms .38
6.1 Differences in granularity between regional terminologies .38
6.2 Organization of regional terms in the database .40
6.2.1 General .40
6.2.2 Addition of regional terms to the database .40
6.2.3 Mapping regional terms to standardized coded concepts . 43
6.2.4 Versioning of mapped regional terms . 43
6.2.5 Mapped regional term example: Extended-release caplet .44
iii
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics, in collaboration
with the European Committee for Standardization (CEN) Technical Committee CEN/TC 251, Health
informatics, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna
Agreement).
This second edition cancels and replaces the first edition (ISO/TS 20440:2016), which has been
technically revised.
The main changes are as follows:
— addition of a recommendation to label administrable dose forms as such, to distinguish them from
those pharmaceutical dose forms that are only manufactured dose forms;
— a section has been added describing how pharmaceutical dose form attributes can be used directly,
rather than simply serving to classify the pharmaceutical dose form;
— several examples have been updated to reflect terms and definitions that are in use.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at http://www.iso.org/members.html.
iv
Introduction
The terminologies described in ISO 11239 and in this document are essential for the implementation of
the IDMP standards as a whole.
Each region traditionally uses its own sets of terminologies to describe the concepts covered in
ISO 11239 within their regions; these terminologies are not harmonised with those of the other regions.
Therefore, harmonised controlled terminologies need to be provided to ensure that all regions can
refer to a given concept in the same manner. The purpose of this document is to describe how these
controlled vocabularies are constructed and illustrate their use for ISO 11239 implementation.
A number of the codes, terms and definitions used as examples in this document are taken from the
Standard Terms database of the European Directorate for the Quality of Medicines & HealthCare,
Council of Europe (EDQM), specifically those for UK English (EN-GB). The EDQM Standard Terms
database is not static and its content changes over time, so the examples provided in this document
might not remain current; furthermore, examples provided in language/region combinations other
than UK English are not necessarily taken from the EDQM Standard Terms database.
The EDQM Standard Terms database is an example of an implementation of ISO 11239, but reference to it
in this document does not imply that it is the standardized terminology to use for IDMP implementation.
v
TEC
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