ISO/DTR 14872

Health informatics — Identification of medicinal products — Core principles for maintenance of identifiers and terms

The purpose of this document is to describe the core principles and proposed service delivery model for supporting implementation and ongoing maintenance of IDMP terminologies. The information provided in this document can be used as evaluation and/or design criteria when considering current or future operations and service level agreements for systems and terminology support services in conformity with IDMP.

Informatique de santé — Identification des médicaments — Principes essentiels pour la mise à jour des identifiants et des termes

General Information

• Status: Not Published
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ISO/TC 215 - Health informatics
• Drafting Committee: ISO/TC 215 - Health informatics
• Current Stage: 6000 - International Standard under publication

Relations

• Revises: ISO/TR 14872:2019 - Health informatics — Identification of medicinal products — Core principles for maintenance of identifiers and terms
• Effective Date: 28-Jan-2023

Standards Content (Sample)

FINAL DRAFT
Technical
Report
ISO/TC 215
Health informatics — Identification
Secretariat: ANSI
of medicinal products — Core
Voting begins on:
principles for maintenance of
2025-05-16
identifiers and terms
Voting terminates on:
2025-07-11
Informatique de santé — Identification des médicaments —
Principes essentiels pour la mise à jour des identifiants et des
termes
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
FINAL DRAFT
Technical
Report
ISO/TC 215
Health informatics — Identification
Secretariat: ANSI
of medicinal products — Core
Voting begins on:
principles for maintenance of
identifiers and terms
Voting terminates on:
Informatique de santé — Identification des médicaments —
Principes essentiels pour la mise à jour des identifiants et des termes
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2025
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms . 2
5 Maintenance of International Standards on IDMP — description of existing relationships
between regulators and other standards development organizations . 3
6 IDMP terminology maintenance . 3
6.1 IDMP maintenance organizations at global level .3
6.2 Core data within IDMP and data that is “derived” .3
7 Current maintenance processes. 4
7.1 Generic description of governance and maintenance process .4
7.2 Governance and maintenance: substances and Global Pharmaceutical Product
Identifier (PhPID) .4
7.3 Governance and maintenance: pharmaceutical dose forms .5
7.4 Governance and maintenance: units of measurement .6
7.5 Governance for SNOMED interactions with IDMP .7
7.6 Governance for MedDRA .7
7.7 Governance for Anatomical Therapeutic Chemical (ATC) classification system and
Defined Daily Dose (DDD) . . .8
7.8 Governance for International Nonproprietary Names (INN) .9
7.9 Governance for GS1 .10
8 IDMP core maintenance processes .11
8.1 General .11
8.2 General processes .11
8.3 Terminology processes . 12
8.4 Unambiguity . 12
9 International mapping and language translations .12
10 Integration of IDMP core with data sources that are considered “derived” .12
Bibliography . 14

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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.).
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.
This second edition cancels and replaces the first edition (ISO/TR 14872:2019), which has been technically
revised.
The main changes are as follows:
— the focus on describing the current (2024) implementation experiences and processes has been
strengthened;
— references to a “federated service delivery model” have been removed, since this remains inspirational
and does not correspond to the current practice;
— information about operating models (governance) of existing maintenance organizations impacting
IDMP on a global level has been included.
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 www.iso.org/members.html.

iv
Introduction
This document describes the core operating principles and presents a description of the current service
delivery models for terminology and identifier maintenance services in support of five International
[1] [2] [3]
Standards on the Identification of Medicinal Products (IDMP), i.e. ISO 11615 , ISO 11616 , ISO 11238 ,
[4] [5]
ISO 11239 , ISO 11240 . Collectively, the International Standards on IDMP provide the basis for data
collection and information exchange about key medicinal product characteristics that support the unique
and unambiguous identification of medicinal products for a variety of regulatory and business objectives
and use cases, with a global focus. The document includes descriptions of maintenance and governance
processes for a number of organizations that can be involved in the provision of core and derived data.
Since the International Standards on IDMP can be applied to a broad range of use cases, (e.g. regulatory
product applications, product registration, creation of medicinal product dictionaries, etc.), description of
common coordination and maintenance principles is critical to help ensure consistent adoption, use and
maintenance of the International Standards associated with IDMP.
Currently, many organizations serve as data owners or terminology service providers in several
jurisdictions. These organizations maintain and distribute their own medicinal product terminology
which does not necessarily fully correspond to terminology mapping and format criteria described in
[6] [7] [8] [9]
Technical Specifications on IDMP (i.e. ISO/TS 20443 , ISO/TS 20451 , ISO/TS 19844 , ISO/TS 20440 ).
It is recognized that a neutral, factual, description of operating principles for global identification and
terminology maintenance not only facilitates a harmonized approach to IDMP implementation globally, but
provides guidance for regional and local service providers to make use of these descriptions.
Since IDMP standards are in the process of adoption internationally, it is anticipated that this document
will be periodically revised to reflect real-world experience in how the information models, data elements
and their associated terminologies are used, as well as to accommodate any potential gaps in mapping,
translation and governance for specific IDMP terminology domains (e.g. substance/specified substance,
dosage form, route of administration).
This document leverages and complements several ISO and joint ISO/IEC specifications, guiding principles
and processes that are exhibited by developers of healthcare terminologies in support of international
healthcare terminology standardization, information technology service management and the design
[10]
and maintenance of quality systems. The applicable International Standards are ISO/IEC 20000-1 ,
[11] [12]
ISO/IEC 20000-2 and ISO/IEC 33002 .
The intended audience for this document includes:
— organizations that have already created or are maintaining IDMP terminologies;
— organizations seeking an opportunity to support creation and/or dissemination of IDMP terminologies;
— organizations interested in implementing or applying the International Standards on IDMP (e.g. technical
format or scientific content, or both) to their internal processes and systems in support of regulatory or
healthcare-related business;
— regulators, pharmaceutical/biopharmaceutical companies, clinical resear
...

ISO/IEC/IEEE/CD 14872(en)
First edition
Stage: 30.60
Date: 2024-11-15
ISO/IEC JTC 1/SC 7
ISO/TC 215
Secretariat: ANSI
Date: 2025-04-29
Health informatics — Identification of medicinal products — Core
principles for maintenance of identifiers and terms
Informatique de santé — Identification des médicaments — Principes essentiels pour la mise à jour des
identifiants et des termes
ISO/CD TRDTR 14872:2025(en)
© ISO/IEC 2024
© IEEE 2024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication
may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying,
or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO
at the address below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
E-mail: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO/CD TRDTR 14872:2025(en)
iii
ISO/CD TRDTR 14872:2025(en)
Contents
Foreword . v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms . 2
5 Maintenance of International Standards on IDMP — description of existing relationships
between regulators and other standards development organizations . 3
6 IDMP terminology maintenance . 3
7 Current maintenance processes . 4
8 IDMP core maintenance processes . 13
9 International mapping and language translations . 14
10 Integration of IDMP core with data sources that are considered “derived” . 14
Bibliography . 17

iv
ISO/CD TRDTR 14872:2025(en)
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 drawnISO draws attention to the possibility that some of the elementsimplementation of this
document may beinvolve the subjectuse of (a) patent(s). ISO takes no position concerning the evidence,
validity or applicability of any claimed patent rights in respect thereof. As of the date of publication of this
document, ISO had not received notice of (a) patent(s) which may be required to implement this document.
However, implementers are cautioned that this may not represent the latest information, which may be
obtained from the patent database available at www.iso.org/patents. 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 ).).
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'sISO’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).
The This second edition cancels and replaces the first edition (ISO/TR 14872:2019)), which has been
technically revised and is hereby nullified and superseded by this second edition.
The main changes to the previous edition are outlined as follows:
— Strengthen the focus on describing the current (2024) implementation experiences and processes. has
been strengthened;
— Eliminate the references to a "“federated service delivery model"” have been removed, since this remains
inspirational and does not correspond to the current practice.;
— Include information about operating models (governance) of existing maintenance organizations
impacting IDMP on a global level has been included.
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 www.iso.org/members.html.
v
ISO/CD TRDTR 14872:2025(en)
Introduction
This document describes the core operating principles and presents a description of the current service
delivery models for terminology and identifier maintenance services in support of five International Standards
[1] [2] [3] [4]
on the Identification of Medicinal Products (IDMP), i.e. ISO 11615 , ISO 11616 , ISO 11238 , ISO 11239 ,
[5]
ISO 11240 . Collectively, the International Standards on IDMP provide the basis for data collection and
information exchange about key medicinal product characteristics that support the unique and unambiguous
identification of medicinal products for a variety of regulatory and business objectives and use cases, with a
global focus. The document includes descriptions of maintenance and governance processes for a number of
organizations that maycan be involved in the provision of core and derived data.
Since the International Standards on IDMP can be applied to a broad range of use cases, (e.g.,. regulatory
product applications, product registration, creation of medicinal product dictionaries, etc.), description of
common coordination and maintenance principles is critical to help ensure consistent adoption, use and
maintenance of the International Standards associated with IDMP.
Currently, many organizations serve as data owners or terminology service providers in several jurisdictions.
These organizations maintain and distribute their own medicinal product terminology which maydoes not
necessarily fully correspond to terminology mapping and format criteria described in Technical Specifications
[6] [7] [8] [9]
on IDMP (i.e. ISO/TS 20443 , ISO/TS 20451 , ISO/TS 19844 , ISO/TS 20440 ). It is recognized that a
neutral, factual, description of operating principles for global identification and terminology maintenance not
only facilitates a harmonized approach to IDMP implementation globally, but provides guidance for regional
and local service providers to make use of these descriptions.
Since IDMP standards are in the process of adoption internationally, it is anticipated that this document will
be periodically revised to reflect real-world experience in how the information models, data elements and
their associated terminologies are used, as well as to accommodate any potential gaps in mapping, translation
and governance for specific IDMP terminology domains (e.g. substance/specified substance, dosage form,
route of administration).
This document leverages and complements several ISO and joint ISO/IEC specifications, guiding principles
and processes that are exhibited by developers of healthcare terminologies in support of international
healthcare terminology standardization, information technology service management and the design and
[10]
maintenance of quality systems. The applicable International Standards are ISO/IEC 20000-1 ,
[11] [12]
ISO/IEC 20000-2 and ISO/IEC 33002 .
The intended audience for this document includes the following:
— Organizations whoorganizations that have already created or are maintaining IDMP terminologies;
— Organizationsorganizations seeking an opportunity to support creation and/or dissemination of IDMP
terminologies;
— Organizationsorganizations interested in implementing or applying the International Standards on IDMP
(e.g. technical format and/or scientific content, or both) to their internal processes and systems in support
of regulatory or healthcare-related business; and
— Regulatorsregulators, pharmaceutical/biopharmaceutical companies, Clinicalclinical research
organizations (CROs) and universities/scientific institutes involved in the development, authorization and
marketing of medicinal products.
vi
Health informatics — Identification of medicinal products — Core
principles for maintenance of identifiers and terms
1 Scope
The scope of thisThis document is to describedescribes the core principles for supporting the development,
implementation and ongoing maintenance of IDMP identifiers and terminologies.
The information provided in thisThis document is guidanceprovides considerations for the evaluation and/or
design when considering current or future operations and service level agreements for systems and
terminology support services in conformity with IDMP.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminologicalterminology databases for use in standardization at the following
addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
3.1
controlled vocabulary
finite list of values that represent the only allowed values for a data item
Note 1 to entry: These values can be codes, text, or numeric.
Note 2 to entry: It includes the use of a taxonomy to classify terms into parent/child or broad-to-narrow relationships.
The terms within a taxonomy can be referred to as a sub-vocabulary.
3.2
data owner
organization that is in the position to obtain, create, and have significant control over the content, access and
distribution of data
3.3
data governance
process focused on managing the quality, consistency, usability, security, and availability of information
Note 1 to entry: This process is closely linked to the notions of data ownership and stewardship.
3.4
maintenance organization
formal and recognized group or legal business entity involved in the direct or indirect provision of terminology
services such as the creation, reconciliation, maintenance and distribution of IDMP controlled vocabularies
3.5
use case
description of a sequence of interactions between a user and a system (e.g. IT or business process component)
used to help identify, clarify, and organize requirements to support a specific business goal
4.0
value set
uniquely identifiable set of values consisting of concept representations drawn from one or more code
systems, which can be resolved at a given point in time to an exact set of codes
74 Abbreviated terms
The following abbreviations are used in this document.
ATC anatomical therapeutic chemical
CDISC Clinicalclinical data interchange standards consortium
CEN European committee for standardization
DDD defined daily dose
GS1 Globalglobal standards one
IDMP Identificationidentification of medicinal products
SDO Standardsstandards development organization
SMS Serviceservice management system
SNOMED CT SNOMED clinical terminology
TC Technicaltechnical committee
UCUM Unifiedunified code for units of measure
EDQM European directorate for the quality of medicines & healthcare
ST Standardstandard terms
ST WP Standardstandard terms working party
GSID Globalglobal substance identifier
PhPID Globalglobal pharmaceutical product identifier
HDS Healthhealth data standards
LOINC Logicallogical observation identifiers names and codes
MedDRA Medicalmedical dictionary for regulatory activities
ICH Internationalinternational council for harmonisation of technical requirements for
pharmaceuticals for Human Usehuman use
MSSO Maintenancemaintenance and support services organization
QMS Qualityquality management system
ATC Anatomicalanatomical therapeutic chemical
DDD Defineddefined daily doses
AIDC Automaticautomatic identification and data capture
EPC Electronicelectronic
...