ISO/TS 20440:2023

TC ISO/TC 215
Date: 2022-08-25
TC /WG ISO/DTS 20440:2022(E)
Secretariat: ANSI
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

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ISO/DTS 20440:2022(E)
© ISO 2022
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-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland.
ii © ISO 2022 – All rights reserved

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ISO/DTS 20440:2022(E)
Contents Page
Foreword . v
Introduction . vi
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 Organisation 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 . 6
4.3 Versioning . 7
4.3.1 Versioning of the term . 7
4.3.2 Versioning of the terminology . 10
5 Terminologies . 11
5.1 General . 11
5.2 Pharmaceutical dose form . 11
5.2.1 Pharmaceutical dose form overview . 11
5.2.2 Pharmaceutical dose form schema . 12
5.2.3 Pharmaceutical dose form example: Prolonged-release tablet . 19
5.2.4 Using pharmaceutical dose form attributes directly . 24
5.3 Combined pharmaceutical dose form . 25
5.3.1 Combined pharmaceutical dose form overview . 25
5.3.2 Combined pharmaceutical dose form schema . 26
5.3.3 Combined pharmaceutical dose form example: Powder and solvent for solution for
injection . 27
5.3.4 Other authorised combinations of terms — Combined terms and combination packs . 29
5.4 Unit of presentation . 30
5.4.1 Unit of presentation overview . 30
5.4.2 Unit of presentation schema . 31
5.4.3 Unit of presentation example: Tablet . 31
5.5 Route of administration . 33
5.5.1 Route of administration overview . 33
5.5.2 Route of administration schema . 33
5.5.3 Route of administration example: Intravenous use . 33
5.6 Packaging . 34
5.6.1 Packaging overview . 34
5.6.2 Packaging schema . 34
5.6.3 Packaging example: Ampoule (Packaging category: Container) . 36
5.6.4 Packaging example: Screw cap (Packaging category: Closure) . 37
5.6.5 Packaging example: Oral syringe (Packaging category: Administration device) . 39
5.6.6 Packaging concept summaries . 40
6 Mapping of regional terms . 41
6.1 Differences in granularity between regional terminologies . 41
6.2 Organisation of regional terms in the database . 44
6.2.1 General . 44
6.2.2 Addition of regional terms to the database . 44
6.2.3 Mapping regional terms to standardised coded concepts . 47
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ISO/DTS 20440:2022(E)
6.2.4 Versioning of mapped regional terms . 47
6.2.5 Mapped regional term example: Extended-release caplet . 48
Bibliography . 49

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ISO/DTS 20440:2022(E)
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/directiveswww.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/patentswww.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.htmlwww.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 secondeditionsecond edition cancels and replaces the first edition (ISO/TS 20440:2016), which has
been technically revised.
The main changes are as follows:
— it is recommended thataddition of a recommendation to label administrable dose forms are
specifically labelled 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 maycan be used
directly, rather than simply serving to classify the pharmaceutical dose form;
— several examples have been updated to reflect genuine terms and definitions that are currently 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.htmlwww.iso.org/members.html.Introduction
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ISO/DTS 20440:2022(E)
Introduction
The terminologies described in EN/ISO 11239 (hereafter referred to as 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 standardised terminology to use for IDMP implementation.
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TECHNICAL SPECIFICATION ISO/DTS 20440:2022(E)

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
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 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 wishwant to map their own terms to a standardised list of controlled
vocabularies;
— other users who wishwant to understand the hierarchy of the controlled vocabularies in order to
help identify the most appropriate term to describe a particular concept.
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 may not remain
current; furthermore, examples provided in language/region combinations other than UK English are not
necessarily taken from the EDQM Standard Terms database. All examples must therefore be considered
as being for illustration purposes only.
Document type:
Document subtype:
Document stage:
Document language:


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ISO/DTS 20440:2022(E)
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 standardised terminology that must be used for IDMP
implementation. This document does not specify a particular terminology to be used for the
implementation of ISO 11239.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
No terms and definitions are listed in this document.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at https://www.electropedia.org/
4 Organisation of controlled terms
4.1 General
This clause describes how each controlled term is built, describing the data types used to convey the
information and the versioning requirements for tracking their creation and evolution. Clause 5 describes
the different types of terminologies and sub-vocabularies that use these data types, and any relevant
relationships between them.
Each field in Clause 4 is described under a separate subclause, consisting of the title of the field and a
table containing the following:
— "User Guidance", a description of the field;
— "Data Type", a description of the data type;
— "Conformance", a description of whether the field is mandatory, optional, or conditional;
— "Value Allowed", indicating the possible values for the field;
— "Business Rules", providing technical guidance for the field.
4.2 Code-term pair and coded concept
4.2.1 General
The code-term pair and the coded concept are the data types that are used to represent the information
that is required to describe each term in each terminology or sub-vocabulary, in each language/region
combination.
4.2.2 Code-term pair
4.2.2.1 Code-term pair overview
This is the underlying class for each term, and it is used to describe and define a term in a specific language
and for a specific region. It contains the core attributes for each concept, including the identifier, the
textual representation of the term (i.e. the controlled term itself), the definition, an optional domain to
indicate whether a term is restricted to veterinary use, an optional textual comment, and the language
and region codes.
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ISO/DTS 20440:2022(E)
Each controlled term or sub-term has a unique code-term pair for each language/region combination.
This combination of language and region allows for regional variants of a specific language to be catered
for; for example, where the spelling of a term or definition differs between UK English and US English, it
is possible to reflect this difference. Where terms and definitions already exist for a particular language
for a particular region, and the same language is used in a second region, it is a regional implementation
issue to decide whether terms and definitions need to be provided for the second region, or whether the
terms and definitions of the first region shallmust be used.
When a new concept is required, a new coded concept mustshall be created, and at least one code-term
pair is required in order to hold the data to describe the concept. The language/region combination
chosen to represent the "value" shall always be created first to represent the concept, even when the
request originates from a different language/region combination. The maintenance organisation shall
provide instructions on how to request a new term or a revision to an existing term.
4.2.2.2 Code-term pair: Code
User Guidance This field contains a unique, machine-readable identifier for the code-term pair.
In this document, the following format is used for the code:
— XXX-12345678-LL-RR
where
This field contains a unique, machine-readable identifier for the code-term pair.
User Guidance Merged Cells
In this document, the following format is used for the code:— XXX-
12345678-LL-RRwhere— XXX represents the class of term (see Table 1);
— 12345678 represents a unique 8-digit number; for sub-vocabularies, a 4-
digit number is used;
— LL represents the language code;
— RR represents the region/country code.
Data Type String
Conformance Mandatory
Value Allowed Free text
Business Rule(s) Each code-term pair shall have one code.
The codes used in this document to represent the various classes of term in the examples that follow are
shown in Table 1.
Table 1 — Codes used to represent the class of term
Code Class
SOM State of matter
BDF Basic dose form
RCA Release characteristics
TRA Transformation
ISI Intended site
AME Administration method
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ISO/DTS 20440:2022(E)
PDF Pharmaceutical dose form
CDF Combined pharmaceutical dose form
UOP Unit of presentation
ROA Route of administration
PCA Packaging category
CON Container
CLO Closure
DEV Administration device
MAP Mapped term
4.2.2.3 Code-term pair: Term
User Guidance This field contains the textual term description for the code-term pair.
Data Type String
Conformance Mandatory
Value Allowed Free text
Business Rule(s) Each code-term pair shall have one term.
4.2.2.4 Code-term pair: Definition
User Guidance This field contains the textual definition for the code-term pair. The definition is
as comprehensive as possible, in order to guide the user to the most
appropriate term to describe a given concept. For example, it should be detailed
enough to distinguish between similar pharmaceutical dose forms, and may
exceptionally make direct reference to related terms in order to exclude them,
although such references may be considered more appropriate in the
Comments section instead.
Data Type String
Conformance Mandatory for the default code-term pair; optional for the translation code-
term pairs
Value Allowed Free text
Business Rule(s) Each code-term pair may have one definition. For each coded concept, the
default code-term pair (e.g. EN-GB) shall have one definition. If a code-term pair
for a given language/region combination does not have a definition provided,
the definition in the code-term pair for the default language/region
combination is adopted.
4.2.2.5 Code-term pair: Domain
User Guidance This field is used to identify whether a term is considered appropriate for both
human and veterinary use, or whether it is considered appropriate for
veterinary use only.
Data Type Concept Descriptor
Conformance Optional
Value Allowed "Human and veterinary"; "Veterinary only"
Business Rule(s) Each code-term pair may have one domain. Although veterinary medicines are
outside the scope of IDMP, certain regions use a single terminology system to
cover both medicines for human use and medicines for veterinary use; this
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ISO/DTS 20440:2022(E)
optional field is therefore included in order to allow veterinary-only terms to
be easily distinguished in such systems.
4.2.2.6 Code-term pair: Comment
User Guidance This optional field contains a textual comment for the code-term pair. It is used
to provide to the user additional information and guidance that would not be
strictly appropriate to appear as part of the definition.
Data Type String
Conformance Optional
Value Allowed Free text
Business Rule(s) Each code-term pair may have one comment.
4.2.2.7 Code-term pair: Language code
User Guidance This field contains the language in which the term, definition and comment are
described; in this document, the working language is English. The language
code used is in lineaccordance with ISO 639-1.
Data Type Concept Descriptor
Conformance Mandatory
Value Allowed ISO 639-1 code, OID reference 1.0.639.1
Business Rule(s) Each code-term pair shall have one language code.
4.2.2.8 Code-term pair: Region code
User Guidance This field contains the region/country that uses this code-term pair, in the
language described above; it can be used to differentiate between regional
variants of that language; in this document, the default region is the United
Kingdom. The region code used is in lineaccordance with ISO 3166-1. Alpha-2
(i.e. 2-letter) codes are used. The additional code EU is also allowed to
represent the European Union. It should be noted that the United Kingdom is
represented in ISO 3166-1 by the 2-letter code GB, as in the examples used in
this document.
Data Type Concept Descriptor
Conformance Mandatory
Value Allowed ISO 3166-1 alpha-2 code, OID reference 1.0.3166.1.2.2.
Business Rule(s) Each code-term pair shall have one region code.
4.2.2.9 Code-term pair example
An example of a code-term pair for the concept "Tablet", a pharmaceutical dose form, is shown in Table 2.
Since the working language of this document is UK English, the language is English and the region is the
United Kingdom.
Table 2 — Example code-term pair for pharmaceutical dose form "Tablet" in UK English
Code PDF-10219000-EN-GB
Term Tablet
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ISO/DTS 20440:2022(E)
Solid single-dose uncoated preparation obtained by compressing uniform volumes of
particulate solids or by other means such as extrusion or moulding. Tablets include
single-layer tablets resulting from a single compression of particles and multi-layer
Definition tablets consisting of concentric or parallel layers obtained by successive compressions
of particles of different composition. Tablets are intended for oral use to release active
substance(s) in the gastrointestinal fluids by a rate depending essentially on the
intrinsic properties of the active substance(s) (conventional release).
languageCode EN
regionCode GB
4.2.3 Coded concept
4.2.3.1 Coded concept overview
This is the class that is used to represent the concept itself, and it is a collection of all of the code-term
pairs that define the same concept for each language/region combination. The code-term pairs for a given
concept can be considered as different translations of that concept; the coded concept groups those
various translations under a single, unique code. In order to represent the coded concept, one of the code-
term pairs is selected as the "value", while each other code-term pair is a "translation".
The use of a coded concept in another system allows for the identification of a concept without specifying
a particular language and region. The code-term pair selected as the "value" may be used by default to
represent the coded concept when a textual term is requested. The default code-term pair in this
document is English/United Kingdom. Where a language/region combination is specified by the
requesting system, the appropriate code-term pair for that combination can be used to represent the
coded concept.
As described in 4.2.2.1, when a new concept is required, a new coded concept mustshall be created, and
at least one code-term pair is required in order to hold the data to describe the concept. The
language/region combination chosen to represent the "value" mustshall always be created, even when
the request originates from a different language/region combination. The maintenance organisation shall
provide instructions on how to request a new term, as well as how to request a revision to an existing
term.
4.2.3.2 Coded concept: Code
User Guidance This field contains a unique, machine-readable identifier for the coded concept.
Data Type String
Conformance Mandatory
Value Allowed Free text
Business Rule(s) Each coded concept shall have one code.
4.2.3.3 Coded concept: Value
User Guidance This field contains the identifier of the code-term pair that has been chosen to
represent the coded concept. In this document this code-term pair is always
that of the English/United Kingdom combination.
Data Type String
Conformance Mandatory
Value Allowed Code-term pair identifier
Business Rule(s) Each coded concept shall have one value, which is considered to be its default
code-term pair. Whenever a new concept is created, the code-term pair with
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ISO/DTS 20440:2022(E)
the language/region combination that is chosen for the "value" shall always be
created first, even if the request is made for a different language/region
combination.
4.2.3.4 Coded concept: Translation
User Guidance This repeatable field contains the identifier of the code-term pair that
represents the concept using a language/region combination that is different
from that of the code-term pair used for the above coded concept value. In this
document, since the above value is always represented by English/United
Kingdom, these code-term pairs will represent combinations such as
English/United States, Japanese/Japan, French/France, etc.
Data Type String
Conformance Optional
Value Allowed Code-term pair identifier
Business Rule(s) Each coded concept may have zero to many translations.
4.2.3.5 Coded concept example
An example of a coded concept for the concept "Tablet" is shown in Table 3. Since the working language
of this document is UK English, the value is the code-term pair that has English as the language and United
Kingdom as the region (as shown in Table 2). In order to
...

FINAL
TECHNICAL ISO/DTS
DRAFT
SPECIFICATION 20440
ISO/TC 215
Health informatics — Identification
Secretariat: ANSI
of medicinal products —
Voting begins on:
2022-09-13 Implementation guidelines for ISO
11239 data elements and structures
Voting terminates on:
2022-12-06
for the unique identification and
exchange of regulated information on
pharmaceutical dose forms, units of
presentation, routes of administration
and packaging
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
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/DTS 20440:2022(E)
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. © ISO 2022

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ISO/DTS 20440:2022(E)
FINAL
TECHNICAL ISO/DTS
DRAFT
SPECIFICATION 20440
ISO/TC 215
Health informatics — Identification
Secretariat: ANSI
of medicinal products —
Voting begins on:
Implementation guidelines for ISO
11239 data elements and structures
Voting terminates on:
for the unique identification and
exchange of regulated information on
pharmaceutical dose forms, units of
presentation, routes of administration
and packaging
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
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.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
ISO copyright office
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
CP 401 • Ch. de Blandonnet 8
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
CH-1214 Vernier, Geneva
DOCUMENTATION.
Phone: +41 22 749 01 11
IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: copyright@iso.org
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/DTS 20440:2022(E)
Website: www.iso.org
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
Published in Switzerland
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN­
DARDS TO WHICH REFERENCE MAY BE MADE IN
ii
  © ISO 2022 – All rights reserved
NATIONAL REGULATIONS. © ISO 2022

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ISO/DTS 20440:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Organisation of controlled terms.2
4.1 General . 2
4.2 Code­term pair and coded concept . 2
4.2.1 General . 2
4.2.2 Code­term 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 Organisation 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 standardised coded concepts . 43
6.2.4 Versioning of mapped regional terms . 43
6.2.5 Mapped regional term example: Extended-release caplet .44
iii
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ISO/DTS 20440:2022(E)
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 non­governmental, 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.
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ISO/DTS 20440:2022(E)
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 standardised terminology to use for IDMP implementation.
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TECHNICAL SPECIFICATION ISO/DTS 20440:2022(E)
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
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 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 want to map their own terms to a standardised 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.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
No terms and definitions are listed in this document.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
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ISO/DTS 20440:2022(E)
4 Organisation of controlled terms
4.1 General
This clause describes how each controlled term is built, describing the data types used to convey
the information and the versioning requirements for tracking their creation and evolution. Clause 5
describes the different types of terminologies and sub-vocabularies that use these data types, and any
relevant relationships between them.
Each field in Clause 4 is described under a separate subclause, consisting of the title of the field and a
table containing the following:
— "User Guidance", a description of the field;
— "Data Type", a description of the data type;
— "Conformance", a description of whether the field is mandatory, optional, or conditional;
— "Value Allowed", indicating the possible values for the field;
— "Business Rules", providing technical guidance for the field.
4.2 Code-term pair and coded concept
4.2.1 General
The code-term pair and the coded concept are the data types that are used to represent the information
that is required to describe each term in each terminology or sub-vocabulary, in each language/region
combination.
4.2.2 Code-term pair
4.2.2.1 Code-term pair overview
This is the underlying class for each term, and it is used to describe and define a term in a specific
language and for a specific region. It contains the core attributes for each concept, including the
identifier, the textual representation of the term (i.e. the controlled term itself), the definition, an
optional domain to indicate whether a term is restricted to veterinary use, an optional textual comment,
and the language and region codes.
Each controlled term or sub-term has a unique code-term pair for each language/region combination.
This combination of language and region allows for regional variants of a specific language to be catered
for; for example, where the spelling of a term or definition differs between UK English and US English, it
is possible to reflect this difference. Where terms and definitions already exist for a particular language
for a particular region, and the same language is used in a second region, it is a regional implementation
issue to decide whether terms and definitions need to be provided for the second region, or whether the
terms and definitions of the first region must be used.
When a new concept is required, a new coded concept shall be created, and at least one code-term pair
is required in order to hold the data to describe the concept. The language/region combination chosen
to represent the "value" shall always be created first to represent the concept, even when the request
originates from a different language/region combination. The maintenance organisation shall provide
instructions on how to request a new term or a revision to an existing term.
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ISO/DTS 20440:2022(E)
4.2.2.2 Code-term pair: Code
User Guidance This field contains a unique, machine-readable identifier for the code-term pair.
In this document, the following format is used for the code:
— XXX­12345678­LL­RR
where
— XXX represents the class of term (see Table 1);
— 12345678 represents a unique 8-digit number; for sub-vocabularies, a
4-digit number is used;
— LL represents the language code;


— RR represents the region/country code.
Data Type String
Conformance Mandatory
Value Allowed Free text
Business Rule(s) Each code­term pair shall have one code.
The codes used in this document to represent the various classes of term in the examples that follow
are shown in Table 1.
Table 1 — Codes used to represent the class of term
Code Class
SOM State of matter
BDF Basic dose form
RCA Release characteristics
TRA Transformation
ISI Intended site
AME Administration method
PDF Pharmaceutical dose form
CDF Combined pharmaceutical dose form
UOP Unit of presentation
ROA Route of administration
PCA Packaging category
CON Container
CLO Closure
DEV Administration device
MAP Mapped term
4.2.2.3 Code-term pair: Term
User Guidance This field contains the textual term description for the code-term pair.
Data Type String
Conformance Mandatory
Value Allowed Free text
Business Rule(s) Each code­term pair shall have one term.
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ISO/DTS 20440:2022(E)
4.2.2.4 Code-term pair: Definition
User Guidance This field contains the textual definition for the code-term pair. The definition
is as comprehensive as possible, in order to guide the user to the most appropri­
ate term to describe a given concept. For example, it should be detailed enough
to distinguish between similar pharmaceutical dose forms, and may exception­
ally make direct reference to related terms in order to exclude them, although
such references may be considered more appropriate in the Comments section
instead.
Data Type String
Conformance Mandatory for the default code-term pair; optional for the translation code-
term pairs
Value Allowed Free text
Business Rule(s) Each code-term pair may have one definition. For each coded concept, the de­
fault code-term pair (e.g. EN-GB) shall have one definition. If a code-term pair
for a given language/region combination does not have a definition provided,
the definition in the code-term pair for the default language/region combina­
tion is adopted.
4.2.2.5 Code-term pair: Domain
User Guidance This field is used to identify whether a term is considered appropriate for both
human and veterinary use, or whether it is considered appropriate for veteri­
nary use only.
Data Type Concept Descriptor
Conformance Optional
Value Allowed "Human and veterinary"; "Veterinary only"
Business Rule(s) Each code-term pair may have one domain. Although veterinary medicines
are outside the scope of IDMP, certain regions use a single terminology system
to cover both medicines for human use and medicines for veterinary use; this
optional field is therefore included in order to allow veterinary-only terms to be
easily distinguished in such systems.
4.2.2.6 Code-term pair: Comment
User Guidance This optional field contains a textual comment for the code-term pair. It is used
to provide to the user additional information and guidance that would not be
strictly appropriate to appear as part of the definition.
Data Type String
Conformance Optional
Value Allowed Free text
Business Rule(s) Each code-term pair may have one comment.
4.2.2.7 Code-term pair: Language code
User Guidance This field contains the language in which the term, definition and comment are
described; in this document, the working language is English. The language
code used is in accordance with ISO 639­1.
Data Type Concept Descriptor
Conformance Mandatory
Value Allowed ISO 639­1 code, OID reference 1.0.639.1
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ISO/DTS 20440:2022(E)
Business Rule(s) Each code­term pair shall have one language code.
4.2.2.8 Code-term pair: Region code
User Guidance This field contains the region/country that uses this code-term pair, in the
language described above; it can be used to differentiate between regional
variants of that language; in this document, the default region is the United
Kingdom. The region code used is in accordance with ISO 3166-1. Alpha-2 (i.e.
2­letter) codes are used. The additional code EU is also allowed to represent the
European Union. It should be noted that the United Kingdom is represented in
ISO 3166-1 by the 2-letter code GB, as in the examples used in this document.
Data Type Concept Descriptor
Conformance Mandatory
Value Allowed ISO 3166­1 alpha­2 code, OID reference 1.0.3166.1.2.2.
Business Rule(s) Each code­term pair shall have one region code.
4.2.2.9 Code-term pair example
An example of a code-term pair for the concept "Tablet", a pharmaceutical dose form, is shown in
Table 2. Since the working language of this document is UK English, the language is English and the
region is the United Kingdom.
Table 2 — Example code-term pair for pharmaceutical dose form "Tablet" in UK English
Code PDF-10219000-EN-GB
Term Tablet
Solid single-dose uncoated preparation obtained by compressing uniform volumes of
particulate solids or by other means such as extrusion or moulding. Tablets include sin­
gle-layer tablets resulting from a single compression of particles and multi-layer tablets
Definition consisting of concentric or parallel layers obtained by successive compressions of particles
of different composition. Tablets are intended for oral use to release active substance(s) in
the gastrointestinal fluids by a rate depending essentially on the intrinsic properties of the
active substance(s) (conventional release).
languageCode EN
regionCode GB
4.2.3 Coded concept
4.2.3.1 Coded concept overview
This is the class that is used to represent the concept itself, and it is a collection of all of the code­term
pairs that define the same concept for each language/region combination. The code-term pairs for a
given concept can be considered as different translations of that concept; the coded concept groups
those various translations under a single, unique code. In order to represent the coded concept, one of
the code­term pairs is selected as the "value", while each other code­term pair is a "translation".
The use of a coded concept in another system allows for the identification of a concept without
specifying a particular language and region. The code-term pair selected as the "value" may be used
by default to represent the coded concept when a textual term is requested. The default code-term pair
in this document is English/United Kingdom. Where a language/region combination is specified by the
requesting system, the appropriate code-term pair for that combination can be used to represent the
coded concept.
As described in 4.2.2.1, when a new concept is required, a new coded concept shall be created, and at
least one code-term pair is required in order to hold the data to describe the concept. The language/
region combination chosen to represent the "value" shall always be created, even when the request
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ISO/DTS 20440:2022(E)
originates from a different language/region combination. The maintenance organisation shall provide
instructions on how to request a new term, as well as how to request a revision to an existing term.
4.2.3.2 Coded concept: Code
User Guidance This field contains a unique, machine-readable identifier for the coded concept.
Data Type String
Conformance Mandatory
Value Allowed Free text
Business Rule(s) Each coded concept shall have one code.
4.2.3.3 Coded concept: Value
User Guidance This field contains the identifier of the code-term pair that has been chosen to
represent the coded concept. In this document this code-term pair is always
that of the English/United Kingdom combination.
Data Type String
Conformance Mandatory
Value Allowed Code-term pair identifier
Business Rule(s) Each coded concept shall have one value, which is considered to be its default
code­term pair. Whenever a new concept is created, the code­term pair with
the language/region combination that is chosen for the "value" shall always be
created first, even if the request is made for a differe
...