EN ISO 11239:2023

SLOVENSKI STANDARD
01-september-2023
Nadomešča:
SIST EN ISO 11239:2013
Zdravstvena informatika - Identifikacija medicinskih izdelkov - Elementi in zgradba
podatkov za enotno identifikacijo in izmenjavo predpisanih informacij na obrazcih
o farmacevtskih odmerkih, predstavitvenih enotah, administrativnih poteh in
pakiranju (ISO 11239:2023)
Health informatics - Identification of medicinal products - 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 (ISO
11239:2023)
Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und -
strukturen zur Identifikation von pharmazeutischen Darreichungsformen,
pharmazeutischen Konventionseinheiten, Anwendungsarten und Verpackungen (ISO
11239:2023)
Informatique de santé - Identification des médicaments - Éléments de données et
structures pour l'identification unique et l'échange d'informations réglementées sur les
formes pharmaceutiques, les unités de présentation, les voies d'administration et les
emballages (ISO 11239:2023)
Ta slovenski standard je istoveten z: EN ISO 11239:2023
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 11239
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2023
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes EN ISO 11239:2012
English Version
Health informatics - Identification of medicinal products -
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 (ISO 11239:2023)
Informatique de santé - Identification des médicaments Medizinische Informatik - Identifikation von
- Éléments de données et structures pour Arzneimitteln - Datenelemente und -strukturen zur
l'identification unique et l'échange d'informations Identifikation von pharmazeutischen
réglementées sur les formes pharmaceutiques, les Darreichungsformen, pharmazeutischen
unités de présentation, les voies d'administration et les Konventionseinheiten, Anwendungsarten und
emballages (ISO 11239:2023) Verpackungen (ISO 11239:2023)
This European Standard was approved by CEN on 9 May 2023.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11239:2023 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 11239:2023) has been prepared by Technical Committee ISO/TC 215 "Health
informatics" in collaboration with Technical Committee CEN/TC 251 “Health informatics” the
secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by December 2023, and conflicting national standards
shall be withdrawn at the latest by December 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 11239:2012.

Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 11239:2023 has been approved by CEN as EN ISO 11239:2023 without any modification.

INTERNATIONAL ISO
STANDARD 11239
Second edition
2023-06
Health informatics — Identification
of medicinal products — 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 médicaments — Éléments
de données et structures pour l'identification unique et l'échange
d'informations réglementées sur les formes pharmaceutiques, les
unités de présentation, les voies d'administration et les emballages
Reference number
ISO 11239:2023(E)
ISO 11239:2023(E)
© ISO 2023
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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 11239:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and abbreviated terms . 1
3.1 Terms and definitions . 1
3.2 Abbreviated terms . 6
4 Requirements . 7
4.1 General information regarding controlled vocabularies . 7
4.2 Requirements for use . 7
5 Schema . 7
5.1 General . 7
5.2 Conceptual models — Supporting concepts . 8
5.2.1 General . 8
5.2.2 Terms and codes . 8
5.3 Conceptual models — High-level concepts . 11
5.3.1 General . 11
5.3.2 Pharmaceutical dose form . 11
5.3.3 Unit of presentation .15
5.3.4 Route of administration . 16
5.3.5 Packaging . 17
Annex A (informative) Examples of controlled vocabularies .18
Annex B (informative) Examples of controlled vocabularies to describe medicinal products .24
Bibliography .29
iii
ISO 11239:2023(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 document 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, 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 11239:2012), which has been technically
revised.
The main changes are as follows:
— it is now specified that pharmaceutical dose form attributes can in some cases be used directly in
order to describe features of a medicinal product, rather than just serving as internal attributes to
classify the pharmaceutical dose form.
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
ISO 11239:2023(E)
Introduction
This document was developed in response to a worldwide demand for internationally harmonized
specifications for medicinal products. It is one of a group of five International Standards, which together
provide the basis for the unique identification of medicinal products; the four other International
Standards are ISO 11615, ISO 11616, ISO 11238 and ISO 11240.
These International Standards on the identification of medicinal products (IDMP) can be used in the
activities of medicines regulatory agencies worldwide. These include a variety of regulatory activities
related to development, registration and life cycle management of medicinal products, as well as
pharmacovigilance and risk management.
The International Standards on IDMP therefore can be used in the following interactions (this is not an
exhaustive list):
— regulator to regulator;
— pharmaceutical company to regulator;
— sponsor of clinical trial to regulator;
— regulator to other stakeholders;
— regulator to worldwide-maintained data sources.
The necessary messaging specifications are included as an integral part of the International Standards
on IDMP to secure the interactions above.
Unique identifiers produced in conformance with the International Standards on IDMP are aimed at
supporting applications where it is needed to reliably identify and trace the use of medicinal products.
There are many terms in use to describe basic concepts in the regulatory, pharmaceutical and
healthcare standards development domain for different purposes and in different contexts.
In the context of identification of pharmaceutical dose forms, units of presentation, routes of
administration and packaging, this document describes the essential elements for the specification,
translation and versioning of the specified controlled terms. Also described are recommendations
concerning the mapping of terms that are already used by stakeholders to the concepts arising from the
implementation of this document.
The high-level concepts described consist of:
— pharmaceutical dose form;
— unit of presentation;
— route of administration;
— packaging.
The supporting, more mechanical, components are described separately from the high-level clinical
concepts. The supporting concepts consist of:
a) terms and codes;
b) translations;
c) versioning;
d) mapping.
v
INTERNATIONAL STANDARD ISO 11239:2023(E)
Health informatics — Identification of medicinal
products — 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 specifies:
— the data elements, structures and relationships between the data elements required for the
exchange of information, which uniquely and with certainty identify pharmaceutical dose forms,
units of presentation, routes of administration and packaging items (containers, closures and
administration devices) related to medicinal products;
— a mechanism for the association of translations of a single concept into different languages, which is
an integral part of the information exchange;
— a mechanism for the versioning of the concepts in order to track their evolution;
— rules to help regional authorities to map existing regional terms to the terms created using this
document, in a harmonized and meaningful way.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 639-1, Codes for the representation of names of languages — Part 1: Alpha-2 code
ISO 3166-1, Codes for the representation of names of countries and their subdivisions — Part 1: Country
code
3 Terms, definitions and abbreviated terms
3.1 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
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/
ISO 11239:2023(E)
3.1.1
administrable dose form
aDF
pharmaceutical dose form (3.1.21) for administration to the patient, after any necessary transformation
(3.1.27) of the manufactured items (3.1.17) and their corresponding manufactured dose forms (3.1.16)
has been carried out
EXAMPLE Solution for injection, tablet for oral use, hard-capsule powder for inhalation.
Note 1 to entry: The administrable dose form is identical to the manufactured dose form in cases where
no transformation of the manufactured item is necessary [i.e. where the manufactured item is equal to the
pharmaceutical product (3.1.22)].
3.1.2
administration device
equipment intended to allow the medicinal product (3.1.18) to be administered correctly to the patient
EXAMPLE Needle, oral syringe.
Note 1 to entry: An administration device may be an integral part of an immediate container (3.1.13) or a closure
(3.1.5).
[SOURCE: ENV 12610:1997, 3.1, modified — The definition has been revised, the Example has been
added, the Notes to entry have been replaced.]
3.1.3
administration method
general technique by which a pharmaceutical product (3.1.22) is intended to be administered to the
patient
EXAMPLE Application, inhalation, injection.
Note 1 to entry: The administration method is used to group related pharmaceutical dose form (3.1.21) concepts,
and is not intended to describe a precise method or route of administration (3.1.25).
Note 2 to entry: In certain circumstances, the administration method may be used, alone or in combination
with one or more other pharmaceutical dose form attributes, to describe a medicinal product (3.1.18) where a
pharmaceutical dose form term cannot be used, for example as part of an adverse event report in which the
precise pharmaceutical dose form is unknown but the administration method is known.
3.1.4
basic dose form
generalized version of the pharmaceutical dose form (3.1.21), used to group together related
pharmaceutical dose forms
EXAMPLE Capsule, tablet, powder, solution.
Note 1 to entry: In certain circumstances, the basic dose form may be used, alone or in combination with one or
more other pharmaceutical dose form attributes, to describe a medicinal product (3.1.18) where a pharmaceutical
dose form term cannot be used, for example as part of an adverse event report in which the precise pharmaceutical
dose form is unknown but the basic dose form is known.
3.1.5
closure
item used to close a container (3.1.9) for the purpose of the correct storage and (where appropriate) use
of the medicinal product (3.1.18)
EXAMPLE Cap, child-resistant closure, screw cap.
Note 1 to entry: A closure may have an administration device (3.1.2) incorporated into it.
Note 2 to entry: A closure may be an integral part of an immediate container (3.1.13).
ISO 11239:2023(E)
3.1.6
coded concept
datatype (3.1.11) that groups together a set of code term pairs (3.1.7) that represent a single concept but
differ in language and/or geographical region
Note 1 to entry: The coded concept is used to manage translations, and is the basic datatype that is found in all of
the high-level conceptual models.
3.1.7
code term pair
datatype (3.1.11) that groups together the attributes required to describe a single concept in a specified
language and for a specified geographical location
3.1.8
combined pharmaceutical dose form
single term to describe two or more manufactured items (3.1.17) that are intended to be combined in a
specific way to produce a single pharmaceutical product (3.1.22), and which includes information on the
manufactured dose form (3.1.16) of each manufactured item and the administrable dose form (3.1.1) of
the pharmaceutical product
EXAMPLE Powder and solvent for solution for injection. The medicinal product (3.1.18) contains
two manufactured items (a powder for solution for injection and a solvent for solution for injection); the
pharmaceutical product that is prepared from the two manufactured items is a solution for injection. The
combined pharmaceutical dose form for the medicinal product is “powder and solvent for solution for injection”
(see also Table A.7).
3.1.9
container
item of packaging that is part of a medicinal product (3.1.18) and is used for storage, identification and/
or transport of the components of the medicinal product
EXAMPLE Ampoule, bottle, box.
Note 1 to entry: "Container" is a general concept that groups together the concepts of immediate container
(3.1.13), intermediate packaging (3.1.15) and outer packaging (3.1.20).
3.1.10
controlled vocabulary
finite set of values that represent the only allowed values for a data item
Note 1 to entry: These values may be codes, text, or numeric.
3.1.11
datatype
set of distinct values, characterized by properties of those values, and by operations on those values
[SOURCE: ISO/IEC 11404:2007, 3.12]
3.1.12
identifier
description that is sufficient to represent an object in a given environment
[SOURCE: ENV 12610:1997, 3.13, modified — The Note to entry has been deleted.]
3.1.13
immediate container
container (3.1.9) in which a manufactured item (3.1.17) or pharmaceutical product (3.1.22) is contained
and with which it is in direct contact
EXAMPLE Ampoule, vial, prefilled syringe, bottle, blister.
Note 1 to entry: An immediate container can be fitted with or have integrated into it an administration device
(3.1.2) and/or closure (3.1.5).
ISO 11239:2023(E)
Note 2 to entry: A pharmaceutical dose form (3.1.21) can fulfil the role of an immediate container, e.g. a capsule
containing a powder for inhalation; the capsule in this case is not a container.
[SOURCE: ENV 12610:1997, 3.14, modified — The definition has been revised, the admitted terms have
been deleted, the Example has been replaced, the Notes to entry have been replaced.]
3.1.14
intended site
general description of the area of the body at which a pharmaceutical product (3.1.22) is intended to be
administered
EXAMPLE Auricular, ocular, oral.
Note 1 to entry: The intended site is used to group related pharmaceutical dose form (3.1.21) concepts, and is not
intended to describe a precise site or route of administration (3.1.25).
Note 2 to entry: In certain circumstances, the intended site may be used, alone or in combination with one or more
other pharmaceutical dose form attributes, to describe a medicinal product (3.1.18) where a pharmaceutical dose
form term cannot be used, for example as part of an adverse event report in which the precise pharmaceutical
dose form is unknown but the intended site is known.
3.1.15
intermediate packaging
container (3.1.9) between the outer packaging (3.1.20) and the immediate container (3.1.13)
EXAMPLE Box.
3.1.16
manufactured dose form
mDF
pharmaceutical dose form (3.1.21) of a manufactured item (3.1.17) as supplied by the manufacturer and,
where applicable, before transformation (3.1.27) into the pharmaceutical product (3.1.22)
EXAMPLE Powder for solution for injection.
Note 1 to entry: The manufactured dose form is identical to the administrable dose form (3.1.1) in cases where
no transformation of the manufactured item is necessary (i.e. where the manufactured item is equal to the
pharmaceutical product).
3.1.17
manufactured item
qualitative and quantitative composition of a product as contained in the packaging of the medicinal
product (3.1.18) as put on the market or investigational medicinal product as used in a clinical trial
Note 1 to entry: A medicinal product may contain one or more manufactured items.
Note 2 to entry: In many instances, the manufactured item is equal to the pharmaceutical product (3.1.22).
However, there are instances where the manufactured item(s) must undergo a transformation (3.1.27) before
being administered to the patient (as the pharmaceutical product) and the two are not equal.
3.1.18
medicinal product
pharmaceutical product (3.1.22) or combination of pharmaceutical products that can be administered to
human beings or animals for treating or preventing disease, with the aim of making a medical diagnosis
or to restore, correct or modify physiological functions
Note 1 to entry: A medicinal product may contain in the packaging one or more manufactured items (3.1.17) and
one or more pharmaceutical products.
Note 2 to entry: In certain regions, a medicinal product is defined as any substance or combination of substances
that can be used to make a medical diagnosis.
[SOURCE: ENV 13607:2000, 3.19, modified — The definition has been revised, The Note to entry has
been replaced.]
ISO 11239:2023(E)
3.1.19
medicinal product identifier
MPID
unique identifier (3.1.12) allocated to a medicinal product (3.1.18) supplementary to any existing
authorisation number as ascribed by a medicines regulatory agency in a region
Note 1 to entry: This is for indexing purposes and to contribute to improving patient safety by allowing for the
unique identification of medicinal products worldwide.
3.1.20
outer packaging
external container (3.1.9) in which a medicinal product (3.1.18) is supplied
EXAMPLE Box.
Note 1 to entry: The manufactured item (3.1.17) or pharmaceutical product (3.1.22) is not in direct contact with
the outer packaging except where the outer packaging also serves as the immediate container (3.1.13).
3.1.21
pharmaceutical dose form
physical manifestation of a product that contains the active ingredient(s) and/or inactive ingredient(s)
that are intended to be delivered to the patient
Note 1 to entry: "Pharmaceutical dose form" can refer to the administrable dose form (3.1.1) or the manufactured
dose form (3.1.16), depending on the product that it is describing.
3.1.22
pharmaceutical product
qualitative and quantitative composition of a medicinal product (3.1.18) in the pharmaceutical dose form
(3.1.21) approved for administration in line with the regulated product information
Note 1 to entry: A medicinal product may contain one or more pharmaceutical products.
Note 2 to entry: In many instances, the pharmaceutical product is equal to the manufactured item (3.1.17).
However, there are instances where the manufactured item(s) must undergo a transformation (3.1.27) before
being administered to the patient (as the pharmaceutical product) and the two are not equal.
3.1.23
pharmaceutical product identifier
PhPID
unique identifier (3.1.12) for a pharmaceutical product (3.1.22)
3.1.24
release characteristics
description of the modified timing by which an active ingredient is made available in the body after
administration of the pharmaceutical product (3.1.22), in comparison with a conventional, direct release
of the active ingredient
EXAMPLE Delayed, extended, none.
Note 1 to entry: In certain circumstances, the release characteristics may be used, alone or in combination with
one or more other pharmaceutical dose form (3.1.21) attributes, to describe a medicinal product (3.1.18) where
a pharmaceutical dose form term cannot be used, for example as part of an adverse event report in which the
precise pharmaceutical dose form is unknown but the release characteristics are known.
3.1.25
route of administration
path by which the pharmaceutical product (3.1.22) is taken into or makes contact with the body
EXAMPLE Intravenous, ocular, oral, oromucosal.
ISO 11239:2023(E)
3.1.26
state of matter
physical condition describing the molecular form of a product
EXAMPLE Gas, liquid, semi-solid, solid.
Note 1 to entry: State of matter is used to group basic dose forms (3.1.4) according to their physical properties.
Note 2 to entry: In certain circumstances, the state of matter may be used, alone or in combination with one
or more other pharmaceutical dose form (3.1.21) attributes, to describe a medicinal product (3.1.18) where a
pharmaceutical dose form term cannot be used, for example as part of an adverse event report in which the
precise pharmaceutical dose form is unknown but the state of matter is known.
3.1.27
transformation
procedure that is carried out in order to convert a manufactured item (3.1.17) that requires such a
procedure into a pharmaceutical product (3.1.22), i.e. from its manufactured dose form (3.1.16) to its
administrable dose form (3.1.1)
EXAMPLE Dilution, dissolution, suspension.
Note 1 to entry: A transformation is not required when the manufactured item is equal to the pharmaceutical
product.
Note 2 to entry: In certain circumstances, the transformation may be used, alone or in combination with one
or more other pharmaceutical dose form (3.1.21) attributes, to describe a medicinal product (3.1.18) where a
pharmaceutical dose form term cannot be used, for example as part of an adverse event report in which the
precise pharmaceutical dose form is unknown but the transformation is known.
3.1.28
unit of measurement
real scalar quantity, defined and adopted by convention, with which any other quantity of the same
kind can be compared in order to express the ratio of the two quantities as a number
Note 1 to entry: Depending on the nature of the reference scale, the unit of measurement expression may stand
either for a physical unit of measurement that is related to a system of quantities (e.g. SI units) or for an arbitrarily
defined unit of measurement, which might refer to a certain reference material, a standard measurement
procedure, a material measure or even a combination of those.
3.1.29
unit of presentation
qualitative term describing the discrete countable entity in which a pharmaceutical product (3.1.22) or
manufactured item (3.1.17) is presented, in cases where strength or quantity is expressed referring to
one instance of this countable entity
EXAMPLE 1 To describe strength: actuation, spray, tablet; “contains 100 mcg per spray” (unit of
presentation = spray).
EXAMPLE 2 To describe quantity: bottle, box, vial; “contains 100 ml per bottle” (unit of presentation = bottle).
Note 1 to entry: A unit of presentation can have the same name as another controlled vocabulary, such as a basic
dose form (3.1.4) or a container (3.1.9), but the two concepts are not equivalent, and each has a unique controlled
vocabulary (3.1.10) term identifier (3.1.12).
3.2 Abbreviated terms
HL7 Health Level Seven
IDMP Identification of medicinal products
SI International System of Units
ISO 11239:2023(E)
4 Requirements
4.1 General information regarding controlled vocabularies
Controlled vocabularies can also be used independently of the International Standards on IDMP.
1)
HL7® messaging is used for communication of controlled vocabulary messages in IDMP.
Management of translations of controlled terms is described in this document so that the exchange of
information related to medicinal products can be implemented on a global scale.
Management of the versioning of the controlled terms is described in this document so that the
controlled vocabularies and any modifications to them can be appropriately tracked, to allow for an
auditable history.
Guidelines are provided in this document to assist users to map existing terms to the controlled terms
so that terms that are already in use in different regions can be associated with the controlled terms.
4.2 Requirements for use
The controlled vocabularies shall satisfy the following criteria:
— provide appropriate terms and identifiers to describe the pharmaceutical dose form for a medicinal
product, as required for the generation and description of the PhPID and the MPID; this includes
the provision of the pharmaceutical dose form attributes (state of matter, basic dose form, release
characteristics, transformation, intended site and administration method):
— provide appropriate terms and identifiers to describe the intended route(s) of administration for
a medicinal product, as required for the complete description of the medicinal product and the
generation of the MPID;
— provide appropriate terms and identifiers to describe the unit of presentation for a medicinal
product, as required for the complete description of the strength of certain types of medicinal
product for the generation of the MPID;
— provide appropriate terms and identifiers to describe the container (which includes the immediate
container, the intermediate packaging and the outer packaging), closure and administration device
for a medicinal product, as required for the description of the medicinal product for the generation
of the MPID.
The controlled terms and codes shall be publicly available.
5 Schema
5.1 General
This document describes the essential elements for the specification, translation and versioning of
the controlled terms. Also described are recommendations concerning the mapping of terms that are
already used by stakeholders to the concepts arising from the implementation of this document.
The supporting components are:
— terms and codes;
— translations;
— versioning;
1)  HL7 is the registered trademark of Health Level Seven International. This information is given for the
convenience of users of this document and does not constitute an endorsement by ISO of the product named.
ISO 11239:2023(E)
— mapping.
The high-level concepts are:
a) pharmaceutical dose form;
b) unit of presentation;
c) route of administration;
d) packaging.
The schemata employ the datatypes ST (String), CD (Concept Descriptor), TS (Point in Time) and INT
(Integer) specified in ISO 21090.
An attribute showing no explicit cardinality means that the attribute shall be valued with one value
(this is equivalent to [1.1]).
5.2 Conceptual models — Supporting concepts
5.2.1 General
The following conceptual models specify the elements, structures and inter-element relationships that
describe the supporting concepts (terms and codes, translations, versioning, mapping) for each set of
controlled terms.
5.2.2 Terms and codes
5.2.2.1 The codeTermPair datatype
The codeTermPair shall be used as the underlying class that carries the base code, the associated
text string and other elements of definition, and will be used as a datatype in the creation of the
codedConcept.
The attributes of the underlying class codeTermPair (see Figure 1) shall be:
a) code: a unique (machine-processable) identifier for the codeTermPair (datatype: ST).
b) term: the textual term description for the concept (datatype: ST);
c) definition: a textual definition for the concept (datatype: ST);
d) domain: an optional indicator for use where veterinary-only terms are also provided in the same
database; indicates that the concept is for either “human and veterinary” or “veterinary only” use
(default value is “human and veterinary”) (datatype: CD);
e) comment: an optional textual comment (datatype: ST);
f) languageCode: the language in which b) to e) are described, which shall conform to ISO 639-1
(datatype: CD);
g) regionCode: the country/region that uses this codeTermPair in this language, which shall conform
to ISO 3166-1 (datatype: CD).
ISO 11239:2023(E)
Figure 1 — Conceptual diagram for the codeTermPair datatype
5.2.2.2 The codedConcept datatype
The codedConcept associates a concept for a selected language and geographical region (e.g. in
English for the UK) with zero to many translations of that same concept for different languages and/
or geographical regions (e.g. in French for France, in German for Germany). The codeTermPair code
for the concept for the user-selected language and region is used for the “value” element, and zero to
many codeTermPair codes for that same concept for different languages and/or regions are used for the
“translation” element; together these specify the codedConcept datatype.
The codedConcept (see Figure 2) shall be made up of the following attributes:
a) code: the unique (machine-processable) identifier for the codedConcept (datatype: ST);
b) value: the codeTermPair code for the concept that has the user-selected language code (e.g. English)
and user-selected region code (e.g. UK) (datatype: codeTermPair);
c) translation: zero to many codeTermPair codes for the same concept with different language and/or
region codes (e.g. French and France, German and Germany) (datatype: codeTermPair).
Figure 2 — Conceptual diagram for the codedConcept datatype
5.2.2.3 The versioning of a concept
Versioning provides a traceable history for each concept from the point of creation of the concept,
including details of all modifications thereafter.
The versioning (see Figure 3) shall be made up of the following attributes:
a) code: the unique (machine-processable) identifier for the concept that is the subject of the
versioning (datatype: ST);
b) creationDate: a time stamp indicating the date and time that the concept was created (datatype:
TS);
c) createdBy: information to identify the person who created the concept (datatype: ST);
d) modificationDate: a time stamp indicating the date and time that the modification was made for
the specified version (datatype: TS);
ISO 11239:2023(E)
e) modificationMade: a description in free text of the modification made for the specified version
(datatype: ST);
f) modifiedBy: information to identify the person who modified the concept (datatype: ST);
g) conceptStatus: the status of the concept, i.e. whether it is current, deprecated, etc. (datatype: CD);
h) currentConcept [0.*]: when a concept is deprecated, the code of the concept that replaces it;
there may be more than one replacement concept for a single deprecated concept (datatype:
codeTermPair/codedConcept);
i) versionNumber: a number that indicates the version of the concept (datatype: INT).
Figure 3 — Conceptual diagram for the versioning of a concept
The concepts that arise from the implementation of this document (referred to here as “standardized
concepts”) will not necessarily match terms that are already in use by the various stakeholders in the
different countries and regions (referred to here as “regional terms”). In order that the regional terms
that are already in use, in particular those specified by the appropriate medicines regulatory agencies
in the different countries and regions, can be linked to the standardized concepts, it is envisaged that
the appropriate stakeholders map their regional terms to these standardized concepts in their own
databases and/or systems. Such a mapping exercise will help users of an existing database to identify
the equivalent standardized concept for a given regional term.
A single regional term can map to zero to many standardized concepts, and zero to many regional terms
can map to a single standardized concept (see Figure 4).
Figure 4 — Conceptual diagram indicating the target of any mapping process
This is to account for the differences in granularity that existing databases in different regions exhibit
when creating and defining regional terms. For example, region A might use less-specific terms with
a low level of detail, such that one of their regional terms maps to three standardized concepts, while
region B might use more specific terms with a high level of detail, such that three of their regional
terms map to a single standardized concept (see Table 1).
ISO 11239:2023(E)
Table 1 — Theoretical examples of mapping to standardized concepts of regional
terms with lower (region A) and higher (region B) levels of granularity
Region A regional term Maps to standardized Region B regional terms Map to standardized
(lower granularity) concepts (one to many) (higher granularity) concept (many to one)
Granule-filled soft cap-
Solution for injection
sule
Injection Soft oral capsule
Suspension for injection Liquid-filled soft capsule
Solution for infusion Powder-filled soft capsule
5.3 Conceptual models — High-level concepts
5.3.1 General
The following conceptual models
...