EN ISO 11239:2012

SLOVENSKI STANDARD
01-februar-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 11239:2012)
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
11239:2012)
Medizinische Informatik - Identifikation von Arzneimitteln - Struktur und kontrollierte
Vokabularien zur Identifikation von pharmazeutischen Darreichungsformen,
pharmazeutischen Konventionseinheiten und Anwendungsarten (ISO 11239:2012)
Informatique de santé - Identification des médicaments - Éléments de données et
structures pour l'identification unique et l'échange d'informations réglementées sur les
formes des doses pharmaceutiques, les unités de présentation, les voies
d'administration et les emballages (ISO 11239:2012)
Ta slovenski standard je istoveten z: EN ISO 11239:2012
ICS:
11.020 0HGLFLQVNHYHGHLQ Medical sciences and health
]GUDYVWYHQRYDUVWYHQL care facilities in general
SULSRPRþNLQDVSORãQR
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.

EUROPEAN STANDARD
EN ISO 11239
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2012
ICS 35.240.80
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 11239:2012)
Informatique de santé - Identification des médicaments - Medizinische Informatik - Identifikation von Arzneimitteln -
Éléments de données et structures pour l'identification Struktur und kontrollierte Vokabularien zur Identifikation von
unique et l'échange d'informations réglementées sur les pharmazeutischen Darreichungsformen, pharmazeutischen
formes des doses pharmaceutiques, les unités de Konventionseinheiten, Anwendungsarten und
présentation, les voies d'administration et les emballages Verpackungen (ISO 11239:2012)
(ISO 11239:2012)
This European Standard was approved by CEN on 24 May 2012.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11239:2012: E
worldwide for CEN national Members.

Contents Page
Foreword .3

Foreword
This document (EN ISO 11239:2012) 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 May 2013, and conflicting national standards shall be withdrawn at the
latest by May 2013.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11239:2012 has been approved by CEN as a EN ISO 11239:2012 without any modification.

INTERNATIONAL ISO
STANDARD 11239
First edition
2012-11-01
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 des doses
pharmaceutiques, les unités de présentation, les voies d’administration
et les emballages
Reference number
ISO 11239:2012(E)
©
ISO 2012
ISO 11239:2012(E)
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
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Published in Switzerland
ii © ISO 2012 – All rights reserved

ISO 11239:2012(E)
Contents Page
Foreword .iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and abbreviations . 1
3.1 Terms and definitions . 1
3.2 Abbreviations . 5
4 Requirements . 6
4.1 General requirements for controlled vocabularies . 6
4.2 Requirements for use within the IDMP set of standards . 7
5 Schema . 7
5.1 General . 7
5.2 Conceptual models — Supporting concepts . 8
5.3 Conceptual models — High-level concepts .10
Annex A (informative) Examples of controlled vocabularies .17
Annex B (informative) Examples of controlled vocabularies to describe medicinal products .23
Bibliography .28
ISO 11239:2012(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 11239 was prepared by Technical Committee ISO/TC 215, Health informatics.
iv © ISO 2012 – All rights reserved

ISO 11239:2012(E)
Introduction
This International Standard was developed in response to a worldwide demand for internationally harmonized
specifications for medicinal products. It is one of a group of five standards which together provide the basis for
the unique identification of medicinal products. The group of standards comprises:
ISO 11615, Health informatics — Identification of medicinal products — Data elements and structures for the
unique identification and exchange of regulated medicinal product information;
ISO 11616, Health informatics — Identification of medicinal products — Data elements and structures for the
unique identification and exchange of regulated pharmaceutical product information;
ISO 11238, Health informatics — Identification of medicinal products — Data elements and structures for the
unique identification and exchange of regulated information on substances;
ISO 11239, 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 11240, Health informatics — Identification of medicinal products — Data elements and structures for the
unique identification and exchange of units of measurement.
These standards for the identification of medicinal products (IDMP) support the activities of medicines
regulatory agencies worldwide by jurisdiction. 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.
To meet the primary objectives of the regulation of medicines and pharmacovigilance it is necessary to exchange
medicinal product information in a robust and reliable manner. The IDMP standards therefore support 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 IDMP standards to secure the
interactions above.
Unique identifiers produced in conformance with the IDMP standards are aimed at supporting applications
where it is necessary 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. The terms and definitions
described in this International Standard are to be applied for the concepts which are required in order to
uniquely identify, characterize and exchange regulated medicinal products and associated information.
The terms and definitions adopted in this International Standard are intended to facilitate the interpretation and
application of legal and regulatory requirements but they are without prejudice to any legally binding document.
In case of doubt or potential conflict, the terms and definitions contained in legally binding documents prevail.
In the context of identification of pharmaceutical dose forms, units of presentation, routes of administration and
packaging, this International Standard 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 International Standard.
ISO 11239:2012(E)
The high-level concepts defined 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.
vi © ISO 2012 – All rights reserved

INTERNATIONAL STANDARD ISO 11239:2012(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 International Standard 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 allow regional authorities to map existing regional terms to the terms created using this International
Standard, in a harmonized and meaningful way.
In addition, to support the successful application of this International Standard, references to standards
concerned with identification of medicinal products (IDMP) and messaging for medicinal product information
are provided as required.
2 Normative references
The following referenced documents are indispensable for the application 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 (all parts), Codes for the representation of names of languages
ISO 3166 (all parts), Codes for the representation of names of countries and their subdivisions
ISO 21090, Health informatics — Harmonized data types for information interchange
3 Terms, definitions and abbreviations
3.1 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1.1
administrable dose form
pharmaceutical dose form for administration to the patient, after any necessary transformation of the
manufactured dose form has been carried out
EXAMPLES Solution for injection, tablet for oral use, hard-capsule powder for inhalation.
NOTE 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).
ISO 11239:2012(E)
3.1.2
administration device
equipment intended for correct administration of the medicinal product
EXAMPLES Needle, oral syringe.
NOTE 1 An administration device may be an integral part of an immediate container or a closure.
NOTE 2 Adapted from ENV 12610:1997.
3.1.3
administration method
general method by which a pharmaceutical product is intended to be administered to the patient
EXAMPLES Application, inhalation, injection.
NOTE The administration method is a general term that is used to group related pharmaceutical dose form concepts,
and is not intended to describe a precise method or route of administration.
3.1.4
basic dose form
generalised version of the pharmaceutical dose form, used to group together related pharmaceutical dose forms
EXAMPLES Capsule, tablet, powder, solution.
3.1.5
closure
item used to close a container for the purpose of the correct storage and (where appropriate) use of the product
EXAMPLES Cap, child-resistant closure, screw cap.
NOTE 1 A closure may have an administration device incorporated into it.
NOTE 2 A closure may be an integral part of an immediate container.
3.1.6
coded concept
data type that groups together a set of code term pairs that represent a single concept but differ in language
and/or geographical region
NOTE The coded concept is used to manage translations, and is the basic data type that is found in all of the high-
level conceptual models.
3.1.7
code term pair
data type 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 that are intended to be combined in a specific way to
produce a single pharmaceutical product, and which includes information on the manufactured dose form of
each manufactured item and the administrable dose form of the pharmaceutical product
EXAMPLE Powder and solvent for solution for injection. The medicinal product 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 Annex A, Table A.7).
2 © ISO 2012 – All rights reserved

ISO 11239:2012(E)
3.1.9
container
item of packaging that is part of a medicinal product and is used for storage, identification and/or transport of
the components of the medicinal product
EXAMPLES Ampoule, bottle, box.
NOTE “Container” is a general concept that groups together the concepts of immediate container, intermediate
packaging and outer packaging.
3.1.10
controlled vocabulary
finite set of values that represent the only allowed values for a data item
NOTE 1 These values may be codes, text, or numeric.
NOTE 2 Adapted from CDISC Clinical Research Glossary V8.0, 2009.
3.1.11
controlled vocabulary term identifier
concept identifier intended to be used as the preferred unique identifier for that concept in that code system
and which is published by the author of a code system
NOTE 1 It remains constant over time, independent of the particular version of the knowledge resource.
NOTE 2 Adapted from HL7 Core Principles.
3.1.12
immediate container
immediate packaging in which a manufactured item or pharmaceutical product is contained and with which it
is in direct contact
EXAMPLES Ampoule, vial, prefilled syringe, bottle, blister.
NOTE 1 An immediate container can be fitted with or have integrated into it an administration device and/or closure.
NOTE 2 A pharmaceutical dose form 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.
NOTE 3 An alternative, compatible definition of immediate container (“immediate packaging”) is given in Directive
92/27/EEC.
NOTE 4 Adapted from ENV 12610:1997.
3.1.13
intended site
general body site at which a pharmaceutical product is intended to be administered
EXAMPLES Auricular, ocular, oral.
NOTE The intended site is a general term that is used to group related pharmaceutical dose form concepts, and is
not intended to describe a precise site or route of administration.
3.1.14
intermediate packaging
level of packaging between the outer packaging and the immediate container
EXAMPLE Box.
3.1.15
manufactured dose form
pharmaceutical dose form of a manufactured item as manufactured and, where applicable, before transformation
into the pharmaceutical product
EXAMPLE Powder for solution for injection.
ISO 11239:2012(E)
NOTE The manufactured dose form is identical to the administrable 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).
3.1.16
manufactured item
qualitative and quantitative composition of a product as contained in the packaging of the medicinal product
NOTE 1 A medicinal product may contain one or more manufactured items.
NOTE 2 In many instances, the manufactured item is equal to the pharmaceutical product. However, there are
instances where the manufactured item(s) must undergo a transformation before being administered to the patient (as the
pharmaceutical product) and the two are not equal.
NOTE 3 The manufactured item is not in direct contact with the outer packaging except where the outer packaging also
serves as the immediate container.
3.1.17
medicinal product
any substance or combination of substances, which may be administered to human beings or animals for
treating or preventing disease, with the view to making a medical diagnosis or to restore, correct or modify
physiological functions
[ENV 13607:2000; ENV 12610:1997]
NOTE 1 A medicinal product may consist of one or more manufactured items and one or more pharmaceutical products.
NOTE 2 In certain jurisdictions, a medicinal product may also be defined as any substance or combination of substances
which may be used to make a medical diagnosis.
3.1.18
MPID
medicinal product identifier
unique identifier allocated to a medicinal product supplementary to any existing authorization number as
ascribed by a medicines regulatory agency in a jurisdiction
NOTE This is for indexing purposes and to contribute to improving patient safety by allowing for the unique identification
of medicinal products worldwide.
3.1.19
outer packaging
external container in which a medicinal product is supplied
EXAMPLE Box.
NOTE 1 The manufactured item or pharmaceutical product is not in direct contact with the outer packaging except
where the outer packaging also serves as the immediate container.
NOTE 2 An alternative, compatible definition of outer packaging is given in Directive 92/27/EEC: “packaging into which
is placed the immediate packaging”.
3.1.20
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 “Pharmaceutical dose form” can refer to the administrable dose form or the manufactured dose form, depending
on the product that it is describing.
3.1.21
pharmaceutical product
qualitative and quantitative composition of a medicinal product in the dose form authorized for administration
by a medicines regulatory agency and as represented with any corresponding regulated product information
NOTE 1 A medicinal product may contain one or more pharmaceutical products.
4 © ISO 2012 – All rights reserved

ISO 11239:2012(E)
NOTE 2 In many instances the pharmaceutical product is equal to the manufactured item. However, there are
instances where the manufactured item(s) must undergo a transformation before being administered to the patient (as the
pharmaceutical product) and the two are not equal.
3.1.22
PhPID
pharmaceutical product identifier
unique identifier assigned to the pharmaceutical product(s)
3.1.23
release characteristics
description of the modified timing by which an active ingredient is made available in the body after administration
of the pharmaceutical product, in comparison with a conventional, direct release of the active ingredient
EXAMPLES Delayed, extended, none.
3.1.24
route of administration
path by which the pharmaceutical product is taken into or makes contact with the body
EXAMPLES Intravenous, oral, ocular, oromucosal.
3.1.25
state of matter
physical condition describing the molecular form of a product
EXAMPLES Gas, liquid, semi-solid, solid.
NOTE State of matter is used to group basic dose forms according to their physical properties.
3.1.26
transformation
procedure that is carried out in order to convert a manufactured item that requires such a procedure into a
pharmaceutical product, i.e. from its manufactured dose form to its administrable dose form
EXAMPLES Dilution, dissolution, suspension.
NOTE A transformation is not required when the manufactured item is equal to the pharmaceutical product.
3.1.27
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 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 to a combination of those.
3.1.28
unit of presentation
qualitative term describing the discrete countable entity in which a pharmaceutical product or manufactured item
is presented, in cases where strength or quantity is expressed referring to one instance of this countable entity
EXAMPLE 1 To describe strength: puff, 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 A unit of presentation can have the same name as another controlled vocabulary, such as a basic dose form
or a container, but the two concepts are not equivalent, and each has a unique controlled vocabulary term identifier.
3.2 Abbreviations
The following abbreviations are used in this International Standard.
ISO 11239:2012(E)
3.2.1
CDISC
Clinical Data Interchange Standards Consortium
3.2.2
CTS
Combined Terminology Services
3.2.3
HL7
Health Level Seven
3.2.4
IDMP
Identification of medicinal products
3.2.5
MPID
medicinal product identifier
3.2.6
PhPID
pharmaceutical product identifier
3.2.6
SI
International System of Units
4 Requirements
4.1 General requirements for controlled vocabularies
This International Standard forms part of a set of standards for the identification of medicinal products (IDMP).
It provides specifications to support the creation of a set of controlled vocabularies that are essential for the
implementation of the set of standards as a whole, in particular:
— ISO 11615, Health informatics — Identification of medicinal products — Data elements and structures for
the unique identification and exchange of regulated medicinal product information (MPID);
— ISO 11616, Health informatics — Identification of medicinal products — Data elements and structures for
the unique identification and exchange of regulated pharmaceutical product information (PhPID).
However, controlled vocabularies can also be used independently of the IDMP set of standards. Health
Level Seven (HL7) Common Terminology Services (CTS) Version 2 messaging is used for communication of
controlled vocabulary messages in the IDMP.
Management of translations of controlled terms is described in this International Standard 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 International Standard 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 International Standard 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.
6 © ISO 2012 – All rights reserved

ISO 11239:2012(E)
4.2 Requirements for use within the IDMP set of standards
In order that the controlled vocabularies provided for in this International Standard are suitable for their purpose
as integral parts of the IDMP set of standards, they 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;
— 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 and the expectation is that their use will be royalty free.
5 Schema
5.1 General
This International Standard 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 International Standard.
The supporting components are:
— terms and codes;
— translations;
— versioning;
— mapping.
The high-level concepts are:
a) pharmaceutical dose form;
b) unit of presentation;
c) route of administration;
d) packaging.
The schema
...