SIST EN ISO 11239:2013
(Main)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)
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)
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.
Medizinische Informatik - Identifikation von Arzneimitteln - Struktur und kontrollierte Vokabularien zur Identifikation von pharmazeutischen Darreichungsformen, pharmazeutischen Konventionseinheiten und Anwendungsarten (ISO 11239:2012)
Diese Internationale Norm legt:
- Datenelemente und strukturen sowie Beziehungen zwischen den Datenelementen , die für den Austausch von Informationen erforderlich sind, mit denen pharmazeutische Dosierungsformen, Bereitstellungseinheiten, Verabreichungswege und Verpackungsartikel (Behältnisse, Verschlüsse und Verabreichungsvorrichtungen) im Zusammenhang mit Arzneimitteln eindeutig und sicher identifiziert werden können, fest;
- einen Mechanismus fest zur Übersetzung der Benennungen aus dem Englischen in weitere Sprachen, was einen festen Bestandteil des Informationsaustausches darstellt;
- einen Mechanismus für die Versionierung der Begriffe fest, um ihre Entwicklung verfolgen zu können;
- Regeln fest, um es regionalen Behörden zu ermöglichen, bestehende regionale Benennungen auf die mit Hilfe dieser Norm erzeugten Benennungen abzubilden, und zwar in einer harmonisierten und sinntragenden Weise.
Darüber hinaus wird zwecks Unterstützung einer erfolgreichen Anwendung dieser Internationalen Norm gegebenenfalls auf weitere Normen zur Identifikation von Arzneimitteln (IDMP) und zur Übermittlung von Informationen zu Arzneimitteln verwiesen.
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)
L'ISO 11239:2012 spécifie
les éléments de données, les structures et les relations entre les éléments de données nécessaires à l'échange des informations qui identifient de manière unique et avec certitude les formes pharmaceutiques, les unités de présentation, les voies d'administration et les emballages (conteneurs, systèmes de fermeture et dispositifs d'administration) liés aux produits médicaux,
un mécanisme permettant d'associer les traductions d'un concept élémentaire en différentes langues, ce qui fait partie intégrante de l'échange d'informations,
un mécanisme permettant de contrôler les versions des concepts afin de suivre leur évolution, et
les règles permettant aux autorités régionales de procéder à la mise en correspondance harmonisée et significative des termes régionaux existants avec les termes créés à l'aide de l'ISO 11239:2012.
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)
Ta mednarodni standard določa: – podatkovne elemente, strukture in povezave med podatkovnimi elementi, potrebnimi za izmenjavo informacij, ki enoznačno in zanesljivo prepoznavajo obrazce o farmacevtskih odmerkih, predstavitvene enote, administrativne poti in dele embalaže (posode, pokrovčki in naprave za doziranje) v zvezi z zdravili; – mehanizem za povezovanje prevodov posameznega koncepta v različne jezike, kar je sestavni del izmenjave informacij; – mehanizem za ustvarjanje različic konceptov za sledenje njihovemu razvoju; – pravila za dovoljenje regionalnih organov, da na usklajen in smiseln način preslikajo obstoječe regionalne izraze v izraze, ustvarjene z uporabo mednarodnega standarda. Poleg tega so v podporo uspešni uporabi tega mednarodnega standarda navedeni sklici na standarde, ki zadevajo identifikacijo medicinskih izdelkov (IDMP) in sporočanje informacij o medicinskih izdelkih.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11239:2013
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
SIST EN ISO 11239:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11239:2013
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SIST EN ISO 11239:2013
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.
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SIST EN ISO 11239:2013
EN ISO 11239:2012 (E)
Contents Page
Foreword .3
2
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SIST EN ISO 11239:2013
EN ISO 11239:2012 (E)
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.
3
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SIST EN ISO 11239:2013
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SIST EN ISO 11239:2013
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
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SIST EN ISO 11239:2013
ISO 11239:2012(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2012
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
Web www.iso.org
Published in Switzerland
ii © ISO 2012 – All rights reserved
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SIST EN ISO 11239:2013
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 2012 – All rights reserved iii
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SIST EN ISO 11239:2013
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
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SIST EN ISO 11239:2013
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.
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SIST EN ISO 11239:2013
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
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SIST EN ISO 11239:2013
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).
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SIST EN ISO 11239:2013
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
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SIST EN ISO 11239:2013
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.
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SIST EN ISO 11239:2013
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.
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SIST EN ISO 11239:2013
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.
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SIST EN ISO 11239:2013
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 standar
...
SLOVENSKI STANDARD
oSIST prEN ISO 11239:2010
01-november-2010
Zdravstvena informatika - Identifikacija medicinskih izdelkov - Elementi in zgradba
podatkov za enotno identifikacijo in izmenjavo predpisanih informacij na obrazcih
o farmacevtskih odmerkih, predstavitvenih enot in administrativnih poti (ISO/DIS
11239:2010)
Health informatics - Identification of medicinal products - Data elements and structures
for unique identification and exchange of regulated information on pharmaceutical dose
forms, units of presentation and routes of administration (ISO/DIS 11239:2010)
Medizinische Informatik - Identifikation von Arzneimitteln - Struktur und kontrollierte
Vokabularien für pharmazeutische Dosierungsformen, zusammengesetzten Einheiten in
Arzneiformen und Anwendungsarten (ISO/DIS 11239:2010)
Informatique de santé - Identification des produits médicaux - Éléments de données et
structures pour l'identification unique et l'échange d'informations réglementées
concernant les formes des doses pharmaceutiques, les unités de présentation et les
voies d'administration (ISO/DIS 11239:2010)
Ta slovenski standard je istoveten z: prEN ISO 11239
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
oSIST prEN ISO 11239:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 11239:2010
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oSIST prEN ISO 11239:2010
EUROPEAN STANDARD
DRAFT
prEN ISO 11239
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2010
ICS 35.240.80
English Version
Health informatics - Identification of medicinal products - Data
elements and structures for unique identification and exchange
of regulated information on pharmaceutical dose forms, units of
presentation and routes of administration (ISO/DIS 11239:2010)
Informatique de santé - Identification des produits Medizinische Informatik - Identifikation von Arzneimitteln -
médicaux - Éléments de données et structures pour Struktur und kontrollierte Vokabularien für pharmazeutische
l'identification unique et l'échange d'informations Dosierungsformen, zusammengesetzten Einheiten in
réglementées concernant les formes des doses Arzneiformen und Anwendungsarten (ISO/DIS 11239:2010)
pharmaceutiques, les unités de présentation et les voies
d'administration (ISO/DIS 11239:2010)
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 251.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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 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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 11239:2010: E
worldwide for CEN national Members.
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oSIST prEN ISO 11239:2010
prEN ISO 11239:2010 (E)
Contents Page
Foreword .3
2
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oSIST prEN ISO 11239:2010
prEN ISO 11239:2010 (E)
Foreword
This document (prEN ISO 11239:2010) 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 document is currently submitted to the parallel Enquiry.
Endorsement notice
The text of ISO/DIS 11239:2010 has been approved by CEN as a prEN ISO 11239:2010 without any
modification.
3
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oSIST prEN ISO 11239:2010
DRAFT INTERNATIONAL STANDARD ISO/DIS 11239
ISO/TC 215 Secretariat: ANSI
Voting begins on: Voting terminates on:
2010-09-23 2011-02-23
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
Health informatics — Identification of medicinal products —
Data elements and structures for unique identification and
exchange of regulated information on pharmaceutical dose
forms, units of presentation and routes of administration
Informatique de santé — Identification des produits médicaux — Éléments de données et structures pour
l'identification unique et l'échange d'informations réglementées concernant les formes des doses
pharmaceutiques, les unités de présentation et les voies d'administration
ICS 35.240.80
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for Standardization (ISO), and
processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
five-month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments received, will be
submitted to a parallel two-month approval vote in ISO and formal vote in CEN.
In accordance with the provisions of Council Resolution 15/1993 this document is circulated in
the English language only.
Conformément aux dispositions de la Résolution du Conseil 15/1993, ce document est distribué
en version anglaise seulement.
To expedite distribution, this document is circulated as received from the committee secretariat.
ISO Central Secretariat work of editing and text composition will be undertaken at publication
stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.
THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
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 SUPPORTING DOCUMENTATION.
©
International Organization for Standardization, 2010
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oSIST prEN ISO 11239:2010
ISO/DIS 11239
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©
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ISO/DIS 11239
Contents Page
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements . 4
4.1 General requirements for the controlled vocabularies . 4
4.2 Requirements for use within the IDMP set of standards . 5
5 Schema . 5
5.1 Introduction . 5
5.2 Conceptual models – supporting concepts . 6
5.2.1 Terms and codes . 6
5.2.2 Translations . 6
5.2.3 Versioning . 7
5.2.4 Mapping . 8
5.3 Conceptual models – high-level concepts . 8
5.3.1 Pharmaceutical dose form concept . 8
5.3.2 Unit of presentation concept . 11
5.3.3 Route of administration concept . 11
5.3.4 Packaging concept . 12
Annex A (informative) Examples of controlled vocabularies . 13
Annex B (informative) Examples of controlled vocabularies to describe medicinal products . 21
Bibliography . 26
© ISO 2010 – All rights reserved iii
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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.
ISO 11239 was prepared by Technical Committee ISO/TC 215, Health informatics, and by Technical
Committee CEN/TC 251, Health informatics and in collaboration and with the co-operation of the Clinical Data
Interchange Standards Consortium (CDISC), Health Level Seven (HL7) and the International Health
Terminology Standards Development Organisation (IHTSDO).
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0 Introduction
0.1 General introduction
This standard was developed in response to a worldwide demand for internationally harmonised specifications
for medicinal products. It is one of a group of five standards which together uniquely identify medicinal
products. The group of standards comprise:
• ISO/DIS 11238 Health informatics — Identification of medicinal products — Data elements and
structures for the unique identification and exchange of regulated information on substances
• ISO/DIS 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/DIS 11240 Health informatics — Identification of medicinal products — Data elements and
structures for the unique identification and exchange of units of measurement
• ISO/DIS 11615 Health informatics — Identification of medicinal products — Data elements and
structures for the unique identification and exchange of regulated medicinal product information
• ISO/DIS 11616 Health informatics — Identification of medicinal products — Data elements and
structures for the unique identification and exchange of regulated pharmaceutical product information
The 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:
— regulator to regulator e.g. European Medicines Agency to the US Food and Drug Administration (FDA) or
vice versa;
— pharmaceutical company to regulator, e.g. Pharma Company A to Health Canada;
— sponsor of clinical trial to regulator, e.g. University X to Austrian Medicines Agency;
— regulator to other stakeholders, e.g. UK Medicines Health Regulatory Agency (MHRA) to National Health
Service (NHS);
— interaction of regulator with worldwide-maintained data sources, e.g. Japanese Pharmaceutical and
Medical Device Agency (PMDA) and the assignment of a new substance identifier.
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 to support 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
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ISO/DIS 11239
described in this standard shall be applied for the concepts which are required to uniquely identify,
characterise and exchange regulated medicinal products and associated information.
The terms and definitions adopted in this standard are intended to facilitate the interpretation and application
of legal and regulatory requirements but they shall be without prejudice to any legally binding document. In
case of doubt or potential conflict, the terms and definitions contained in legally binding documents shall
prevail.
0.2 Context of identification of pharmaceutical dose form, unit of presentation, routes of
administration and packaging
This 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 standard.
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: Terms and codes; Translations; Versioning; Mapping.
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.
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oSIST prEN ISO 11239:2010
DRAFT INTERNATIONAL STANDARD ISO/DIS 11239
Health informatics — Identification of medicinal products —
Data elements and structures for unique identification and
exchange of regulated information on pharmaceutical dose
forms, units of presentation and routes of administration
1 Scope
This international standard:
— specifies the data elements, structures, and relationships between the data elements required for the
exchange of information that 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;
— specifies a mechanism for the translation of the terms from English into other languages, which is an
integral part of the information exchange;
— specifies a mechanism for the versioning of the concepts in order to track their evolution;
— specifies rules to allow regional authorities to map existing regional terms to the terms created using this
standard, in a harmonised and meaningful way.
In addition, to support the successful application of this International Standard, references to other normative
Identification of Medicinal Products (IDMP) and messaging standards 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 639-2:1998, Codes for the representation of names of languages — Part 1: Alpha-2 code
ISO 3166-1:2006, Codes for the representation of names of countries and their subdivisions — Part 1:
Country codes
1
ISO 21090, Health informatics — Harmonized data types for information interchange
HL7 Version 3 Standard, Common Terminology Services (CTS) HL7 Draft Standard for Trial Use DSTU
Release 2, 14 October 2009, HL7 Inc.
1
To be published
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3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
administrable dose form
pharmaceutical dose form as administered to the patient, after any necessary transformation of the
manufactured dose form has been carried out
EXAMPLE Solution for injection, tablet for oral use, hard-capsule powder for inhalation.
3.2
administration device
device intended for the correct administration of the medicinal product
[ENV 12610:1997]
3.3
closure
item used to close a container for the purpose of the correct storage and use of the product inside the
container
3.4
container
immediate container, intermediate packaging or outer packaging
3.5
controlled vocabulary
a finite set of values that represent the only allowed values for a data item
EXAMPLE These values may be codes, text, or numeric.
[Adapted from CDISC Clinical Research Glossary V8.0, 2009]
3.6
controlled vocabulary term identifier
a concept identifier intended for use as the preferred unique identifier for that concept in that code system and
is published by the author of a code system
NOTE It remains constant over time, independent of the particular version of the knowledge resource.
[Adapted from HL7 Core Principles]
3.7
immediate container
immediate packaging in which a manufactured item or pharmaceutical product is contained and with which it
is in direct contact
EXAMPLE Sealed vial, ampoule, foil pouch, prefilled syringe, bottle, blister strip.
NOTE 1 An immediate container can be fitted with or have integrated into it a 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.
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3.8
intermediate packaging
container between the outer packaging and the immediate container
3.9
manufactured dose form
pharmaceutical dose form of a medicinal product as manufactured and where applicable before reconstitution
EXAMPLE Powder and solvent for solution for injection.
3.10
manufactured item
qualitative and quantitative composition of the product as contained in the packaging of the medicinal product
NOTE 1 A medicinal product can 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.
3.11
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, ENV 12610]
NOTE 1 A medicinal product can consist of one or several pharmaceutical products.
NOTE 2 In certain jurisdictions a medicinal product can also be defined as any substance or combination of
substances which may be used to make a medical diagnosis.
3.12
medicinal product identifier
MPID
a unique identifier allocated to a medicinal product supplementary to any existing authorisation number as
ascribed by a medicines regulatory authority 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.
3.13
outer packaging
external container in which a medicinal product is supplied
EXAMPLE Box, carton.
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.
3.14
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.
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3.15
pharmaceutical product
qualitative and quantitative composition of the pharmaceutical product as administered to the patient in line
with the regulated product information
NOTE 1 A medicinal product can contain one or more administered pharmaceutical products.
NOTE 2 In many instances the administered pharmaceutical product is equal to the packaged manufactured item.
However, there are instances where the packaged manufactured item(s) shall undergo a transformation before being
administered to the patient (as the pharmaceutical product) and the two are not equal.
3.16
pharmaceutical product identifier
PhPID
unique identifier assigned to the pharmaceutical product(s)
3.17
route of administration
path by which the pharmaceutical product is taken into or makes contact with the body
EXAMPLE Oral, intravenous, oromucosal, ocular.
3.18
transformation
procedure that is carried out in order to convert a product that requires such a procedure from its
manufactured dose form to its administrable dose form
EXAMPLE Dissolution, suspension, dilution.
NOTE A transformation is not required when the manufactured item is equal to the pharmaceutical product.
3.19
unit of measurement
real scalar quantity, defined and adopted by convention, with which any other quantity of the same kind can
be compared 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 can 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 can refer to a certain reference material, a standard measurement procedure, a material measure or
even to a combination of those.
3.20
unit of presentation
qualitative term describing the unit in which the strength(s) of the manufactured item or pharmaceutical
product is presented and described, often specifically at the point of delivery to the patient, in cases where a
quantitative unit of measurement is not applicable
EXAMPLE Tablet, spray, puff. “Contains 100 mcg per spray” (unit of presentation = spray).
NOTE A unit of presentation can have the same name as another controlled vocabulary, such as a pharmaceutical
dose form, but the two concepts are not equivalent, and each has a unique controlled vocabulary term identifier.
4 Requirements
4.1 General requirements for the controlled vocabularies
This 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:
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⎯ ISO/DIS 11615 Health informatics — Identification of medicinal products — Data elements and structures
for the unique identification and exchange of regulated medicinal product information (MPID)n,
⎯ ISO/DIS 11616, Health informatics — Identification of medicinal products — Data elements and
structures for the unique identification and exchange of regulated pharmaceutical product information
(PhPID) .
However, the controlled vocabularies can also be used independently of the IDMP set of standards. HL7 CTS
2 messaging is used for communication of controlled vocabulary messages in the IDMP.
I
...
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