SIST EN ISO 11238:2018

SLOVENSKI STANDARD
SIST EN ISO 11238:2018
01-oktober-2018
1DGRPHãþD
SIST EN ISO 11238:2013
Zdravstvena informatika - Identifikacija medicinskih izdelkov - Elementi in zgradba
podatkov za enotno identifikacijo in izmenjavo predpisanih informacij o
substancah (ISO 11238:2018)
Health informatics - Identification of medicinal products - Data elements and structures
for the unique identification and exchange of regulated information on substances (ISO
11238:2018)
Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und Strukturen
zur eindeutigen Identifikation und zum Austausch von vorgeschriebenen Informationen
zu Stoffen (ISO 11238:2018)
Informatique de santé - Identification des médicaments - Éléments de données et
structures pour l'identification unique et l'échange d'informations réglementées sur les
substances (ISO 11238:2018)
Ta slovenski standard je istoveten z: EN ISO 11238:2018
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 11238:2018 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11238:2018

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SIST EN ISO 11238:2018


EN ISO 11238
EUROPEAN STANDARD

NORME EUROPÉENNE

August 2018
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes EN ISO 11238:2012
English Version

Health informatics - Identification of medicinal products -
Data elements and structures for the unique identification
and exchange of regulated information on substances (ISO
11238:2018)
Informatique de santé - Identification des produits Medizinische Informatik - Identifikation von
médicaux - Éléments de données et structures pour Arzneimitteln - Datenelemente und Strukturen zur
l'identification unique et l'échange d'informations eindeutigen Identifikation und zum Austausch von
réglementées sur les substances (ISO 11238:2018) vorgeschriebenen Informationen zu Stoffen (ISO
11238:2018)
This European Standard was approved by CEN on 24 July 2018.

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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey 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
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11238:2018 E
worldwide for CEN national Members.

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SIST EN ISO 11238:2018
EN ISO 11238:2018 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 11238:2018
EN ISO 11238:2018 (E)
European foreword
This document (EN ISO 11238:2018) 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 February 2019, and conflicting national standards
shall be withdrawn at the latest by February 2019.
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 11238:2012.
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11238:2018 has been approved by CEN as EN ISO 11238:2018 without any modification.

3

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SIST EN ISO 11238:2018

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SIST EN ISO 11238:2018
INTERNATIONAL ISO
STANDARD 11238
Second edition
2018-07
Health informatics — Identification
of medicinal products — Data
elements and structures for the
unique identification and exchange of
regulated information on substances
Informatique de santé — Identification des produits médicaux —
Eléments de données et structures pour l'identification unique et
l'échange d'informations réglementées sur les substances
Reference number
ISO 11238:2018(E)
©
ISO 2018

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SIST EN ISO 11238:2018
ISO 11238:2018(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2018
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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

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SIST EN ISO 11238:2018
ISO 11238:2018(E)

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols and abbreviated terms .14
5 Description of the information modelling principles and practices .17
5.1 General considerations .17
5.2 Conceptual overview diagrams .17
5.3 Section high-level diagrams .18
5.4 Detailed diagrams.18
5.5 Relationships between classes .19
5.6 Notes .21
5.7 Attributes .21
5.8 Message exchange format .21
5.9 Conformance terminology and context as it relates to ISO 11238 and ISO/TS 19844 .22
6 Requirements .22
6.1 General .22
6.2 Concepts required for the unique identification and description of substances .22
6.3 Concepts required for the description of specified substances .24
6.3.1 Relationship between Substances and Specified Substance Groups .26
6.4 Naming of substances .27
6.5 Requirements for unique identifiers .28
6.6 Existing identifiers and molecular structure representation .28
7 Types of substances .29
7.1 General .29
7.2 Element sets common to multiple types of substances .29
7.2.1 Structure .29
7.2.2 Isotope .29
7.2.3 Modification .30
7.2.4 Reference information .31
7.2.5 Source material .32
7.2.6 Taxonomy .33
7.2.7 Authentication of Herbal Drugs .33
7.2.8 Substance codes .34
7.3 Chemical substances .34
7.4 Protein substances .35
7.5 Nucleic acid substances .37
7.6 Polymer substances .38
7.7 Structurally diverse substances .39
7.8 Mixture .42
8 Defining specified substances .43
8.1 General .43
8.2 Specified Substance Group 1 .44
8.3 Specified Substance Group 2 .47
8.4 Specified Substance Group 3 .49
8.5 Specified Substance Group 4 .50
8.5.1 General.50
8.5.2 Specified Substance Group 4 Name .50
8.5.3 Grade .51
8.5.4 Use of analytical data .51
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SIST EN ISO 11238:2018
ISO 11238:2018(E)

8.5.5 Manufacturing .52
8.5.6 Version and specification.52
Annex A (informative) Existing identifiers and molecular structure representations .56
Bibliography .60
iv © ISO 2018 – All rights reserved

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SIST EN ISO 11238:2018
ISO 11238:2018(E)

Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2. www .iso .org/directives
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received. www .iso .org/patents
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on 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 WTO
principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary
information.
This document was prepared by ISO/TC 215, Health informatics.
[2]
This second edition cancels and replaces the first edition ISO 11238:2012 , which has been technically
revised.
© ISO 2018 – All rights reserved v

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SIST EN ISO 11238:2018
ISO 11238:2018(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 standards and four technical
specifications which together provide the basis for the unique identification of medicinal products. The
group of standards and technical specifications comprises:
[3]
ISO 11615 , Health informatics — Identification of medicinal products — Data elements and structures
for the unique identification and exchange of regulated medicinal product information
[4]
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
[5]
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
[6]
ISO 11240 , Health informatics — Identification of medicinal products — Data elements and structures
for the unique identification and exchange of units of measurement
ISO/TS 19844, Health informatics — Identification of medicinal products — Implementation guidelines
for data elements and structures for the unique identification and exchange of regulated information on
substances
[7]
ISO/TS 20440 , Health informatics — Identification of Medicinal Products — Implementation guide for
ISO 11239 data elements and structures for the unique identification and exchange of regulated information
on pharmaceutical dose forms, units of presentation, routes of administration and packaging
[8]
ISO/TS 20443 , Health informatics — Identification of Medicinal Products — Implementation guide for
ISO 11615 data elements and structures for the unique identification and exchange of regulated Medicinal
Product information
[9]
ISO/TS 20451 , Health informatics — Identification of Medicinal Products — Implementation guide
for ISO 11616 data elements and structures for the unique identification and exchange of regulated
pharmaceutical product information
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
reliably exchange medicinal product information in a robust and reliable manner. The IDMP standards
therefore support the following interactions:
— between one medicine regulatory agency and another, e.g. European Medicines Agency to the US
Food and Drug Administration (FDA), or vice versa; and between the European Medicines Agency
and the National Competent Authorities in the EU, vice versa;
— between pharmaceutical companies and medicine regulatory agencies, e.g. "Pharma Company A" to
Health Canada;
— between the sponsor of a clinical trial to a medicine regulatory agency, e.g. "University X" to the
Austrian Agency for Health and Food Safety (AGES);
— between a medicine regulatory agency and other stakeholders, e.g. UK Medicines and Health Care
Products Regulatory Agency (MHRA) to the National Health Service (NHS);
vi © ISO 2018 – All rights reserved

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SIST EN ISO 11238:2018
ISO 11238:2018(E)

— between medicine regulatory agencies and worldwide-maintained data sources, e.g. the
Pharmaceutical and Medical Device Agency (PMDA) and the organization responsible for assigning
substance identifiers.
Unique identifiers produced in conformance with the IDMP standards will support applications for
which it is necessary to reliably identify and trace the use of medicinal products and the ingredients
within medicinal products.
This document provides a structure that enables the assignment and maintenance of unique identifiers
for all substances in medicinal products. This document sets out the general rules for defining and
distinguishing substances, and provides a high-level model for substances and specified substances to
support the organization and capturing of data.
It is anticipated that implementation will use the ISO/TS 19844 and HL7 messaging (see 5.8) to deliver
a strong, non-semantic unique identifier for every substance present in a medicinal product. It is
anticipated that a single maintenance organization will be responsible for the generation of global
identifiers for every substance and that such an organization would retain the defining elements upon
which the substance identifier was based. At the specified substance level, a more regional approach
may be necessary because of the proprietary nature of much of the information.
The use of the identifier is essential for the description of substances in medicinal products on a global
scale. This document does not involve developing nomenclature for substances or specified substances,
but common and official substance names in current use can be mapped to each identifier.
Ingredients used in medicinal products range from simple chemicals to gene-modified cells to animal
tissues. To unambiguously define these substances is particularly challenging. This document defines
substances based on their scientific identity (i.e. what they are) rather than on their use or method of
production. Molecular structure or other immutable properties, such as taxonomic, anatomical and/or
fractionation information, are used to define substances. This document contains five single substance
types and a mixture substance class that are sufficient to define all substances. Although it is certainly
possible to define or classify substances in other ways, this document uses a minimalistic structured
scientific concept approach focusing on the critical elements necessary to distinguish two substances
from one another. There are frequently interactions between substances when they are mixed together,
but this document has intentionally not included these supramolecular interactions at the substance
level because of the variable nature and strength of such interactions. This document also allows for
the capture of multiple terms which refer to a given substance and a variety of reference information
that could be used to classify substances or relate one substance to another.
In addition to the substance level, this document also provides elements for the capture of further
information on substances that make up the defining characteristics of specified substances, such as
grade, manufacturer, manufacturing information and specifications, and also to capture information
on substances that are frequently combined together in commerce but are not strictly a medicinal
product. At the specified substance level, four groups of elements provide information essential to the
tracking and description of substances in medicinal products.
The basic concepts in the regulatory and pharmaceutical standards development domain use a wide
variety of terms in various contexts. The information models presented in this document depict
elements and the relationship between elements that are necessary to define substances. The terms and
definitions described in this document are to be applied for the concepts that are required to uniquely
identify, characterize and exchange information on substances in regulated medicinal products.
The terms and definitions adopted in this document 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 this document, “% (V/V)” is used in place of “% volume fraction”.
© ISO 2018 – All rights reserved vii

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SIST EN ISO 11238:2018

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SIST EN ISO 11238:2018
INTERNATIONAL STANDARD ISO 11238:2018(E)
Health informatics — Identification of medicinal
products — Data elements and structures for the unique
identification and exchange of regulated information on
substances
CAUTION — This document uses colour. This should be taken into consideration when printing.
1 Scope
This document provides an information model to define and identify substances within medicinal
products or substances used for medicinal purposes, including dietary supplements, foods and
cosmetics. The information model can be used in the human and veterinary domain since the principles
are transferrable. Other standards and external terminological resources are referenced that are
applicable to this document.
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/TS 19844:2018, Health informatics — Identification of medicinal products (IDMP) — Implementation
guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of
regulated information on substances
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at http: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
3.1
adjuvant
component that potentiates the immune response to an antigen and/or modulates it towards the
desired immune response
3.2
active marker
constituent or groups of constituents of a (herbal) Substance (fresh), Herbal Drug, Herbal preparation
or herbal medicinal product which are of interest for control purposes and are generally accepted t
...