Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances (ISO 11238:2018)

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.

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 produits médicaux - Éléments de données et structures pour l'identification unique et l'échange d'informations réglementées sur les substances (ISO 11238:2018)

Le présent document donne un modèle d'informations visant à définir et identifier des substances utilisées dans des médicaments ou à des fins médicinales, y compris les compléments alimentaires, les produits alimentaires et les produits cosmétiques. Le modèle d'informations, qui repose sur des principes transférables, peut être utilisé aussi bien dans le domaine humain que vétérinaire. Il est fait référence à d'autres normes et ressources terminologiques externes applicables au présent document.

Zdravstvena informatika - Identifikacija medicinskih izdelkov - Elementi in zgradba podatkov za enotno identifikacijo in izmenjavo predpisanih informacij o substancah (ISO 11238:2018)

Ta dokument podaja informacijski model za opredelitev in identifikacijo substanc v medicinskih proizvodih ali substanc, ki se uporabljajo v medicinske namene, vključno s prehranskimi dopolnili, živili in kozmetičnimi proizvodi. Informacijski model je mogoče uporabljati za ljudi in živali, saj so načela prenosljiva. Omenjeni so tudi drugi standardi in zunanji terminološki viri, ki se nanašajo na ta dokument.

General Information

Status
Published
Publication Date
31-Jul-2018
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
01-Aug-2018
Completion Date
01-Aug-2018

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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

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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.

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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

© ISO 2018 – All rights reserved iii
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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

...

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