SIST EN ISO 11238:2013
(Main)Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances (ISO 11238:2012)
Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances (ISO 11238:2012)
This International Standard provides an information model to define and identify substances within medicinal products or substances used for medicinal purposes, including dietary supplements, foods and cosmetics. Other standards and external terminological resources are referenced that are applicable to this International Standard.
Medizinische Informatik - Identifikation von Arzneimitteln - Struktur und kontrollierte Vokabularien zur Identifikation und Beschreibung von Substanzen und Inhaltsstoffen (ISO 11238:2012)
Diese Internationale Norm stellt ein Informationsmodell zur Definition und Identifikation von in Arzneimitteln enthaltenen oder zu medizinischen Zwecken verwendeten Stoffen bereit, einschließlich Nahrungsergänzungsmittel, Lebens und Futtermittelzusatzstoffe und Kosmetika. Es wird auf weitere Normen und externe Terminologiequellen verwiesen, die für diese Internationale Norm gelten.
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 11238:2012)
L'ISO 11238:2012 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, la nourriture et les produits cosmétiques.
Zdravstvena informatika - Identifikacija medicinskih izdelkov - Elementi in zgradba podatkov za enotno identifikacijo in izmenjavo predpisanih informacij o substancah (ISO 11238:2012)
Ta mednarodni standard zagotavlja informacijski model za določitev in identifikacijo substanc v medicinskih izdelkih ali substanc, ki se uporabljajo v medicinske namene, vključno s prehranskimi dopolnili, živili in kozmetičnimi proizvodi. Drugi navedeni standardi in zunanji terminološki viri se nanašajo na ta mednarodni standard.
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11238:2013
01-februar-2013
Zdravstvena informatika - Identifikacija medicinskih izdelkov - Elementi in zgradba
podatkov za enotno identifikacijo in izmenjavo predpisanih informacij o
substancah (ISO 11238:2012)
Health informatics - Identification of medicinal products - Data elements and structures
for the unique identification and exchange of regulated information on substances (ISO
11238:2012)
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SIST EN ISO 11238:2013 en
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SIST EN ISO 11238:2013
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SIST EN ISO 11238:2013
EUROPEAN STANDARD
EN ISO 11238
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 substances (ISO
11238:2012)
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
unique et l'échange d'informations réglementées sur les und Beschreibung von Substanzen und Inhaltsstoffen (ISO
substances (ISO 11238:2012) 11238:2012)
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 11238:2012: E
worldwide for CEN national Members.
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SIST EN ISO 11238:2013
EN ISO 11238:2012 (E)
Contents Page
Foreword .3
2
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SIST EN ISO 11238:2013
EN ISO 11238:2012 (E)
Foreword
This document (EN ISO 11238:2012) 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 11238:2012 has been approved by CEN as a EN ISO 11238:2012 without any modification.
3
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SIST EN ISO 11238:2013
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SIST EN ISO 11238:2013
INTERNATIONAL ISO
STANDARD 11238
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 substances
Informatique de santé — Identification des médicaments — Éléments
de données et structures pour l’identification unique et l’échange
d’informations réglementées concernant les substances
Reference number
ISO 11238:2012(E)
©
ISO 2012
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SIST EN ISO 11238:2013
ISO 11238:2012(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 11238:2013
ISO 11238:2012(E)
Contents Page
Foreword .iv
Introduction . v
1 Scope . 1
2 Terms, definitions, symbols and abbreviated terms . 1
2.1 Terms and definitions . 1
2.2 Symbols and abbreviated terms . 8
3 Requirements . 9
3.1 General . 9
3.2 Concepts required for the unique identification and description of substances . 9
3.3 Concepts required for the description of specified substances . 11
3.4 Naming of substances .12
3.5 Requirements for unique identifiers .13
3.6 Types of substances .14
3.7 Defining specified substances .27
Annex A (informative) Existing identifiers and molecular structure representations .35
Bibliography .38
© ISO 2012 – All rights reserved iii
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SIST EN ISO 11238:2013
ISO 11238:2012(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 11238 was prepared by Technical Committee ISO/TC 215, Health informatics.
iv © ISO 2012 – All rights reserved
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SIST EN ISO 11238:2013
ISO 11238:2012(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 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;
— 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
Medicines Agency;
— 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);
— 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.
The necessary messaging specifications are included as an integral part of the IDMP standards to secure the
interactions listed above.
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 materials within medicinal products.
This International Standard provides a structure that enables the assignment and maintenance of unique
identifiers for all substances in medicinal products or in packaging materials in which medicinal products are
contained. This International Standard sets out the general rules for defining and distinguishing substances,
and provides a high-level model that structures substances and specified substances for the organization and
capturing of data.
This International Standard has been developed using HL7’s Common Product Model, and detailed modelling of
substances and specified substances has been undertaken in that domain. It is anticipated that implementation
will use the HL7 substances implementation guide and messaging to deliver a strong, non-semantic unique
identifier for every substance present in a medicinal product. It is anticipated that a single organization will be
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SIST EN ISO 11238:2013
ISO 11238:2012(E)
responsible for the generation of 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 International Standard 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.
Materials used in medicinal products range from simple chemicals to gene-modified cells to animal tissues.
To unambiguously define these substances is particularly challenging. This International Standard 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 International Standard contains five groups of elements that
are sufficient to define all substances. Although it is certainly possible to define or classify substances in other
ways, this International Standard uses a minimalist 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 International Standard has intentionally not
included these supramolecular interactions at the substance level because of the variable nature and strength
of such interactions. This International Standard 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 International Standard also provides elements for the capture of further
information on substances, such as grade, manufacturer, manufacturing 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 International Standard depict elements
and the relationship between elements that are necessary to define substances. The terms and definitions
described in this International Standard 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 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.
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SIST EN ISO 11238:2013
INTERNATIONAL STANDARD ISO 11238:2012(E)
Health informatics — Identification of medicinal products —
Data elements and structures for the unique identification and
exchange of regulated information on substances
1 Scope
This International Standard provides an information model to define and identify substances within medicinal
products or substances used for medicinal purposes, including dietary supplements, foods and cosmetics. Other
standards and external terminological resources are referenced that are applicable to this International Standard.
2 Terms, definitions, symbols and abbreviated terms
2.1 Terms and definitions
For the purposes of this document, the following terms, definitions and abbreviations apply.
2.1.1
active marker
constituent, or groups of constituents, of an herbal substance, herbal preparation or herbal medicinal product
which are of interest for control purposes and are generally accepted to contribute to therapeutic activity
NOTE Active markers are not equivalent to analytical or signature markers that serve solely for identification or
control purposes.
2.1.2
analytical data
set of elements to describe and capture methods and reference material used to determine purity, potency or
identity in a specified substance
2.1.3
chemical bond
condition that occurs when forces acting between two atoms or groups of atoms lead to the formation of a
stable discrete molecular entity
2.1.4
chemical substance
type of substance that can be described as a stoichiometric or non-stoichiometric single molecular entity and
is not a protein or nucleic acid substance
NOTE Chemical substances are generally considered “small” molecules which have associated salts, solvates or
ions and may be described using a single definitive or representative structure.
2.1.5
chiral substance
substance whose molecular structure is not superimposable on its mirror image
2.1.6
component
intended constituent of a specified substance
EXAMPLE Dimethicone and silicon dioxide are components of simethicone. Human insulin protamine and zinc are
the components in human insulin isophane.
NOTE Components are used to describe the substances and specified substances that form a multi-substance material.
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ISO 11238:2012(E)
2.1.7
composition stoichiometry
quantitative relationships between the chemical elements or moieties that make up a substance
EXAMPLE Sodium phosphate dibasic heptahydrate and sodium phosphate dibasic dihydrate are defined as
different substances.
2.1.8
constituent
substance present within a specified substance
NOTE Constituents can be impurities, degradants, active markers or signature substances, or single substances
mixed together to form a product. Constituents shall have an associated role and amount. Constituent specifications shall
be used to describe components as well as limits on impurities or related substances for a given material.
2.1.9
controlled vocabulary
finite set of values that represent the only allowed values for a data item
NOTE 1 The allowed values can be codes, text or numeric.
NOTE 2 Adapted from CDISC Clinical Research Glossary V8.0, 2009.
2.1.10
copolymer
polymer with more than one type of structural repeating unit linked through covalent bonds
NOTE Copolymers are obtained by copolymerization or sequential polymerization of two or more monomers.
Copolymers can be random, alternating, block or graft.
2.1.11
critical process step
manufacturing step necessary for production of a specified substance
2.1.12
degree of polymerization
number of structural repeating units in a polymeric block or chain
NOTE Applies to both homopolymers and block copolymers where it refers to the degree of polymerization within a block.
2.1.13
diverse origin
substances that are not isolated together or the result of the same chemical synthetic process
NOTE Material containing multiple substances is defined either as a mixture substance or a multi-substance (group 1)
specified substance based on origin. Two substances brought together that do not undergo a chemical reaction resulting
in the formation or breakage of specific chemical bonds would be defined as separate substances, even if there are non-
bonding interactions between the substances.
2.1.14
enhancer
cis-acting sequence of DNA that increases the utilization of some eukaryotic promoters and which can function
in either orientation and in any location (upstream or downstream) relative to the promoter
2.1.15
fraction
distinct portion of material derived from a complex matrix, the composition of which differs from antecedent material
NOTE This concept is used to describe source material and is recursive in that a subsequent fraction can be derived
from an antecedent fraction, which is implied in the order of listing.
EXAMPLE Serum immunoglobulins to polyclonal IgG is an example of recursive fractionation.
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ISO 11238:2012(E)
2.1.16
gene
basic unit of hereditary material that encodes and controls the expression of a protein or protein subunit
2.1.17
gene element
individual element within a gene such as a promoter, enhancer, silencer or coding sequence
2.1.18
glycosylation
enzymatic process that links saccharides or oligosaccharides to proteins, lipids or other organic molecules
2.1.19
glycosylation type
significant differences in glycosylation between different types of organisms
NOTE This distinguishes the pattern of glycosylation across organism types, e.g. human, mammalian and avian. The
glycosylation type is a defining element when polydisperse organism-based glycosylation exists in a substance.
2.1.20
grade
set of specifications indicating the quality of a specified substance
2.1.21
homopolymer
polymer containing a single structural repeating unit
2.1.22
isotope
variants of a chemical element that differ by molecular mass
NOTE Radionuclides or nuclides with a non-natural isotopic ratio are shown in the structural representation with the
nuclide number displayed. Natural abundance isotopes are represented by an elemental symbol without a nuclide number.
13
EXAMPLE C refers to a carbon atom that has an atomic mass of 13.
2.1.23
manufacturing
process of production for a substance or medicinal product from the acquisition of all materials through all
processing stages
NOTE The critical process, starting and processing materials, and critical production parameters are included.
2.1.24
material
any entity that has mass, occupies space and consists of one or more substances
2.1.25
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
NOTE 1 A medicinal product may contain 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.
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ISO 11238:2012(E)
2.1.26
microheterogeneity
substances isolated together that contain minor differences in glycosylation, or post-translational modification
such as glycosylation or sequence heterogeneity
NOTE 1 Microheterogeneity is not a defining characteristic of either substances or specified substances.
NOTE 2 Microheterogeneity consists of variability in the type of glycosylation (biantennary, triantennary), extent of
glycosylation at a given site (site occupancy), sequence heterogeneity due to polymorphism in source material, translation
errors, variable proteolytic processing or other.
2.1.27
mixture substance
type of polydisperse substance that is a combination of single substances isolated together or produced in the
same synthetic process
NOTE Single substances of diverse origin that are brought together and do not undergo a chemical transformation
as a result of that combination are defined as multi-substance materials (Group 1 specified substances) and not as
mixture substances.
EXAMPLE Gentamicin is defined as a mixture substance of Gentamicin C1A, Gentamicin C1 and Gentamicin C2.
Glyceryl monoesters are defined as mixture substances of two single substances which differ in the position of esterification.
Simethicone, which consists of dimethicone and silicon dioxide, is not defined as a mixture substance since these are
diverse materials brought together to form a product.
2.1.28
moiety
entity within a substance that has a complete and continuous molecular structure
EXAMPLE The strength of a medicinal product is often based on what is referred to as the active moiety and should
be defined in a consistent manner across all products. To avoid ambiguity, the free acid and/or free base should be used
as the moiety upon which strength is based.
NOTE In this International Standard, moiety shall be used in the context of non-stoichiometric chemical substances
and in modification of nucleic acid, proteins, polymers and structurally diverse substances. Moieties shall be single
substances, ions or solvate molecules.
2.1.29
molecular fragment
portion of a molecule that has one or more sites of attachment to other fragments or moieties
NOTE Molecular fragments are used in the description of polymers to represent substituents and in structural
modifications to a substance.
2.1.30
molecular structure
unambiguous representation of the arrangement of atoms
NOTE 1 For the purposes of defining substances, the three dimensional conformations are not captured. Individual
conformations or conformers of substances would only be captured in either a general sense for proteins (i.e. denatured)
or when a given rotation about a single bond is restricted in such a way that the two different conformers are isolatable
from each other and do not interconvert at room temperature (e.g. substituted biphenyls).
NOTE 2 This representation should be generally translatable into a graphical representation.
2.1.31
molecular weight
mass of one molecule of a homogenous substance or the average mass of molecules that comprise a
heterogeneous substance
NOTE 1 The unified atomic mass unit is the unit of molecular weight. The type of molecular weight should always be captured.
NOTE 2 For polymers, there are several different types of molecular weight (weight average, number average, etc.).
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2.1.32
multi-substance material
multiple substances and/or specified substances of diverse origin used as a component in the formulation of
a medicinal product
EXAMPLE Materials such as human insulin isophane, simethicone, aluminium lakes, nicotine polacrilex, and
phosphate buffered saline are all multi-substance ingredients.
NOTE Multi-substance materials are Group 1 specified substances. Any medicinal product used to formulate another
medicinal product could also be considered a multi-substance material.
2.1.33
nucleic acid substance
type of substance that can be defined by a linear sequence of nucleosides typically linked through phosphate esters
NOTE The type of nucleic acid substance (RNA, DNA) is also identified. Oligonucleotides an
...
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