prEN ISO 11238

SLOVENSKI STANDARD
01-marec-2026
Zdravstvena informatika - Identifikacija medicinskih izdelkov - Elementi in zgradba
podatkov za enotno identifikacijo in izmenjavo predpisanih informacij o
substancah (ISO/DIS 11238:2026)
Health informatics - Identification of medicinal products - Data elements and structures
for the unique identification and exchange of regulated information on substances
(ISO/DIS 11238:2026)
Medizinische Informatik - Identifikation von Arzneimitteln - Dateielemente und Strukturen
zur eindeutigen Identifikation und zum Austausch von vorgeschriebenen Informationen
zu Stoffen (ISO/DIS 11238:2026)
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/DIS 11238:2026)
Ta slovenski standard je istoveten z: prEN ISO 11238
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
International
Standard
ISO/DIS 11238
ISO/TC 215
Health informatics — Identification
Secretariat: ANSI
of medicinal products — Data
Voting begins on:
elements and structures for the
2026-01-23
unique identification and exchange
Voting terminates on:
of regulated information on
2026-04-17
substances
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
ICS: 35.240.80
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
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.
Reference number
ISO/DIS 11238:2026(en)
DRAFT
ISO/DIS 11238:2026(en)
International
Standard
ISO/DIS 11238
ISO/TC 215
Health informatics — Identification
Secretariat: ANSI
of medicinal products — Data
Voting begins on:
elements and structures for the
unique identification and exchange
Voting terminates on:
of regulated information on
substances
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
ICS: 35.240.80
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2026
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: +41 22 749 01 11
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 11238:2026(en)
ii
ISO/DIS 11238:2026(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols and abbreviated terms.13
5 Description of the information modelling principles and practices . 14
5.1 General considerations.14
5.2 Conceptual overview diagrams . 15
5.3 Section high-level diagrams .16
5.4 Detailed diagrams .16
5.5 Relationships between classes .17
5.6 Notes . 20
5.7 Attributes . 20
5.8 Conformance terminology and context as it relates to this document and ISO/TS 19844 . 20
6 Requirements .21
6.1 General .21
6.2 Concepts required for the unique identification and description of substances .21
6.3 Concepts required for the description of specified substances. 22
6.3.1 General . 22
6.3.2 Relationship between Substances and Specified Substance Groups .24
6.4 Naming of substances. 25
6.5 Requirements for unique identifiers . 26
6.6 Existing identifiers and molecular structure representation .27
7 Types of substances .27
7.1 General .27
7.2 Element sets common to multiple types of substances .27
7.2.1 Structure .27
7.2.2 Isotope .27
7.2.3 Modification . . . 28
7.2.4 Reference information . 29
7.2.5 Source material . 30
7.2.6 Taxonomy .31
7.2.7 Authentication of Herbal Drugs .31
7.2.8 Substance codes .32
7.3 Chemical substances .32
7.4 Protein substances . 33
7.5 Nucleic acid substances . 35
7.6 Polymer substances . 36
7.7 Structurally diverse substances . 38
7.8 Mixture . 40
8 Defining specified substances . 41
8.1 General .41
8.2 Specified Substance Group 1 .42
8.3 Specified Substance Group 2 .45
8.4 Specified Substance Group 3 .47
8.5 Specified Substance Group 4 . 49
8.5.1 Preliminary remarks on the Status of Specified Substance Group 4 Section . 49
8.5.2 General . 49
8.5.3 Specified Substance Group 4 Name . 50
8.5.4 Grade . 50
8.5.5 Use of analytical data . 50

iii
ISO/DIS 11238:2026(en)
8.5.6 Manufacturing .51
8.5.7 Version and specification .52
Annex A (informative) Existing identifiers and molecular structure representations .55
Bibliography .59

iv
ISO/DIS 11238:2026(en)
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.
This third edition cancels and replaces the second edition (ISO 11238:2018), which has been technically
revised.
The main changes are correction in the elements describing chemical substance type, as well as various
adjustment in the document.
To be noted: the section related to Specified Substance Group 4 represented in this document hasn't been
updated, and the authors acknowledge that the proposed model would need updates. However, a work item
proposal has been adopted and is currently being developed within ISO/TC 215, Health informatics, related
to the unique identification and exchange of Manufacturing Process & Controls Information of products and
substances (ISO/NP 26060). When ready, this document will cancels and replaces the section related to
Specified Substance Group 4, in ISO 11238 and ISO/TS 19844 series.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

v
ISO/DIS 11238:2026(en)
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:
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 11239Health 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
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
ISO/TS 20440 Health informatics — Identification of Medicinal Products — Implementation guide for
ISO 11239data 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/TS 20443 Health informatics — Identification of Medicinal Products — Implementation guide for
ISO 11615data elements and structures for the unique identification and exchange of regulated Medicinal
Product information
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, 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
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);
— 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.

vi
ISO/DIS 11238:2026(en)
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 to deliver a strong, non-semantic unique
identifier for every substance present in a medicinal product. It is anticipated that a single maintenance
organization (such as Uppsala Monitoring Centre) 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. Region may also define their own regional identifier, which would be a
regional alias of the global identifier. 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 and pharmacopoeia, 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,
three 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”.

vii
DRAFT International Standard ISO/DIS 11238:2026(en)
Health informatics — Identification of medicinal products —
Data elements and structures for the unique identification
and exchange of regulated information on substances
CAUTION — 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 transferable.
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 11615:2017, Health informatics — Identification of medicinal products — Data elements and structures for
the unique identification and exchange of regulated medicinal product information
ISO 11616:2017, Health informatics — Identification of medicinal products — Data elements and structures for
unique identification and exchange of regulated pharmaceutical product information
ISO/TS 20443:2017, Health informatics — Identification of medicinal products — Implementation guidelines
for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal
product information
ISO/TS 20451:2017, Health informatics — Identification of medicinal products — Implementation guidelines for
ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical
product information
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/

ISO/DIS 11238:2026(en)
3.1
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 to contribute
to therapeutic activity
Note 1 to entry: Active markers are not equivalent to analytical or signature markers that serve solely for identification
or control purposes.
3.2
allergen
material (3.34) capable of stimulating a type-I hypersensitivity or allergic reaction in atopic individuals
Note 1 to entry: In this document the definition is specified to a molecule (substance) capable of inducing an
immunoglobulin E (IgE) response and/or a Type I allergenic reaction.
3.3
analytical data
set of elements to describe and capture methods and reference material used to determine purity, potency
or identity in a specified substance (3.68)
Note 1 to entry: This definition is valid in the context of this document and ISO/TS 19844.
3.4
ATC Code
Anatomical Therapeutic Chemical Classification code
substance classification code
code used for the classification of drugs
1)
Note 1 to entry: It is controlled by the WHO Collaborating Centre for Drug Statistics Methodology (WHOCC) .
Note 2 to entry: This pharmaceutical coding system divides drugs into different groups according to the organ or
system on which they act and/or their therapeutic, pharmacological and chemical properties. Each bottom-level ATC
Code (3.4) stands for a pharmaceutically used substance (3.74) or a combination of substances in a single indication (or
use). This means that one drug can have more than one code: Acetylsalicylic acid, for example, has A01AD05 as a drug
for local oral treatment, B01AC06 as a platelet inhibitor, and N02BA01 as an analgesic and antipyretic. On the other
hand, several different brands share the same code if they have the same active substance and indications.
3.5
CAS Registry Number
2)
CAS number
unique numerical identifier of a substance in the CAS Registry system
Note 1 to entry: For further explanations see A.1.2.
3.6
chemical substance
type of substance (3.74) that can be described as a stoichiometric or non-stoichiometric single molecular
entity and is not a protein, nucleic acid or polymer substance (3.54)
Note 1 to entry: 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.
3.7
chiral substance
substance (3.74) whose molecular structure (3.42) is not superimposable on its mirror image
1) https:// www .whocc .no/ atc/ structure _and _principles/
2) https:// www .cas .org/ content/ chemical -substances/ faqs

ISO/DIS 11238:2026(en)
3.8
component
substance (3.74) which is part of a mixture (3.37) and that defines a multi-substance material (3.44) at the
Specified Substance Group 1 level
EXAMPLE Dimethicone and silicon dioxide are components of simethicone. Human insulin and protamine are the
components in human insulin isophane.
Note 1 to entry: Components are used to describe a multi-substance material (3.44).
Note 2 to entry: This definition is valid in the context of this document and ISO/TS 19844.
3.9
composition stoichiometry
quantitative relationships between the chemical elements or moieties that make up a substance (3.74)
EXAMPLE Disodium hydrogen phosphate heptahydrate and disodium hydrogen phosphate dihydrate are defined
as different substances because they differ in composition stoichiometry (3.9).
3.10
configuration
method for indicating the three-dimensional arrangement of atoms at a stereogenic carbon, phosphorous,
sulfur centre or stereocenter
Note 1 to entry: This definition is valid in the context of this document and ISO/TS 19844.
3.11
constituent
substance (3.74) present within a specified substance (3.68) or a parent substance (3.74)
Note 1 to entry: Constituents can be impurities, degradants, extraction solvents (3.20), vehicles, active markers or
signature substances, parent substances or single substances mixed together to form a multi-substance material (3.44).
Note 2 to entry: Constituents shall have an associated role and amount at the Specified Substance Group 1 information
model. constituent (3.11) specifications shall be used to describe components as well as limits on impurities or related
substances for a given material (3.34).
EXAMPLE The substance (3.74), triamcinolone acetonide is the parent (constituent) substance of the Specified
Substance Group 1 substance, triamcinolone acetonide, micronized.
Note 3 to entry: Constituent component is part of a mixture belonging to a homologous group of individual components,
described as parent substances for the manufacture of an allergenic extract.
3.12
controlled vocabulary
finite set of values that represent the only allowed values for a data item
Note 1 to entry: These values may be codes, text or numeric.
[[1]]
[SOURCE: CDISC Clinical Research Glossary V19.0, 2024, modified]
3.13
copolymer
polymer with more than one type of structural repeat unit linked through covalent bonds
Note 1 to entry: Copolymers are obtained by copolymerization or sequential polymerization of two or more different
monomers. Copolymers can be random, statistical, alternating, periodic, block, cross, graft or mixed.

ISO/DIS 11238:2026(en)
3.14
critical process parameter
process parameter whose variability has an impact on a critical quality attribute and therefore should be
monitored or controlled to ensure the process produces the desired quality
Note 1 to entry: A manufacturing parameter is considered “critical” and necessary for production of substance or
specified Substance e.g. inclusion of chromatographic step for removal or reduction of impurities, viruses.
Note 2 to entry: The critical process is tied to the Production Method type.
3.15
degree of polymerization
average number of monomers or repeat units in a polymeric block or chain
Note 1 to entry: Applies to both homopolymers and block copolymers where it refers to the degree of polymerization
within a block.
3.16
diverse origin
substances that are not isolated together or the result of the same process
3.17
drug extract ratio
ratio of the quantity of the (Herbal) substance (fresh), or Herbal Drug to the quantity of the resulting Herbal
preparation
3.18
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
3.19
extract ratio [for allergens]
extraction ratio indicating the relative proportions (m/V) of allergenic source materials and solvents
Note 1 to entry: This ratio is a minimal requirement for allergens for which there are not enough patients to determine
the total allergenic activity in vivo or in vitro.
3.20
extraction solvents
solvents which are used for the extraction process
3.21
fraction
distinct portion of material derived from a complex matrix, the composition of which differs from antecedent
material
Note 1 to entry: This concept is used to describe source material and is recursive in that a subsequent fraction can be
derived from an antecedent fraction.
EXAMPLE Serum immunoglobulins to polyclonal IgG is an example of recursive fractionation.
3.22
gene
basic unit of hereditary information composed of chains of nucleotide base pairs in specific sequences that
encodes a protein or protein subunit
3.23
gene element
individual element within a gene such as a promoter, enhancer, silencer or coding sequence

ISO/DIS 11238:2026(en)
3.24
glycosylation
enzymatic process that links saccharides or oligosaccharides to substances
3.25
glycosylation type
significant differences in glycosylation between different types of organisms
Note 1 to entry: This distinguishes the pattern of glycosylation across organism types, e.g. human, mammalian and
avian. The glycosylation type is a defining element when a glycosylated protein exists as a substance.
3.26
grade
set of specifications indicating the quality of a substance or specified substance
3.27
harvesting
process of collecting a (Herbal) substance (fresh) or parts of botanical material from the field or process of
collecting viral or bacterial material from its production/manufacturing site
3.28
homeopathic stocks
substances, products of preparations used as starting materials for the production of homeopathic
preparations.
Note 1 to entry: A stock is usually one of the following: a mother tincture or a glycerol macerate, for raw materials of
botanical, zoological or human origin, or the substance itself, for raw materials of chemical or mineral origin.
3.29
homopolymer
polymer containing a single structural repeat unit
3.30
isotope
variants of a chemical element that differ by atomic mass, having the same number of protons and differing
in the number of neutrons in the nucleus
Note 1 to entry: 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.
EXAMPLE C refers to a carbon atom that has 6 protons and 7 neutons.
3.31
manufactured item
qualitative and quantitative composition of a product as contained in the packaging of the Medicinal Product
Note 1 to entry: A Medicinal Product may contain one or more manufactured items. In many instances the
manufactured item is equal to the pharmaceutical product. However, there are instances where the manufactured
item(s) undergo a transformation before being administered to the patient (as the pharmaceutical product) and the
two are not equal.
Note 2 to entry: This definition is valid in the context of ISO 11615:2017, ISO/TS 20443:2017, ISO 11616:2017 ,
ISO/TS 20451:2017, this document and ISO/TS 19844.
3.32
manufacturer
organization that holds the authorization for the manufacturing process
Note 1 to entry: In this document the definition refers to a company responsible for the manufacturing of the substance

ISO/DIS 11238:2026(en)
3.33
manufacturing
process of production for a substance or medicinal product from the acquisition of all materials through all
processing stages
Note 1 to entry: The critical process, critical process steps, starting and processing materials and critical production
parameters are included.
3.34
material
entity that has mass, occupies space and consists of one or more substances
3.35
medicinal product
pharmaceutical product or combination of pharmaceutical products that can be administered to human
beings (or animals) for treating or preventing disease, with the aim/purpose of making a medical diagnosis
or to restore, correct or modify physiological functions
Note 1 to entry: A medicinal product may contain in the packaging one or more manufactured items and one or more
pharmaceutical products. In certain regions, a medicinal product may also be defined as any substance or combination
of substances which may be used to make a medical diagnosis.
3.36
microheterogeneity
substances isolated together that contain minor differences in structure between essentially identical
substances that are isolated/source material (e.g. sequence heterogeneity) and/or post-translational
modification such as glycosylation
Note 1 to entry: Microheterogeneity is not a defining characteristic of substances but can be a defining one at the
specified substance group 1 information level, e.g. differences in glycans.
Note 2 to entry: 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 or variable proteolytic processing or other.
3.37
mixture
type of polydisperse substance that is a combination of single substances isolated together or produced in
the same synthetic process
Note 1 to entry: 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 (Specified Substance Group 1)
and not as mixture.
EXAMPLE 1 Gentamicin is defined as a mixture substance of Gentamicin C1, Gentamicin C1A, Gentamicin C2,
Gentamicin C2A and Gentamicin C2B.
EXAMPLE 2 Glyceryl monoesters are defined as mixture substances of two single substances which differ in the
position of esterification.
EXAMPLE 3 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 multi-substance material.
Note 2 to entry: Mixture could be used for a homologous group of structurally diverse single substances used as
starting materials in order to prepare an allergen extract. The extract is further described by using the class Fraction
Description (allergen preparation) obtained from the structurally diverse single substances (starting materials) as
parent substances. This substance (allergen extract) is the result of the same (synthetic) process and hence the extract
is considered as a mixture substance.

ISO/DIS 11238:2026(en)
3.38
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 of the
molecule, responsible for the physiological or pharmacological action of the drug substance. To avoid ambiguity, the
free acid and/or free base should be used as the moiety upon which strength is based.
Note 1 to entry: The active moiety of a stoichiometric or non-stoichiometrical substance molecule is considered that
part of the molecule that is the base, free acid or ion molecular part of a salt, solvate, chelate, clathrate, molecular
complex or ester.
3.39
molecular formula
chemical formula that shows the total n
...