oSIST prEN ISO 22532:2025

Health informatics - Identification of medicinal products - Core vocabulary (terms and definitions) for the IDMP Standards (ISO/DIS 22532:2025)

This standard lists the terms and definitions to be used in the IDMP (Identification of medicinal products) standards and technical specifications, when terms and definitions as to be used in more than one of these standards.

Medizinische Informatik - Identifikation von Arzneimitteln - Kernvokabular (Begriffe und Definitionen) für die IDMP-Normen (ISO/DIS 22532:2025)

Informatique de santé - Identification des médicaments - Vocabulaire de base (termes et définitions) pour les normes IDMP (ISO/DIS 22532:2025)

Zdravstvena informatika - Identifikacija medicinskih izdelkov - Temeljno besedišče (izrazi in definicije) za standarde IDMP (ISO/DIS 22532:2025)

General Information

• Status: Not Published
• Public Enquiry End Date: 09-Jun-2025
• ICS: 01.040.11 - Health care technology (Vocabularies)
• ICS: 11.040.01 - Medical equipment in general
• ICS: 11.120.10 - Medicaments
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ITC - Information technology
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 25-Mar-2025
• Due Date: 12-Aug-2025
• Completion Date: 23-Jun-2025
• Ref Project: prEN ISO 22532 - Health informatics - Identification of medicinal products - Core vocabulary (terms and definitions) for the IDMP Standards (ISO/DIS 22532:2025)

Overview

prEN ISO 22532 / ISO/DIS 22532:2025 defines the core vocabulary (terms and definitions) for the IDMP (Identification of Medicinal Products) family of standards. Its purpose is to provide a single, authoritative list of shared terms and definitions used across IDMP standards and related technical specifications, reducing divergence as documents evolve. This draft international standard is part of ISO/TC 215 (Health informatics) and targets consistency in medicinal product identification, terminology and data exchange.

Key topics and technical requirements

• Core definitions list: A comprehensive catalogue of terms and definitions used in at least three IDMP standards or specifications (examples in the draft include administrable dose form, combined pharmaceutical dose form, co-crystals, adjuvant, allergen, confidentiality, constituent).
• Single reference source: Consolidates commonly shared definitions so implementers and standards developers can align on meaning and reduce ambiguity.
• Homonymy and context rules: Where a term has multiple meanings, the context must be stated (in conformance with ISO/IEC Directives, Part 2) to distinguish different concepts.
• Data and coding considerations: Definitions acknowledge practical representation (for example, combined pharmaceutical dose forms are described with display names and codes within an XML structure), supporting consistent data modelling and exchange.
• Scope and governance notes: Identifies core definitions as those used across multiple IDMP documents, and explains maintenance and patent-rights considerations typical of ISO drafts.
• No normative references: The draft explicitly contains no normative references, serving purely as a terminological resource.

Practical applications

• Ensures semantic interoperability for regulatory submissions, pharmacovigilance, clinical trials, and product registries by standardizing terminology for medicinal product identification.
• Guides health IT vendors and terminology managers when implementing IDMP-compliant data models, XML payloads and controlled vocabularies.
• Supports regulators, MAHs (marketing authorization holders) and pharmaceutical manufacturers in preparing consistent product master data and regulatory dossiers.
• Helps harmonize data across electronic health records (EHRs), supply chain systems and safety reporting tools where precise medicinal product identification is required.

Who uses this standard

• Standards developers and implementers working with IDMP (ISO 11238/11239/11240 etc.)
• Regulatory authorities and assessors
• Pharmaceutical companies (data governance, regulatory affairs)
• Health IT vendors, terminology specialists and semantic architects
• Clinical safety, pharmacovigilance and regulatory submission teams

Related standards

• ISO 11239 (manufactured dose forms) and ISO/TS 20440 (referenced in the draft notes)
• ISO/IEC Directives (for context and terminology rules)
• ISO Online Browsing Platform and IEC Electropedia for broader terminological resources

Keywords: IDMP, ISO 22532, core vocabulary, identification of medicinal products, terms and definitions, health informatics, medicinal product identification, regulatory interoperability, XML coding.

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2025
Zdravstvena informatika - Identifikacija medicinskih izdelkov - Temeljno besedišče
(izrazi in definicije) za standarde IDMP (ISO/DIS 22532:2025)
Health informatics - Identification of medicinal products - Core vocabulary (terms and
definitions) for the IDMP Standards (ISO/DIS 22532:2025)
Medizinische Informatik - Identifikation von Arzneimitteln - Kernvokabular (Begriffe und
Definitionen) für die IDMP-Normen (ISO/DIS 22532:2025)
Informatique de santé - Identification des médicaments - Vocabulaire de base (termes et
définitions) pour les normes IDMP (ISO/DIS 22532:2025)
Ta slovenski standard je istoveten z: prEN ISO 22532
ICS:
01.040.11 Zdravstveno varstvo Health care technology
(Slovarji) (Vocabularies)
11.040.01 Medicinska oprema na Medical equipment in general
splošno
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 22532
ISO/TC 215
Health informatics — Identification
Secretariat: ANSI
of medicinal products — Core
Voting begins on:
vocabulary (terms and definitions)
2025-03-10
for the IDMP Standards
Voting terminates on:
ICS: 01.040.11; 35.240.80; 11.120.10
2025-06-02
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 22532:2025(en)
DRAFT
ISO/DIS 22532:2025(en)
International
Standard
ISO/DIS 22532
ISO/TC 215
Health informatics — Identification
Secretariat: ANSI
of medicinal products — Core
Voting begins on:
vocabulary (terms and definitions)
for the IDMP Standards
Voting terminates on:
ICS: 01.040.11; 35.240.80; 11.120.10
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 2025
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: [phone]
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 22532:2025(en)
ii
ISO/DIS 22532:2025(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 Definitions .1
Bibliography .30

iii
ISO/DIS 22532:2025(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 (see 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 (see 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 meaning of ISO specific terms and expressions related to conformity assessment,
as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the
Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 215, Health Informatics.
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 <>.

iv
ISO/DIS 22532:2025(en)
Introduction
The series of “Identification of Medicinal Products” (IDMP) consists in five international standards and
four technical specifications. When these documents were developed, a special attention was given to use
identical terms and definitions; in the meantime, successive revision of these documents has shown that it
becomes challenging to keep terms and definition perfectly aligned. Further in the meantime new technical
specifications have been developed or are in development, which will inherit IDMP core definitions.
IDMP core definitions are these which are used in at least three of the IDMP series of standards and
technical specifications. The need to group core definitions in one single international standard helps keep
the alignment of core definitions over the time and simplifies the work of all interested parties (standards
developers and implementers) since the core definitions are available in one single place.
If a term can designate more than one concept (homonymy), usually different concepts in different contexts,
the context for the given definition should be stated in conformance with the ISO/IEC Directives, part 2,
16.5.6. In that case the context should precede the definition text enclosed between angle parentheses
(). This indicates that the same term may occur in another context with another definition,
designating another concept, in the same document or in another document.
The International Organization for Standardization (ISO) draws attention to the fact that it is claimed that
conformity with this document may involve the use of a patent.
ISO takes no position concerning the evidence, validity and scope of this patent right.
The holder of this patent right has assured ISO that he/she is willing to negotiate licences under reasonable
and non-discriminatory terms and conditions with applicants throughout the world. In this respect, the
statement of the holder of this patent right is registered with ISO. Information may be obtained from the
patent database available at www.iso.org/patents.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights other than those in the patent database. ISO shall not be held responsible for identifying any or all
such patent rights.
v
DRAFT International Standard ISO/DIS 22532:2025(en)
Health informatics — Identification of medicinal products
— Core vocabulary (terms and definitions) for the IDMP
Standards
1 Scope
This document provides the comprehensive list of terms and definitions (“core definitions”) used in the
IDMP standards and their related standards and technical specifications.
The purpose is to provide a single reference to the core definitions in each of the IDMP standards and related
normative documents, as well as in technical reports.
2 Normative references
There are no normative references in this document.
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:
— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at http:// www .iso .org/ obp
3.1 Definitions
3.1.1
adjuvant
component that potentiates the immune response to an antigen and/or modulates it towards the desired
immune response
3.1.2
administrable dose form
pharmaceutical administrable dose form
pharmaceutical dose form for administration to the patient
Note 1 to entry: Transformation of the manufactured items and their corresponding manufactured dose forms may be
necessary before administration.
Note 2 to entry: The administrable dose form is identical to the manufactured dose form in cases where no
transformation of the manufactured item is necessary [i.e. where the manufactured item is equal to the pharmaceutical
product]
— ("administrable dose form", "is a type of", "pharmaceutical dose form")
— ("administrable dose form", "is for", "administration to the patient")
— ("administrable dose form", "is equal to", "manufactured dose form ", "when", "no transformation")

ISO/DIS 22532:2025(en)
3.1.3
allergen
substance used as ingredient or in a device capable of stimulating a type-I hypersensitivity and allergic
reaction
Note 1 to entry: The active allergens are structurally diverse substance derived from biological matrices. In several
instances, if the allergenic protein responsible for the allergenic response has been isolated and characterised in the
majority of patients, then the substance is classified as protein.
— ("allergen", "is a type of", "material")
— ("allergen", "used as", "ingredient or in a device")
— ("allergen", "capable of", "stimulating a type-I hypersensitivity")
— ("allergen", "capable of", "stimulating an allergic reaction")
— ("allergen", "is derived from", "biological matrices")
— ("allergen", "is classified as", "protein")
3.1.4
co-crystals
homogenous (single phase) crystalline structures made up of two or more components in a definite
stoichiometric ratio where the arrangement in the crystal lattice is not based on ionic bonds
Note 1 to entry: Over the last decade, co-crystals have gained considerable attention as alternative solid-state forms
in drug development. By making co-crystals of pharmaceutically interesting substances, their solid state properties
such as solubility, hygroscopicity and stability may be improved as well as manufacturing behaviour (e.g., compaction,
flowability, filterability, etc.). The salt formation is already widely used for this purpose, but with co-crystal formation
this can now be achieved also for substances that lack the possibility of salt formation. A principal tool is the hydrogen
bond, which is responsible for the majority of directed intermolecular interactions in molecular solids. Co-crystals are
multi-component crystals based on hydrogen bonding interactions without the transfer of hydrogen ions to form salts;
this is an important feature, since bronsted acid-base chemistry is not a requirement for the formation of a co-crystal.
— ("co-crystals", "are", "homogenous crystalline structures")
— ("co-crystals", "made up of", "two or more components in a definite stoichiometric ratio")
— ("co-crystals", "arrangement in the crystal lattice", "not based on ionic bonds")
— ("co-crystals", "are used as", "alternative solid-state forms in drug development")
— ("co-crystals", "can improve", "solid state properties (such as solubility, hygroscopicity and stability)")
— ("solid state properties", "includes", "solubility, hygroscopicity and stability")
— ("co-crystals", "can improve", "manufacturing behaviour (e.g. compaction, flowability, filterability, etc.)")
— ("manufacturing behaviour", "includes", "compaction, flowability, filterability, etc.")
— ("co-crystals", "are based on", "hydrogen bonding interactions without the transfer of hydrogen ions to form salts")
3.1.5
combined pharmaceutical dose form
single term used to describe two or more manufactured items that are intended to be combined in a specific
way to produce a single pharmaceutical product
EXAMPLE The term "powder and solvent for solution for injection" articulates a combined pharmaceutical dose
form wherein the medicinal product comprises a powder and a solvent, both intended for solution for injection. Once
combined, these items produce an injectable solution.

ISO/DIS 22532:2025(en)
Note 1 to entry: This term encompasses detailed information regarding each item's manufactured dose form as well
as the final administrable dose form of the compounded pharmaceutical product. In accordance with the standards
[1] [2]
outlined in ISO 11239 and ISO/TS 20440, the combined pharmaceutical dose form is characterized by a distinctive
term and a corresponding term identifier, each of which is expressed by a "display name" and a "code" within an XML
structure. This combined form is identified and coded within the established terminology framework, reflecting the
comprehensive nature of the product. In essence, the combined pharmaceutical dose form is an integral term utilized
in the identification and classification of complex medicinal products that are composed of multiple components,
which, when combined as directed, result in a final pharmaceutical product ready for administration to the patient.
Note 2 to entry: includes information on the manufactured dose form of each manufactured item and the administrable
dose form of the pharmaceutical product
— ("combined pharmaceutical dose form", "is composed of", "two or more manufactured items")
— ("combined pharmaceutical dose form", "is intended to", "produce a single pharmaceutical product")
— ("combined pharmaceutical dose form", "includes information on", "the manufactured dose form of each
manufactured item")
— ("combined pharmaceutical dose form", "includes information on", "the administrable dose form of the
pharmaceutical product")
— ("combined pharmaceutical dose form", "is characterized by", "a distinctive term and a corresponding term
identifier")
— ("combined pharmaceutical dose form", "is expressed by", "a 'display name' and a 'code' within an XML structure")
— ("combined pharmaceutical dose form", "is utilized in", "the identification and classification of complex medicinal
products")
— ("combined pharmaceutical dose form", "results in", "a final pharmaceutical product ready for administration to
the patient")
3.1.6
confidentiality
safety and privacy of a piece of information or an entity
EXAMPLE Content of the information can be trusted by the reader. The authorized reader can trust that no
unauthorised persons can access the information. This means that the information can contain enterprise secrets
which are not available to unauthorised persons, personal information cannot be accessed unless proper credentials
and the informations can always be trusted.
Note 1 to entry: Confidentiality is a property especially of information which means that the information is available
only to authorized persons
— ("confidentiality", "is related to", "safety and privacy", "of", "a piece of information")
— ("confidentiality", "implies", "available only to authorised persons")
— ("confidentiality", "ensures", "no unauthorised persons can access the information")
— ("confidentiality", "protects", "enterprise secrets")
— ("confidentiality", "protects", "personal information cannot be accessed unless proper credentials")
Note 2 to entry: In certain jurisdictions there is a distinct difference between on one hand confidentiality = safety and
accuracy of information and on the other hand confidentiality = privacy of information.
3.1.7
constituent
substance present within a specified substance or mixture
EXAMPLE The substance, triamcinolone acetonide is the parent (constituent) substance of the specified substance
group 1 substance, triamcinolone acetonide, micronized.
Note 1 to entry: Constituents can be impurities, degradants, extraction solvents, vehicles, active markers or signature
substances, parent substances or single substances mixed together to form a multi-substance material.

ISO/DIS 22532:2025(en)
Note 2 to entry: Constituents shall have an associated role and amount at the specified substance group 1 information
model. Constituent specifications shall be used to describe components as well as limits on impurities or related
substances for a given material.
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.
— ("constituent", "is", "a substance")
— ("constituent", "can be present within", " specified substance")
— ("constituent", "can be present within", "mixture")
— ("constituent", "may have", "an amount")
— ("constituent", "shall have", "an associated role")
— ("constituent", "can have role of", "impurities")
— ("constituent", "can have role of", "degradants")
— ("constituent", "can have role of", "extraction solvents")
— ("constituent", "can have role of", "vehicles")
— ("constituent", "can have role of", "active markers")
— ("constituent", "can have role of", "signature substances")
— ("constituent", "can be part of", "a multi-substance material")
— ("constituent", "is part of", "a mixture belonging to a homologous group of individual components")
— ("constituent", "can be", "impurities, degradants, extraction solvents, vehicles, active markers or signature
substances, parent substances or single substances mixed together to form a multi-substance material")
3.1.8
constituent (to delete)
substance present within a specified substance or mixture
EXAMPLE The substance, triamcinolone acetonide is the parent (constituent) substance of the specified substance
group 1 substance, triamcinolone acetonide, micronized.
Note 1 to entry: Constituents can be impurities, degradants, extraction solvents, vehicles, active markers or signature
substances, parent substances or single substances mixed together to form a multi-substance material.
Note 2 to entry: Constituents shall have an associated role and amount at the Specified Substance Group 1 information
model. Constituent specifications shall be used to describe components as well as limits on impurities or related
substances for a given material.
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.
— ("constituent", "is a", "substance")
— ("constituent", "can be present within", " Specified Substance")
— ("constituent", "can be present within", "Mixture")
— ("constituent", "may have", "an amount")
— ("constituent", "shall have", "an associated role")
— ("constituent", "can have role of", "impurities")
— ("constituent", "can have role of", "degradants")
— ("constituent", "can have role of", "extraction solvents")

ISO/DIS 22532:2025(en)
— ("constituent", "can have role of", "vehicles")
— ("constituent", "can have role of", "active markers")
— ("constituent", "can have role of", "signature substances")
— ("constituent", "can be part of", "a multi-substance material")
— ("constituent", "is part of", "a mixture belonging to a homologous group of individual components")
— ("constituent", "can be", "impurities, degradants, extraction solvents, vehicles, active markers or signature
substances, parent substances or single substances mixed together to form a multi-substance material")
3.1.9
controlled vocabulary
controlled terminology
finite set of predetermined values that constitute the exclusive permissible options for a given data item
Note 1 to entry: These values ensure consistency and standardization in data representation and can manifest as
codes, textual descriptions, or numeric designations.
Note 2 to entry: The set of values is restricted in scope to facilitate data accuracy, interoperability, and conformance
with established data standards.
Note 3 to entry: Controlled vocabularies may encompass a taxonomy that organizes terms hierarchically or relationally,
and any subset of terms within such a taxonomy may be referred to as a sub-vocabulary.
Note 4 to entry: When relevant, the definition and concept of controlled vocabulary are adapted to external glossary
such as from the CDISC clinical research glossary, ensuring alignment with clinical research data standards and
practices.
— ("controlled vocabulary", "is", "a finite set of predetermined values")
— ("controlled vocabulary", "constitutes", "the exclusive permissible options", "for", "a given data item")
— ("controlled vocabulary", "ensures", "consistency")
— ("controlled vocabulary", "ensures", "standardization")
— ("controlled vocabulary", "support","data representation")
— ("controlled vocabulary", "can manifest as", "codes")
— ("controlled vocabulary", "can manifest as", "textual descriptions")
— ("controlled vocabulary", "can manifest as", "numeric designations")
— ("controlled vocabulary", "is restricted in scope to facilitate", "data accuracy, interoperability, and compliance
with established data standards")
— ("controlled vocabulary", "is restricted in scope to facilitate", "interoperability")
— ("controlled vocabulary", "is restricted in scope to facilitate", " compliance", "with", "established data standards")
— ("controlled vocabulary", "may encompass", "a taxonomy")
— ("controlled vocabulary", "may refer to", "a sub-vocabulary")
— ("sub-vocabulary", "is part of", "taxonomy")
— ("controlled vocabulary", "is adapted to", "external glossary")
— ("CDISC clinical research glossary", "is", "a external glossary")

ISO/DIS 22532:2025(en)
3.1.10
country
recognized territorial entity
Note 1 to entry: The designation of a country is essential in regulatory contexts to ensure clarity and uniformity in the
identification of jurisdictions pertaining to pharmaceutical and clinical activities.
[3]
Note 2 to entry: For the purposes of international harmonization, the ISO 3166-1 alpha-2 code elements serve as the
standardized nomenclature for the representation of countries and significant geographic areas.
[3]
Note 3 to entry: In certain instances, the code "EU" is used to represent the European Union within the ISO 3166-1
framework. While the European Union is not a country, this designation is reserved to signify the collective member
states in contexts where unified regulatory or marketing authorisation is applicable.
[3]
Note 4 to entry: A country should be designated using the two-letter codes as defined by the ISO 3166-1 alpha-2
standard.
Note 5 to entry: Information about the medicinal product may be marketing authorisation, measurement points,
medicinal product applicability, or clinical trial authorisation, is specified.
— ("country", "is", "a recognized territorial entity")
— ("country", "is used to characterize", "medicinal product")
— ("country", "is used to characterize", "marketing authorization")
— ("country", "is used to characterize", "clinical trial authorization")
— ("country", "is used to characterize", "measurement points")
— ("country", "is used to characterize", "medicinal product applicability")
— ("country", "is essential in", "regulatory contexts")
— ("country", "is represented by", "the ISO 3166-1 alpha-2 code elements")
— ("the ISO 3166-1 alpha-2 code elements", is used for", "the purposes of international harmonization")
3.1.11
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 etc.
Note 2 to entry: The critical process is tied to the production method type.
[4]
Note 3 to entry: Critical process parameter is defined in accordance with the ICH Q8 Guideline as: a 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.
— ("critical process parameter", "is", "a process parameter")
— ("critical process parameter", "has", "a variability")
— ("critical process parameter variability", "has", "an impact on a critical quality attribute")
— ("critical process parameter", "should be", "monitored or controlled")
— ("critical process parameter", "is linked to", "production process")
— ("critical process parameter monitoring/controlling", "ensure", " the desired quality")
— ("critical process parameter", "is tied to", "the production method type")
— ("critical process parameter", "is defined in accordance with", "the ICH Q8 guideline")

ISO/DIS 22532:2025(en)
3.1.12
extraction solvent
solvents which are used for the extraction process
— ("extraction solvent", "is a type of", "solvent")
— ("extraction solvent", "is used for", "the extraction process")
3.1.13
identifier
descriptor adequate to represent an entity uniquely in a specific context, ensuring its distinction from other
entities
Note 1 to entry: In the realm of medicinal products, an identifier consists of a set of identifying characteristics that,
when combined, unambiguously distinguish a medicinal product, pharmaceutical product, substance, specified
substance, route of administration, pharmaceutical dose form, or any other element necessitating unique recognition.
Note 2 to entry: Identifiers may be represented through various forms such as alphanumeric codes, global unique
identifiers (GUID) / universally unique identifier (UUID), or other internationally accepted coding systems. When
applied to organizations or locations, an international system for unique identifiers may be utilized in accordance
with regional regulatory requirements.
Note 3 to entry: The purpose of an identifier is to provide clarity and precision in the tracking, regulation, and
management of entities within the pharmaceutical environment, as established by recognized standards.
— ("identifier", "is", "a descriptor")
— ("identifier", "is characterize", "one entity or record"
— ("identifier", "is bound to", "a specific context")
— ("identifier", "ensures", "distinct identification")
— ("identifier", "charaterizes", "medicinal product")
— ("identifier", "charaterizes", "pharmaceutical produc")
— ("identifier", "charaterizes", "substance")
— ("identifier", "charaterizes", "specified substance")
3.1.14
ingredient
substance utilized in the formulation of a pharmaceutical product or manufactured item, with a defined role
and a defined strength
Note 1 to entry: An ingredient constitutes a part of a medicinal product, either in isolation or in conjunction with other
ingredients. It has a strength and a specific role within the product, which could be as an active ingredient, adjuvant,
or excipient.
Note 2 to entry: The ingredient corresponds to one substance as defined, with additional context provided by its
function in the manufactured item or pharmaceutical product.
Note 3 to entry: For every distinct ingredient present in a manufactured item or pharmaceutical product, a separate
instance of the ingredient class should be recorded to ensure comprehensive documentation and traceability.
— ("ingredient","must have", "ingredient role")
— ("ingredient","has", "a strength")
— ("ingredient", "is", "a substance")
— ("ingredient", "charatacterize", "a pharmaceutical product or a manufactured item")
— ("ingredient","cannot exist", "outside of a pharmaceutical product or manufactured item")

ISO/DIS 22532:2025(en)
3.1.15
ingredient role
specific function or purpose of a substance when included as a constituent of a manufactured item or
pharmaceutical product
Note 1 to entry: Each ingredient's role must be clearly defined and classified using a controlled vocabulary according
to its contribution to the product, such as active substance or specified substance. Both the controlled term and its
associated identifier, which uniquely characterizes the role, shall be specified.
— ("ingredient role", "is", "a classification")
— ('substance", "has", "ingredient role")
— ("manufactured item", "contains", "substance')
— ("pharmaceutical product", "contains", "substance")
— ("ingredient role", "uses", "controlled vocabulary")
— ("controlled vocabulary", "provides", "controlled term")
— ("controlled term", "has", "term identifier")
— ("active substance", "is", "a ingredient role")
3.1.16
investigational medicinal product
IMP
pharmaceutical product, or combination of pharmaceutical products, or placebo(s) that is subject to
investigation in a clinical trial and is authorised for investigation by a medicines regulatory agency within a
given region
Note 1 to entry: An investigational medicinal product may be an entirely new pharmaceutical product (i.e., one not
having received marketing authorisation) or an already authorised product that is being explored further. Hence, this
includes products with existing marketing authorisation that are being tested or used in a manner differing from the
authorised form, are employed for an indication not authorised, or are under investigation to collect additional data
pertaining to the authorised form.
Note 2 to entry: The investigational use of a medicinal product encompasses variations in its formulation, packaging,
dosing, route of administration, or indication from that which has been authorised.
Note 3 to entry: Each investigational medicinal product is identified and characterised uniquely by an IMPID
(investigational medicinal product identifier) and is authorised for investigation by a medicines regulatory agency
within a given region.
— ("investigational medicinal product", "plays the role of", "pharmaceutical product, or combination of pharmaceutical
products, or placebo(s) that is subject to investigation in a clinical trial")
— ("investigational medicinal product", "is authorised for", "investigation by a medicines regulatory agency within a
given region")
— ("investigational medicinal product", "may be", "an entirely new pharmaceutical product or an already authorised
product that is being explored further")
— ("investigational medicinal product", "includes", "products with existing marketing authorisation that are being
tested or used in a manner differing from the authorised form, are employed for an indication not authorised, or
are under investigation to collect additional data pertaining to the authorised form")
— ("investigational medicinal product", "encompasses", "variations in its formulation, packaging, dosing, route of
administration, or indication from that which has been authorised")
— ("investigational medicinal product", "is identified and characterised uniquely by", "an IMPID (investigational
medicinal product identifier)")

ISO/DIS 22532:2025(en)
3.1.17
jurisdiction
specific geographical area within a country or region, or the particular domain of authority and
responsibility, to which a medicines regulatory agency's oversight and regulations apply
Note 1 to entry: Jurisdiction refers to the territorial scope within which medicinal product names, marketing
authorisations, and clinical trial approvals are relevant and enforceable. It defines the legal and regulatory boundaries
for the medicines regulatory agency's activities.
Note 2 to entry: When describing jurisdiction, controlled terms and their corresponding identifiers must be specified.
These terms are structured similarly to country identifiers but are distinct in that they represent subdivisions or
specific areas within a country or region.
Note 3 to entry: In cases where clinical trial authorisations or marketing activities span multiple jurisdictions, the
relevant jurisdictions are to be identified using ISO 3166-1 alpha-2 codes or other compatible jurisdictional code lists.
Note 4 to entry: The jurisdiction of an official medicinal product name or marketing activity should be clearly
indicated, for example, "US" for the United States, "EU" for the European Union, or "JP" for Japan.
— ("jurisdiction", "is", "a specific geographical area within a country or region, or the particular domain of authority
and responsibility, to which a medicines regulatory agency's oversight and regulations apply")
— ("jurisdiction", "refers to", "the territorial scope within which medicinal product names, marketing authorisations,
and clinical trial approvals are relevant and enforceable")
— ("jurisdiction", "defines", "the legal and regulatory boundaries for the Medicines Regulatory Agency's activities")
— ("jurisdiction", "should be described using", "controlled terms and their corresponding identifiers")
— ("jurisdiction", "should be identified using", "ISO 3166-1 alpha-2 codes or other compatible jurisdictional code lists")
— ("jurisdiction", "should be clearly indicated for", "an official medicinal product name or marketing activity")
3.1.18
legal status of supply
classification determined by regional or jurisdictional regulation that dictates the way that a medicinal
product/package can be dispensed to a patient or consumer.
Note 1 to entry: The legal status of supply is a key regulatory attribute of a medicinal product that defines the
conditions under which the product is made available to the public within a given jurisdiction.
Note 2 to entry: A controlled vocabulary should be employed to describe the legal status of supply for a medicinal
product. Both the term and its unique identifier within this vocabulary must be provided to ensure clarity and
interoperability across regulatory systems.
Note 3 to entry: The medicinal product's legal status of supply is classified and specified by the regulatory medicines
agency and is an essential element in the product's regulatory profile.
— ("medicinal product", "has", "a legal status of supply")
— ("legal status of supply", "is classified by", "regulatory medicines agency")
— ("legal status of supply", "is described using", "controlled vocabulary")
— ("controlled vocabulary", "includes term", "medical prescription required")
— ("controlled vocabulary", "includes term", "no prescription required")
— ("legal status of supply", "applies in", "jurisdiction")
3.1.19
manufactured dose form
pharmaceutical dose form of a manufactured item as supplied by the manufacturer
EXAMPLE Powder for solution for injection

ISO/DIS 22532:2025(en)
Note 1 to entry: The manufactured dose form is identical to the administrable dose form in cases where no
transformation of the manufactured item is necessary (i.e. where the manufactured item is equal to the pharmaceutical
product).
Note 2 to entry: A medicinal product can have two manufactured items, one with a manufactured dose form of powder
for solution for injection and the other with a manufactured dose form of solvent for solution for injection. These
are then to be reconstituted/transformed to a powder and solvent for solution for injection before the medicine
can be administered to a patient. Solution for injection is the “administrable dose form”, which is an attribute of
“pharmaceutical product”.
— ("manufactured dose form", "is identical to", "the administrable dose form in cases where no transformation of the
manufactured item is necessary")
— ("manufactured dose form", "can have", "two manufactured items, one with a manufactured dose form of powder
for solution for injection and the other with a manufactured dose form of solvent for solution for injection")
— ("manufactured dose form", "is to be reconstituted/transformed to", "a powder and solvent for solution for
injection before the medicine can be administered to a patient")
3.1.20
manufactured item
MI
qualitative and quantitative composition containing one or more ingredients in
specific dose form
Note 1 to entry: A manufactured item may be contained in the packaging of a medicinal product as made available to
the market or investigational medicinal product as used in a clinical trial
Note 2 to entry: A medicinal product or investigational medicinal product may comprise one or more manufactured
items, which may be equivalent to the final pharmaceutical product or may differ from it if further processing is
required before administration to the patient.
Note 3 to entry: The manufactured item encompasses the actual physical form of the product delivered by the
manufacturer, such as a tablet, capsule, liquid, or cream, and is intended to be the entity that is ultimately dispensed
or used in a clinical trial.
Note 4 to entry: In instances where a transformation of the manufactured item is required, the product's final
administered form, known as the pharmaceutical product, may differ from the initial manufactured item.
Note 5 to entry: Dosage forms defined by ICH as “a pharmaceutical product type (e.g., tablet, capsule, solution, cream)
that contains a drug substance generally, but not necessarily, in association with excipients” are considered as
manufactured items.
— ("manufactured item", "is contained in", "packaging [package item container]")
— ("manufactured item", "has", "qualitative composition")
— ("manufactured item", "has", "quantitative composition")
— ("medicinal product", "may contain", "manufactured tem(s)")
— ("investigational medicinal product", "may contain", "manufactured item(s)")
— ("manufactured item", "may undergo", "transformation")
— ("transformation", "results in", "pharmaceutical product")
— ("manufactured item", "is delivered by", "manufacturer")
— ("manufactured item", "made of", "ingredients")
— ("manufactured item", "has, "manufactured dose form")
— ("manufactured item", "made of", "unit of presentation")

ISO/DIS 22532:2025(en)
3.1.21
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.
— ("manufacturing", "is", "a process of production for a substance or medicinal product from the acquisition of all
materials through all processing stages")
— ("manufacturing", "includes", "the critical process, critical process steps, starting and processing materials and
critical production parameters")
3.1.22
marketing authorization
official permission issued by a medicines regulatory agency, which grants permission to a pharmaceutical
company to place a medicinal product on the market in a specific region
Note 1 to entry: This authorisation is a regulatory procedure that must be issued before a medicinal product can be
marketed
Note 2 to entry: The marketing authorisation is identified by, marketing authorisation Number, and specially
marketing authorisation holder
— ("marketing authorisation", "is issued by", "medicinal regulatory agency")
— ("marketing authorisation", "grants permission to","pharmaceutical company")
— ("pharmaceutical company", "to place on the market", "medicinal product")
— ("marketing authorisation", "is a", "regulatory procedure")
— ("marketing authorisation", "specify", "marketing authorisation holder")
— ("marketing authorisation", "is identified by", "marketing authorisation number")
3.1.23
marketing authorisation number
unique identifier assigned to a medicinal product by a medicines regulatory agency, which signifies that the
product has been granted approval for marketing within the agency's jurisdiction
Note 1 to entry: In certain cases, the marketing authorisation number may refer to a regulatory provision or legislation
under which a medicinal product is authorized (e.g., grandfathered medicinal products).
— ("marketing authorisation number", "is", "an identifier")
— ("marketing authorisation number", "assigned by", "medicines regulatory agency")
— ("medicinal product,
...