EN ISO 22532:2026

• Abstract:

  This document defines the terms used in the ISO standards on the identification of medicinal products (IDMP) and their related technical specifications.

• Status: Published
• Publication Date: 18-Aug-2026
• ICS: 01.040.11 - Health care technology (Vocabularies)
• ICS: 11.120.10 - Medicaments
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: CEN/TC 251 - Medical informatics
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 19-Aug-2026
• Due Date: 12-Jun-2026
• Completion Date: 19-Aug-2026
• Ref Project: SIST EN ISO 22532:2026 - Health informatics - Identification of medicinal products - Core vocabulary (ISO 22532:2026)

• Consolidated By: ISO 22532:2026 - Health informatics — Identification of medicinal products — Core vocabulary
• Effective Date: 12-Feb-2026

EN ISO 22532:2026 is the CEN adoption of ISO 22532:2026 for health informatics. It defines the core vocabulary used in the ISO standards on identification of medicinal products (IDMP) and the related technical specifications, so people building, managing or reviewing medicinal product data can use the same terms in the same way.

What does EN ISO 22532:2026 specify?

EN ISO 22532:2026 specifies the terms and definitions used across the IDMP standards family. It is a vocabulary document, not a product monograph or a test method, and its role is to make terminology consistent for substances, medicinal products, dose forms, identifiers and regulatory data.

The document is organized into a short front matter, an introduction, clause 1 on scope, clause 2 on normative references, and clause 3 on terms and definitions. It also includes a bibliography and an index for navigation.

What are the key requirements of EN ISO 22532:2026?

EN ISO 22532:2026 mainly requires that IDMP-related information be described using the terms defined in clause 3, with controlled terms and identifiers where the definitions call for them. In practice, this supports interoperability between databases, regulatory submissions and product dictionaries.

Core terminology and identifiers

• Controlled vocabulary (3.8) is a finite set of permitted values for a data item. This matters because IDMP data should be coded consistently, not described with free text that varies from system to system.
• Identifier (3.12) is a descriptor that uniquely represents an entity in a specific context. In practice, it is what lets systems distinguish one medicinal product, substance or route from another without ambiguity.
• Vocabulary (3.59) is a terminological dictionary of designations and definitions from one or more subject fields. That is the document’s own function here: it gives a common language for IDMP implementation.

Product, packaging and presentation concepts

• Medicinal product (3.27), pharmaceutical product (3.38) and packaged medicinal product (3.35) are distinct concepts. The first is the regulated medicinal product concept, the second is the qualitative and quantitative composition in administrable dose form, and the third includes the complete package and its components. This distinction matters when systems must separate product content from packaging and supply data.
• Manufactured item (3.19), manufactured dose form (3.18), administrable dose form (3.2) and combined pharmaceutical dose form (3.5) describe what is made, what is supplied and what is actually given to the patient. In practice, these terms support products that need reconstitution or combination before use.
• Pharmaceutical dose form (3.37) ties the product to the way substances are delivered to the patient. That helps with coding and exchange because the same medicinal product can be represented differently depending on whether the focus is manufacturing, administration or combination.

Substance and composition concepts

• Substance (3.56), specified substance (3.49), constituent (3.7) and multi-substance material (3.34) structure how material is described. This matters for traceability, especially where a product contains mixtures, derived materials or components with roles and amounts.
• Ingredient (3.13) and ingredient role (3.14) separate what the substance is from what it does in the product, such as active, excipient or adjuvant. That distinction is important when the same substance can appear in different roles in different products.
• Strength (3.52), strength presentation (3.53) and strength concentration (3.54) define how quantity is expressed. In practice, this tells implementers whether to encode total amount per presentation or amount per unit volume or mass.

Regulatory and jurisdictional data

• Country (3.9) and jurisdiction (3.16) anchor product information to a regulatory territory. This is important because names, authorizations and supply status can vary by market.
• Marketing authorisation (3.21), marketing authorisation number (3.22), marketing status (3.23) and legal status of supply (3.17) describe whether a product may be marketed and under what conditions. These terms are central to regulatory exchange and product lifecycle tracking.
• Route of administration (3.47) and measurement point (3.25) define how and where a product is used or measured. This matters because dose and effect can depend on the administration route and, for some products, the exact measurement location.
• Manufacturing (3.20), critical process parameter (3.10), starting material (3.51) and resultant material (3.46) support process-related descriptions. They are useful when product data must connect manufacturing steps with the material that results from them.

What terms does EN ISO 22532:2026 define?

EN ISO 22532:2026 defines a shared IDMP vocabulary for substances, products, dose forms, regulatory status and related concepts. A few central terms are:

• Identification of medicinal products (IDMP) - the ISO domain covered by this vocabulary, concerned with consistent identification and exchange of medicinal product information.
• Controlled vocabulary - a permitted set of coded values used to keep data standardized and interoperable.
• Medicinal product (3.27) - a pharmaceutical product, or combination of pharmaceutical products, intended for treating, preventing or diagnosing disease, or for restoring, correcting or modifying physiological functions.
• Pharmaceutical product (PhP) (3.38) - the qualitative and quantitative composition of a medicinal product in administrable dose form.
• Packaged medicinal product (PMP) (3.35) - a medicinal product within a package, including the packaging components and containers intended for sale or supply.
• Manufactured item (MI) (3.19) - the qualitative and quantitative composition supplied by the manufacturer in a specific dose form.
• Route of administration (RoA) (3.47) - the path by which a pharmaceutical product enters the body or comes into contact with it.
• Specified substance group (SSG) (3.50) - a classification used to define a specified substance with structured element groups.

Who uses EN ISO 22532:2026?

EN ISO 22532:2026 is used by standards developers, health informatics implementers, terminology managers, regulatory affairs teams and suppliers of medicinal product dictionary systems. It is also relevant to medicines regulatory agencies, pharmaceutical manufacturers and clinical trial data teams.

In practice, these users rely on the document when they map codes, define database fields, align product data across systems, and maintain regulated product vocabularies. The introduction states that the vocabulary helps keep IDMP core definitions aligned over time and simplifies work for both standards developers and implementers.

What changed in EN ISO 22532:2026 from the previous edition?

EN ISO 22532:2026 is the first edition of ISO 22532. The CEN endorsement notice states that ISO 22532:2026 was approved as EN ISO 22532:2026 without modification.

Which standards are used with EN ISO 22532:2026?

EN ISO 22532:2026 has no normative references in clause 2. The bibliography names related IDMP and terminology documents that provide the surrounding data structures and coding rules:

• ISO 11238:2018 - substance identification and exchange data elements.
• ISO 11239 - pharmaceutical dose forms, units of presentation, routes of administration and packaging.
• ISO 11240 - units of measurement.
• ISO 11615 - regulated medicinal product information.
• ISO 11616 - regulated pharmaceutical product information.
• ISO/TS 19256:2016 - medicinal product dictionary system requirements.
• ISO/TS 19844 - implementation guidance for ISO 11238.
• ISO/TS 20440 - implementation guidance for ISO 11239.
• ISO 3166-1 - country code representation.
• ISO 1087:2019 - terminology work and vocabulary principles.
• ICH Q8 Guideline - the source named for the definition of critical process parameter.

What does the EN ISO 22532:2026 document contain?

EN ISO 22532:2026 contains a 59-term vocabulary in clause 3, with definitions, notes to entry and, for many terms, ontology-style semantic triples. Those triples help software and data models understand how terms relate to each other, not just what they mean in prose.

The document covers product identity, substance description, composition, dose forms, strength, regulatory status, manufacturing concepts and controlled terminology. The bibliography provides the related IDMP standards, and the index gives a quick way to locate terms such as substance, route of administration, strength, PMP and SSG.

This is a terminology reference for harmonizing data definitions, supporting database design, and improving exchange between regulatory, clinical and manufacturing systems.

SLOVENSKI STANDARD
01-november-2026
Zdravstvena informatika - Identifikacija medicinskih izdelkov - Temeljno besedišče
(ISO 22532:2026)
Health informatics - Identification of medicinal products - Core vocabulary (ISO
22532:2026)
Medizinische Informatik - Identifikation von Arzneimitteln - Kernvokabular (Begriffe und
Definitionen) für die IDMP-Normen (ISO 22532:2026)
Informatique de santé - Identification des produits destinés à des fins médicinales -
Vocabulaire de base (ISO 22532:2026)
Ta slovenski standard je istoveten z: EN ISO 22532:2026
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.

EN ISO 22532
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2026
EUROPÄISCHE NORM
ICS 01.040.11; 11.120.10; 35.240.80
English Version
Health informatics - Identification of medicinal products -
Core vocabulary (ISO 22532:2026)
Informatique de santé - Identification des produits Medizinische Informatik - Identifikation von
destinés à des fins médicinales - Vocabulaire de base Arzneimitteln - Kernvokabular (Begriffe und
(ISO 22532:2026) Definitionen) für die IDMP-Normen (ISO 22532:2026)
This European Standard was approved by CEN on 9 August 2026.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22532:2026 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 22532:2026) has been prepared by Technical Committee ISO/TC 215 "Health
informatics" in collaboration with Technical Committee CEN/TC 251 “Health informatics” the
secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by February 2027, and conflicting national standards
shall be withdrawn at the latest by February 2027.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 22532:2026 has been approved by CEN as EN ISO 22532:2026 without any modification.

International
Standard
ISO 22532
First edition
Health informatics — Identification
2026-08
of medicinal products — Core
vocabulary
Informatique de santé — Identification des produits destinés à
des fins médicinales — Vocabulaire de base
Reference number
ISO 22532:2026(en) © ISO 2026
ISO 22532:2026(en)
© ISO 2026
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 22532:2026(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
Bibliography .31
Index .32

iii
ISO 22532:2026(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 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of 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 World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics, in collaboration with
the European Committee for Standardization (CEN) Technical Committee CEN/TC 251, Health informatics, in
accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
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.

iv
ISO 22532:2026(en)
Introduction
The documents on the identification of medicinal products (IDMP) developed by the ISO/TC 215 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 and refer to the IDMP core definitions and therefore remove the risk of misalignment.
IDMP core definitions are used in at least three of the ISO standards and technical specifications on
IDMP. The need to group core definitions in one single International Standard helps keep the alignment
of core definitions over time and simplifies the work of all interested parties (standards developers and
implementers).
If a term can designate more than one concept (homonymy), usually different concepts in different contexts,
the context for the given definition is stated in conformance with the ISO/IEC Directives, Part 2, 16.5.6. In that
case, the context (“domain”) precedes 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.
Each term has its own defining triples (ontology), which provides the hook for computer understanding of
each definition.
v
International Standard ISO 22532:2026(en)
Health informatics — Identification of medicinal products —
Core vocabulary
1 Scope
This document defines the terms used in the ISO standards on the identification of medicinal products
(IDMP) and their related technical specifications.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
adjuvant
component that potentiates either the immune response to an antigen or modulates it towards the desired
immune response, or both
3.2
administrable dose form
pharmaceutical administrable dose form
pharmaceutical dose form (3.37) for administration to the patient
Note 1 to entry: Transformation of the manufactured items (3.19) and their corresponding manufactured dose forms
(3.18) can 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 (3.38)).
Note 3 to entry: semantic triples (Ontology):
— ("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")
3.3
allergen
substance (3.56) used as ingredient (3.13) or in a device capable of stimulating a type-I hypersensitivity and
allergic reaction
Note 1 to entry: The active allergens are structurally diverse substances (3.55) 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.
Note 2 to entry: semantic triples (Ontology):

ISO 22532:2026(en)
— ("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")
3.4
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: semantic triples (Ontology):
— ("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")
3.5
combined pharmaceutical dose form
dose form consisting of two or more manufactured items (3.19) that are intended to be combined in a specific
way to produce a single pharmaceutical product (3.38)
EXAMPLE The term “powder and solvent for solution for injection” articulates a combined pharmaceutical dose
form wherein the medicinal product (3.27) comprises a powder and a solvent, both intended for solution for injection.
Once combined, these items produce an administrable dose form (3.2): “solution for injection”.
Note 1 to entry: This term encompasses detailed information regarding each item’s manufactured dose form (3.18)
as well as the final administrable dose form of the compounded pharmaceutical product. In accordance with the
standards outlined in ISO 11239 and ISO/TS 20440, the combined pharmaceutical dose form is characterized by a
distinctive term and a corresponding term identifier (3.12), 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: The combined pharmaceutical dose form includes information on the manufactured dose form of each
manufactured item and the administrable dose form of the pharmaceutical product,
Note 3 to entry: semantic triples (Ontology):
— ("combined pharmaceutical dose form", "is composed of", "two or more manufactured items")
— ("combined pharmaceutical dose form", "is intended to", "produce a single pharmaceutical product")

ISO 22532:2026(en)
— ("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")
3.6
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 without proper credentials
and the information 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.
Note 2 to entry: In certain jurisdictions (3.16) there is a distinct difference between confidentiality intended as safety
and accuracy of information and confidentiality intended as privacy of information.
Note 3 to entry: semantic triples (Ontology):
— ("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")
3.7
constituent
substance present within a specified substance (3.49) or mixture (3.30)
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 (3.11), vehicles (3.58), active markers
or signature substances, parent substances or single substances mixed together to form a multi-substance material
(3.34).
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 (3.24).
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.
Note 4 to entry: semantic triples (Ontology):
— ("constituent", "is", "a substance")
— ("constituent", "can be present within", " specified substance")

ISO 22532:2026(en)
— ("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")
3.8
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 Data Interchange Standards Consortium) clinical research glossary, ensuring
alignment with clinical research data standards and practices.
Note 5 to entry: semantic triples (Ontology):
— ("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 conformance
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")

ISO 22532:2026(en)
— ("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", "an external glossary")
— ("controlled vocabulary", "provides", "controlled term")
— ("controlled term", "has", "term identifier")
3.9
country
recognized territorial entity
Note 1 to entry: The designation of a country is critical in regulatory contexts to ensure clarity and uniformity in the
identification of jurisdictions (3.16) pertaining to pharmaceutical and clinical activities.
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.
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.
Note 4 to entry: A country is 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 (3.27) may be marketing authorisation, measurement points
(3.25), medicinal product applicability, or clinical trial authorisation, is specified.
Note 6 to entry: semantic triples (Ontology):
— ("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 critical in", "regulatory contexts")
— ("country", "is represented by", "the ISO 3166-1 alpha-2 code elements")
— ("the ISO 3166-1 alpha-2 code elements", "are used for", "the purposes of international harmonization")
3.10
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 (3.20) parameter is considered “critical” and necessary for the production of
substance (3.56) or specified substance (3.49), 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.
Note 3 to entry: Adapted from Reference [12].
Note 4 to entry: semantic triples (Ontology):

ISO 22532:2026(en)
— ("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 or 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")
3.11
extraction solvent
solvent which is used for the extraction process
Note 1 to entry: semantic triples (Ontology):
— ("extraction solvent", "is a type of", "solvent")
— ("extraction solvent", "is used for", "the extraction process")
3.12
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 (3.27), an identifier consists of a set of identifying characteristics
that, when combined, unambiguously distinguish a medicinal product, pharmaceutical product (3.38), substance,
specified substance (3.49), route of administration (3.47), pharmaceutical dose form (3.37), 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) or 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.
Note 4 to entry: semantic triples (Ontology):
— ("identifier", "is", "a descriptor")
— ("identifier", "is characterized", "one entity or record")
— ("identifier", "is bound to", "a specific context")
— ("identifier", "ensures", "distinct identification")
— ("identifier", "characterizes", "medicinal product")
— ("identifier", "characterizes", "pharmaceutical product")
— ("identifier", "characterizes", "substance")
— ("identifier", "characterizes", "specified substance")

ISO 22532:2026(en)
3.13
ingredient
substance utilized in the composition of a pharmaceutical product (3.38) or manufactured item (3.19), with a
defined role and a defined strength (3.52)
Note 1 to entry: An ingredient constitutes a part of a medicinal product (3.27), 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 (3.1), 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.
Note 4 to entry: semantic triples (Ontology):
— ("ingredient", "shall have", "ingredient role")
— ("ingredient", "has", "a role")
— ("ingredient", "has", "a strength")
— ("ingredient role", "is played by", "a substance")
— ("ingredient", "is manifested in", "a pharmaceutical product or a manufactured item")
— ("ingredient", "cannot exist", "outside of a pharmaceutical product or manufactured item")
3.14
ingredient role
specific function or purpose of a substance when included as a constituent (3.7) of the composition of a
manufactured item (3.19) or pharmaceutical product (3.38)
Note 1 to entry: Each ingredient’s (3.13) role shall be clearly defined and classified using a controlled vocabulary (3.8)
according to its contribution to the product, such as active, excipient, adjuvant (3.1). Both the controlled term and its
associated identifier (3.12), which uniquely characterizes the role, shall be specified.
Note 2 to entry: semantic triples (Ontology):
— ("ingredient role", "is", "a classification")
— (“substance", "plays", "ingredient role")
— ("manufactured item", "contains", "substance”)
— ("pharmaceutical product", "contains", "substance")
— ("ingredient role", "uses", "controlled vocabulary")
— ("active", "is", "an ingredient role")
— ("excipient", "is", "an ingredient role")
— ("adjuvant", "is", "an ingredient role")

ISO 22532:2026(en)
3.15
investigational medicinal product
IMP
pharmaceutical product (3.38), 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 can 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 (3.27) encompasses variations in its formulation,
packaging, dosing, route of administration (3.47), 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.
Note 4 to entry: semantic triples (Ontology):
— ("investigational medicinal product", "is ", "a 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 by", "an IMPID (investigational medicinal product identifier)")
3.16
jurisdiction
specific geographical area within a country (3.9) 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 (3.28), 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 (3.12) shall
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 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.
Note 5 to entry: semantic triples (Ontology):
— ("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")

ISO 22532:2026(en)
— ("jurisdiction", "defines", "the legal and regulatory boundaries for the Medicines Regulatory Agency’s activities")
— ("jurisdiction", "shall be described using", "controlled terms and their corresponding identifiers")
— ("jurisdiction", "are 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")
3.17
legal status of supply
classification determined by regional or jurisdictional regulation that dictates the way that a medicinal
product (3.27) or package or both 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 (3.8) should be employed to describe the legal status of supply for a medicinal
product. Both the term and its unique identifier (3.12) within this vocabulary shall 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 medicines regulatory
agency and is a critical element in the product’s regulatory profile.
Note 4 to entry: semantic triples (Ontology):
— ("medicinal product", "has", "a legal status of supply")
— ("legal status of supply", "is classified by", "medicines regulatory 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")
3.18
manufactured dose form
pharmaceutical dose form (3.37) of a manufactured item (3.19) as supplied by the manufacturer
EXAMPLE Powder for solution for injection.
Note 1 to entry: The manufactured dose form is identical to the administrable dose form (3.2) in cases where no
transformation of the manufactured item is necessary (i.e. where the manufactured item is equal to the pharmaceutical
product (3.38)).
Note 2 to entry: A medicinal product (3.27) can contain multiple package items that have one or more manufactured
items, one with a manufactured dose form of powder for solution for injection and another with a manufactured dose
form of solvent for solution for injection. These are then to be reconstituted or transformed to a “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”.
Note 3 to entry: semantic triples (Ontology):
— ("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 or transformed to", "a solution for injection before the medicine
can be administered to a patient")

ISO 22532:2026(en)
3.19
manufactured item
MI
qualitative and quantitative composition containing one or more ingredients (3.13) in
specific dose form
Note 1 to entry: A manufactured item may be contained in the packaging of a medicinal product (3.27) as made
available to the market or investigational medicinal product (3.15) as used in a clinical trial.
Note 2 to entry: A medicinal product or investigational medicinal product can comprise one or more manufactured
items (3.19), which may be equivalent to the final pharmaceutical product (3.38) or can 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 the International Council for Harmonisation (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.
Note 6 to entry: semantic triples (Ontology):
— ("manufactured item", "is contained in", "packaging (package item container)")
— ("manufactured item", "has", "qualitative composition")
— ("manufactured item", "has", "quantitative composition")
— ("medicinal product", "may contain", "manufactured item(s)")
— ("investigational medicinal product", "may contain", "manufactured item(s)")
— ("manufactured item", "may undergo", "transformation")
— ("transformation", "results in", "pharmaceutical product")
— ("manufactured item", "is manufactured by", "manufacturer")
— ("manufactured item", "made of", "ingredients")
— ("manufactured item", "has, "manufactured dose form")
— ("manufactured item", "made of", "unit of presentation")
3.20
manufacturing
process of production for a substance (3.56) or medicinal product (3.27) from the acquisition of all materials
(3.24) through all processing stages
Note 1 to entry: The critical process, critical process steps, starting and processing materials (3.41), and critical
production parameters are included.
Note 2 to entry: semantic triples (Ontology):
— ("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")

ISO 22532:2026(en)
3.21
marketing authorization
official permission issued by a medicines regulatory agency, which grants permission to a pharmaceutical
company to place a medicinal product (3.27) on the market in a specific region
Note 1 to entry: This authorisation is a regulatory procedure to be issued before a medicinal product can be marketed.
Note 2 to entry: The marketing authorisation is identified by, marketing authorisation number (3.22), and specially
marketing authorisation holder.
Note 3 to entry: semantic triples (Ontology):
— ("marketing authorisation", "has authorizing party", "medicines regulatory agency")
— ("marketing authorisation", "has authorized party", "marketing authorisation holder")
— ("marketing authorisation ", "applies to", "medicinal product")
— ("marketing authorisation ", "applies to", "packaged medicinal product")
— ("marketing authorisation", "has authorization procedure", "marketing authorization procedure")
— ("marketing authorisation", "is identified by", "marketing authorisation number")
3.22
marketing authorisation number
unique identifier (3.12) assigned to a medicinal product (3.27) by a medicines regulatory agency, which
signifies that the medicinal 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).
Note 2 to entry: semantic triples (Ontology):
— ("marketing authorisation number", "is", "an identifier")
— ("marketing authorisation number", "is registered by", "medicines regulatory agency")
— ("marketing authorisat
...