ISO/FDIS 22532

Health informatics — Identification of medicinal products — Core vocabulary

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.

Informatique de santé — Identification des produits destinés à des fins médicinales — Vocabulaire de base

General Information

• Status: Not Published
• 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: ISO/TC 215 - Health informatics
• Drafting Committee: ISO/TC 215 - Health informatics
• Current Stage: 5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
• Start Date: 13-May-2026
• Completion Date: 13-May-2026

Relations

• Consolidates: FprEN ISO 22532 - Health informatics - Identification of medicinal products - Core vocabulary (ISO/FDIS 22532:2026)
• Effective Date: 12-Feb-2026

Overview

ISO/FDIS 22532: Health informatics - Identification of medicinal products - Core vocabulary provides a unified set of terms and definitions essential for the suite of IDMP (Identification of Medicinal Products) standards. Developed by the International Organization for Standardization (ISO) Technical Committee ISO/TC 215, this standard ensures consistency and interoperability across health informatics documentation by consolidating core vocabulary used throughout multiple IDMP standards and technical specifications.

By standardizing terminology, ISO/FDIS 22532 supports global harmonization in regulatory practices regarding medicinal product identification, exchange of regulated information, and data interoperability across healthcare, pharmaceutical, and regulatory environments.

Key Topics

• Core Vocabulary for IDMP
  The standard establishes a definitive list of terms and definitions frequently used in multiple IDMP standards and technical specifications, focusing on clear, unambiguous usage.

• Terminology Alignment
  By grouping core terms in a single location, ISO/FDIS 22532 facilitates the maintenance and alignment of essential medical product vocabulary across evolving IDMP-related documents, reducing the risk of inconsistencies.

• Ontology and Context
  Each term is defined with clear context and, where appropriate, semantic relationships modeled as "defining triples" (ontology), aiding both human understanding and machine-readable data processing.

• Regulatory and Technical Interoperability
  The vocabulary supports data exchange, regulatory submissions, and global pharmaceutical regulation through standardized language, contributing to patient safety and effective healthcare communication.

Applications

ISO/FDIS 22532 is vital in various practical scenarios where consistent terminology is needed for medicinal product identification:

• Regulatory Submissions
  Ensures all stakeholders-regulatory authorities, industry partners, and software vendors-use agreed terms when submitting or exchanging data for product approval, marketing authorization, or clinical trial applications.

• Healthcare Informatics Systems
  Facilitates data interoperability in electronic health records (EHRs), pharmacovigilance databases, and healthcare information exchanges by providing a common vocabulary understood across countries and organizations.

• Pharmaceutical Supply Chain
  Enhances tracking, traceability, and reporting of medicinal products in global supply chains by ensuring that product descriptions are clear and standardized.

• Clinical Research and Trials
  Supports the accurate identification and comparison of investigational medicinal products, substances, dose forms, and other attributes within and across clinical trials.

• Standard Development and Implementation
  Assists developers and implementers of IDMP-related standards in aligning terminology, reducing duplication, and improving the reliability of their documentation and systems.

Related Standards

ISO/FDIS 22532 is foundational within the IDMP standards ecosystem. Related standards include:

• ISO 11238: Unique identification and exchange of regulated information on substances.
• ISO 11616: Data elements and structures for pharmaceutical product identification.
• ISO 11239: Terminology and data elements for dosage forms, routes of administration, packing, etc.
• ISO 11240: Data elements and structures for unique identification and exchange of units of measurement.
• ISO/TS 19844: Implementation guidelines for data elements for unique identification of substances.
• ISO 3166-1: Codes for the representation of country names and subdivisions.

Practical Value

ISO/FDIS 22532 significantly enhances health informatics by:

• Promoting Consistency: Ensures reliable, unambiguous communication around medicinal products.
• Supporting Global Regulatory Compliance: Facilitates international cooperation and harmonization.
• Enabling Data Interoperability: Supports seamless data exchange in clinical and regulatory contexts.
• Empowering Automated Processing: Machine-readable definitions and ontologies improve data quality and workflow automation.

This core vocabulary is a critical resource for regulatory authorities, healthcare organizations, pharmaceutical companies, and technology providers seeking to optimize the accuracy and efficiency of medicinal product information management worldwide.

Standards Content (Sample)

FINAL DRAFT
International
Standard
ISO/TC 215
Health informatics — Identification
Secretariat: ANSI
of medicinal products — Core
Voting begins on:
vocabulary
2026-05-13
Voting terminates on:
2026-07-08
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 SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/CEN PARALLEL PROCESSING LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
FINAL DRAFT
International
Standard
ISO/TC 215
Health informatics — Identification
Secretariat: ANSI
of medicinal products — Core
Voting begins on:
vocabulary
Voting terminates on:
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 SUPPOR TING DOCUMENTATION.
© ISO 2026
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
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 Reference number
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
Bibliography .31
Index .32

iii
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
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
FINAL DRAFT International Standard ISO/FDIS 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):

— ("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 (3.37) 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")

— ("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")

— ("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")

— ("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):

— ("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")

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")

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")

— ("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 regulatory medicines
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", "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")
3.18
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")

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")

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 authorisation number", "is unique within", "jurisdiction")
— ("marketing authorisation number, "identifies", "marketing authorisation")
3.23
marketing status
information that indicates whether the product is actively marketed, has ceased marketing temporarily or
permanently, has been withdrawn from the market, or has not been marketed within a specific country (3.9)
or jurisdiction (3.16)
Note 1 to entry: The marketing status also reflects the legal status of supply (3.17), categorizing the medicinal product
(3.27) as either prescription-only or non-prescription, and any other conditions or restrictions on its distribution.
Note 2 to entry: Additional information pertaining to the marketing status may be required to address local variations
within the jurisdiction, such as state, provincial, or territorial differences.
Note 3 to entry: semantic triples (Ontology):
— ("marketing status", "describes whether", "a medicinal product is marketable")
— ("marketing status", "indicates", "actual marketing presence")
— ("marketing status", "includes", "legal status of supply")
— ("medicinal product, "is described by", "marketing status")
— ("marketing status", "is applicable in jurisdiction", "country or jurisdiction")
— ("marketing status", "may vary within", "country or jurisdiction subdivision")

— ("marketing status", "includes", "temporary cease")
— ("marketing status", "includes", "permanently cease")
— ("marketing status", "includes", "withdrawn from market")
— ("marketing status", "includes", "marketed")
— ("marketing status", "includes", "not marketed")
3.24
material
entity that has mass, occupies space and consists of one or more substances of which a
certain packaging or device is made
Note 1 to entry: This applies to a package item (container), package (component) and device material.
Note 2 to entry: semantic triples (Ontology):
— ("material", "is an", "entity that has mass, occupies space and consists of one or more substances of which a certain
packaging or device is made")
— ("material", "applies to", "a package item (container), package (component) and device material")
3.25
measurement point
physical location on an administration device where the quantity of a medication being delivered is
measured at the time of delivery
Note 1 to entry: The measurement point is critical for certain medicinal products (3.27) where the strength (3.52) and
efficacy are dependent on the precise location at which the dosage is quantified, such as the distance from the point of
aerosolization in inhalers.
Note 2 to entry: semantic triples (Ontology):
— ('measurement point", "is a", "physical location")
— ("measurement point", "linked to", "administration device")
— ("medication quantity", "is measured at", "measurement point")
— ("medicinal product strength", "is determined at", "measurement point")
— ("measurement point", "is critical for", "certain medicinal products")
— ("measurement point", "may require", "textual description")
— ("measurement point", "ensures", "correct strength administration")
— ("measurement point", "varies by", "jurisdiction")
3.26
medical device
instrument, apparatus, appliance, software, material (3.24) or other article, whether used alone or in
combination, including the software intended by its manufacturer to be used specifically for diagnostic or
therapeutic (or both) purposes and necessary for its proper application, intended by the manufacturer to be
used for human beings for the purpose of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease;
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability;
— investigation, replacement or modification of the anatomy or of a physiological process;
— control of conception;
and which does not achieve its principal intended action in or on the human body by pharmacological,
immunological or metabolic means, but which may be assisted in its function by such means
Note 1 to entry: semantic triples (Ontology):
— ("medical device", "is a", "instrument
...

ISO/TC 215
Secretariat: ANSI
Date: 2025-05-262026-04-28
Health informatics — Identification of medicinal products — Core
vocabulary
FDIS stage
This draft is submitted to a parallel vote in ISO, CEN.

ISO/DISFDIS 22532:20252026(en)
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication
may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying,
or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO
at the address below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
E-mail: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
Contents
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
Bibliography . 35
Index 36
iii
ISO/DISFDIS 22532:20252026(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'sISO’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
Introduction
The documents on the “Identificationidentification of Medicinal Productsmedicinal 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
miss-alignmentmisalignment.
IDMP core definitions are used in at least three of the IDMPISO standards and technical specifications on IDMP.
The need to group core definitions in one single international standardInternational 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 is stated in conformance with the ISO/IEC Directives, part 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
FINAL DRAFT International Standard ISO/FDIS 22532

Health informatics — Identification of medicinal products — Core
vocabulary (terms and definitions) for the IDMP Standards
1 Scope
This “core definitions” document providesdefines the comprehensive list of terms and definitions used in the
IDMPISO standards on the identification of medicinal products (IDMP) and their related standards and
technical specifications.
2 Normative references
• ISO 3166-1:2020 Codes for the representation of names of countries and their subdivisions – Part 1:
Country code
• ISO 11238:2018 Health informatics – Identification of medicinal products – Data elements and
structures for the unique identification and exchange of regulated information on substances
• ISO 11616:2017 Health informatics — Identification of medicinal products — Data elements and
structures for unique identification and exchange of regulated pharmaceutical product information
• ISO 11239:2023 Health informatics — Identification of medicinal products — Data elements and
structures for the unique identification and exchange of regulated information on pharmaceutical dose
forms, units of presentation, routes of administration and packaging
• ISO 11240: 2012 Health informatics — Identification of medicinal products — Data elements and
structures for the unique identification and exchange of units of measurement
• ISO/TS 19844:2018 Health informatics — Identification of medicinal products (IDMP) —
Implementation guidelines for ISO 11238 for data elements and structures for the unique
identification and exchange of regulated information on substances

There are no normative references in this document.
3 Terms and definitions
ISO and IEC maintain terminologicalterminology databases for use in standardization at the following
addresses:
— — IEC Electropedia: available at
— — ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at https://www.electropedia.org/
ISO/DISFDIS 22532:20252026(en)
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(3.1.38)) 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 (3.1.19) 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 (3.55substance) 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):
— — ("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")
ISO/DISFDIS 22532:20252026(en)
— — ("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 (3.37) 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'sitem’s manufactured dose form (3.18)
as well as the final administrable dose form of the compounded pharmaceutical product. In accordance with the
[1] [2]
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")
— — ("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")
ISO/DISFDIS 22532:20252026(en)
— — ("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 unlesswithout 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 on one hand confidentiality intended
as safety and accuracy of information and on the other hand 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")
— — ("constituent", "can be present within", "mixture")
— — ("constituent", "may have", "an amount")
— — ("constituent", "shall have", "an associated role")
ISO/DISFDIS 22532:20252026(en)
— — ("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
complianceconformance with established data standards")
— — ("controlled vocabulary", "is restricted in scope to facilitate", "interoperability")
ISO/DISFDIS 22532:20252026(en)
— — ("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", "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.
[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 beis 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", is"are used for", "the purposes of international harmonization")
ISO/DISFDIS 22532:20252026(en)
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] Critical.
Note 4 to entry: semantic triples (Ontology):
[4]
— ("critical process parameter", "is adapted from the reference: ICH Q8 Guideline as: ", "a process parameter whose
")
— ("critical process parameter", "has", "a variability has ")
— ("critical process parameter 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 4 to entry: semantic triples (Ontology):
— — ("critical process parameter", "is", "a process parameter")
— — ("critical process parameter", "has", "a variabilityshould be", "monitored or controlled")
— — ("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
ISO/DISFDIS 22532:20252026(en)
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 characterizecharacterized", "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")
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("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")
ISO/DISFDIS 22532:20252026(en)
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 (3.13ingredient's) 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")
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")
ISO/DISFDIS 22532:20252026(en)
— — ("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'sagency’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'sagency’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 shall beare 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'sagency’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'sAgency’s
activities")
— — ("jurisdiction", "shouldshall be described using", "controlled terms and their corresponding identifiers")
— — ("jurisdiction", "should beare 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.
ISO/DISFDIS 22532:20252026(en)
Note 3 to entry: The medicinal product'sproduct’s legal status of supply is classified and specified by the regulatory
medicines agency and is a critical element in the product'sproduct’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", "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")
3.18
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(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 reconstitutedorreconstituted 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")
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.
ISO/DISFDIS 22532:20252026(en)
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'sproduct’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")
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 that shallto be issued before a medicinal product can be
marketed.
ISO/DISFDIS 22532:20252026(en)
Note 2 to entry: The marketing authorisation is identified by, marketing authorisation number (3.22(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'sagency’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 authorisation number", "is unique within", "jurisdiction")
— — ("marketing authorisation number, "identifies", "marketing authorisation")
3.23
marketing status
information that indicates whether the product is actively marketed, has ceased marketing temporarily or
permanently, has been withdrawn from the market, or has not been marketed within a specific country (3.9)
or jurisdiction (3.16)
Note 1 to entry: The marketing status also reflects the legal status of supply (3.17,), categorizing the medicinal product
(3.27) as either prescription-only or non-prescription, and any other conditions or restrictions on its distribution.
Note 2 to entry: Additional information pertaining to the marketing status may be required to address local variations
within the jurisdiction, such as state, provincial, or territorial differences.
Note 3 to entry: semantic triples (Ontology):
— — ("marketing status", "describes whether", "a medicinal product is marketable")
— — ("marketing status", "indicates", "actual marketing presence")
— — ("marketing status", "includes", "legal status of supply")
— — ("medicinal product, "is described by", "marketing status")
ISO/DISFDIS 22532:20252026(en)
— — ("marketing status", "is applicable in jurisdiction", "country/ or jurisdiction")
— — ("marketing status", "may vary within", "country/ or jurisdiction subdivision")
— — ("marketing status", "includes", "temporary cease")
— — ("marketing status", "includes", "permanently cease")
— — ("marketing status", "includes", "withdrawn from market")
— — ("marketing status", "includes", "marketed")
— — ("marketing status", "includes", "not marketed")
3.24
material
entity that has mass, occupies space and consists of one or more substances of which a
certain packaging or device is made
Note 1 to entry: This applies to a package item (container), package (component) and device material.
Note 2 to entry: semantic triples (Ontology):
— — ("material", "is an", "entity that has mass, occupies space and consists of one or more substances of which a
certain packaging or device is made")
— — ("material", "applies to", "a package item [(container],), package (component) and device material")
3.25
measurement point
physical location on an administration device where the quantity of a medication being delivered is measured
at the time of delivery
Note 1 to entry: The measurement point is critical for certain medicinal products (3.27) where the strength (3.52) and
efficacy are dependent on the precise location at which the dosage is quantified, such as the distance from the point of
aerosolization in inhalers.
Note 2 to entry: semantic triples (Ontology):
— — ('measurement point", "is a", "physical location")
— — ("measurement point"
...

PROJET FINAL
Norme
internationale
ISO/TC 215
Informatique de santé —
Secrétariat: ANSI
Identification des produits
Début de vote:
destinés à des fins médicinales —
2026-05-13
Vocabulaire de base
Vote clos le:
2026-07-08
Health informatics — Identification of medicinal products —
Core vocabulary
LES DESTINATAIRES DU PRÉSENT PROJET SONT
INVITÉS À PRÉSENTER, AVEC LEURS OBSERVATIONS,
NOTIFICATION DES DROITS DE PROPRIÉTÉ DONT ILS
AURAIENT ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE.
OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
ÉTABLIR S’ILS SONT ACCEPTABLES À DES FINS
INDUSTRIELLES, TECHNOLOGIQUES ET COM-MERCIALES,
AINSI QUE DU POINT DE VUE DES UTILISATEURS, LES
PROJETS DE NORMES
TRAITEMENT PARALLÈLE ISO/CEN
INTERNATIONALES DOIVENT PARFOIS ÊTRE CONSIDÉRÉS
DU POINT DE VUE DE LEUR POSSI BILITÉ DE DEVENIR DES
NORMES POUVANT
SERVIR DE RÉFÉRENCE DANS LA RÉGLEMENTATION
NATIONALE.
Numéro de référence
PROJET FINAL
Norme
internationale
ISO/TC 215
Informatique de santé —
Secrétariat: ANSI
Identification des produits
Début de vote:
destinés à des fins médicinales —
2026-05-13
Vocabulaire de base
Vote clos le:
2026-07-08
Health informatics — Identification of medicinal products —
Core vocabulary
LES DESTINATAIRES DU PRÉSENT PROJET SONT
INVITÉS À PRÉSENTER, AVEC LEURS OBSERVATIONS,
NOTIFICATION DES DROITS DE PROPRIÉTÉ DONT ILS
AURAIENT ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE.
DOCUMENT PROTÉGÉ PAR COPYRIGHT
OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
ÉTABLIR S’ILS SONT ACCEPTABLES À DES FINS
© ISO 2026 INDUSTRIELLES, TECHNOLOGIQUES ET COM-MERCIALES,
AINSI QUE DU POINT DE VUE DES UTILISATEURS, LES
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
PROJETS DE NORMES
TRAITEMENT PARALLÈLE ISO/CEN
INTERNATIONALES DOIVENT PARFOIS ÊTRE CONSIDÉRÉS
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
DU POINT DE VUE DE LEUR POSSI BILITÉ DE DEVENIR DES
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
NORMES POUVANT
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
SERVIR DE RÉFÉRENCE DANS LA RÉGLEMENTATION
NATIONALE.
ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: [phone]
E-mail: [e-mail]
Web: www.iso.org
Publié en Suisse Numéro de référence
ii
Sommaire Page
Avant- pcropos .iv
Introduction .v
1 Domaine d’application . 1
2 Références normatives . 1
3 Termes et définitions . 1
Bibliographie .32
Index .33

iii
Avant- pcropos
L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes nationaux
de normalisation (comités membres de l’ISO). Le travail d’élaboration des Normes internationales est
normalement effectué par l’intermédiaire des comités d’études de l’ISO. Chaque comité membre intéressé
par un sujet pour lequel un comité technique a été créé a le droit d’être représenté au sein de ce comité. Des
organisations internationales, gouvernementales et non gouvernementales, en liaison avec l’ISO, participent
également aux travaux. L’ISO collabore étroitement avec la Commission électrotechnique internationale
(IEC) sur toutes les questions de normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont décrites
dans les directives ISO/IEC, Partie 1. En particulier, il convient de noter les différents critères d’approbation
nécessaires pour les différents types de documents ISO. Le présent document a été rédigé conformément
aux règles de rédaction des directives ISO/IEC, Partie 2 (voir www.iso.org/directives).
L’ISO attire l’attention sur le fait que la mise en œuvre du présent document peut impliquer l’utilisation
d’un ou de plusieurs brevets. L’ISO ne prend pas position quant à la preuve, à la validité ou à l’applicabilité
des droits de propriété revendiqués à cet égard. À la date de publication du présent document, l’ISO n’avait
pas reçu notification d’un ou de plusieurs brevets qui pourraient être nécessaires à sa mise en application.
Toutefois, les responsables de la mise en œuvre sont avertis que cela peut ne pas représenter les informations
les plus récentes, qui peuvent être obtenues à partir de la base de données sur les brevets disponible à
l’adresse www.iso.org/brevets. L’ISO ne saurait être tenue pour responsable d’avoir identifié tout ou partie
de tels droits de propriété.
Toute appellation commerciale utilisée dans le présent document est donnée par souci de commodité à
l’intention des utilisateurs et ne saurait constituer un engagement.
Pour une explication de la nature volontaire des normes, la signification des termes et expressions
spécifiques de l’ISO liés à l’évaluation de la conformité, ou pour toute information au sujet de l’adhésion de
l’ISO aux principes de l’Organisation mondiale du commerce (OMC) concernant les obstacles techniques au
commerce (OTC), voir le lien suivant: www.iso.org/avant-propos.
Le présent document a été élaboré par le comité technique ISO/TC 215, Informatique de santé, en collaboration
avec le comité technique CEN/TC 251, Informatique de santé, du Comité européen de normalisation (CEN),
conformément à l’Accord de coopération technique entre l’ISO et le CEN (Accord de Vienne).
Il convient que tout retour d’information ou toute question concernant le présent document soit adressé
à l’organisme national de normalisation de l’utilisateur. Une liste complète de ces organismes peut être
consultée à l’adresse www.iso.org/members.html.

iv
Introduction
Les documents relatifs à l’identification des médicaments (IDMP) élaborés par l’ISO/TC 215 sont constitués
de cinq normes internationales et de quatre spécifications techniques. Lors de l’élaboration de ces documents,
une attention particulière a été accordée à l’utilisation de termes et de définitions identiques; entre-temps,
les révisions successives de ces documents ont montré qu’il devenait difficile de conserver des termes et des
définitions parfaitement alignés. En outre, dans l’intervalle, de nouvelles spécifications techniques ont été
élaborées ou sont en cours d’élaboration, qui hériteront des définitions de base de l’IDMP et s’y référeront et
élimineront donc le risque de défaut d’alignement.
Les définitions fondamentales de l’IDMP sont utilisées dans au moins trois des normes ISO et spécifications
techniques relatives à l’IDMP. La nécessité de regrouper les définitions de base dans une seule Norme
internationale aide à maintenir l’alignement des définitions de base dans le temps et simplifie le travail de
toutes les parties intéressées (concepteurs et responsables de la mise en œuvre des normes).
Si un terme peut désigner plusieurs concepts (homonymie), généralement différents dans différents
contextes, le contexte de la définition donnée est indiqué conformément aux directives ISO/IEC, Partie 2,
16.5.6. Dans ce cas, le contexte ("domaine") précède le texte de définition entre parenthèses angulaires
(). Cela indique que le même terme peut apparaître dans un autre contexte avec une autre
définition, désignant un autre concept, dans le même document ou dans un autre document.
Chaque terme a ses propres triples de définition (ontologie), qui fournit le crochet pour la compréhension
informatique de chaque définition.

v
PROJET FINAL Norme internationale ISO/FDIS 22532:2026(fr)
Informatique de santé — Identification des produits destinés
à des fins médicinales — Vocabulaire de base
1 Domaine d’application
Le présent document définit les termes utilisés dans les normes ISO sur l’identification des médicaments
(IDMP) et leurs spécifications techniques associées.
2 Références normatives
Le présent document ne contient aucune référence normative.
3 Termes et définitions
L’ISO et l’IEC tiennent à jour des bases de données terminologiques destinées à être utilisées en normalisation
aux adresses suivantes:
— ISO Online browsing platform: disponible à l’adresse https:// www .iso .org/ obp
— IEC Electropedia: disponible à l’adresse https:// www .electropedia .org/
3.1
adjuvant
composant qui potentialise la réponse immunitaire à un antigène ou qui la module vers la réponse
immunitaire souhaitée, ou les deux
3.2
forme posologique administrable
forme posologique administrable pharmaceutique
forme posologique pharmaceutique (3.37) destinée à être administrée au patient
Note 1 à l'article: La transformation des articles manufacturés (3.19) et des formes de dose manufacturées
correspondantes (3.18) peut être nécessaire avant administration.
Note 2 à l'article: La forme posologique administrable est identique à la forme posologique fabriquée dans les cas où
aucune transformation de l’article fabriqué n’est nécessaire (c’est-à-dire lorsque l’article fabriqué est égal au produit
pharmaceutique (3.38)).
Note 3 à l'article: Triples sémantiques (Ontologie):
— ("forme posologique administrable", "est un type de", "forme posologique pharmaceutique")
— ("forme posologique administrable", "est destinée", "administration au patient")
— ("forme de dose administrable", "est égal à", "forme de dose fabriquée", "quand", "pas de transformation")
3.3
allergène
substance (3.56) utilisée comme ingrédient (3.13) ou dans un dispositif capable de stimuler une
hypersensibilité de type I et une réaction allergique
Note 1 à l'article: Les allergènes actifs sont des substances de structure diverse (3.55) dérivées de matrices biologiques.
Dans plusieurs cas, si la protéine allergénique responsable de la réponse allergénique a été isolée et caractérisée chez
la majorité des patients, alors la substance est classée comme protéine.

Note 2 à l'article: Triples sémantiques (Ontologie):
— ("allergène", "est un type de", "matériau")
— ("allergène", "utilisé comme", "ingrédient ou dans un dispositif")
— ("allergène", "capable de", "stimulant une hypersensibilité de type I")
— ("allergène", "capable de", "stimulant une réaction allergique")
— ("allergène", "est dérivé de", "matrices biologiques")
— ("allergène", "est classé comme", "protéine")
3.4
co-cristaux
structures cristallines homogènes (monophasées) composées de deux composants ou plus dans un rapport
stoechiométrique défini où la disposition dans le réseau cristallin n’est pas basée sur des liaisons ioniques
Note 1 à l'article: Triples sémantiques (Ontologie):
— ("co-cristaux", "sont", "structures cristallines homogènes")
— ("co-cristaux", "constitués de", "au moins deux composants dans un rapport stoechiométrique défini")
— ("co-cristaux", "disposition dans le réseau cristallin", "non basée sur des liaisons ioniques")
— ("co-cristaux", "sont utilisés comme", "formes solides alternatives dans le développement de médicaments")
— ("co-cristaux", "peut améliorer", "propriétés à l’état solide (telles que solubilité, hygroscopicité et stabilité)")
— ("propriétés à l’état solide", "inclut", "solubilité, hygroscopicité et stabilité")
— ("co-cristaux", "peut améliorer", "comportement de fabrication" (par exemple compactage, fluidité, filtrabilité,
etc.)")
— ("comportement de fabrication", "comprend", "compactage, fluidité, filtrabilité, etc.")
— ("co-cristaux", "sont basés sur", "interactions de liaison hydrogène sans transfert d’ions hydrogène pour former
des sels")
3.5
forme pharmaceutique combinée
forme de dose constituée d’au moins deux articles manufacturés (3.19) destinés à être combinés de manière
spécifique pour produire un seul produit pharmaceutique (3.38)
EXEMPLE Le terme "poudre et solvant pour solution injectable" décrit une forme pharmaceutique combinée de
dose (3.37) dans laquelle le médicament (3.27) comprend une poudre et un solvant, tous deux destinés à une solution
injectable. Une fois combinés, ces éléments produisent une forme posologique administrable (3.2): "solution injectable".
Note 1 à l'article: Ce terme englobe des informations détaillées concernant la forme posologique fabriquée de
chaque élément (3.18) ainsi que la forme posologique administrable finale du produit pharmaceutique composé.
Conformément aux normes décrites dans l’ISO 11239 et l’ISO/TS 20440, la forme pharmaceutique combinée est
caractérisée par un terme distinctif et un identificateur de terme correspondant (3.12), chacun étant exprimé par un
"nom d’affichage" et un "code" dans une structure XML. Ce formulaire combiné est identifié et codé dans le cadre
terminologique établi, reflétant la nature complète du produit. Essentiellement, la forme pharmaceutique combinée
est un terme intégral utilisé dans l’identification et la classification des médicaments complexes qui sont composés
de plusieurs composants, qui, lorsqu’ils sont combinés comme indiqué, conduisent à un produit pharmaceutique final
prêt à être administré au patient.
Note 2 à l'article: La forme posologique pharmaceutique combinée comprend des informations sur la forme posologique
fabriquée de chaque article fabriqué et la forme posologique administrable du produit pharmaceutique.
Note 3 à l'article: Triples sémantiques (Ontologie):
— ("forme de dose pharmaceutique combinée", "est composé de", "deux ou plusieurs articles manufacturés")

— ("forme pharmaceutique combinée", "est destinée à", "produire un seul produit pharmaceutique")
— ("forme de dose pharmaceutique combinée", "comprend des informations sur", "la forme de dose fabriquée de
chaque article fabriqué")
— ("forme posologique pharmaceutique combinée", "comprend des informations sur", "forme posologique
administrable du produit pharmaceutique")
— ("forme de dose pharmaceutique combinée", "est caractérisée par", "un terme distinctif et un identificateur de
terme correspondant")
— ("forme de dose pharmaceutique combinée", "est exprimée par", "un ‘nom d’affichage’ et un ‘code’ dans une
structure XML")
— ("forme pharmaceutique combinée", "est utilisé dans", "l’identification et la classification des médicaments
complexes")
— ("forme de dose pharmaceutique combinée", "résulte en", "un produit pharmaceutique final prêt à être administré
au patient")
3.6
confidentialité
sécurité et confidentialité d’une information ou d’une entité
EXEMPLE Le lecteur peut se fier au contenu des informations. Le lecteur autorisé peut être sûr qu’aucune
personne non autorisée ne peut accéder aux informations. Cela signifie que les informations peuvent contenir des
secrets d’entreprise qui ne sont pas accessibles à des personnes non autorisées, que les informations personnelles ne
peuvent pas être accessibles sans authentifiants appropriés et que les informations peuvent toujours être fiables.
Note 1 à l'article: à l’article La confidentialité est une propriété, en particulier des informations, ce qui signifie que ces
informations ne sont accessibles qu’aux personnes autorisées.
Note 2 à l'article: Dans certaines juridictions (3.16), il existe une différence distincte entre la confidentialité destinée
à assurer la sécurité et l’exactitude des informations et la confidentialité destinée à assurer la confidentialité des
informations.
Note 3 à l'article: Triples sémantiques (Ontologie):
— ("confidentialité", "est liée à", "sécurité et vie privée", "de", "une information")
— ("confidentialité", "implique", "disponible uniquement pour les personnes autorisées")
— ("confidentialité", "assure", "aucune personne non autorisée ne peut accéder aux informations")
— ("confidentialité", "protection", "secrets d’entreprise")
— ("confidentialité", "protège", "les informations personnelles ne peuvent pas être consultées à moins que des
justificatifs d’identité appropriés")
3.7
constituant
substance présente dans une substance spécifiée (3.49) ou un mélange (3.30)
EXEMPLE La substance acétonide de triamcinolone est la substance mère (constituant) de la substance du groupe
de substances 1 spécifiée, acétonide de triamcinolone, micronisée.
Note 1 à l'article: Les constituants peuvent être des impuretés, des dégradants, des solvants d’extraction (3.11),
des véhicules (3.58), des marqueurs actifs ou des substances de signature, des substances mères ou des substances
individuelles mélangées pour former un matériau multisubstances (3.34).
Note 2 à l'article: Les constituants doivent avoir un rôle et une quantité associés au modèle d’information du groupe de
substances 1 spécifié. Les spécifications des constituants doivent être utilisées pour décrire les composants ainsi que
les limites relatives aux impuretés ou aux substances apparentées pour un matériau donné (3.24).
Note 3 à l'article: Le constituant fait partie d’un mélange appartenant à un groupe homologue de composants
individuels, décrit comme des substances mères pour la fabrication d’un extrait allergène.

Note 4 à l'article: Triples sémantiques (Ontologie):
— ("constituant", "est", "une substance")
— ("constituant", "pouvant être présent dans", "substance spécifiée")
— ("constituant", "pouvant être présent dans", "mélange")
— ("constituant", "peut avoir", "une quantité")
— ("constituant", "doit avoir", "un rôle associé")
— ("constituant", "peut avoir un rôle de", "impuretés")
— ("constituant", "peut avoir un rôle de", "dégradant")
— ("constituant", "peut avoir un rôle de", "solvants d’extraction")
— ("constituant", "peut avoir le rôle de", "véhicules")
— ("constituant", "peut avoir le rôle de", "marqueurs actifs")
— ("constituant", "peut avoir un rôle de", "substances de signature")
— ("constituant", "peut faire partie", "matériau multisubstance")
— ("constituant", "fait partie de", "mélange appartenant à un groupe homologue de composants individuels")
— ("constituant", "peut être", "impuretés, dégradants, solvants d’extraction, véhicules, marqueurs actifs ou
substances de signature, substances mères ou substances individuelles mélangées pour former un matériau
multisubstances")
3.8
vocabulaire contrôlé
terminologie contrôlée
ensemble fini de valeurs prédéterminées qui constituent les options admissibles exclusives pour une donnée
donnée
Note 1 à l'article: Ces valeurs assurent la cohérence et la normalisation de la représentation des données et peuvent se
manifester sous forme de codes, de descriptions textuelles ou de désignations numériques.
Note 2 à l'article: Le domaine d’application de l’ensemble de valeurs est limité afin de faciliter l’exactitude des données,
l’interopérabilité et la conformité aux normes de données établies.
Note 3 à l'article: Les vocabulaires contrôlés peuvent englober une taxonomie qui organise les termes de manière
hiérarchique ou relationnelle, et tout sous-ensemble de termes au sein d’une telle taxonomie peut être appelé
sous-vocabulaire.
Note 4 à l'article: Le cas échéant, la définition et le concept de vocabulaire contrôlé sont adaptés au glossaire externe
tel que celui du CDISC (Clinical Data Interchange Standards Consortium), assurant l’alignement avec les normes et
pratiques relatives aux données de recherche clinique.
Note 5 à l'article: Triples sémantiques (Ontologie):
— ("vocabulaire contrôlé", "est", "ensemble fini de valeurs prédéterminées")
— ("vocabulaire contrôlé", "constitue", "les options autorisées exclusives", "pour", "une donnée donnée")
— ("vocabulaire contrôlé", "assure", "cohérence")
— ("vocabulaire contrôlé", "assure", "normalisation")
— ("vocabulaire contrôlé", "support", "représentation des données")
— ("vocabulaire contrôlé", "peut se manifester par", "codes")
— ("vocabulaire contrôlé", "peut se manifester sous la forme", "descriptions textuelles")

— ("vocabulaire contrôlé", "peut se manifester par", "désignations numériques")
— ("vocabulaire contrôlé", "dont le domaine d’application est restreint pour faciliter", "exactitude des données,
interopérabilité et conformité aux normes de données établies")
— ("vocabulaire contrôlé", "dont le domaine d’application est restreint pour faciliter", "interopérabilité")
— ("vocabulaire contrôlé", "est limité dans son domaine d’application pour faciliter", "conformité", "avec", "normes
de données établies")
— ("vocabulaire contrôlé", "peut englober", "taxonomie")
— ("vocabulaire contrôlé", "peut faire référence", "un sous-vocabulaire")
— ("sous-vocabulaire", "fait partie de", "taxonomie")
— ("vocabulaire contrôlé", "est adapté à", "glossaire externe")
— ("glossaire de recherche clinique du CDISC", "est", "un glossaire externe")
— ("vocabulaire contrôlé", "fournit", "terme contrôlé")
— ("terme contrôlé", "a", "identificateur de terme")
3.9
pays
entité territoriale reconnue
Note 1 à l'article: à l’article La désignation d’un pays est essentielle dans les contextes réglementaires pour assurer la
clarté et l’uniformité de l’identification des juridictions (3.16) relatives aux activités pharmaceutiques et cliniques.
Note 2 à l'article: Aux fins de l’harmonisation internationale, les éléments de code alpha -2 de l’ISO 3166-1 servent de
nomenclature normalisée pour la représentation des pays et des zones géographiques importantes.
Note 3 à l'article: Dans certains cas, le code "UE" est utilisé pour représenter l’Union européenne dans le cadre de
l’ISO 3166-1. Bien que l’Union européenne ne soit pas un pays, cette désignation est réservée pour désigner les
États membres collectifs dans les contextes où une autorisation réglementaire ou de mise sur le marché unifiée est
applicable.
Note 4 à l'article: Un pays est désigné en utilisant les codes à deux lettres définis par la norme ISO 3166-1 alpha -2.
Note 5 à l'article: Les informations relatives au médicament (3.27) peuvent être l’autorisation de mise sur le marché,
les points de mesure (3.25), l’applicabilité du médicament ou l’autorisation d’essai clinique.
Note 6 à l'article: Triples sémantiques (Ontologie):
— ("pays", "est", "une entité territoriale reconnue")
— ("pays", "est utilisé pour caractériser", "médicament")
— ("pays", "est utilisé pour caractériser", "autorisation de mise sur le marché")
— ("pays", "est utilisé pour caractériser", "autorisation d’essai clinique")
— ("pays", "est utilisé pour caractériser", "points de mesure")
— ("pays", "est utilisé pour caractériser", "applicabilité du médicament")
— ("pays", "est critique dans", "contextes réglementaires")
— ("pays", "est représenté par", "les éléments de code alpha -2 de l’ISO 3166-1")
— ("les éléments de code alpha -2 de l’ISO 3166-1", "sont utilisés pour", "aux fins de l’harmonisation internationale")

3.10
paramètre critique du processus
paramètre du processus dont la variabilité a un impact sur un attribut qualité critique et qu’il convient donc
de surveiller ou de contrôler pour s’assurer que le processus produit la qualité souhaitée
Note 1 à l'article: Un paramètre de fabrication (3.20) est considéré comme "critique" et nécessaire pour la production
de substance (3.56) ou de substance spécifiée (3.49), par exemple l’inclusion d’une étape chromatographique pour
l’élimination ou la réduction des impuretés, des virus, etc.
Note 2 à l'article: Le processus critique est lié au type de méthode de production.
Note 3 à l'article: Adapté de la Référence [12].
Note 4 à l'article: Triples sémantiques (Ontologie):
— ("paramètre de processus critique", "est", "paramètre de processus")
— ("paramètre critique du processus", "a", "une variabilité")
— ("variabilité des paramètres critiques du processus", "a", "un impact sur un attribut qualité critique")
— ("paramètre critique du processus", "il convient", "surveillé ou contrôlé")
— ("paramètre critique du processus", "est lié à", "processus de production")
— ("surveillance ou contrôle des paramètres critiques du processus", "assurer", "la qualité souhaitée")
— ("paramètre critique du processus", "est lié à", "type de méthode de production")
— ("paramètre critique du processus", "est défini conformément à", "la ligne directrice ICH Q8")
3.11
solvant d’extraction
solvant utilisé pour le procédé d’extraction
Note 1 à l'article: Triples sémantiques (Ontologie):
— ("solvant d’extraction", "est un type de", "solvant")
— ("solvant d’extraction", "est utilisé pour", "le procédé d’extraction")
3.12
identificateur
descripteur approprié pour représenter une entité de manière unique dans un contexte spécifique, assurant
sa distinction par rapport aux autres entités
Note 1 à l'article: Dans le domaine des médicaments (3.27), un identificateur comprend un ensemble de
caractéristiques d’identification qui, lorsqu’elles sont combinées, distinguent sans ambiguïté un médicament, un
produit pharmaceutique (3.38), une substance, une substance spécifiée (3.49), la voie d’administration (3.47), la forme
posologique pharmaceutique (3.37) ou tout autre élément nécessitant une reconnaissance unique.
Note 2 à l'article: Les identificateurs peuvent être représentés sous différentes formes telles que des codes
alphanumériques, des identificateurs uniques globaux (GUID) ou des identificateurs uniques universels (UUID), ou
d’autres systèmes de codage reconnus au niveau international. Lorsqu’il est appliqué à des organisations ou à des
sites, un système international d’identificateurs uniques peut être utilisé conformément aux exigences réglementaires
régionales.
Note 3 à l'article: L’objet d’un identifiant est de fournir clarté et fidélité dans le suivi, la réglementation et la gestion des
entités dans l’environnement pharmaceutique, comme établi par des normes reconnues.
Note 4 à l'article: Triples sémantiques (Ontologie):
— ("identificateur", "est", "un descripteur")
— ("identificateur", "est caractérisé", "une entité ou un enregistrement")
— ("identificateur", "lié à", "un contexte spécifique")

— ("identifiant", "assure", "identification distincte")
— ("identificateur", "caractérise", "médicament")
— ("identificateur", "caractérise", "produit pharmaceutique")
— ("identificateur", "caractérise", "substance")
— ("identificateur", "caractérise", "substance spécifiée")
3.13
ingrédient
substance utilisée dans la composition d’un produit pharmaceutique (3.38) ou d’un article manufacturé
(3.19), ayant un rôle défini et une concentration (3.52) définie
Note 1 à l'article: à l’article Un ingrédient constitue une partie d’un médicament (3.27), soit isolément, soit conjointement
avec d’autres ingrédients. Il a une force et un rôle spécifique dans le produit, qui peut être un ingrédient actif, un
adjuvant (3.1) ou un excipient.
Note 2 à l'article: L’ingrédient correspond à une substance telle que définie, avec un contexte supplémentaire fourni
par sa fonction dans l’article manufacturé ou le produit pharmaceutique.
Note 3 à l'article: Pour chaque ingrédient distinct présent dans un article manufacturé ou un produit pharmaceutique,
il convient d’enregistrer une instance distincte de la classe d’ingrédient pour assurer une documentation complète et
la traçabilité.
Note 4 à l'article: Triples sémantiques (Ontologie):
— ("ingrédient", "doit avoir", "rôle d’ingrédient")
— ("ingrédient", "a", "un rôle")
— ("ingrédient", "a", "une concentration")
— ("rôle de l’ingrédient", "est joué par", "une substance")
— ("ingrédient", "se manifeste par", "produit pharmaceutique ou article manufacturé")
— ("ingrédient", "ne peut exister", "en dehors d’un produit pharmaceutique ou d’un article manufacturé")
3.14
rôle de l’ingrédient
fonction ou objectif spécifique d’une substance lorsqu’elle est incluse comme constituant (3.7) de la
composition d’un article manufacturé (3.19) ou d’un produit pharmaceutique (3.38)
Note 1 à l'article: Le rôle de chaque ingrédient (3.13) doit être clairement défini et classé en utilisant un vocabulaire
contrôlé (3.8) en fonction de sa contribution au produit, par exemple actif, excipient, adjuvant (3.1). Le terme contrôlé
et son identificateur associé (3.12), qui caractérise de manière unique le rôle, doivent être spécifiés.
Note 2 à l'article: Triples sémantiques (Ontologie):
— ("rôle de l’ingrédient", "est", "une classification")
— ("substance", "joue", "rôle d’ingrédient")
— ("article manufacturé", "contient", "substance")
— ("produit pharmaceutique", "contient", "substance")
— ("rôle de l’ingrédient", "utilisations", "vocabulaire contrôlé")
— ("actif", "est", "un rôle d’ingrédient")
— ("excipient", "est", "un rôle d’ingrédient")
— ("adjuvant", "est", "un rôle d’ingrédient")

3.15
médicament expérimental
IMP
produit pharmaceutique (3.38), ou combinaison de produits pharmaceutiques, ou placebo(s) qui fait l’objet
d’une investigation dans le cadre d’un essai clinique et qui est autorisé à faire l’objet d’une investigation par
une agence de réglementation pharmaceutique dans une région donnée
Note 1 à l'article: Un médicament expérimental peut être un produit pharmaceutique entièrement nouveau (c’est-à-dire
n’ayant pas reçu d’autorisation de mise sur le marché) ou un produit déjà autorisé qui est à l’étude. Par conséquent, cela
inclut les produits bénéficiant d’une autorisation de mise sur le marché existante qui sont soumis à essai ou utilisés
d’une manière différente de la forme autorisée, qui sont utilisés pour une indication non autorisée ou qui font l’objet
d’une enquête pour collecter des données supplémentaires relatives à la forme autorisée.
Note 2 à l'article: L’usage expérimental d’un médicament (3.27) englobe les variations de sa formulation, de son
emballage, de son dosage, de sa voie d’administration (3.47) ou les indications de celui qui a été autorisé.
Note 3 à l'article: à l’article Chaque médicament expérimental est identifié et caractérisé de manière unique par un
IMPID (identificateur de médicament expérimental) et est autorisé à être étudié par une agence de réglementation
pharmaceutique dans une région donnée.
Note 4 à l'article: Triples sémantiques (Ontologie):
— ("médicament expérimental", "est "un produit pharmaceutique, ou une combinaison de produits pharmaceutiques,
ou un ou plusieurs placebo(s) qui fait l’objet d’une investigation dans un essai clinique")
— ("médicament expérimental", "est autorisé pour", "investigation par une agence de réglementation pharmaceutique
dans une région donnée")
— ("médicament expérimental", "peut être", "un produit pharmaceutique entièrement nouveau ou un produit déjà
autorisé qui fait l’objet d’une étude plus approfondie")
— ("médicament expérimental", "comprend", "les produits bénéficiant d’une autorisation de mise sur le marché
existante qui sont soumis à essai ou utilisés d’une manière différente de la forme autorisée, qui sont utilisés pour
une indication non autorisée ou qui font l’objet d’une investigation pour recueillir des données supplémentaires
relatives à la forme autorisée")
— ("médicament expérimental", "englobe", "les variations de sa formulation, de son emballage, de son dosage, de sa
voie d’administration ou d’une indication par rapport à celle qui a été autorisée")
— ("médicament expérimental", "est identifié par", "un IMPID (identificateur de médicament expérimental)")
3.16
juridiction
zone géographique spécifique d’un pays (3.9) ou d’une région, ou domaine particulier d’autorité et de
responsabilité, auquel s’appliquent la surveillance et les réglementations d’une agence de réglementation
pharmaceutique
Note 1 à l'article: à l’article La compétence fait référence au domaine d’application territorial dans lequel les noms
de médicaments (3.28), les autorisations de mise sur le marché et les autorisations d’essais cliniques sont pertinents
et exécutoires. Elle définit les limites légales et réglementaires des activités de l’agence de réglementation
pharmaceutique.
Note 2 à l'article: Lors de la description de la juridiction, les termes contrôlés et leurs identifiants correspondants
(3.12) doivent être spécifiés. Ces termes sont structurés de la même manière que les identifiants de pays mais sont
distincts en ce qu’ils représentent des subdivisions ou des zones spécifiques dans un pays ou une région.
Note 3 à l'article: à l’article Dans les cas où les autorisations d’essais cliniques ou les activités de commercialisation
couvrent plusieurs juridictions, les juridictions pertinentes sont identifiées à l’aide des codes alpha -2 de l’ISO 3166-1
ou d’autres listes de codes de juridictions compatibles.
Note 4 à l'article: Il convient d’indiquer clairement la juridiction d’un nom officiel de médicament ou l’activité de
commercialisation, par exemple "US" pour les États-Unis, "EU" pour l’Union européenne, ou "JP" pour le Japon.
Note 5 à l'article: Triples sémantiques (Ontologie):

— ("juridiction", "est", "une zone géographique spécifique à l’intérieur d’un pays ou d’une région, ou le domaine
particulier d’autorité et de responsabilité, auquel s’appliquent la surveillance et la réglementation d’une agence de
réglementation pharmaceutique")
— ("juridiction", "se réfère", "le champ d’application territorial dans lequel les noms de médicaments, les autorisations
de mise sur le marché et les approbations d’essais cliniques sont pertinents et exécutoires")
— ("juridiction", "définit", "les limites légales et réglementaires des activités de l’Agence de réglementation
pharmaceutique")
— ("juridiction", "doit être décrit en utilisant", "termes contrôlés et leurs identifiants correspondants")
— ("juridiction", "sont identifiés à l’aide", "codes alpha -2 de l’ISO 3166-1 ou autres listes de codes de juridiction
compatibles")
— ("juridiction", "il convient d’indiquer clairement", "nom officiel du médicament ou activité de commercialisation")
3.17
statut juridique de la fourniture
classification déterminée par une réglementation régionale ou juridictionnelle qui détermine la manière dont
un médicament (3.27) ou un emballage, ou les deux, peuvent être délivrés à un patient ou à un consommateur
Note 1 à l'article: à l’article Le statut juridique de la délivrance est un attribut réglementaire clé d’un médicament qui
définit les conditions dans lesquelles le produit est mis à la disposition du public dans une juridiction donnée.
Note 2 à l'article: Il convient d’utiliser un vocabulaire contrôlé (3.8) pour décrire le statut juridique de la délivrance
d’un médicament. Le terme et son identifiant unique (3.12) doivent être fournis dans ce vocabulaire pour assurer la
clarté et l’interopérabilité entre les systèmes réglementaires.
Note 3 à l'article: à l’article Le statut légal de fourniture du médicament est classé et spécifié par l’agence réglementaire
des médicaments et constitue un élément critique du profil réglementaire du produit.
Note 4 à l'article: Triples sémantiques (Ontologie):
— ("médicament", "a", "un statut juridique de fourniture")
— ("statut juridique de la fourniture", "est classé par", "agence réglementaire des médicaments")
— ("statut juridique de la fourniture", "est décrit en utilisant", "vocabulaire contrôlé")
— ("vocabulaire contrôlé", "inclut le terme", "prescription médicale requise")
— ("vocabulaire contrôlé", "inclut le terme", "pas de prescription requise")
— ("statut juridique de la fourniture", "s’applique dans", "juridiction")
3.18
forme de dose fabriquée
forme posologique pharmaceutique (3.37) d’un article manufacturé (3.19) telle que fournie par le fabricant
EXEMPLE Poudre pour solution injectable.
Note 1 à l'article: La forme de dose fabriquée est identique à la forme de dose administrable (3.2) dans les cas où
aucune transformation de l’article fabriqué n’est nécessaire (c’est-à-dire lorsque l’article fabriqué est égal au produit
pharmaceutique (3.38)).
Note 2 à l'article: Un médicament (3.27) peut contenir plusieurs éléments d’emballage qui comportent un ou plusieurs
éléments manufacturés, l’un avec une forme de dose manufacturée de poudre pour solution injectable et l’autre
avec une forme de dose manufacturée de solvant pour solution injectable. Ceux-ci doivent ensuite être reconstitués
ou transformés en "solution injectable" avant que le médicament ne puisse être administré à un patient. La solution
injectable est la "forme posologique administrable", qui est un attribut du "produit pharmaceutique".
Note 3 à l'article: Triples sémantiques (Ontologie):
— ("forme de dose fabriquée", "est identique à", "forme de dose administrable dans les cas où aucune transformation
de l’article fabriqué n’est nécessaire")

— ("forme de dose fabriquée", "peut avoir", "deux articles fabriqués, l’un avec une forme de dose fabriquée de poudre
pour solution injectable et l’autre avec une forme de dose fabriquée de solvant pour solution injectable")
— ("forme de dose fabriquée", "doit être reconstituée ou transformée en", "une solution injectable avant que le
médicament ne puisse être administré à un patient")
3.19
article manufacturé
MI
composition qualitative et quantitative contenant un ou plusieurs ingrédients (3.13) sous
forme de dose spécifique
Note 1 à l'article: Un article manufacturé peut être contenu dans l’emballage d’un médicament (3.27) tel qu’il est mis à
disposition sur le marché ou d’un médicament expérimental (3.15) tel qu’utilisé dans un essai clinique.
Note 2 à l'article: Un médicament ou un médicament expérimental peut comprendre un ou plusieurs articles
manufacturés (3.19), qui peuvent être équivalents au produit pharmaceutique final (3.38) ou peuvent différer de celui-
ci si un traitement supplémentaire est requis avant l’administration au patient.
Note 3 à l'article: L’article manufacturé englobe la forme physique réelle du produit livré par le fabricant, par exemple
un comprimé, une capsule, un liquide ou une crème, et est destiné à être l’entité qui est finalement distribuée ou
utilisée dans un essai clinique.
Note 4 à l'article: Dans les cas où une transformation de l’article manufacturé est requise, la forme finale administrée
du produit, connue sous le nom de produit pharmaceutique, peut différer de l’article manufacturé initial.
Note 5 à l'article: à l’article Les formes posologiques définies par le Conseil international de l’harmonisation (ICH)
comme "un type de produit pharmaceutique (par exemple, comprimé, capsule, solution, crème) qui contient une
substance médicamenteuse généralement, mais pas nécessairement, en association avec des excipients" sont
considérées comme des articles manufacturés.
Note 6 à l'article: Triples sémantiques (Ontologie):
— ("article manufacturé", "est contenu dans", "emballage (emballage d’article)")
— ("article manufacturé", "a", "composition qualitative")
— ("article manufacturé", "a", "composition quantitative")
— ("médicament", "peut contenir", "article(s) manufacturé(s)")
— ("médicament expérimental", "peut contenir", "produit(s) manufacturé(s)")
— ("article manufacturé", "peut subir", "transformation")
— ("transformation", "résultats", "produit pharmaceutique")
— ("article manufacturé", "est fabriqué par", "fabricant")
— ("produit manufacturé", "composé de", "ingrédients")
— ("article manufacturé", "possède", "forme de dose manufacturée")
— ("article manufacturé", "en", "unité de présentation")
3.20
fabrication
processus de production d’une substance (3.56) ou d’un médicament (3.27), depuis l’acquisition de tous les
matériaux (3.24) jusqu’à toutes les étapes de transformation
Note 1 à l'article: Le processus critique, les étapes critiques du processus, les matériaux de départ et de traitement
(3.41) et les paramètres de production critiques sont inclus.
Note 2 à l'article: Triples sémantiques (Ontologie):
— ("fabrication", "est", "processus de production d’une substance ou d’un médicament depuis l’acquisition de tous les
matériaux jusqu’à toutes les étapes de transformation")

— ("fabrication", "comprend", "le processus critique, les étapes critiques du processus, les matériaux de départ et de
traitement, et les paramètres critiques de production")
3.21
autorisation de commercialisation
autorisation officielle délivrée par une agence de réglementation pharmaceutique, qui autorise une société
pharmaceutique à mettre un médicament (3.27) sur le marché dans une région spécifique
Note 1 à l'article: Cette autorisation est une procédure réglementaire à délivrer avant qu’un médicament puisse être
commercialisé.
Note 2 à l'article: à l’article L ’autorisation de mise sur le marché est identifiée par son numéro d’autorisation de mise sur
le marché (3.22) et par son titulaire.
Note 3 à l'article: Triples sémantiques (Ontologie):
— ("autorisation de mise sur le marché", "partie habilitée", "agence de réglementation pharmaceutique")
— ("autorisation de mise sur le marché", "partie autorisée", "titulaire de l’autorisation de mise sur le marché")
— ("autorisation de mise sur le marché", "s’applique à", "médicament")
— ("autorisation de mise sur le marché", "s’applique à", "médicament emballé")
— ("autorisation de mise sur le marché", "a une procédure d’autorisation", "procédure d’autorisation de mise sur le
marché")
— ("autorisation de mise sur le marché", "est identifié par", "numéro d’autorisation de mise sur le marché")
3.22
numéro d’autorisation de mise sur le marché
identifiant unique (3.12) attribué à un médicament (3.27) par une agence de réglementation pharmaceutique,
ce qui signifie que le médicament a obtenu une autorisation de mise sur le marché dans le cadre de la
juridiction de l’agence
Note 1 à l'article: Dans certains cas, le numéro d’autorisation de mise sur le marché peut faire référence à une
disposition réglementaire ou à une législation en vertu de laquelle un médicament est autorisé (par exemple,
médicaments bénéficiant de droits acquis).
Note 2 à l'article: Triples sémantiques (Ontologie):
— ("numéro d’autorisation de mise sur le marché", "est", "ide
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