oSIST prEN ISO 11615:2025

Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO/DIS 11615:2025)

ISO 11615:2017 establishes definitions and concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicinal Products.
Taken together, the standards listed in the Introduction define, characterise and uniquely identify regulated Medicinal Products for human use during their entire life cycle, i.e. from development to authorisation, post-marketing and renewal or withdrawal from the market, where applicable.
Furthermore, to support successful information exchange in relation to the unique identification and characterisation of Medicinal Products, the use of other normative IDMP messaging standards is included, which are to be applied in the context of ISO 11615:2017.

Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und Strukturen zur eindeutigen Identifikation und zum Austausch von vorgeschriebenen Arzneimittelinformationen (ISO/DIS 11615:2025)

Informatique de santé - Identification des médicaments - Éléments de données et structures pour l'identification unique et l'échange d'informations sur les médicaments contrôlés (ISO/DIS 11615:2025)

ISO 11615:2017 établit des définitions et des concepts, et décrit des éléments de données et leurs relations structurelles, nécessaires à l'identification unique et à la description détaillée des médicaments.
Considérées ensemble, les normes listées dans l'introduction définissent, caractérisent et identifient de façon unique des médicaments réglementés à usage humain pendant leur cycle de vie complet, c'est-à-dire depuis leur développement jusqu'à leur autorisation, leur mise sur le marché consécutive et leur renouvellement ou leur retrait du marché, le cas échéant.
En outre, pour garantir l'échange satisfaisant des informations relatives à l'identification unique et à la caractérisation des médicaments, le recours à d'autres normes IDMP et de messagerie à appliquer dans le contexte du présent document est inclus.

Zdravstvena informatika - Identifikacija zdravil - Elementi in zgradba podatkov za enotno identifikacijo in izmenjavo predpisanih informacij o zdravilih (ISO/DIS 11615:2025)

General Information

• Status: Not Published
• Public Enquiry End Date: 09-Dec-2025
• ICS: 11.120.10 - Medicaments
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ITC - Information technology
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 06-Oct-2025
• Due Date: 23-Feb-2026
• Completion Date: 05-Dec-2025
• Ref Project: prEN ISO 11615 - Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO/DIS 11615:2025)

Relations

• Revises: SIST EN ISO 11615:2018/A1:2023 - Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information - Amendment 1 (ISO 11615:2017/Amd 1:2022)
• Effective Date: 06-Dec-2023
• Revises: SIST EN ISO 11615:2018 - Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO 11615:2017)
• Effective Date: 06-Dec-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2025
Zdravstvena informatika - Identifikacija zdravil - Elementi in zgradba podatkov za
enotno identifikacijo in izmenjavo predpisanih informacij o zdravilih (ISO/DIS
11615:2025)
Health informatics - Identification of medicinal products - Data elements and structures
for the unique identification and exchange of regulated medicinal product information
(ISO/DIS 11615:2025)
Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und
Strukturen zur eindeutigen Identifikation und zum Austausch von vorgeschriebenen
Arzneimittelinformationen (ISO/DIS 11615:2025)
Informatique de santé - Identification des médicaments - Éléments de données et
structures pour l'identification unique et l'échange d'informations sur les médicaments
contrôlés (ISO/DIS 11615:2025)
Ta slovenski standard je istoveten z: prEN ISO 11615
ICS:
11.120.10 Zdravila Medicaments
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
International
Standard
ISO/DIS 11615
ISO/TC 215
Health informatics — Identification
Secretariat: ANSI
of medicinal products — Data
Voting begins on:
elements and structures for the
2025-09-19
unique identification and exchange
Voting terminates on:
of regulated medicinal product
2025-12-12
information
Informatique de santé — Identification des médicaments —
Éléments de données et structures pour l'identification unique et
l'échange d'informations sur les médicaments contrôlés
ICS: 35.240.80
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document has not been edited by the ISO Central Secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 11615:2025(en)
DRAFT
ISO/DIS 11615:2025(en)
International
Standard
ISO/DIS 11615
ISO/TC 215
Health informatics — Identification
Secretariat: ANSI
of medicinal products — Data
Voting begins on:
elements and structures for the
unique identification and exchange
Voting terminates on:
of regulated medicinal product
information
Informatique de santé — Identification des médicaments —
Éléments de données et structures pour l'identification unique et
l'échange d'informations sur les médicaments contrôlés
ICS: 35.240.80
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document has not been edited by the ISO Central Secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: [phone]
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 11615:2025(en)
ii
ISO/DIS 11615:2025(en)
Contents Page
Foreword .vi
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
3.1 Terms and definitions .2
3.2 Abbreviated terms . 12
4 Message exchange format .13
5 Conformance terminology and context as it relates to the ISO IDMP standards and
corresponding IDMP technical specifications .13
6 Concepts required for the unique identification of medicinal products .13
6.1 General considerations. 13
6.2 Authorised medicinal products .14
6.3 Investigational medicinal products .14
6.4 Concepts required for the unique identification of a medicinal product and the
association with PhPID(s) .14
6.5 Concepts required for the unique identification of medicinal products and the
association with the marketing authorisation number . 15
6.6 Concepts required for the unique identification of medicinal products and the
association with data carrier identifiers . 15
7 Description of the information modelling principles and practices .16
7.1 General considerations.16
7.2 Conceptual overview diagrams .16
7.3 High-level diagrams .17
7.4 Detailed description diagrams . .18
7.4.1 General .18
7.4.2 Relationships between classes .18
7.4.3 Attributes of classes .19
7.4.4 Generalised classes and patterns .19
7.4.5 Translation and language .19
8 Identifying characteristics for authorised Medicinal Products . 19
8.1 Primary identifiers — General considerations .19
8.2 Medicinal Product Identifier (MPID) . 20
8.2.1 General considerations . 20
8.2.2 MPID code segments . 20
8.3 Packaged Medicinal Product Identifier (PCID) .21
8.3.1 General considerations .21
8.3.2 Package description (PCID) code segment . 22
8.4 Medicinal Product Batch Identifier (BAID1) . 22
8.5 Medicinal Product Batch Identifier (BAID2) . . 22
9 Information for an authorised medicinal product .23
9.1 Authorised medicinal product — Information overview . 23
9.1.1 General . 23
9.1.2 Medicinal product . 23
9.1.3 Medicinal product name . 23
9.1.4 Header .24
9.1.5 Manufacturer or establishment (organisation) .24
9.1.6 Marketing authorisation .24
9.1.7 Packaged medicinal product.24
9.1.8 Pharmaceutical product .24
9.1.9 Ingredient .24

iii
ISO/DIS 11615:2025(en)
9.1.10 Clinical particulars .24
9.2 Medicinal product .24
9.2.1 General .24
9.2.2 Detailed description of medicinal product information . 25
9.3 Marketing authorisation .31
9.3.1 General .31
9.3.2 Detailed description of marketing authorisation information .32
9.4 Organisation .37
9.4.1 General .37
9.4.2 Detailed description of organisation information .37
9.5 Manufacturer or Establishment (organisation) . 40
9.5.1 General . 40
9.5.2 Detailed description of manufacturer or establishment (organisation)
information . 40
9.6 Packaged medicinal product, including manufactured item and device .41
9.6.1 General .41
9.6.2 Detailed description of packaged medicinal product information .42
9.7 Ingredient, substance and strength .52
9.7.1 General .52
9.7.2 Detailed description of ingredients, substance and strength information .52
9.8 Pharmaceutical product and device . 55
9.8.1 General . 55
9.8.2 Detailed description of pharmaceutical product and device information . 56
9.9 Clinical particulars . 58
9.9.1 General . 58
9.9.2 Detailed description for clinical particulars information .59
10 Identifying characteristics for investigational medicinal products .63
10.1 General . 63
10.2 Primary identifiers . 63
10.3 Investigational medicinal product identifier (IMPID) . 64
10.3.1 General considerations . 64
10.3.2 IMPID code segments . 64
10.4 Investigational medicinal product package identifier (IPCID) . 65
10.4.1 General provisions . 65
10.4.2 Package description code segment . 65
10.5 Investigational medicinal product batch identifier (BAID1) . 65
10.6 Investigational medicinal product batch identifier (BAID2) . 66
11 Information for an investigational medicinal product .66
11.1 General . 66
11.2 Conceptual overview of the information for an investigational medicinal product . 66
11.2.1 General . 66
11.2.2 Investigational medicinal product .67
11.2.3 Investigational medicinal product name .67
11.2.4 Header .67
11.2.5 Manufacturer or Establishment (organisation) .67
11.2.6 Clinical trial authorisation . 68
11.2.7 Investigational packaged medicinal product . 68
11.2.8 Pharmaceutical product . 68
11.2.9 Ingredient . 68
11.2.10 Clinical particulars . 68
11.3 Investigational medicinal product . 68
11.3.1 General . 68
11.3.2 Detailed description of investigational medicinal product information . 69
11.4 Clinical trial authorisation .71
11.4.1 General .71
11.4.2 Detailed description of clinical trial authorisation information .71
11.5 Manufacturer or establishment (organisation) . 73
11.6 Investigational packaged medicinal product . 73

iv
ISO/DIS 11615:2025(en)
11.7 Pharmaceutical product . 73
11.7.1 General . 73
11.7.2 Pharmaceutical product .74
11.7.3 Dosing and route of administration .74
11.8 Ingredient. 75
11.9 Clinical particulars . 75
11.10 PhPID sets . 75
11.11 Device nomenclature . 75
11.12 Device batch identifier. 75
11.13 Physical characteristics . 75
Annex A (normative) Full model — Authorised medicinal products detailed diagram . 76
Annex B (normative) Full model — Investigational medicinal products detailed diagram .77
Annex C (informative) Class name and attribute translations and synonyms for the
identification of medicinal products (IDMP).78
Bibliography .79

v
ISO/DIS 11615:2025(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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).
This third edition cancels and replaces the second edition (ISO 11615:2017), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— Clarifications on the scope of ISO IDMP, including compounding products, veterinary use, and re-use of
components to avoid duplication;
— Adding identifiers and descriptions for manufactured items, differentiating multi-packs, and clarifying
shelf-life attributes;
— Normalizing strength expressions, adding quantity operators, and handling complex compositions;
— Adding attributes for different types of authorizations and linking orphan designations to therapeutic
indications;
— Additional granularity for the identification of investigational medicinal products.
A list of all parts in the ISO IDMP series can be found on the ISO website.
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.

vi
ISO/DIS 11615:2025(en)
Introduction
This document was developed in response to a worldwide demand for internationally harmonised
specifications for medicinal products. It is part of a set of five ISO Standards and four ISO Technical
Specifications which together provide the basis for the unique identification of medicinal products (IDMP).
These sets of standards and technical specifications comprise:
— ISO 11615
— ISO/TS 20443;
— ISO 11616;
— ISO/TS 20451;
— ISO 11238;
— ISO/TS 19844;
— ISO 11239;
— ISO/TS 20440;
— ISO 11240.
These standards and technical specifications for the identification of medicinal products (IDMP) support
the activities of medicines regulatory agencies worldwide by region. These include a variety of regulatory
activities related to development, registration and life cycle management of medicinal products, as well as
pharmacovigilance and risk management.
To meet the primary objectives of the regulation of medicines and pharmacovigilance, it is necessary to
reliably exchange Medicinal Product information in a robust and consistent manner. The IDMP standards
therefore support, at a minimum, the following interactions:
— regulatory medicines authority to regulatory medicines authority;
— pharmaceutical company to regulatory medicines authority;
— sponsor of a clinical trial to regulatory medicines authority;
— regulatory medicines authority to other stakeholders (as applicable);
— regulatory medicines authority to worldwide-maintained data sources.
The necessary messaging specifications are included as an integral non-normative part of the IDMP
standards to secure the interactions above.
Unique identifiers produced in conformance with the IDMP standards are aimed at supporting applications
where it is necessary to reliably identify and trace the use of medicinal products.
There are many terms in use to describe basic concepts in the regulatory, pharmaceutical and healthcare
standards development domain for different purposes and in different contexts. The terms and definitions
given in this document are to be applied for the concepts which are required to uniquely identify, characterise
and exchange regulated medicinal products and associated information.
The terms and definitions adopted in this document are intended to facilitate the interpretation and
application of legal and regulatory requirements.
In the context of exchange of regulatory information, the purpose of this document is twofold:
— to specify data elements, structures and relationships between the data elements which are required to
uniquely and with certainty identify medicinal products for human use;

vii
ISO/DIS 11615:2025(en)
— to specify definitions of terms for all data elements required to uniquely and with certainty identify
medicinal products for human use.
Reference to the use of other normative IDMP and non-normative messaging standards for medicinal
product information is included in this document to support successful information exchange.

viii
DRAFT International Standard ISO/DIS 11615:2025(en)
Health informatics — Identification of medicinal products —
Data elements and structures for the unique identification
and exchange of regulated medicinal product information
1 Scope
This document establishes definitions and concepts and describes data elements and their structural
relationships, which are required for the unique identification and the detailed description of medicinal
products.
Taken together, the standards listed in the Introduction define, characterise and uniquely identify regulated
medicinal products for human use during their entire life cycle, i.e. from development to authorisation, post-
marketing and renewal or withdrawal from the market, where applicable.
Furthermore, to support successful information exchange in relation to the unique identification and
characterisation of medicinal products, the use of other non-normative IDMP messaging standards is
included, which are to be applied in the context of this document.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 639-1, Codes for the representation of names of languages — Part 1: Alpha-2 code
ISO 3166-1:2013, Codes for the representation of names of countries and their subdivisions — Part 1: Country codes
ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates and times
ISO 11238, Health informatics — Identification of medicinal products — Data elements and structures for the
unique identification and exchange of regulated information on substances
ISO 11239, Health informatics — Identification of medicinal products — Data elements and structures for the
unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation,
routes of administration and packaging
ISO 11240, Health informatics — Identification of medicinal products — Data elements and structures for the
unique identification and exchange of units of measurement
ISO 11616, Health informatics — Identification of medicinal products — Data elements and structures for
unique identification and exchange of regulated pharmaceutical product information
ISO/TS 19844, 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
ISO/TS 20440, Health informatics — Identification of medicinal products — Implementation guidelines for
ISO 11239 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/TS 20443, Health informatics — Identification of medicinal products — Implementation guidelines for
ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal
product information
ISO/DIS 11615:2025(en)
ISO/TS 20451, Health informatics — Identification of medicinal products — Implementation guidelines for
ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical
product information
ISO/IEC 5218, Information technology — Codes for the representation of human sexes
3 Terms and definitions
3.1 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
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/
3.1.1
adjuvant
component that potentiates the immune response to an antigen or modulates it towards the desired immune
response
3.1.2
administrable dose form
pharmaceutical dose form for administration to the patient, after any necessary transformation of the
manufactured items (3.1.37) and their corresponding manufactured dose forms (3.1.36) has been carried out
Note 1 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).
Note 2 to entry: Administered dose form and pharmaceutical administrable dose form are synonyms of administrable
dose form.
3.1.3
administration device
equipment intended for correct administration of the medicinal product (3.1.50)
Note 1 to entry: An administration device may be an integral part of an immediate container (3.1.27) or a closure.
[SOURCE: ENV 12610:1997]
3.1.4
allergen
material (3.1.47) of concern used as ingredient (3.1.28) or in a device capable of stimulating a type-I
hypersensitivity or allergic reaction in atopic individuals
3.1.5
authorisation date
date when the authorisation was granted by a medicines regulatory agency (3.1.56) following a specific
regulatory activity
3.1.6
authorisation procedure
formal procedure applied by a medicines regulatory agency (3.1.56) to grant a marketing authorisation
(3.1.40), to amend an existing one, to extend its duration or to revoke it
Note 1 to entry: The terms authorisation procedure and marketing authorisation procedure (3.1.43) are synonymous.

ISO/DIS 11615:2025(en)
3.1.7
authorisation status
phase of the marketing authorisation (3.1.40) during its life cycle
Note 1 to entry: The status indicates a particular moment in its life cycle.
3.1.8
batch
specific quantity of a drug or other material (3.1.47) that is intended to have uniform character and quality,
within specified limits, and is produced according to a single manufacturing order during the same cycle of
manufacture
3.1.9
batch number
identifier (3.1.26) assigned to a specific batch (3.1.8) of a medicinal product (3.1.50) or item resulting from a
manufacturing process at a specific point of time
3.1.10
characteristic
abstraction of a property of an object
3.1.11
clinical trial
investigation in human subjects intended to discover or verify the clinical, pharmacological or other
pharmacodynamic effects of an investigational product(s), or to identify any adverse reactions to an
investigational medicinal product(s) (3.1.31), or to study absorption, distribution, metabolism and excretion
of Investigational medicinal product(s) with the object of ascertaining its safety and/or efficacy
Note 1 to entry: The terms clinical trial and clinical study are synonymous.
3.1.12
clinical trial authorisation
approval given by a medicines regulatory agency (3.1.56) to conduct a clinical trial (3.1.11) in a region (3.1.73)
3.1.13
class
set of objects that share the same specifications of features, constraints, and semantics
3.1.14
combined pharmaceutical dose form
two or more manufactured items (3.1.37) that are intended to be combined in a specific way to produce a
single pharmaceutical product, and that includes information on the manufactured dose form (3.1.36) of each
manufactured item and the administrable dose form (3.1.2) of the pharmaceutical product
3.1.15
common name
official non-proprietary or generic name recommended by the World Health Organisation (WHO), or, if one
does not exist, a non-proprietary name recommended by the region (3.1.73) within which the name is used
Note 1 to entry: Generic name and international non-proprietary name are synonymous of common name.
[SOURCE: WHO 46th Consultation on International Nonproprietary Names (INNs) for pharmaceutical
substances]
3.1.16
container
item of packaging that is part of a medicinal product (3.1.50) and is used for storage, identification or
transport of the components of the medicinal product
3.1.17
contraindication
situations where the medicinal product (3.1.50) shall not be given for safety reasons

ISO/DIS 11615:2025(en)
3.1.18
controlled vocabulary
finite set of values that represent the only allowed values for a data item
Note 1 to entry: The allowed values can be codes, text or numeric.
[SOURCE: CDISC Clinical Research Glossary V10.0, 2016]
3.1.19
datatype
set of distinct values, characterised by properties of those values, and by operations on those values
[SOURCE: ISO 11404:2007, 3.12]
3.1.20
device listing number
number assigned by a medicines regulatory agency (3.1.56) during registration or listing to all devices in
commercial distribution, regardless of pre-market authorisation requirements, per regional registration
and listing requirements
3.1.21
device model number
identifier (3.1.26) assigned by a medical device manufacturer (3.1.38) to a particular design or version of a
medical device (3.1.49)
3.1.22
distributor
organisation in possession of a license covering the procuring, holding, supplying or exporting of medicinal
products (3.1.50), apart from supplying medicinal products to the public
Note 1 to entry: This is applicable to “wholesale distribution of medicinal products”.
3.1.23
dose
specified quantity of a medicine, to be taken at one time or at stated intervals
3.1.24
dose form
physical manifestation of a medicinal product (3.1.50) that contains the active ingredient(s) (3.1.28) or
inactive ingredient(s) that are intended to be delivered to the patient
Note 1 to entry: Dose form, dosage form and pharmaceutical dose form are synonymous. “Pharmaceutical dose form”
can refer to the administrable dose form (3.1.2) or the manufactured dose form (3.1.36).
3.1.25
Global Trade Item Number
GTIN
GS1 unique identifier (3.1.26) of items that are traded [e.g. pharmaceuticals, medical devices (3.1.49)] in the
supply chain
Note 1 to entry: A GTIN is used to identify any item upon which there is a need to retrieve predefined information and
that may be priced, ordered or invoiced at any point in any supply chain. GTINs may be 8, 12, 13 or 14 digits in length.
3.1.26
identifier
description that is sufficient to represent an object in a given environment
Note 1 to entry: In the context of this document, this is a list of identifying characteristics (3.1.10) that together
unamb
...