oSIST prEN ISO 11616:2026
(Main)Health informatics - Identification of medicinal products - Data elements and structures for unique identification and exchange of regulated pharmaceutical product information (ISO/DIS 11616:2025)
Health informatics - Identification of medicinal products - Data elements and structures for unique identification and exchange of regulated pharmaceutical product information (ISO/DIS 11616:2025)
ISO 11616:2017 is intended to provide specific levels of information relevant to the identification of a Medicinal Product or group of Medicinal Products. It defines the data elements, structures and relationships between data elements that are required for the exchange of regulated information, in order to uniquely identify pharmaceutical products. This identification is to be applied throughout the product lifecycle to support pharmacovigilance, regulatory and other activities worldwide. In addition, ISO 11616:2017 is essential to ensure that pharmaceutical product information is assembled in a structured format with transmission between a diverse set of stakeholders for both regulatory and clinical (e.g. e-prescribing, clinical decision support) purposes. This ensures interoperability and compatibility for both the sender and the recipient.
ISO 11616:2017 is not intended to be a scientific classification for pharmaceutical products. Rather, it is a formal association of particular data elements categorised in prescribed combinations and uniquely identified when levelling degrees of information are incomplete. This allows for Medicinal Products to be unequivocally identified on a global level.
References to other normative IDMP and messaging standards for pharmaceutical product information are included in Clause 2, to be applied in the context of ISO 11616:2017.
Medicinal products for veterinary use are out of scope of ISO 11616:2017.
Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und Strukturen zur eindeutigen Identifikation und zum Austausch von vorgeschriebenen pharmazeutischen Produktkennzeichen (ISO/DIS 11616:2025)
Informatique de santé - Identification des médicaments - Éléments de données et structures pour l'identification unique et l'échange d'informations réglementées sur les produits pharmaceutiques (ISO/DIS 11616:2025)
ISO 11616:2017 vise à fournir des niveaux d'informations spécifiques pertinents pour l'identification d'un médicament ou d'un groupe de médicaments. Elle définit les éléments de données, les structures et les relations entre des éléments de données nécessaires à l'échange d'informations réglementées visant à identifier de façon unique des produits pharmaceutiques. Cette identification est destinée à être appliquée tout au long du cycle de vie du produit afin de soutenir sur le plan mondial les activités réglementaires, de pharmacovigilance et autres. De plus, le présent document est essentiel pour garantir que les informations sur un produit pharmaceutique sont rassemblées dans un format structuré pouvant être transmis entre différentes parties prenantes, à des fins aussi bien réglementaires que cliniques (par exemple, ordonnances électroniques, aide à la décision clinique). Cela permet d'assurer l'interopérabilité et la compatibilité entre émetteur et destinataire.
ISO 11616:2017 n'est pas destiné à constituer une classification scientifique des produits pharmaceutiques. Il s'agit plutôt d'une association formelle d'éléments de données en particulier, catégorisés en combinaisons spécifiées et identifiés de manière unique lorsque les informations d'un niveau parmi une hiérarchie de niveaux sont insuffisantes. Cela permet l'identification des médicaments sans ambiguïté au niveau mondial.
Des références à d'autres normes IDMP et de messagerie relatives aux informations sur les produits pharmaceutiques sont incluses dans l'Article 2, pour application dans le contexte du présent document.
Les médicaments à usage vétérinaire ne relèvent pas du domaine d'application du présent document.
Zdravstvena informatika - Identifikacija zdravil - Elementi in zgradba podatkov za enotno identifikacijo in izmenjavo predpisanih informacij o farmacevtskih izdelkih (ISO/DIS 11616:2025)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2026
Zdravstvena informatika - Identifikacija zdravil - Elementi in zgradba podatkov za
enotno identifikacijo in izmenjavo predpisanih informacij o farmacevtskih izdelkih
(ISO/DIS 11616:2025)
Health informatics - Identification of medicinal products - Data elements and structures
for unique identification and exchange of regulated pharmaceutical product information
(ISO/DIS 11616:2025)
Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und
Strukturen zur eindeutigen Identifikation und zum Austausch von vorgeschriebenen
pharmazeutischen Produktkennzeichen (ISO/DIS 11616:2025)
Informatique de santé - Identification des médicaments - Éléments de données et
structures pour l'identification unique et l'échange d'informations réglementées sur les
produits pharmaceutiques (ISO/DIS 11616:2025)
Ta slovenski standard je istoveten z: prEN ISO 11616
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 11616
ISO/TC 215
Health informatics — Identification
Secretariat: ANSI
of medicinal products — Data
Voting begins on:
elements and structures for unique
2025-11-10
identification and exchange of
Voting terminates on:
regulated pharmaceutical product
2026-02-02
information
Informatique de santé — Identification des médicaments —
Éléments de données et structures pour l'identification unique
et l'échange d'informations réglementées sur les produits
pharmaceutiques
ICS: 35.240.80
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
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BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
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POTENTIAL TO BECOME STANDARDS TO
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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 11616:2025(en)
DRAFT
ISO/DIS 11616:2025(en)
International
Standard
ISO/DIS 11616
ISO/TC 215
Health informatics — Identification
Secretariat: ANSI
of medicinal products — Data
Voting begins on:
elements and structures for unique
identification and exchange of
Voting terminates on:
regulated pharmaceutical product
information
Informatique de santé — Identification des médicaments —
Éléments de données et structures pour l'identification unique
et l'échange d'informations réglementées sur les produits
pharmaceutiques
ICS: 35.240.80
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 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
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BE CONSIDERED IN THE LIGHT OF THEIR
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POTENTIAL TO BECOME STANDARDS TO
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NATIONAL REGULATIONS.
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Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 11616:2025(en)
ii
ISO/DIS 11616:2025(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
3.1 Terms and definitions .2
3.2 Abbreviated terms .8
4 Conformance terminology and context as it relates to the ISO IDMP standards and
corresponding IDMP technical specifications . 9
5 Requirements . 9
5.1 Elements required for the unique identification of pharmaceutical products .9
5.2 Exchange of pharmaceutical product information .10
5.3 Requirements to facilitate global implementation.10
6 Description of the information modelling principles and practices .10
6.1 General considerations.10
6.2 Conceptual overview diagrams .11
6.3 High-level diagrams . 12
6.4 Detailed description diagrams . . 12
6.4.1 General . 12
6.4.2 Relationships between classes . 13
6.4.3 Attributes of classes . 13
6.4.4 Generalised classes and patterns .14
6.4.5 Translation and language .14
7 Identifying characteristics for the identification of pharmaceutical products . 14
7.1 Pharmaceutical product identification strata and levels .14
7.1.1 General .14
7.1.2 PhPID specified substance . 15
7.1.3 Pharmaceutical product specified substance identification (PhPID SpSub) .16
7.2 Cardinality.16
7.3 Representation of strength concentration .17
7.4 Pharmaceutical product identifier (PhPID) .17
7.5 Pharmaceutical product substance stratum elements (PhPID_SUB_Lx) .18
7.5.1 Construct of the pharmaceutical product substance stratum .18
7.5.2 Substance set .18
7.5.3 Administrable dose form .18
7.5.4 Unit of presentation .18
7.5.5 Adjuvant .18
7.5.6 Medical device .19
7.6 Pharmaceutical product specified substance stratum elements (PhPID_SpSUB_Lx) .19
7.6.1 Construct of the pharmaceutical product specified substance stratum .19
7.6.2 Specified substance set.19
7.6.3 Administrable dose form .19
7.6.4 Unit of presentation . 20
7.6.5 Medical device . 20
7.7 Identifying characteristics to express strength . 20
7.7.1 Expressing strength . 20
7.7.2 Attributes for representation of strength in PhPID stratum elements . 20
7.7.3 Representation of strength (delivery rate over time) . 22
8 Relationship between MPID/PCID and PhPID .23
8.1 Concepts required for the unique identification of a Medicinal Product and the
association with PhPIDs . 23
8.2 Pharmaceutical product identification criteria . 25
iii
ISO/DIS 11616:2025(en)
8.2.1 General considerations . 25
8.2.2 Multiple products packaged as a kit and administered as separate Medicinal
Products . 25
8.2.3 Multiple products packaged as a kit for reconstitution and administered as one
Medicinal Product . 25
8.2.4 Components of kits which are not packaged together (e.g. radiopharmaceutical
kits) . 26
8.2.5 Different representations of strength in two or more regions for identical
products . 26
9 Relationship between IMPID/IPCID and PhPID .26
10 Conceptual model . .28
Annex A (normative) Requirements to facilitate global implementation .29
Bibliography .40
iv
ISO/DIS 11616:2025(en)
Foreword
ISO (the International Organization for Standardisation) 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 organisations,
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 standardisation.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent
rights identified during the development of the document will be in the Introduction and/or on the ISO list of
patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the 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 the following URL:
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics.
This second edition cancels and replaces the first edition (ISO 11616:2012), which has been technically
revised.
v
ISO/DIS 11616:2025(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/TS 20451;
— ISO 11238;
— ISO/TS 19844;
— ISO 11239;
— ISO/TS 20440;
— ISO 11240; and
— this document.
The purpose of this document is to present data elements, structures and their relationships in order to
uniquely identify and exchange regulated pharmaceutical product information. This document provides
an accurate and consistent mechanism to fully represent the relationship of pharmaceutical product
identifier(s) (3.1.26) with the following:
— Medicinal Product Identifier(s) (3.1.21);
— Package Component Identifier(s);
— Investigational Medicinal Product Identifier(s) (3.1.14);
— Investigational Package Component Identifier(s).
These standards and technical specifications for the identification of medicinal products 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, risk management, prescription, dispensation and monitoring/management of shortages.
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 specifications for data exchange mechanisms are included as an integral part of the IDMP
standards to secure the interactions above. This is critical to describing and protecting the integrity of the
interactions listed above for the submission of regulated Medicinal Product information in the context of
unique product identification and acknowledgement of receipt (which includes a validation of transmitted
information).
vi
ISO/DIS 11616:2025(en)
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 but they are without prejudice to any legally binding
document. In case of doubt or potential conflict, the terms and definitions contained in legally binding
documents prevail.
vii
DRAFT International Standard ISO/DIS 11616:2025(en)
Health informatics — Identification of medicinal products —
Data elements and structures for unique identification and
exchange of regulated pharmaceutical product information
1 Scope
This document is intended to provide specific levels of information relevant to the identification of a
Pharmaceutical Product or groups of Pharmaceutical Products. It defines the data elements, structures and
relationships between data elements that are required for the exchange of regulated information, in order
to uniquely identify pharmaceutical products. This identification is to be applied throughout the product
lifecycle to support pharmacovigilance, regulatory and other activities worldwide. In addition, this document
is essential to ensure that pharmaceutical product information is assembled in a structured format with
transmission between a diverse set of stakeholders for both regulatory and clinical (e.g. e-prescribing,
clinical decision support) purposes. This ensures interoperability and compatibility for both the sender and
the recipient.
This document is not intended to be a scientific classification for pharmaceutical products. Rather, it is
a formal association of particular data elements categorised in prescribed combinations and uniquely
identified when levelling degrees of information are incomplete. This allows for Pharmaceutical Products to
be unequivocally identified on a global level.
References to other normative IDMP standards and specifications for data exchange mechanisms for
pharmaceutical product information are included in Clause 2, to be applied in the context of this document.
Medicinal products for veterinary use are out of scope 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 3166-1, Codes for the representation of names of countries and their subdivisions — Part 1: Country code
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 11615, Health informatics — Identification of medicinal products — Data elements and structures for the
unique identification and exchange of regulated medicinal 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/DIS 11616:2025(en)
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/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
3 Terms and definitions
ISO and IEC maintain terminological databases for use in standardisation at the following addresses:
— ISO Online browsing platform: available at http:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1 Terms and definitions
3.1.1
adjuvant
component that potentiates the immune response to an antigen and/or modulates it towards the desired
immune response
3.1.2
administrable dose form
pharmaceutical dose form (3.1.7) for administration to the patient, after any necessary transformation of the
manufactured items (3.1.18) and their corresponding manufactured dose forms (3.1.17) 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 (3.1.25)].
Note 2 to entry: Administered dose form and pharmaceutical administrable dose form are synonyms of administrable
dose form.
3.1.3
clinical trial
any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or
other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions
to an investigational Medicinal Product(s) (3.1.13), and/or to study absorption, distribution, metabolism and
excretion of investigational Medicinal Product(s) (3.1.13) with the object of ascertaining its safety and/or
efficacy
Note 1 to entry: The terms clinical trial and clinical study are synonymous.
3.1.4
controlled vocabulary
finite set of predetermined values that constitute the exclusive permissible options for a given data item
Note 1 to entry: These values may be codes, text, or numeric.
3.1.5
controlled vocabulary term identifier
concept identifier (3.1.11) intended to be used as the preferred unique identifier for that concept in that code
system and which is published by the author of a code system
Note 1 to entry: The TermID remains constant over time, independent of the particular version of the knowledge
resource.
Note 2 to entry: TermID is a synonym of controlled vocabulary term identifier.
ISO/DIS 11616:2025(en)
3.1.6
designation
symbolic representation of a concept
3.1.7
dose form
physical manifestation of a Medicinal Product (3.1.20) that contains the active ingredient(s) and/or inactive
ingredient(s) that are intended to be delivered to the patient
EXAMPLE Examples of dose forms are: powder for solution for injection (manufactured dose form), solution for
injection (can be both manufactured dose form or administrable dose form), tablet (is both manufactured dose form
and administrable dose form).
Note 1 to entry: Dose form, dosage form and pharmaceutical dose form are synonymous.
Note 2 to entry: “Pharmaceutical dose form” can refer to the administrable dose form (3.1.2) or the manufactured dose
form (3.1.17). The terms pharmaceutical dose and dosage form are synonymous.
3.1.8
globally unique identifier
identifier (3.1.11) that is different from any other such identifier in any domain namespace
3.1.9
global
not considering borders or geographic boundaries
3.1.10
healthcare professional
person entrusted with the direct or indirect provision of defined healthcare services to a subject of care or
a population of subjects of care
[1]
[SOURCE: ENV 1613:1995 , 3.13, modified — “who is” has been removed and “subject or population of
subjects” has been replaced by “subject of care or a population of subjects of care”.]
3.1.11
identifier
description that is sufficient to represent an object in a given environment
Note 1 to entry: In the realm of medicinal products, an identifier consists of a set of identifying characteristics that,
when combined, unambiguously distinguish a medicinal product, pharmaceutical product, substance, specified
substance, route of administration, pharmaceutical dose form, or any other element necessitating unique recognition.
3.1.12
investigational code
code assigned by a m (3.1.23)edicines regulatory agency to a sponsor’s (3.1.36) investigational new drug
application prior to the initiation of a clinical trial (3.1.3)
Note 1 to entry: Sponsor code is a synonym of investigational code.
3.1.13
investigational Medicinal Product
any pharmaceutical product (3.1.25) or combination of pharmaceutical products or placebo(s) (3.1.28)
being tested or used as a reference in a clinical trial (3.1.3), including products already with a marketing
authorisation but used or assembled (packaged) in a way different from the authorised form, used for an
unauthorised indication, or used to gain further information about the authorised form
3.1.14
investigational Medicinal Product identifier
unique identifier (3.1.11) allocated to an investigational Medicinal Product (3.1.13) supplementary to any
existing identifier as ascribed by a medicines regulatory agency (3.1.23) in a region (3.1.34) /jurisdiction
(3.1.16) or a sponsor (3.1.36) of a clinical trial (3.1.3)
Note 1 to entry: This is an alphanumeric text field.
ISO/DIS 11616:2025(en)
Note 2 to entry: This is for indexing purposes and to contribute to improving patient safety by allowing for the unique
identification of Medicinal Products (3.1.20) worldwide.
3.1.15
investigational Medicinal Product package identifier
unique identifier (3.1.11) allocated to an Investigational packaged Medicinal Product (3.1.24) at package level
supplementary to any existing identifier as ascribed by a medicines regulatory agency (3.1.23) in a region
(3.1.34)/jurisdiction (3.1.16) or a sponsor (3.1.36) of a clinical trial (3.1.3)
Note 1 to entry: This is for indexing purposes and to contribute to improving patient safety by allowing for the unique
identification of Medicinal Products worldwide.
3.1.16
jurisdiction
geographical area within a country/region (3.1.34) or subject matter to which the medicines regulatory
agency (3.1.23) applies
3.1.17
manufactured dose form
pharmaceutical dose form (3.1.7) of a manufactured item (3.1.18) as manufactured and, where applicable,
before transformation into the pharmaceutical product (3.1.25)
EXAMPLE An example where the manufactured dose form differs from the administrable dose form is a powder
for solution for injection, in which case the administrable dose form will be solution for injection. An example where
the manufactured dose form is the same as the administrable dose form is a tablet.
Note 1 to entry: The manufactured dose form is identical to the administrable dose form (3.1.2) in cases where no
transformation of the manufactured item is necessary (i.e. where the manufactured item is equal to the pharmaceutical
product).
3.1.18
manufactured item
qualitative and quantitative composition (3.1.29) of a product as contained in the packaging of the Medicinal
Product (3.1.20) as put on the market or investigational Medicinal Product (3.1.13) as used in a clinical trial (3.1.3)
Note 1 to entry: A Medicinal Product may contain one or more manufactured items. In many instances, the manufactured
item is equal to the pharmaceutical product (3.1.25). However, there are instances where the manufactured item(s)
undergo a transformation before being administered to the patient (as the pharmaceutical product) and the two are
not equal.
3.1.19
medical device
any instrument, apparatus, appliance, software, material or other article, whether used alone or in
combination, including the software intended by its manufacturer to be used specifically for diagnostic and/
or therapeutic 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 handicap;
— 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: This definition is applicable for the purposes of this and related standards alone (ISO 11238, ISO 11239,
ISO 11240, ISO 11615 and this document).
[2]
[SOURCE: EC Directive 2007/47 on Medical Devices , https:// eur -lex .europa .eu/ LexUriServ/ LexUriServ .do
?uri = OJ: L: 2007: 247: 0021: 0055: en: PDF]
ISO/DIS 11616:2025(en)
3.1.20
Medicinal Product
any pharmaceutical product (3.1.25) or combination of pharmaceutical products that may be administered
to human beings (or animals) for treating or preventing disease, with the aim/purpose of making a medical
diagnosis or to restore, correct or modify physiological functions
Note 1 to entry: A Medicinal Product may contain in the packaging one or more manufactured items (3.1.18) and
one or more pharmaceutical products. In certain regions (3.1.34), a Medicinal Product may also be defined as any
substance (3.1.38) or combination of substances which may be used to make a medical diagnosis. The provisions in
this document apply to proprietary Medicinal Products for human use intended to be placed on the market and to
industrially manufactured Medicinal Products, the marketing of which has been authorised by a medicines regulatory
agency (3.1.23). However, the provisions do not apply to:
a) Medicinal Products prepared according to prescription (e.g. prepared in a pharmacy from a prescription intended
for a specific patient),
b) Medicinal Products prepared in accordance with an official formula (e.g. prepared in a pharmacy in accordance
with the instructions in a pharmacopoeia and intended to be given direct to the patient by the pharmacy),
c) Medicinal Products intended for research and development trials, and
d) intermediate products intended for subsequent processing by an authorised manufacturer.
3.1.21
Medicinal Product identifier
unique identifier (3.1.11) allocated to a Medicinal Product (3.1.20) supplementary to any existing authorisation
number as ascribed by a medicines regulatory agency (3.1.23) in a region (3.1.34)
Note 1 to entry: This is an alphanumeric text field.
Note 2 to entry: This is for indexing purposes and to contribute to improved patient safety by allowing for the unique
identification of Medicinal Products worldwide.
3.1.22
Medicinal Product package identifier
unique identifier (3.1.11) allocated to a packaged Medicinal Product (3.1.24) supplementary to any existing
authorisation number as ascribed by a medicines regulatory agency (3.1.23) in a region (3.1.34)
Note 1 to entry: This is for indexing purposes and to contribute to improving patient safety by allowing for the unique
identification of Medicinal Products worldwide.
3.1.23
medicines regulatory agency
institutional body that, according to the legal system under which it has been established, is responsible
for the granting of marketing authorisations, clinical trial (3.1.3) authorisations and manufacturing
authorisations for Medicinal Products (3.1.20)
Note 1 to entry: In certain regions (3.1.34), the role of the institutional body which according to the legal system
grants the marketing authorisation of Medicinal Products may be complemented by an additional institutional
body responsible for the evaluation and supervision of Medicinal Products. For example, in the EU, the European
Commission is the institutional body that grants the marketing authorisation of Medicinal Products and the European
Medicines Agency is the body responsible for the evaluation and supervision of Medicinal Products.
3.1.24
packaged Medicinal Product
Medicinal Product (3.1.20) in a container being part of a package, representing the entirety that has been
packaged for sale or supply
ISO/DIS 11616:2025(en)
3.1.25
pharmaceutical product
qualitative and quantitative composition (3.1.29) of a Medicinal Product (3.1.20) in the dose form (3.1.7)
approved for administration
Note 1 to entry: In many instances, the pharmaceutical product is equal to the manufactured item (3.1.18). However,
there are instances where the manufactured item must undergo a transformation before being administered to the
patient (as the pharmaceutical product) and the two are not equal.
3.1.26
pharmaceutical product identifier
unique identifier (3.1.11) for a pharmaceutical product (3.1.25)
3.1.27
pharmacovigilance
process and science of monitoring the safety of medicines and taking action to reduce the risks and increase
the benefits of medicines
Note 1 to entry: Pharmacovigilance is a key public health function which comprises:
— collecting and managing data on the safety of medicines;
— looking at the data to detect “signals” (any new or changing safety issue);
— evaluating the data and making decisions with regard to safety issues;
— acting to protect public health (including regulatory action);
— communicating with stakeholders;
— auditing of both the outcomes of action taken and the key processes involved.
Note 2 to entry: Those directly involved in pharmacovigilance include:
— patients as the users of medicines;
— doctors, pharmacists, nurses and all other healthcare professionals (3.1.10) working with medicines and regulatory
authorities responsible for monitoring the safety of medicines;
— pharmaceutical companies and companies importing or distributing medicines.
3.1.28
placebo
substance or combination of substances without intended pharmacological effect on the health condition
Note 1 to entry: Placebo is not an active substance (substance of physiological or pharmacological action,
ISO 19609-2:2021, 3.1).
Note 2 to entry: Having no effect on the health condition, placebo is often used as control substance in controlled
clinical trials. It may, however, also be used as inactive substance in a sequential therapy, e.g. contraceptives, where
active hormonal substance is administered during a defined period of time followed by placebo during a period when
the pharmacological effect of the active hormonal substance is not desired. It may also be used as a single “treatment”
when the patient gets a prescription but cannot be subject to pharmacological effect.
3.1.29
quantitative composition
amount of substance (3.1.38) and specified substance (3.1.35) constituents of the investigational or authorised
Medicinal Product (3.1.20) expressed in a ratio scale
Note 1 to entry: It is necessary for the quantitative composition of the substance(s) or the specified substance
descriptions of the finished investigational or authorised Medicinal Products (depending on the pharmaceutical form
concerned) to specify the mass, or the number of units of biological activity, either per dosage unit or per unit of mass
or volume, of each substance or specified substance. Substance or specified substance descriptions present in the form
of compounds or derivatives are always designated quantitatively by their total mass and, if necessary or relevant, by
the mass of active entity, or entities, of the molecule. The term strength is a synonym of quantitative composition.
ISO/DIS 11616:2025(en)
3.1.30
quantity value
value of a quantity number and unit (reference), together expressing magnitude of a quantity
Note 1 to entry: A quantity value expresses the magnitude of a quantity. This expression consists of a numerical value
together with a unit of measurement (3.1.39). The unit of measurement represents a quantitative scale of reference
that relates the measured (or estimated) quantity value to one or more reference quantity values. The numerical
value is the result of comparing the measured quantity to this reference scale. The word “magnitude” is not defined
in ISO/IEC Guide 99. However, this definition of quantity value indicates that “magnitude” is expressed as a quantity
value, i.e. a quantity value is an expression of a magnitude and the same magnitude might be expressed in many
quantity values. A reference can be a unit of measurement, a measurement procedure, a reference material, or a
combination of such.
3.1.31
radiopharmaceutical
medicinal product (3.1.20) containing a radioactive isotope
3.1.32
radiopharmaceutical kit
preparation to be reconstituted or combined with radionuclides in the final radiopharmaceutical, usually
prior to its administration
3.1.33
reference strength
strength of an active substance(s) (3.1.38) and/or specified substance(s) (3.1.35) used as a reference from
which the strength of an investigational or authorised Medicinal Product (3.1.20) is described
Note 1 to entry: The strength of the active substance(s) and/or specified substance(s) shall be described as a quantity
of the substance present in a given unit of the pharmaceutical product (3.1.25) or manufactured item (3.1.18).
3.1.34
region
area, especially part of a country or the world, having definable characteristics but not always fixed
boundaries
3.1.35
specified substance
substance (3.1.38) defined by groups of elements that describes multi-substance materials or specifies
further information on substances relevant to the description of Medicinal Products (3.1.20)
Note 1 to entry: This could include grade, units of measure, physical form, constituents, manufacturer, critical
manufacturing processes (e.g. extraction, synthetic or recombinant processes), specification and the analytical
methods used to determine whether a substance is in compliance with a specification. There are four different groups
of elements that can be used to define a gi
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