SIST EN ISO 11616:2018

SLOVENSKI STANDARD
01-april-2018
1DGRPHãþD
SIST EN ISO 11616:2013
Zdravstvena informatika - Identifikacija zdravil - Elementi in zgradba podatkov za
enotno identifikacijo in izmenjavo predpisanih informacij o farmacevtskih izdelkih
(ISO 11616:2017)
Health informatics - Identification of medicinal products - Data elements and structures
for the Unique Identification and Exchange of regulated Pharmaceutical Product
Information (ISO 11616:2017)
Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und -
strukturen zur Identifikation und zum Austausch von pharmazeutischen
Produktkennzeichen (ISO 11616:2017)
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 11616:2017)
Ta slovenski standard je istoveten z: EN ISO 11616:2017
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.

EN ISO 11616
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2017
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes EN ISO 11616:2012
English Version
Health informatics - Identification of medicinal products -
Data elements and structures for the Unique Identification
and Exchange of regulated Pharmaceutical Product
Information (ISO 11616:2017)
Informatique de santé - Identification des médicaments Medizinische Informatik - Identifikation von
- Éléments de données et structures pour Arzneimitteln - Datenelemente und -strukturen zur
l'identification unique et l'échange d'informations Identifikation und zum Austausch von
réglementées sur les produits pharmaceutiques (ISO pharmazeutischen Produktkennzeichen (ISO
11616:2017) 11616:2017)
This European Standard was approved by CEN on 17 November 2017.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11616:2017 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 11616:2017) has been prepared by Technical Committee ISO/TC 215 "Health
informatics" in collaboration with Technical Committee CEN/TC 251 “Health informatics” the
secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by June 2018, and conflicting national standards shall be
withdrawn at the latest by June 2018.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 11616:2012.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11616:2017 has been approved by CEN as EN ISO 11616:2017 without any modification.

INTERNATIONAL ISO
STANDARD 11616
Second edition
2017-10
Health informatics — Identification
of medicinal products — Data
elements and structures for unique
identification and exchange of
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
Reference number
ISO 11616:2017(E)
©
ISO 2017
ISO 11616:2017(E)
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved

ISO 11616:2017(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and abbreviated terms . 2
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
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 .11
6.4 Detailed description diagrams .12
6.4.1 General.12
6.4.2 Relationships between classes .13
6.4.3 Attributes of classes .14
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 .17
7.3 Representation of strength concentration .17
7.4 Pharmaceutical product identifier (PhPID) .18
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 .19
7.5.4 Unit of presentation .19
7.5.5 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 .20
7.6.3 Administrable dose form .20
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 .21
7.7.3 Representation of strength for a patch .23
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
8.2.1 General considerations .25
8.2.2 Multiple products packaged as a kit and administered as separate
Medicinal Products .25
ISO 11616:2017(E)
8.2.3 Multiple products packaged as a kit for reconstitution and administered
as one Medicinal Product .26
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
8.2.6 Representation of PhPID for a patch .27
9 Relationship between IMPID/IPCID and PhPID .27
10 Conceptual model .29
Bibliography .30
iv © ISO 2017 – All rights reserved

ISO 11616:2017(E)
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.
ISO 11616:2017(E)
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.
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) (PhPID) with the following:
— Medicinal Product Identifier(s) (MPIDs);
— Package Component Identifier(s) (PCIDs);
— Investigational Medicinal Product Identifier(s) (IMPIDs);
— Investigational Package Component Identifier(s) (IPCIDs).
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 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 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 the validation of transmitted
information).
vi © ISO 2017 – All rights reserved

ISO 11616:2017(E)
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.
This document has been developed in conjunction with the Common Product Model (CPM) and
Structured Product Labelling (SPL) in HL7.
INTERNATIONAL STANDARD ISO 11616:2017(E)
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 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, 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 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 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 codes
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 11615:2017, 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 — Implementation guidelines
for data elements and structures for the unique identification and exchange of regulated information on
substances
ISO 11616:2017(E)
ISO/TS 20440, Health informatics — Identification of Medicinal Products — Implementation guide 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/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
HL7 Version 3 Standard, Common Clinical Product Model
HL7 Version 3 Standard, Common Product Model CMETS
HL7 Version 3 Standard, Regulated Product Submission
HL7 Version 3 Standard, Structured Product Labelling
3 Terms, definitions and abbreviated terms
3.1 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
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/
3.1.1
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 (3.1.17) and their corresponding manufactured dose forms (3.1.16) 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 (3.1.24)].
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) (3.1.12), and/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.
2 © ISO 2017 – All rights reserved

ISO 11616:2017(E)
3.1.4
controlled vocabulary
finite set of values that represent the only allowed values for a data item
Note 1 to entry: These values may be codes, text, or numeric.
[SOURCE: CDISC Clinical Research Glossary V10, 2016, modified — “These values may be codes, text, or
numeric” has been set as note to entry.]
3.1.5
controlled vocabulary term identifier
concept identifier (3.1.10) 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: This definition is adapted from HL7 Core Principles.
Note 3 to entry: TermID is a synonym of controlled vocabulary term identifier.
3.1.6
designation
symbolic representation of a concept
3.1.7
dose form
physical manifestation of a Medicinal Product (3.1.19) that contains the active ingredient(s) and/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.
Note 2 to entry: “Pharmaceutical dose form” can refer to the administrable dose form (3.1.2) or the manufactured
dose form (3.1.16). The terms pharmaceutical dose and dosage form are synonymous.
3.1.8
globally unique identifier
identifier (3.1.10) that is different from any other such identifier in any domain namespace
3.1.9
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
[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”.]
3.1.10
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 that together
unambiguously identify a Medicinal Product (3.1.19), pharmaceutical product (3.1.24), substance (3.1.35), specified
substance (3.1.32), pharmaceutical dose form (3.1.7) or any other element which requires to be uniquely identified.
[SOURCE: ENV 12610:1998]
3.1.11
investigational code
code assigned by a medicines regulatory agency (3.1.22) to a sponsor’s (3.1.33) 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.
ISO 11616:2017(E)
3.1.12
investigational Medicinal Product
any pharmaceutical product (3.1.24) or combination of pharmaceutical products or placebo(s) 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
3.1.13
investigational Medicinal Product identifier
unique identifier (3.1.10) allocated to an investigational Medicinal Product (3.1.12) supplementary to any
existing identifier as ascribed by a medicines regulatory agency (3.1.22) in a region (3.1.31)/jurisdiction
(3.1.15) or a sponsor (3.1.33) of a clinical trial (3.1.3)
Note 1 to entry: This is an alphanumeric text field.
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 (3.1.19) worldwide.
3.1.14
investigational Medicinal Product package identifier
unique identifier (3.1.10) allocated to an Investigational packaged Medicinal Product (3.1.23) at package
level supplementary to any existing identifier as ascribed by a medicines regulatory agency (3.1.22) in a
region (3.1.31)/jurisdiction (3.1.15) or a sponsor (3.1.33) 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.
3.1.15
jurisdiction
geographical area within a country/region (3.1.31) or subject matter to which the medicines regulatory
agency (3.1.22) applies
3.1.16
manufactured dose form
pharmaceutical dose form (3.1.7) of a manufactured item (3.1.17) as manufactured and, where applicable,
before transformation into the pharmaceutical product (3.1.24)
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).
3.1.17
manufactured item
qualitative and quantitative composition (3.1.27) of a product as contained in the packaging of the
Medicinal Product (3.1.19) as put on the market or investigational Medicinal Product (3.1.12) 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 (3.1.24). 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.
3.1.18
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;
4 © ISO 2017 – All rights reserved

ISO 11616:2017(E)
— 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).
[SOURCE: EC Directive 2007/47 on Medical Devices]
3.1.19
Medicinal Product
any pharmaceutical product (3.1.24) 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 (3.1.17) and
one or more pharmaceutical products. In certain regions (3.1.31), a Medicinal Product may also be defined as any
substance (3.1.35) 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 (3.1.22). However, the provisions do not apply to: i) Medicinal Products prepared according
to prescription (e.g. prepared in a pharmacy from a prescription intended for a specific patient), ii) 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), iii) Medicinal
Products intended for research and development trials, and iv) intermediate products intended for subsequent
processing by an authorised manufacturer.
3.1.20
Medicinal Product identifier
unique identifier (3.1.10) allocated to a Medicinal Product (3.1.19) supplementary to any existing
authorisation number as ascribed by a medicines regulatory agency (3.1.22) in a region (3.1.31)
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.
3.1.21
Medicinal Product package identifier
unique identifier (3.1.10) allocated to a packaged Medicinal Product (3.1.23) supplementary to any
existing authorisation number as ascribed by a medicines regulatory agency (3.1.22) in a region (3.1.31)
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.
3.1.22
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 (3.1.19)
Note 1 to entry: In certain regions (3.1.31), 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.
3.1.23
packaged Medicinal Product
Medicinal Product (3.1.19) in a container being part of a package, representing the entirety that has
been packaged for sale or supply
ISO 11616:2017(E)
3.1.24
pharmaceutical product
qualitative and quantitative composition (3.1.27) of a Medicinal Product (3.1.19) 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 (3.1.17).
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.
3.1.25
pharmaceutical product identifier
unique identifier (3.1.10) for a pharmaceutical product (3.1.24)
3.1.26
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 (3.1.9) working with medicines and
regulatory authorities responsible for monitoring the safety of medicines;
— pharmaceutical companies and companies importing or distributing medicines.
3.1.27
quantitative composition
amount of substance (3.1.35) and specified substance (3.1.32) constituents of the investigational or
authorised Medicinal Product (3.1.19) 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.
6 © ISO 2017 – All rights reserved

ISO 11616:2017(E)
3.1.28
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 (3.1.36). 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.
3.1.29
radiopharmaceutical kit
preparation to be reconstituted or combined with radionuclides in the final radiopharmaceutical,
usually prior to its administration
Note 1 to entry: In the context of a radiopharmaceutical kit, which is to be radio-labelled after supply by the
manufacturer, the active substance (3.1.35)/specified substance (3.1.32) is considered to be that part of the
formulation which is intended to carry or bind the radionuclide.
3.1.30
reference strength
strength of an active substance(s) (3.1.35) and/or specified substance(s) (3.1.32) used as a reference from
which the strength of an investigational or authorised Medicinal Product (3.1.19) 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 (3.1.24) or manufactured item
(3.1.17).
3.1.31
region
area, especially part of a country or the world, having definable characteristics but not always fixed
boundaries
3.1.32
specified substance
substance (3.1.35) defined by groups of elements that describes multi-substance materials or specifies
further information on substances relevant to the description of Medicinal Products (3.1.19)
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 given specified substance and specific relationships between
each group of elements.
3.1.33
sponsor
individual, company, institution or organisation, which takes responsibility for the initiation,
management and/or financing of a clinical trial (3.1.3)
3.1.34
strength range
interval defined by a lower and an upper limit of the amounts of substance (3.1.35) and specified
substance (3.1.32) constituents of the investigational or authorised Medicinal Product (3.1.19)
SIST EN ISO 11616:201
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