EN ISO 11616:2012

SLOVENSKI STANDARD
01-februar-2013
Zdravstvena informatika - Identifikacija medicinskih izdelkov - Elementi in zgradba
podatkov za enotno identifikacijo in izmenjavo predpisanih informacij o
farmacevtskih izdelkih (ISO 11616:2012)
Health informatics - Identification of medicinal products - Data elements and structures
for the unique identification and exchange of regulated pharmaceutical product
information (ISO 11616:2012)
Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und -
strukturen zur Identifikation und zum Austausch von pharmazeutischen
produktkennzeichen (ISO 11616:2012)
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 11616:2012)
Ta slovenski standard je istoveten z: EN ISO 11616:2012
ICS:
11.020 0HGLFLQVNHYHGHLQ Medical sciences and health
]GUDYVWYHQRYDUVWYHQL care facilities in general
SULSRPRþNLQDVSORãQR
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.

EUROPEAN STANDARD
EN ISO 11616
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2012
ICS 35.240.80
English Version
Health informatics - Identification of medicinal products - Data
elements and structures for the unique identification and
exchange of regulated pharmaceutical product information (ISO
11616:2012)
Informatique de santé - Identification des médicaments - Medizinische Informatik - Identifikation von Arzneimitteln -
Éléments de données et structures pour l'identification Datenelemente und -strukturen zur Identifikation und zum
unique et l'échange d'informations réglementées sur les Austausch von pharmazeutischen Produktkennzeichen
produits pharmaceutiques (ISO 11616:2012) (ISO 11616:2012)
This European Standard was approved by CEN on 24 May 2012.

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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11616:2012: E
worldwide for CEN national Members.

Contents Page
Foreword .3

Foreword
This document (EN ISO 11616:2012) 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 May 2013, and conflicting national standards shall be withdrawn at the
latest by May 2013.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
According to the CEN/CENELEC Internal Regulations, the national standards organisations 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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11616:2012 has been approved by CEN as a EN ISO 11616:2012 without any modification.

INTERNATIONAL ISO
STANDARD 11616
First edition
2012-11-01
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 11616:2012(E)
©
ISO 2012
ISO 11616:2012(E)
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2012 – All rights reserved

ISO 11616:2012(E)
Contents Page
Foreword .iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and abbreviations . 2
3.1 Terms and definitions . 2
3.2 Abbreviations . 7
4 Requirements . 8
4.1 Elements required for the unique identification of pharmaceutical products . 8
4.2 Exchange of pharmaceutical product information . 9
5 Identifying characteristics for the identification of pharmaceutical products . 9
5.1 Pharmaceutical product identification strata and levels . 9
5.2 Cardinality . 11
5.3 Representation of strength concentration .12
5.4 Pharmaceutical product identifier (PhPID) .12
5.5 Pharmaceutical product substance stratum elements (PhPID_SUB_Lx) .13
5.6 Pharmaceutical Product Specified Substance Stratum Elements (PhPID_SpSUB_Lx) .15
5.7 Identifying characteristics to express strength .17
6 Relationship between MPID and PhPID .19
6.1 Concepts required for the unique identification of a medicinal product and the association
with PhPIDs .19
6.2 Pharmaceutical product identification criteria .21
7 Relationship between IMPID and PhPID .23
8 Conceptual model .25
Annex A (informative) Examples .27
Annex B (informative) Tabled examples .35
Bibliography .38
ISO 11616:2012(E)
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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 11616 was prepared by Technical Committee ISO/TC 215, Health informatics.
iv © ISO 2012 – All rights reserved

ISO 11616:2012(E)
Introduction
This International Standard was developed in response to a worldwide demand for internationally harmonized
specifications for medicinal products. It is one of five standards which together provide the basis for the unique
identification of medicinal products. The group of standards comprises:
ISO 11615, Health informatics — Identification of medicinal products — Data elements and structures for the
unique identification and exchange of regulated medicinal product information;
ISO 11616, Health informatics — Identification of medicinal products — Data elements and structures for the
unique identification and exchange of regulated pharmaceutical product information;
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.
The purpose of this International Standard is to present data elements, structures and their relationships in
order to uniquely identify and exchange regulated pharmaceutical product information. This International
Standard 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);
— Investigational Medicinal Product Identifier(s) (IMPIDs).
These standards for the Identification of Medicinal Products (IDMP) support the activities of medicines
regulatory agencies worldwide by jurisdiction. 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 reliable manner. The IDMP standards therefore support
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.
Unique identifiers produced in conformance with the IDMP standards are intended to support applications
where it is necessary to reliably identify and trace the use of medicinal and pharmaceutical products.
Messaging specifications are included as an integral part of the IDMP standards. 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).
There are many terms in use to describe basic concepts in the regulatory and pharmaceutical standards
development domain for different purposes and in different contexts. The terms and definitions described in
this International Standard are to be applied for the concepts required to uniquely identify, characterize and
exchange regulated medicinal products and associated information.
ISO 11616:2012(E)
The terms and definitions adopted in this International Standard 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 International Standard has been developed in conjunction with the Common Product Model in HL7. It is
anticipated that implementation will use HL7 V3 messaging to transmit information between stakeholders.
vi © ISO 2012 – All rights reserved

INTERNATIONAL STANDARD ISO 11616:2012(E)
Health informatics — Identification of medicinal products —
Data elements and structures for unique identification and
exchange of regulated pharmaceutical product information
1 Scope
This International Standard 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 International Standard is essential
to ensuring that pharmaceutical product information is assembled in a structured format with transmission
between a diverse set of stakeholders. This ensures interoperability and compatibility for both the sender and
the recipient.
This International Standard is not intended to be a scientific classification for pharmaceutical products. Rather,
it is a formal association of particular data elements categorized in prescribed combinations and uniquely
identified when levelling degrees of information are incomplete. This allows for medicinal products to be
unequivocally identified.
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 International Standard.
Medicinal products for veterinary use are out of scope of this International Standard.
2 Normative references
The following referenced documents are indispensable for the application 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 11615, Health informatics — Identification of medicinal products — Data elements and structures for the
unique identification and exchange of regulated medicinal product information
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
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 Labeling
ISO 11616:2012(E)
3 Terms, definitions and abbreviations
3.1 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1.1
administrable dose form
pharmaceutical dose form as administered to the patient, after any necessary transformation of the packaged
pharmaceutical dose form has been carried out
EXAMPLES Solution for injection, tablet for oral use, hard-capsule powder for inhalation.
3.1.2
adverse drug reaction
noxious and unintended response associated with the use of a drug in humans
NOTE 1 This can be post-approval (an adverse event that occurs at doses normally used in man for prophylaxis,
diagnosis, or therapy of diseases or for modification of physiological function) or pre-approval (an adverse event that
occurs at any dose and where a causal relationship is at least a reasonable possibility).
NOTE 2 FDA 21 CFR 310.305 defines an adverse drug experience to include any adverse event, “whether or not
considered to be drug-related.” CDISC recognizes that current usage incorporates the concept of causality.
NOTE 3 Adapted from WHO Technical Report 498(1972); ICH E2A.
3.1.3
clinical trial
research investigation involving human subjects that is designed to answer specific questions about the
safety and efficacy of a biomedical intervention (drug, treatment, device) or new ways of using a known drug,
treatment, or device
[ICH E6 Glossary, Directive 2001/20/EC:2002, Version: 1-2009/04/19]
3.1.4
clinical trial registration number
registration number (identifier for tracking purposes) for a clinical trial as assigned by the Regulatory
Medicines Authority
3.1.5
code value
result of applying a coding scheme to an element within a coded set
NOTE Adapted from ISO/IEC 2382-4:1999.
3.1.6
coding scheme
collection of rules that maps the elements of one set onto the elements of a second set
NOTE 1 The coding scheme applied in this International Standard refers to the following standards:
— ISO 11615, Health informatics — Identification of medicinal products — Data elements and structures for the unique
identification and exchange of regulated medicinal product information;
— 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.
2 © ISO 2012 – All rights reserved

ISO 11616:2012(E)
NOTE 2 Adapted from ISO/IEC 2382-4:1999.
3.1.7
controlled vocabulary
finite set of values that represent the only allowed values for a data item
NOTE These values may be codes, text, or numeric.
[CDISC Clinical Research Glossary V8.0, 2009]
3.1.8
TermID
controlled vocabulary term identifier
concept identifier 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 The TermID remains constant over time, independent of the particular version of the knowledge resource.
NOTE 2 Adapted from HL7 Core Principles.
3.1.9
designation
symbolic representation of a concept
NOTE Adapted from ISO 1087-1:2000.
3.1.10
dose form
pharmaceutical dose form
physical manifestation of a product that contains the active ingredient(s) and/or inactive ingredient(s) that are
intended to be delivered to the patient
NOTE Pharmaceutical dose form may refer to the administered dose form or the packaged dose form, depending on
the product it is describing.
3.1.11
globally unique identifier
identifier that is different from any other such identifier in any domain namespace
3.1.12
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
EXAMPLES Qualified medical practitioner, pharmacist, nurse, social worker, radiographer, medical secretary or clerk.
[ENV 1613:1995]
3.1.13
identifier
description that is sufficient to differentiate objects in a given environment
[ENV 12610]
NOTE In the context of this International Standard, this is a list of identifying characteristics that together unambiguously
identify a medicinal product, pharmaceutical product, substance, detailed substance description, excipient, route of
administration, dose form and any other element that requires to be uniquely identified.
3.1.14
investigational code
sponsor code
code assigned by a regulatory authority to a sponsor’s investigational new drug application prior to the initiation
of a clinical trial
ISO 11616:2012(E)
3.1.15
investigational medicinal product
pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial,
including products already with a marketing authorization but used or assembled (formulated or packaged) in
a way different from the authorized form, or when used for an unauthorized indication, or when used to gain
further information about the authorized form
3.1.16
jurisdiction
geographical area or subject matter to which the pharmaceutical legislative authority applies
3.1.17
manufactured dose form
pharmaceutical dose form as presented in the packaging by the manufacturer, before any necessary
transformation has been carried out to yield the administered dose form
EXAMPLE Powder for solution for injection.
NOTE In many instances, there is no transformation necessary and the manufactured dose form is equal to the
administered dose form.
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;
— 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
[EC Directive 2007/47 on Medical Devices]
NOTE This definition is applicable for the purposes of this and related standards alone (ISO 11238, ISO 11239,
ISO 11240, ISO 11615 and this International Standard).
3.1.19
medicinal product
any substance or combination of substances, which may be administered to human beings for treating or preventing
disease with the view to making a medical diagnosis or to restore, correct or modify physiological functions
[ENV 13607, ENV 12610]
NOTE 1 A medicinal product may contain one or more manufactured items and one or more pharmaceutical products.
NOTE 2 In certain jurisdictions, a medicinal product may also be defined as any substance or combination of substances
that may be used to make a medical diagnosis.
3.1.20
pharmaceutical product
qualitative and quantitative composition of a medicinal product in the dose form authorized for administration
by a regulatory authority, and as represented with any corresponding regulated product information
NOTE 1 A medicinal product may contain one or more pharmaceutical products.
NOTE 2 In many instances, the pharmaceutical product is equal to the manufactured item. However, there are instances
where the manufactured item undergoes a transformation before being administered to the patient (as the pharmaceutical
product) and the two are not equal.
4 © ISO 2012 – All rights reserved

ISO 11616:2012(E)
3.1.21
packaged pharmaceutical product
qualitative and quantitative composition of the pharmaceutical product as contained in the package of the
medicinal product
NOTE In many instances the packaged pharmaceutical medicinal product will be equal to the medicinal product.
However, there are instances where, for example, the packaged pharmaceutical product(s) must be reconstituted before
it can be administered to the patient (powder and solvent for solution for injection).
EXAMPLE Each vial of Fabrazyme contains a nominal value of 35 mg of agalsidase beta (packaged pharmaceutical
product). After reconstitution with 7,2 ml of water for injections, each vial of Fabrazyme contains 5 mg/ml (35 mg/7 ml) of
agalsidase beta (pharmaceutical product after reconstitution).
3.1.22
PHPID
pharmaceutical product identifier
globally unique identifier assigned to the pharmaceutical product(s)
3.1.23
pharmacovigilance
the process and science of monitoring the safety of medicines and taking action to reduce risks and increase
benefits from medicines
NOTE 1 It is a key public health function.
EXAMPLE Pharmacovigilance includes:
— collecting and managing data on the safety of medicines;
— looking at the data to detect “signals” (any new or changing safety issue) and evaluating the data and making decisions
with regard to safety issues;
— acting to protect public health (including regulatory action) and communicating with stakeholders;
— auditing, both of the outcomes of action taken and of the key processes involved.
NOTE 2 Those directly involved in pharmacovigilance include:
— patients as the users of medicines;
— doctors, pharmacists, nurses and all other healthcare professionals working with medicines and regulatory authorities
responsible for monitoring the safety of medicines;
— pharmaceutical companies and companies importing or distributing medicines.
3.1.24
quantity value
value of a quantity number and unit (reference), together expressing magnitude of a quantity
NOTE 1 A quantity value expresses the magnitude of a quantity. This expression consists of a numerical value together
with a unit of measurement. 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.
NOTE 2 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.
NOTE 3 A reference can be a unit of measurement, a measurement procedure, a reference material, or a
combination of such.
ISO 11616:2012(E)
3.1.25
radiopharmaceutical kit
preparation to be reconstituted or combined with radionuclides in the final radiopharmaceutical, usually prior
to its administration
NOTE In the context of a radiopharmaceutical kit, which is to be radio-labelled after supply by the manufacturer, the
active substance/specified substance is considered to be that part of the formulation which is intended to carry or bind the
radio-nuclide.
3.1.26
reference strength
substance(s) and/or specified substance(s) used as a reference to form the basis of strength of an investigational
or authorized medicinal product
NOTE The reference strength refers to the strengths of the base, in case the strength of the substance is expressed
as the salt or water for hydration.
3.1.27
specified substance
group of elements that describe multiple substance materials and specify further information on substances
and multi-substance materials relevant to the description of medicinal products
NOTE 1 This could include grade, units of measure, physical form, constituents, manufacturer, critical manufacturing
processes (i.e. extraction, synthetic, recombinant processes), specification and the analytical methods used to determine
whether a substance is in compliance with a specification.
NOTE 2 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.
3.1.28
sponsor
individual, company, institution or organization which takes responsibility for the initiation, management and/or
financing of a clinical trial
3.1.29
strength
quantitative composition
amount of substance or specified substance expressed quantitatively per dosage unit, per unit of mass or
volume, according to the dosage form
NOTE 1 It is necessary for the quantitative composition of the substance(s)/specified substance descriptions of the
finished authorized/investigational 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/specified substance.
NOTE 2 Substances/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.
3.1.30
substance
matter of defined composition that has discrete existence, whose origin may be biological, mineral or chemical
NOTE 1 Substances may be either single substances or mixture substances.
NOTE 2 Single substances are always defined using a minimally sufficient set of data elements divided into five types:
chemical, protein, nucleic acid, polymer and structurally diverse. Substances may be salts, solvates, free acids, free
bases, or mixtures of related compounds that are either isolated or synthesized together.
NOTE 3 Pharmacopeial terminology and defining characteristics are used when available and appropriate. Defining
elements are dependent on the type of substance.
6 © ISO 2012 – All rights reserved

ISO 11616:2012(E)
NOTE 4 Discrete existence refers to the ability of a substance to exist independently of any other substance. Substances
may either be well-defined entities containing definite chemical structures, synthetic (i.e. isomeric mixtures) or naturally-
occurring (i.e. conjugated oestrogens) mixtures of chemicals containing definite molecular structures, or materials derived from
plants, animals, microorganisms or inorganic matrices for which the chemical structure may be unknown or difficult to define.
3.1.31
unit of measurement
real scalar quantity, defined and adopted by convention, with which any other quantity of the same kind can be
compared in order to express the ratio of the two quantities as a number
NOTE Depending on the nature of the reference scale, the unit of measurement expression may stand either for
a physical unit of measurement that is related to a system of quantities (e.g. SI units) or for an arbitrarily defined unit of
measurement, which may refer to a certain reference material, a standard measurement procedure, a material measure
or even to a combination of those.
3.1.32
unit of presentation
qualitative term describing the unit in which the strength(s) of the manufactured item or pharmaceutical product
is presented and described
NOTE 1 This is often used specifically at the point of delivery to the patient in cases where a quantitative unit of
measurement is not applicable.
NOTE 2 A unit of presentation may have the same “display name” as in another controlled vocabulary, such as a
pharmaceutical dose form, but the two concepts are not equivalent, and each has a unique controlled vocabulary term identifier.
EXAMPLE A tablet, spray or puff “contains 100 µg per spray” (unit of presentation = spray).
3.1.33
UDI
unique device identifier
unique identifier assigned to a medicinal product as defined by the International Medical Device Regulators’
Forum (IMDRF)
3.1.34
(vaccine) adjuvant
component that potentiates the immune response to an antigen and/or modulates it towards the desired
immune response
3.1.35
vocabulary
terminological dictionary which contains designations and definitions from one or more specific subject fields
NOTE Adapted from ISO 1087-1:2000, definition 3.7.2.
3.2 Abbreviations
3.2.1
CV
Controlled Vocabulary
3.2.2
FDA
United States Food and Drug Administration
3.2.3
EP
European Pharmacopeia
3.2.4
IMDRF
International Medical Device Regulators’ Forum
ISO 11616:2012(E)
3.2.5
ICH
International Conference on Harmonization
3.2.6
ICSR
Individual Case Safety Report
3.2.7
IMP
Investigational Medicinal Products
3.2.8
IMPID
Investigational Medicinal Product Identifier
3.2.9
MPID
Medicinal Product Identifier
3.2.10
PhPID
Pharmaceutical Product Identifier
3.2.11
UoM
Unit of Measurement
3.2.12
USP
United States Pharmacopeia
3.2.13
UDI
Unique Device Identification Code
3.2.14
HL7
Health Level Seven
3.2.15
TermID
Term Identifier (Controlled Vocabulary)
4 Requirements
4.1 Elements required for the unique identification of pharmaceutical products
This chapter describes the elements required to uniquely identify and characterize a pharmaceutical product.
It provides the requirements to support pharmaceutical product identification.
Pharmaceutical Product Identification (PhPID) shall be based on the following subset of elements that describe
the pharmaceutical product:
a) substance(s)/specified substance(s);
b) strength(s), strength units (units of measurement and/or unit of presentation);
c) reference strengths;
d) administrable dose form;
8 © ISO 2012 – All rights reserved

ISO 11616:2012(E)
e) medical device, when it is a component of a medicinal product.
These elements are described in detail in ISO 11615. In addition, ISO 11615 describes manufactured items that
require reconstitution prior to administration.
Pharmaceutical identifiers and elements shall represent pharmaceutical products as represented in a medicinal
product per the authorization by a regulatory authority. Off-label usage of medicinal products is outside the
scope of this International Standard.
This International Standard and the related IDMP standards shall not be a substitute for evidence to support
broader claims of efficacy in relation to other medicinal products that are assigned identical PhPIDs as outlined
in ISO 11615.
The data elements required for the generation of PhPIDs depend further on controlled vocabularies (CVs) as
described in the following documents:
ISO 11615, Health informatics — Identification of medicinal products — Data elements and structures for the
unique identification and exchange of regulated medicinal product information;
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.
4.2 Exchange of pharmaceutical product information
To successfully support information sharing in the exchange of regulated product information between the
parties mentioned in the Introduction, the construct of the message shall be in a format that allows for full
compatibility and interoperability between stakeholders upon implementation.
The HL7 Version 3 messaging standard shall be utilized for the exchange of medicinal product information
emphasizing the importance of having a standardized method of exchanging medicinal product information in
support of regulatory and pharmacovigilance activities.
5 Identifying characteristics for the identification of pharmaceutical products
5.1 Pharmaceutical product identification strata and levels
5.1.1 General
PhPIDs shall be represented within two strata (active substance stratum and specified substance stratum), both of
which contain four PhPID identification levels, for each pharmaceutical product contained in a medicinal product.
PhPIDs shall be generated using the substance standard (see ISO 11238), the Strength and Administrable
Dose Form section (see ISO 11239) and Unit(s) of Measurement standard (see ISO 11240) as illustrated below.
Reference strength shall be repeated in both PhPID strata. The reference strength shall be derived from the
active substance and the specified substance depending on the specific product characteristics.
NOTE All the PhPID Strata can be described at four different levels from 1 to 4.
ISO 11616:2012(E)
Table 1 — The four levels of PhPID
PhPID_SUB_L1 → Substance(s) Term
PhPID_ SUB _L2 → Substance Term(s) + Strength + Reference Strength
PhPID Active
Substance PhPID_ SUB _L3 → Substance Term(s) + Administrable Dose Form
Stratum
PhPID_ SUB _L4 → Substance(s) Term+ Strength + Reference Strength
+ Administrable Dose Form
PhPID_SpSUB_L1 → Specified Substance(s) Term
PhPID_SpSUB_L2 → Specified Substance(s) Term+ Strength + Reference Strength
PhPID Specified
Substance PhPID_SpSUB_L3 → Specified Substance(s) Term + Administrable Dose Form
Stratum
PhPID_SpSUB_L4 → Specified Substance(s) Term + Strength + Reference Strength
+ Administrable Dose Form
NOTE 1 A pharmaceutical product may refer to a drug that is associated with a medical device (e.g. drug/device,
biologic/device). In this instance, the device term and term ID (unique device identifier) shall be displayed with the
substance(s) and specified substance(s) terms for the product at all applicable PhPID levels. This association shall be
made by directly associating the assigned PhPIDs to a medicinal product and its corresponding MPID and PCID as
outlined in ISO 11615.
NOTE 2 Strength is not applicable to a device.
NOTE 3 A jurisdiction may further refine the requirements in relation to specification of the medical device as part of
this International Standard at implementation so that this information is to be specified only if required.
NOTE 4 A pharmaceutical product may refer to a drug that is associated with an adjuvant (e.g. vaccine). In this instance,
the adjuvant term and term ID shall be displayed with the substance(s) and specified substance(s) terms for the product
at all applicable PhPID levels. This association shall be made by directly associating the assigned PhPIDs to a medicinal
product and its corresponding MPID and PCID as outlined in ISO 11615.
Strength shall indicate quantity, unit of measurement and/or unit of presentation.
Administrable dose form is derived from the pharmaceutical product.
5.1.2 PhPID Specified Substance
As described in ISO 11238, specified substance(s) shall capture detailed characteristics of single substances
or the composition of material that contains multiple substances or multiple physical forms.
The elements necessary to define specified substances shall be divided into four groups to facilitate
implementation.
These groups are described as follows.
a) Group 1 Specified Substance. Elements shall be used to describe material that contains
multiple substances, solvents used in the preparation of herbal or allergenic extracts, specific
marker or signature substances present in plant or animal derived materials, the physical form
of a substance, when relevant, and any properties essential to the description of the material.

The element groups used to define a group 1 specified substance shall include constituents, physical form
and property.
NOTE This grouping of elements allows for the definitions of many materials in commerce that are used in the
formulation of medicinal products.
b) Group 2 specified substance. Group 2 elements shall be used to capture the manufacturer of
either a substance or a group 1
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