SIST EN ISO 11616:2013

Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information (ISO 11616:2012)

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.

Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und -strukturen zur Identifikation und zum Austausch von pharmazeutischen produktkennzeichen (ISO 11616:2012)

Diese Internationale Norm definiert Datenelemente, Strukturen und Beziehungen zwischen Datenelementen, die für den Austausch zulassungsbezogener Informationen zwecks Identifikation pharmazeutischer Produkte erforderlich sind. Sie ist anwendbar auf weltweit stattfindende Aktivitäten im Zusammenhang mit der Zulassung von Arzneimitteln und der Pharmakovigilanz.
Mit dieser Norm sollen Definitionen und Begriffe eingeführt sowie Datenelemente und deren strukturelle Beziehungen untereinander festgelegt werden, um eine detaillierte Beschreibung und eindeutige Identifikation pharmazeutischer Produkte zu ermöglichen.
Es sind Verweisungen auf weitere Normen zur Identifikation von Arzneimitteln und zur Nachrichtenübertragung im Zusammenhang mit Informationen zu pharmazeutischen Produkten angegeben, die in Verbindung mit der vorliegenden Norm anzuwenden sind.
Tierarzneimittel liegen außerhalb des Anwendungsbereichs dieser Norm.

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)

L'ISO 11616:2012 vise à fournir des niveaux d'informations spécifiques pertinents pour l'identification d'un médicament ou d'un groupe de médicaments. Elle doit définir des éléments de données, des structures et des relations entre des éléments de données nécessaires pour l'échange d'informations réglementées pour identifier de façon unique des produits pharmaceutiques. Cette identification doit être appliquée tout au long de la durée de vie du produit afin de soutenir sur le plan mondial les activités réglementaires, de pharmacovigilance et autres. De plus, l'ISO 11616:2012 est essentielle pour assurer que les informations sur un produit pharmaceutique sont rassemblées dans un format structuré pouvant être transmis entre différentes parties prenantes et permettant d'assurer l'interopérabilité et la compatibilité entre émetteur et destinataire.

Zdravstvena informatika - Identifikacija medicinskih izdelkov - Elementi in zgradba podatkov za enotno identifikacijo in izmenjavo predpisanih informacij o farmacevtskih izdelkih (ISO 11616:2012)

Namen tega mednarodnega standarda je zagotoviti specifične ravni informacij v zvezi z identifikacijo medicinskega izdelka ali skupine medicinskih izdelkov. Določa podatkovne elemente, strukture in odnose med podatkovnimi elementi, ki so potrebni za izmenjavo predpisanih informacij, da se enotno identificirajo farmacevtski izdelki. Ta identifikacija se mora uporabljati skozi celoten življenjski cikel izdelka, da se podpirajo farmakovigilanca, regulativne in druge dejavnosti na globalni ravni. Poleg tega je ta mednarodni standard nujen za zagotavljanje zbiranja informacij o farmacevtskih izdelkih v strukturirani obliki s prenosom med raznolikimi interesnimi skupinami. To zagotavlja interoperabilnost in usklajenost za oba, pošiljatelja in prejemnika. Namen tega mednarodnega standarda ni znanstvena klasifikacija farmacevtskih izdelkov. To je uradna zbirka posebnih podatkovnih elementov, kategoriziranih v predpisanih kombinacijah in enoznačno prepoznavnih, ko so ravni informacij nepopolne. To omogoča nedvoumno identifikacijo medicinskih izdelkov. Sklici na druge normativne standarde za identifikacijo medicinskih izdelkov (IDMP) in sporočanje informacij o farmacevtskih izdelkih so vključeni v točki 2 in namenjeni uporabi v okviru tega mednarodnega standarda. Medicinski izdelki za uporabo v veterini niso del področja uporabe tega mednarodnega standarda.

General Information

• Status: Withdrawn
• Public Enquiry End Date: 30-Nov-2010
• Publication Date: 14-Jan-2013
• Withdrawal Date: 05-Mar-2018
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ITC - Information technology
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 22-Dec-2017
• Due Date: 14-Jan-2018
• Completion Date: 06-Mar-2018
• Ref Project: EN 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)

Relations

• Replaced By: SIST EN ISO 11616:2018 - Health informatics - Identification of medicinal products - Data elements and structures for the Unique Identification and Exchange of regulated Pharmaceutical Product Information (ISO 11616:2017)
• Effective Date: 13-Dec-2017

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11616:2013
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
SIST EN ISO 11616:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11616:2013

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SIST EN ISO 11616:2013


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.

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SIST EN ISO 11616:2013
EN ISO 11616:2012 (E)
Contents Page
Foreword .3

2

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SIST EN ISO 11616:2013
EN ISO 11616:2012 (E)
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.

3

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SIST EN ISO 11616:2013

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SIST EN ISO 11616:2013
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

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SIST EN ISO 11616:2013
ISO 11616:2012(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2012
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 [e-mail]
Web www.iso.org
Published in Switzerland
ii © ISO 2012 – All rights reserved

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SIST EN ISO 11616:2013
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 2012 – All rights reserved iii

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SIST EN ISO 11616:2013
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

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SIST EN ISO 11616:2013
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 2012 – All rights reserved v

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SIST EN ISO 11616:2013
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

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SIST EN ISO 11616:2013
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 2012 – All rights reserved 1

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SIST EN ISO 11616:2013
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

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SIST EN ISO 11616:2013
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 2012 – All rights reserved 3

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SIST EN ISO 11616:2013
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

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SIST EN ISO 11616:2013
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 o
...