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)

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.

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)

ISO 11616:2017 vise à fournir des niveaux d'informations spécifiques pertinents pour l'identification d'un médicament ou d'un groupe de médicaments. Elle définit les éléments de données, les structures et les relations entre des éléments de données nécessaires à l'échange d'informations réglementées visant à identifier de façon unique des produits pharmaceutiques. Cette identification est destinée à être appliquée tout au long du cycle de vie du produit afin de soutenir sur le plan mondial les activités réglementaires, de pharmacovigilance et autres. De plus, le présent document est essentiel pour garantir que les informations sur un produit pharmaceutique sont rassemblées dans un format structuré pouvant être transmis entre différentes parties prenantes, à des fins aussi bien réglementaires que cliniques (par exemple, ordonnances électroniques, aide à la décision clinique). Cela permet d'assurer l'interopérabilité et la compatibilité entre émetteur et destinataire.
ISO 11616:2017 n'est pas destiné à constituer une classification scientifique des produits pharmaceutiques. Il s'agit plutôt d'une association formelle d'éléments de données en particulier, catégorisés en combinaisons spécifiées et identifiés de manière unique lorsque les informations d'un niveau parmi une hiérarchie de niveaux sont insuffisantes. Cela permet l'identification des médicaments sans ambiguïté au niveau mondial.
Des références à d'autres normes IDMP et de messagerie relatives aux informations sur les produits pharmaceutiques sont incluses dans l'Article 2, pour application dans le contexte du présent document.
Les médicaments à usage vétérinaire ne relèvent pas du domaine d'application du présent document.

Zdravstvena informatika - Identifikacija zdravil - Elementi in zgradba podatkov za enotno identifikacijo in izmenjavo predpisanih informacij o farmacevtskih izdelkih (ISO 11616:2017)

Namen tega dokumenta 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 dejavnosti in druge dejavnosti na globalni ravni. Poleg tega je ta dokument bistvenega pomena za zagotavljanje zbiranja informacij o farmacevtskih izdelkih v strukturirani obliki s prenosom med raznolikimi interesnimi skupinami v zakonodajne in klinične namene (npr. e-predpisovanje, podpora za klinično odločanje). To zagotavlja interoperabilnost in usklajenost za pošiljatelja in prejemnika.
Namen tega dokumenta ni znanstvena klasifikacija farmacevtskih izdelkov. To je
uradna zbirka posebnih podatkovnih elementov, ki so kategorizirani v predpisanih kombinacijah in enoznačno prepoznavni, kadar so ravni informacij nepopolne. To omogoča nedvoumno identifikacijo medicinskih izdelkov na globalni ravni.
Sklici na druge normativne standarde za identifikacijo medicinskih izdelkov in sporočanje informacij o farmacevtskih izdelkih so vključeni v točki 2 in namenjeni uporabi v okviru tega dokumenta.
Medicinski izdelki za uporabo v veterini niso del področja uporabe tega dokumenta.

General Information

• Status: Published
• Public Enquiry End Date: 30-Dec-2016
• Publication Date: 06-Mar-2018
• ICS: 11.120.10 - Medicaments
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ITC - Information technology
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 22-Dec-2017
• Due Date: 26-Feb-2018
• Completion Date: 07-Mar-2018
• Ref Project: EN 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)

Relations

• Replaces: 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)
• Effective Date: 13-Dec-2017

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11616:2018
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
SIST EN ISO 11616:2018 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11616:2018

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SIST EN ISO 11616:2018


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.

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SIST EN ISO 11616:2018
EN ISO 11616:2017 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 11616:2018
EN ISO 11616:2017 (E)
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.

3

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SIST EN ISO 11616:2018

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SIST EN ISO 11616:2018
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

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SIST EN ISO 11616:2018
ISO 11616:2017(E)

COPYRIGHT PROTECTED DOCUMENT
© 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. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2017 – All rights reserved

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SIST EN ISO 11616:2018
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 2017 – All rights reserved iii

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SIST EN ISO 11616:2018
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

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SIST EN ISO 11616:2018
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 2017 – All rights reserved v

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SIST EN ISO 11616:2018
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

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SIST EN ISO 11616:2018
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.
© ISO 2017 – All rights reserved vii

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SIST EN ISO 11616:2018

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SIST EN ISO 11616:2018
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 2017 – All rights reserved 1

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SIST EN ISO 11616:2018
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

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SIST EN ISO 11616:2018
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
...

SLOVENSKI STANDARD
oSIST prEN ISO 11616:2016
01-december-2016
Zdravstvena informatika - Identifikacija medicinskih izdelkov - Elementi in zgradba
podatkov za enotno identifikacijo in izmenjavo predpisanih informacij o
farmacevtskih izdelkih (ISO/DIS 11616:2016)
Health informatics - Identification of medicinal products - Data elements and structures
for the Unique Identification and Exchange of regulated Pharmaceutical Product
Information (ISO/DIS 11616:2016)
Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und -
strukturen zur Identifikation und zum Austausch von pharmazeutischen
Produktkennzeichen (ISO/DIS 11616:2016)
Informatique de santé - Identification des médicaments - Éléments de données et
structures pour l'identification unique et l'échange d'informations réglementées sur les
produits pharmaceutiques (ISO/DIS 11616:2016)
Ta slovenski standard je istoveten z: prEN ISO 11616
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
oSIST prEN ISO 11616:2016 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 11616:2016

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oSIST prEN ISO 11616:2016
DRAFT INTERNATIONAL STANDARD
ISO/DIS 11616
ISO/TC 215 Secretariat: ANSI
Voting begins on: Voting terminates on:
2016-08-09 2016-10-31
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
ICS: 35.240.80
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 11616:2016(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
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COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, 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
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Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and abbreviations . 2
3.1 Terms and definitions . 2
3.2 Abbreviations . 8
4 Description of the information modelling principles and practices .9
4.1 General considerations . 9
4.2 Conceptual overview diagrams .10
4.3 Section high-level diagrams .10
4.4 Detailed description diagrams .11
4.4.1 General.11
4.4.2 Relationships between classes .12
4.4.3 Attributes of classes .13
4.4.4 Generalized classes and patterns .13
4.4.5 Translation and language .13
5 Requirements .13
5.1 Elements required for the unique identification of pharmaceutical products .13
5.2 Exchange of pharmaceutical product information .14
6 Identifying characteristics for the identification of pharmaceutical products .15
6.1 Pharmaceutical product identification strata and levels .15
6.1.1 General.15
6.1.2 PhPID Specified Substance .15
6.1.3 Pharmaceutical Product Specified Substance Identification (PhPID SpSub) .16
6.2 Cardinality .17
6.3 Representation of strength concentration .17
6.4 Pharmaceutical product identifier (PhPID) .18
6.5 Pharmaceutical product substance stratum elements (PhPID_SUB_Lx) .19
6.5.1 The construct of the pharmaceutical product substance stratum .19
6.5.2 Substance Set .19
6.5.3 Administrable dose form .19
6.5.4 Unit of presentation .20
6.5.5 Medical device .20
6.5.6 Confidentiality indicator .20
6.6 Pharmaceutical Product Specified Substance Stratum Elements (PhPID_SpSUB_Lx) .21
6.6.1 The construct of the pharmaceutical product specified substance stratum .21
6.6.2 Specified Substance Set .21
6.6.3 Administrable dose form .21
6.6.4 Unit of presentation .22
6.6.5 Medical device .22
6.7 Identifying characteristics to express strength .22
6.7.1 Expressing strength .22
6.7.2 Attributes for representation of strength in PhPID stratum elements .23
6.7.3 Representation of strength for a patch .25
7 Relationship between MPID/PCID and PhPID .25
7.1 Concepts required for the unique identification of a medicinal product and the
association with PhPIDs .25
7.2 Pharmaceutical product identification criteria .27
7.2.1 General considerations .27
7.2.2 Multiple products packaged as a kit and administered as separate
medicinal products .27
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7.2.3 Multiple products packaged as a kit for reconstitution and administered
as one medicinal product .28
7.2.4 Components of kits which are not packaged together (e.g.
radiopharmaceutical kits) .28
7.2.5 Different representations of strength in two or more regions for
identical products .29
7.2.6 Representation of PhPID for a patch .29
8 Relationship between IMPID/IPCID and PhPID .29
9 Conceptual model .31
Bibliography .32
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Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2. 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. 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 meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 215, Health informatics.
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Introduction
This International Standard was developed in response to a worldwide demand for internationally
harmonised 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 and corresponding
Technical Specification 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/TS 20443, Health informatics — Identification of Medicinal Products — Implementation Guide
for EN ISO 11615 Data Elements, Structures and Message Specifications for 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/TS 20451, Health informatics – Identification of Medicinal Products – Implementation Guide for
EN ISO 11616 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/TS 19844, Health informatics — Identification of Medicinal Products - Implementation Guide of
EN ISO 11238 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/TS 20440, Health informatics — Identification of Medicinal Products — Implementation
Guide for EN 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 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);
— Package Component Identifier(s) (PCIDs);
— Investigational Medicinal Product Identifier(s) (IMPIDs);
— Investigational Package Component Identifier(s) (IPCIDs).
These standards for the Identification of Medicinal Products (IDMP) support the activities of medicines
regulatory agencies worldwide by region. These include a variety of regulatory activities related
to development, registration and product life cycle management of medicinal products, as well as
pharmacovigilance, compliance, and risk management.
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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, track 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,
characterise and exchange regulated medicinal products and associated information.
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 (CPM)
and Structured Product Labeling (SPL) in HL7. Implementation shall use HL7 V3 messaging to transmit
information between stakeholders.
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oSIST prEN ISO 11616:2016
DRAFT INTERNATIONAL STANDARD ISO/DIS 11616:2016(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 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 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 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 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
ISO/TS 20443, Health informatics — Identification of Medicinal Products — Implementation Guide for EN
ISO 11615 Data Elements, Structures and Message Specifications for Unique Identification and Exchange of
Regulated Medicinal Product Information;
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ISO/TS 20451, Health informatics– Identification of Medicinal Products – Implementation Guide for
EN ISO 11616 Data elements and structures for the unique identification and exchange of regulated
pharmaceutical 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/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
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
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
EXAMPLE Solution for injection, tablet for oral use, hard-capsule powder for inhalation.
3.1.2
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
[SOURCE: ICH E6 Glossary, Directive 2001/20/EC:2002, Version: 1-2009/04/19]
3.1.3
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 V8.0, 2009]
3.1.4
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 to entry: The TermID remains constant over time, independent of the particular version of the knowledge
resource.
Note 2 to entry: Adapted from HL7 Core Principles.
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3.1.5
designation
symbolic representation of a concept
Note 1 to entry: Adapted from ISO 1087-1:2000.
3.1.6
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 1 to entry: Pharmaceutical dose form may refer to the administered dose form or the packaged dose form,
depending on the product it is describing.
3.1.7
globally unique identifier
identifier that is different from any other such identifier in any domain namespace
3.1.8
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
EXAMPLE Qualified medical practitioner, pharmacist, nurse, social worker, radiographer, medical secretary
or clerk.
[SOURCE: ENV 1613:1995]
3.1.9
identifier
description that is sufficient to differentiate objects in a given environment
[SOURCE: ENV 12610]
Note 1 to entry: 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.
3.1.10
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
3.1.11
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
3.1.12
Investigational Medicinal Product Identifier
IMPID
unique identifier allocated to an Investigational Medicinal Product supplementary to any existing
identifier as ascribed by a Medicines Regulatory Agency in a jurisdiction or a sponsor of a clinical trial
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.
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