SIST EN ISO 11615:2018

SLOVENSKI STANDARD
01-april-2018
1DGRPHãþD
SIST EN ISO 11615:2013
Zdravstvena informatika - Identifikacija zdravil - Elementi in zgradba podatkov za
enotno identifikacijo in izmenjavo predpisanih informacij o zdravilih (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 11615:2017)
Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und -
strukturen zur Identifikation von Arzneimitteln für den Austausch von behördlich
genehmigten Arzneimittelinformationen (ISO 11615:2017)
Informatique de santé - Identification des médicaments - Éléments de données et
structures pour l'identification unique et l'échange d'informations sur les médicaments
(ISO 11615:2017)
Ta slovenski standard je istoveten z: EN ISO 11615:2017
ICS:
11.120.10 Zdravila Medicaments
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 11615
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2017
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes EN ISO 11615:2012
English Version
Health informatics - Identification of medicinal products -
Data elements and structures for the unique identification
and exchange of regulated medicinal product information
(ISO 11615:2017)
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 sur Identifikation von Arzneimitteln für den Austausch von
les médicaments contrôlés (ISO 11615:2017) behördlich genehmigten Arzneimittelinformationen
(ISO 11615:2017)
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 11615:2017 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 11615:2017) 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 11615:2012.
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 11615:2017 has been approved by CEN as EN ISO 11615:2017 without any modification.

INTERNATIONAL ISO
STANDARD 11615
Second edition
2017-10
Health informatics — Identification
of medicinal products — Data
elements and structures for the
unique identification and exchange
of regulated medicinal product
information
Informatique de santé — Identification des médicaments — Éléments
de données et structures pour l'identification unique et l'échange
d'informations sur les médicaments contrôlés
Reference number
ISO 11615:2017(E)
©
ISO 2017
ISO 11615:2017(E)
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved

ISO 11615:2017(E)
Contents Page
Foreword .vi
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and abbreviated terms . 2
4 Message exchange format .13
5 Conformance terminology and context as it relates to the ISO IDMP standards and
corresponding IDMP technical specifications .14
6 Concepts required for the unique identification of Medicinal Products.14
6.1 General considerations .14
6.2 Authorised Medicinal Products .14
6.3 Investigational Medicinal Products .15
6.4 Concepts required for the unique identification of a Medicinal Product and the
association with PhPID(s) .15
6.5 Concepts required for the unique identification of Medicinal Products and the
association with the marketing authorisation number .15
6.6 Concepts required for the unique identification of Medicinal Products and the
association with data carrier identifiers .16
7 Description of the information modelling principles and practices .17
7.1 General considerations .17
7.2 Conceptual overview diagrams .17
7.3 High-level diagrams .18
7.4 Detailed description diagrams .18
7.4.1 General.18
7.4.2 Relationships between classes .19
7.4.3 Attributes of classes .20
7.4.4 Generalised classes and patterns .20
7.4.5 Translation and language .20
8 Identifying characteristics for authorised Medicinal Products.20
8.1 Primary identifiers — General considerations .20
8.2 Medicinal Product Identifier (MPID) .21
8.2.1 General considerations .21
8.2.2 MPID code segments .21
8.3 Packaged Medicinal Product Identifier (PCID) .22
8.3.1 General considerations .22
8.3.2 Package description (PCID) code segment.23
8.4 Medicinal Product Batch Identifier (BAID1) .23
8.5 Medicinal Product Batch Identifier (BAID2) .23
9 Information for an authorised Medicinal Product .24
9.1 Authorised Medicinal Product — Information overview .24
9.1.1 General.24
9.1.2 Medicinal Product .24
9.1.3 Medicinal Product name .24
9.1.4 Header .25
9.1.5 Manufacturer/Establishment (organisation) .25
9.1.6 Marketing authorisation .25
9.1.7 Packaged Medicinal Product .25
9.1.8 Pharmaceutical product .25
9.1.9 Ingredient .25
9.1.10 Clinical particulars .25
9.2 Medicinal Product .25
ISO 11615:2017(E)
9.2.1 General.25
9.2.2 Detailed description of Medicinal Product information .26
9.3 Marketing authorisation .32
9.3.1 General.32
9.3.2 Detailed description of marketing authorisation information .33
9.4 Organisation .38
9.4.1 General.38
9.4.2 Detailed description of organisation information .38
9.5 Manufacturer/Establishment (organisation) .41
9.5.1 General.41
9.5.2 Detailed description of manufacturer/establishment
(organisation) information .41
9.6 Packaged Medicinal Product, including manufactured item and device .42
9.6.1 General.42
9.6.2 Detailed description of Packaged Medicinal Product information .43
9.7 Ingredient, substance and strength .52
9.7.1 General.52
9.7.2 Detailed description of ingredients, substance and strength information .52
9.8 Pharmaceutical product and device .55
9.8.1 General.55
9.8.2 Detailed description of pharmaceutical product and device information .55
9.9 Clinical particulars .57
9.9.1 General.57
9.9.2 Detailed description for clinical particulars information .58
10 Identifying characteristics for Investigational Medicinal Products .62
10.1 General .62
10.2 Primary identifiers .62
10.2.1 General considerations .62
10.3 Investigational Medicinal Product Identifier (IMPID) .63
10.3.1 General considerations .63
10.3.2 IMPID code segments .63
10.4 Investigational Medicinal Product Package Identifier (IPCID) .64
10.4.1 General provisions.64
10.4.2 Package description code segment .64
10.5 Investigational Medicinal Product Batch Identifier (BAID1) .65
10.6 Investigational Medicinal Product Batch Identifier (BAID2) .65
11 Information for an Investigational Medicinal Product .65
11.1 General .65
11.2 Conceptual overview of the information for an Investigational Medicinal Product .65
11.2.1 General.65
11.2.2 Investigational Medicinal Product .66
11.2.3 Investigational Medicinal Product name .66
11.2.4 Header .66
11.2.5 Manufacturer/Establishment (organisation) .66
11.2.6 Clinical trial authorisation .67
11.2.7 Investigational Packaged Medicinal Product .67
11.2.8 Pharmaceutical product .67
11.2.9 Ingredient .67
11.2.10 Clinical particulars .67
11.3 Investigational Medicinal Product .67
11.3.1 General.67
11.3.2 Detailed description of Investigational Medicinal Product information .67
11.4 Clinical trial authorisation .70
11.4.1 General.70
11.4.2 Detailed description of clinical trial authorisation information .70
11.5 Manufacturer/Establishment (organisation) .72
11.6 Investigational Packaged Medicinal Product .72
iv © ISO 2017 – All rights reserved

ISO 11615:2017(E)
11.7 Pharmaceutical product .72
11.7.1 General.72
11.7.2 Pharmaceutical product .73
11.7.3 Dosing and route of administration .73
11.8 Ingredient .73
11.9 Clinical particulars .74
11.10 PhPID sets .74
11.11 Device nomenclature .74
11.12 Device batch identifier .74
11.13 Physical characteristics .74
11.14 Other characteristics .74
Annex A (normative) Full model — Authorised Medicinal Products detailed diagram.75
Annex B (normative) Full model — Investigational Medicinal Products detailed diagram .76
Bibliography .77
ISO 11615:2017(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.
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 11615:2012), which has been technically
revised.
vi © ISO 2017 – All rights reserved

ISO 11615:2017(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.
These standards and technical specifications 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 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.
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.
This document has been developed in conjunction with the Common Product Model (CPM) and
Structured Product Labelling (SPL) in HL7.
ISO 11615:2017(E)
In the context of exchange of regulatory information, the purpose of this document is twofold:
— to specify data elements, structures and relationships between the data elements which are required
to uniquely and with certainty identify Medicinal Products for human use;
— to specify definitions of terms for all data elements required to uniquely and with certainty identify
Medicinal Products for human use.
In addition, reference to the use of other normative IDMP and messaging standards for Medicinal
Product information is included in this document in order to support successful information exchange.
viii © ISO 2017 – All rights reserved

INTERNATIONAL STANDARD ISO 11615:2017(E)
Health informatics — Identification of medicinal
products — Data elements and structures for the unique
identification and exchange of regulated medicinal product
information
1 Scope
This document establishes definitions and concepts and describes data elements and their structural
relationships, which are required for the unique identification and the detailed description of Medicinal
Products.
Taken together, the standards listed in the Introduction define, characterise and uniquely identify
regulated Medicinal Products for human use during their entire life cycle, i.e. from development to
authorisation, post-marketing and renewal or withdrawal from the market, where applicable.
Furthermore, to support successful information exchange in relation to the unique identification
and characterisation of Medicinal Products, the use of other normative IDMP messaging standards is
included, which are to be applied in the context 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 639-1, Codes for the representation of names of languages — Part 1: Alpha-2 code
ISO 3166-1:2013, Codes for the representation of names of countries and their subdivisions — Part 1:
Country codes
ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates
and times
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 11616, Health informatics — Identification of Medicinal Products — 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
ISO 11615:2017(E)
ISO/TS 20443, Health informatics — Identification of Medicinal Products — Implementation guide 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 guide
for ISO 11616 data elements and structures for the unique identification and exchange of regulated
pharmaceutical product information
ISO/IEC 5218, Information technology — Codes for the representation of human sexes
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 standardization 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 for administration to the patient, after any necessary transformation of
the manufactured items (3.1.37) and their corresponding manufactured dose forms (3.1.36) 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).
Note 2 to entry: Administered dose form and pharmaceutical administrable dose form are synonyms of
administrable dose form.
3.1.3
administration device
equipment intended for correct administration of the Medicinal Product (3.1.50)
Note 1 to entry: An administration device may be an integral part of an immediate container (3.1.27) or a closure.
[SOURCE: ENV 12610:1997]
3.1.4
allergen
material (3.1.47) of concern used as ingredient (3.1.28) or in a device capable of stimulating a type-I
hypersensitivity or allergic reaction in atopic individuals
3.1.5
authorisation date
date when the authorisation was granted by a Medicines Regulatory Agency (3.1.56) following a specific
regulatory activity
2 © ISO 2017 – All rights reserved

ISO 11615:2017(E)
3.1.6
authorisation procedure
formal procedure applied by a Medicines Regulatory Agency (3.1.56) to grant a marketing authorisation
(3.1.40), to amend an existing one, to extend its duration or to revoke it
Note 1 to entry: The terms authorisation procedure and marketing authorisation procedure (3.1.43) are
synonymous.
3.1.7
authorisation status
phase of the marketing authorisation (3.1.40) during its life cycle
Note 1 to entry: The status indicates a particular moment in its life cycle.
3.1.8
batch
specific quantity of a drug or other material (3.1.47) that is intended to have uniform character and
quality, within specified limits, and is produced according to a single manufacturing order during the
same cycle of manufacture
3.1.9
batch number
identifier (3.1.26) assigned to a specific batch (3.1.8) of a Medicinal Product (3.1.50) or item resulting
from a manufacturing process at a specific point of time
3.1.10
characteristic
abstraction of a property of an object
3.1.11
clinical trial
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) (3.1.31), 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.
3.1.12
clinical trial authorisation
approval given by a Medicines Regulatory Agency (3.1.56) to conduct a clinical trial (3.1.11) in a region
(3.1.73)
3.1.13
class
set of objects that share the same specifications of features, constraints, and semantics
3.1.14
combined pharmaceutical dose form
two or more manufactured items (3.1.37) that are intended to be combined in a specific way to produce
a single pharmaceutical product, and that includes information on the manufactured dose form (3.1.36)
of each manufactured item and the administrable dose form (3.1.2) of the pharmaceutical product
3.1.15
common name
official non-proprietary or generic name recommended by the World Health Organisation (WHO), or,
if one does not exist, a non-proprietary name recommended by the region (3.1.73) within which the
name is used
Note 1 to entry: Generic name and international non-proprietary name are synonymous of common name.
ISO 11615:2017(E)
[SOURCE: WHO 46th Consultation on International Nonproprietary Names (INNs) for Pharmaceutical
Substances]
3.1.16
container
item of packaging that is part of a Medicinal Product (3.1.50) and is used for storage, identification
and/or transport of the components of the Medicinal Product
3.1.17
contraindication
situations where the Medicinal Product (3.1.50) shall not be given for safety reasons
3.1.18
controlled vocabulary
finite set of values that represent the only allowed values for a data item
Note 1 to entry: The allowed values can be codes, text or numeric.
[SOURCE: CDISC Clinical Research Glossary V10.0, 2016]
3.1.19
datatype
set of distinct values, characterised by properties of those values, and by operations on those values
[SOURCE: ISO 11404:2007, 3.12]
3.1.20
device listing number
number assigned by a Medicines Regulatory Agency (3.1.56) during registration and/or listing to all
devices in commercial distribution, regardless of pre-market authorisation requirements, per regional
registration and listing requirements
3.1.21
device model number
identifier (3.1.26) assigned by a medical device manufacturer (3.1.38) to a particular design or version
of a medical device (3.1.49)
3.1.22
distributor
organisation in possession of a license covering the procuring, holding, supplying or exporting of
Medicinal Products (3.1.50), apart from supplying Medicinal Products to the public
Note 1 to entry: This is applicable to “wholesale distribution of Medicinal Products”.
3.1.23
dose
specified quantity of a medicine, to be taken at one time or at stated intervals
3.1.24
dose form
physical manifestation of a Medicinal Product (3.1.50) that contains the active ingredient(s) (3.1.28)
and/or inactive ingredient(s) that are intended to be delivered to the patient
Note 1 to entry: Dose form, dosage form and pharmaceutical dose form are synonymous. “Pharmaceutical dose
form” can refer to the administrable dose form (3.1.2) or the manufactured dose form (3.1.36).
4 © ISO 2017 – All rights reserved

ISO 11615:2017(E)
3.1.25
Global Trade Item Number
GTIN
GS1 unique identifier (3.1.26) of items that are traded [e.g. pharmaceuticals, medical devices (3.1.49)] in
the supply chain
Note 1 to entry: A GTIN is used to identify any item upon which there is a need to retrieve predefined information
and that may be priced, ordered or invoiced at any point in any supply chain. GTINs may be 8, 12, 13 or 14 digits
in length.
3.1.26
identifier
description that is sufficient to represent an object in a given environment
Note 1 to entry: In the context of this document, this is a list of identifying characteristics (3.1.10) that together
unambiguously identify a Medicinal Product (3.1.50), pharmaceutical product, substance (3.1.80), specified
substance (3.1.77), route of administration (3.1.76), pharmaceutical dose form or any other element which
requires to be uniquely identified.
[SOURCE: ENV 12610:1997]
3.1.27
immediate container
packaging in which a manufactured item (3.1.37) or pharmaceutical product is contained and with
which it is in direct contact
Note 1 to entry: An immediate container can be fitted with or have integrated into it an administration device
(3.1.3) and/or closure. A pharmaceutical dose form can fulfil the role of an immediate container, e.g. a capsule
containing a powder for inhalation; the capsule in this case is not a container (3.1.16). An alternative, compatible
definition of immediate container (“immediate packaging”) is given in Directive 92/27/EEC.
[SOURCE: ENV 12610:1997]
3.1.28
ingredient
material (3.1.47) use
...