SIST-TS CEN ISO/TS 20443:2018
(Main)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 20443:2017)
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 20443:2017)
ISO/TS 20443:2017 defines 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, all ISO IDMP standards (ISO 11615, ISO 11616, ISO 11238, ISO 11239 and ISO 11240) define, characterise, and uniquely identify regulated Medicinal Products for human use from approval, to 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 normative use of HL7 common product model (CPM) and structured product labeling (SPL) messaging is described. References to the use of other relevant standards for Medicinal Product information are included in ISO/TS 20443:2017 to support successful information exchange.
Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und -strukturen zur Identifikation von Arzneimitteln für den Austausch von behördlich genehmigten Arzneimittelinformationen (ISO/TS 20443:2017)
Informatique de santé - Identification des médicaments - Lignes directrices pour l’implémentation des éléments de données et structures ISO 11615 pour l’identification unique et l’échange d’informations réglementées sur les médicaments (ISO/TS 20443:2017)
Zdravstvena informatika - Identifikacija medicinskih izdelkov - Smernice za uporabo ISO 11615 podatkovnih elementov in struktur za enotno identifikacijo in izmenjavo predpisanih informacij o medicinskih izdelkih (ISO/TS 20443:2017)
Standard ISO/TS 20443:2017 določa opredelitve ter opisuje podatkovne elemente in njihove strukturne povezave, ki so potrebni za enotno identifikacijo in podroben opis medicinskih izdelkov.
Vsi standardi ISO IDMP (ISO 11615, ISO 11616, ISO 11238, ISO 11239 in ISO 11240) opredeljujejo, označujejo in enotno določajo predpisane medicinske izdelke za uporabo pri ljudeh od odobritve do poprodaje in podaljšanja ali umika s trga, kjer je to primerno.
Poleg tega je za podporo uspešne izmenjave informacij v zvezi z enotno identifikacijo in karakterizacijo medicinskih izdelkov opisana normativna uporaba splošnega modela za izdelke HL7 (CPM) in strukturiranega označevanja izdelkov (SPL). Sklici na uporabo drugih ustreznih standardov za informacije o medicinskih izdelkih so vključeni v standardu ISO/TS 20443:2017 z namenom podpore uspešne izmenjave informacij.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2018
Zdravstvena informatika - Identifikacija medicinskih izdelkov - Smernice za
uporabo ISO 11615 podatkovnih elementov in struktur za enotno identifikacijo in
izmenjavo predpisanih informacij o medicinskih izdelkih (ISO/TS 20443:2017)
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 20443:2017)
Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und -
strukturen zur Identifikation von Arzneimitteln für den Austausch von behördlich
genehmigten Arzneimittelinformationen (ISO/TS 20443:2017)
Informatique de santé - Identification des médicaments - Lignes directrices pour
l’implémentation des éléments de données et structures ISO 11615 pour l’identification
unique et l’échange d’informations réglementées sur les médicaments (ISO/TS
20443:2017)
Ta slovenski standard je istoveten z: CEN ISO/TS 20443:2018
ICS:
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.
CEN ISO/TS 20443
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
May 2018
TECHNISCHE SPEZIFIKATION
ICS 35.240.80
English Version
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
20443:2017)
Informatique de santé - Identification des médicaments Medizinische Informatik - Identifikation von
- Lignes directrices pour l'implémentation des Arzneimitteln - Datenelemente und -strukturen zur
éléments de données et structures ISO 11615 pour Identifikation von Arzneimitteln für den Austausch von
l'identification unique et l'échange d'informations behördlich genehmigten Arzneimittelinformationen
réglementées sur les médicaments (ISO/TS (ISO/TS 20443:2017)
20443:2017)
This Technical Specification (CEN/TS) was approved by CEN on 13 May 2018 for provisional application.
The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to
submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard.
CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS
available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in
parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.
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
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 20443:2018 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Endorsement notice . 3
European foreword
This document (CEN ISO/TS 20443:2018) 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.
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.
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/TS 20443:2017 has been approved by CEN as CEN ISO/TS 20443:2018 without any
modification.
TECHNICAL ISO/TS
SPECIFICATION 20443
First edition
2017-10
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
Informatique de santé — Identification des médicaments — Lignes
directrices pour l’implémentation des éléments de données et
structures ISO 11615 pour l’identification unique et l’échange
d’informations réglementées sur les médicaments
Reference number
ISO/TS 20443:2017(E)
©
ISO 2017
ISO/TS 20443:2017(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/TS 20443:2017(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Message exchange . 2
4.1 General . 2
4.2 Message exchange format . 2
4.3 Controlled vocabularies . 3
5 Conformance terminology and context as it relates to the ISO IDMP standards and
corresponding technical specifications . 3
6 Maintenance of IDMP data elements and IDMP identifiers . 3
6.1 General . 3
6.2 Translation and language . 3
7 Why standardisation of identification of Medicinal Products is needed .4
8 General considerations . 4
8.1 Overview . 4
8.2 General considerations related to the description of the information modelling
principles and practices . 5
8.2.1 Overview . 5
8.2.2 Conceptual overview diagrams . 5
8.2.3 Section high-level diagrams . 6
8.2.4 Detailed description diagrams . 7
8.2.5 Relationships between classes . 8
8.2.6 Attributes of classes . 9
8.2.7 Generalised classes and patterns . 9
9 Information for an authorised Medicinal Product . 9
9.1 General . 9
9.2 Medicinal Product .11
9.3 Header .11
9.4 Medicinal Product name .11
9.5 Manufacturer/establishment (organisation) .11
9.6 Marketing authorisation .12
9.7 Packaged Medicinal Product .12
9.8 Pharmaceutical Product .12
9.9 Ingredient .13
9.10 Clinical particulars .13
10 Investigational Medicinal Product Identifier (IMPID) .13
10.1 Conceptual overview of the information for an Investigational Medicinal Product .13
10.2 Investigational Medicinal Product .15
10.3 Clinical trial authorisation .15
10.4 Investigational Medicinal Product name .15
10.5 Header .15
10.6 Manufacturer/establishment (organisation) .15
10.7 Pharmaceutical product .16
10.8 Investigational Packaged Medicinal Product .16
10.9 Ingredient .17
10.10 Clinical particulars .17
Annex A (normative) Medicinal Product .20
ISO/TS 20443:2017(E)
Annex B (normative) Marketing authorisation .47
Annex C (normative) Packaged Medicinal Product (including manufactured item and device) .71
Annex D (normative) Ingredient, substance and strength .110
Annex E (normative) Pharmaceutical product and device .125
Annex F (normative) Clinical particulars .133
Annex G (normative) Organisation .151
Annex H (normative) Manufacturer/establishment .156
Annex I (normative) Investigational Medicinal Product .164
Annex J (normative) SPL documents .180
Annex K (informative) Abbreviations .200
Bibliography .202
iv © ISO 2017 – All rights reserved
ISO/TS 20443:2017(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
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.
ISO/TS 20443:2017(E)
Introduction
This document is a guide for implementing ISO 11615, one of the five ISO IDMP standards. The five ISO
standards and four ISO Technical Specifications, when used together, provide the basis for exchanging
data elements that will support the unique and unambiguous identification of Medicinal Products. The
primary purpose for this document is to provide technical guidance to software implementers. Short
descriptions of business rationale are also included, where relevant, to provide context. Thus, this
document focuses on business and technical considerations for implementation that will construct and
parse well-formed, transmittable IDMP messages. Following transmission of required data elements,
unique identifiers are to be produced in conformance with the standards to support applications where
it is necessary to reliably identify and trace regulated biopharmaceutical products. However, this
document does not include extensive information on creation or maintenance of identifier repositories.
Reference is made to regional guidance/implementation guides to support practical implementation
within a given region/jurisdiction. The development of an ISO technical report for identifying core
principles for the maintenance of identifiers and terms for ISO IDMP is to be developed and referenced
for applicable ISO IDMP standards and corresponding technical specifications.
Purpose
To meet the primary objectives of the regulation of medicines (pharmacovigilance) it is necessary
to reliably exchange Medicinal Product information in a robust and consistent manner. The data
elements and message specifications described in this document support, at a minimum, the following
interactions within the following scope:
— regulator to regulator;
— biopharmaceutical company to regulator;
— sponsor of clinical trials to regulator;
— regulator to other stakeholders;
— regulator to worldwide-maintained data sources.
Unique identifiers produced in conformance with this document are aimed at supporting applications
where it is necessary to reliably identify and trace the use of Medicinal Products.
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 identify Medicinal Products for human use;
— to specify definitions of terms for all data elements required to uniquely identify Medicinal Products
for human use.
vi © ISO 2017 – All rights reserved
TECHNICAL SPECIFICATION ISO/TS 20443:2017(E)
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
1 Scope
This document defines 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, all ISO IDMP standards (ISO 11615, ISO 11616, ISO 11238, ISO 11239 and ISO 11240)
define, characterise, and uniquely identify regulated Medicinal Products for human use from approval,
to 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 normative use of HL7 common product model (CPM) and
structured product labeling (SPL) messaging is described. References to the use of other relevant
standards for Medicinal Product information are included in this document to support successful
information exchange.
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/IEC 5218, Information technology — Codes for the representation of human sexes
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 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/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 Reference Information Model (RIM).
ISO/TS 20443:2017(E)
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 and definitions
No terms and definitions are listed in this document.
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/
4 Message exchange
4.1 General
HL7 messaging standards are widely implemented globally. The HL7 V3 messaging standard deals with
a static model of healthcare information as viewed within the scope of HL7 standards development
activities. ISO recognises HL7 as an accredited partner organisation for mutually issuing standards.
The first mutually published standard was ISO/HL7 21731:2006.
HL7 V3 was developed to address the complex requirements of health information technology. The
HL7 Reference Information Model (RIM) is the cornerstone of V3 and the essential model from which
all HL7 messages are derived. The RIM defines data content needed in a specific context and provides
an explicit representation of the semantic and lexical connections that exist between the information
carried in the elements of a message. V3 seeks to develop specifications that facilitate interoperability
between systems. The HL7 model-driven methodology is used to develop consensus-based standards
for healthcare system interoperability and information exchange. HL7 V3 messages are based on an
XML encoding syntax.
The ISO IDMP standards were designed to specify the necessary data elements and associated
standards to be used for unique identifiers. These were developed as an integral part of the IDMP
consensus requirements and are consistent with the HL7 Common Product Model (CPM). The IDMP
data elements represent a subset of those in the CPM. The normative use of HL7 standards will facilitate
the integration of IDMP into the broader healthcare community.
4.2 Message exchange format
In the context of this document, the normative message exchange format to be utilised as reference
in transactions is HL7 Structured Product Labeling (SPL). SPL is a standard message exchange format
based on Clinical Document Architecture (CDA) and the HL7 Reference Information Model (RIM).
Various solutions for creating SPL files exist and range from basic software tools to comprehensive
information management systems. SPL instances (code snippets) are provided throughout to illustrate
the representation of an IDMP concept within the HL7 SPL message exchange format. Technical
conformance criteria for SPL messages will not be addressed in this document and shall be left to
regional guidance/implementation per their respective requirements. A reference to the most up
to date HL7 CPM and SPL reference as a resource for IDMP implementation is accessible on the HL7
1)
website .
2 © ISO 2017 – All rights reserved
ISO/TS 20443:2017(E)
4.3 Controlled vocabularies
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 described in this document apply to the concepts, which are required to uniquely
identify, characterise, and exchange regulated Medicinal Products and associated information. A
long-term goal for IDMP is to promote the development of controlled vocabularies for worldwide
application, with transitional measures envisioned to accommodate regional requirements. Regional
guidance/implementation guides shall be developed to support practical implementation within a
given region/jurisdiction. The development of a technical report for identifying core principles for the
maintenance of identifiers and terms for ISO IDMP shall be developed and referenced for applicable
ISO IDMP standards and corresponding technical specifications upon completion.
NOTE Harmonisation by regions to adopt identical controlled vocabularies for IDMP implementation is out
of the scope of this document, but is being facilitated by external activities outside of ISO. It is anticipated that
this will be revisited as an in scope activity within ISO IDMP as the standard is adopted worldwide over time.
5 Conformance terminology and context as it relates to the ISO IDMP standards
and corresponding technical specifications
— Mandatory: Defining elements necessary for the unique identification of Medicinal Products per the
ISO IDMP standards/technical specifications.
— Conditional: Conditional applies to the “within category” data elements, as applicable, when there
are alternative data sources for a given data element(s) to identify a medicinal/pharmaceutical
product. Regional implementation of the ISO IDMP standards/technical specifications may elevate
the conditional conformance categories to “mandatory” per regional requirements.
— Optional: When listed at the category level (e.g. specified substance), optional corresponds to
ISO categories or data elements that are not absolutely necessary for the unique identification of
medicinal/pharmaceutical products according to the ISO IDMP standards/technical specifications.
Regional implementation of the ISO IDMP standards/technical specifications may elevate the
optional conformance categories to “mandatory” or “conditional” per regional requirements.
6 Maintenance of IDMP data elements and IDMP identifiers
6.1 General
Creation, maintenance, and publication of the actual IDMP identifiers are envisioned as a distributed
process where each participating regulatory authority would establish and maintain the identifiers
utilised in their respective regions. Over the longer term, a list of certain identifiers for global use may
be developed and agreed via a federated approach, and associated with the regulatory process in each
respective region. It is anticipated that IDMP maintenance requirements will mature and evolve over
time and IDMP scope and use cases expand.
6.2 Translation and language
With the specific exception of Medicinal Product name information (see A.2.13), there is no description
of the translation of information described in ISO 11615. It was acknowledged that, for global
implementation, translation of the information will be required and will occur according to regional
implementation guidelines as applicable.
The requirement for translation is determined by a region. An international body may or may not
require documents translated in some or all languages of its member nationalities. In addition, a
country with multiple sizable sub-populations using multiple languages may or may not require
translations into more than one of these languages. The IDMP standards do not set such requirements.
The multilingual make-up of many regions are supported by HL7 CPM and SPL for multilingual contexts
ISO/TS 20443:2017(E)
and international exchange of IDMP data. Annex J specifies how SPL is to be utilised in support of
multilingual requirements.
7 Why standardisation of identification of Medicinal Products is needed
Medicines regulatory authorities and pharmaceutical industry engage in an intensive information
exchange during drug development, drug evaluation and approval phase and the post-authorisation
phase. The standardisation of Medicinal Product information is regarded as one of the key elements of
this information flow.
However, regulators in the various regions have established their own procedures and applications
with standards that differ in data format, content, language, and applied terminology (e.g. different
terminology is used for describing substances, routes of administration, pharmaceutical dose forms,
pharmaceutical products, and Medicinal Products).
Due to the lack of a common and harmonised approach, both regulators and pharmaceutical industry
are confronted with the following issues:
— no possibility to exchange Medicinal Product information between medicines regulatory authorities
and pharmaceutical industry in a structured and efficient way;
— difficulties in ensuring data consistency and in evaluating and comparing Medicinal Product-
related information across the regions due to the lack of harmonised definitions of terminologies
and data sets, which impairs pharmacovigilance and electronic prescription/dispensing activities,
especially across borders;
— for the pharmaceutical industry, major administrative burdens and duplication of efforts
requiring substantial human and financial resources to comply with and handle different regional
requirements;
— lack of consistency in the use of terminology in the healthcare community.
The objectives of the IDMP are to address the issues outlined above by developing harmonised
standards that build on the regulatory, scientific, and technical processes already established and to
support the population and maintenance of existing systems/applications with fully reliable regulatory
Medicinal Product information.
Harmonised standards will support external stakeholders in developing “off-the-shelf” interoperable
tools in conformance with international standards. International standards will also help maximise
forward compatibility of data and minimise the complexities of backward compatibility.
8 General considerations
8.1 Overview
This document is intended to accompany, but not replace, ISO 11615 or HL7 CPM/SPL standards.
To satisfy the requirements as described in this document, the following identifiers shall be specified as
described in this document for the unique identification of Medicinal Products:
— Medicinal Product Identifier (MPID),
— Medicinal Product Package Identifier (PCID);
— Medicinal Product Batch Identifier (BAID 1), allocated to a specific batch of a Medicinal Product,
which appears on the outer packaging of the Medicinal Product;
— Medicinal Product Batch Identifier (BAID 2), allocated to a specific batch of a Medicinal Product,
which appears on the immediate packaging, where this is not the outer packaging;
4 © ISO 2017 – All rights reserved
ISO/TS 20443:2017(E)
— expiration date;
— serialisation-package level identification of a packaged Medicinal Product (including the particular
package configuration). Serial numbers should be numeric (numbers) or alphanumeric (include
letters and/or numbers) and should have no more than 20 characters (letters and/or numbers).
NOTE 1 Serialisation requirements are given in regional guidance.
NOTE 2 In addition, there is an association with Pharmaceutical Product Identifiers (PhPIDs) as defined in
ISO 11616 and ISO/TS 20451.
NOTE 3 Reference made to ISO 11615 for description/context of BAID 1 and BAID 2.
8.2 General considerations related to the description of the information modelling
principles and practices
8.2.1 Overview
The information modelling in this document uses the Unified Modelling Language (UML), which is
maintained by the Object Management Group (OMG).
UML may say the same thing in several different ways, and there are different styles and patterns that
may be followed. The use of UML in this document utilises classes, attributes and basic association
relationships only. Some constructs (such as stereotypes and complex relationships) have been
explicitly avoided for the reason cited above. In addition, colour has been used in the diagrams to help
visualise groups of associated entities together with one another (see Figure 1).
Figure 1 explains the represented approach for this document.
Figure 1 — Legends for colour coding of model classes
8.2.2 Conceptual overview diagrams
The conceptual overview diagram provides a framework with which to view the more detailed
descriptions of information (see Figure 2).
The Medicinal Product and investigational Medicinal Product overarching models (see Figure 5 and
Figure 7) show a single representative class from each particular information section, related to the
core concept (either the Medicinal Product or the Investigational Medicinal Product).
Basic cardinalities between the Medicinal Product or the Investigational Medicinal Product and these
core classes are shown, but none of the detailed entities, relationships or attributes is described.
ISO/TS 20443:2017(E)
Figure 2 — Example conceptual overview diagram
8.2.3 Section high-level diagrams
The high-level diagrams provided at the start of each section of information show all the classes
required to describe the information for that section and the conceptual relationships between those
classes, with the starting point always as the (Investigational) Medicinal Product.
No attributes and no detailed cardinalities are shown in these conceptual diagrams, as again their
primary purpose is to provide a framework with which to view the more detailed descriptions of
information that follow in the detailed description diagrams.
6 © ISO 2017 – All rights reserved
ISO/TS 20443:2017(E)
Figure 3 — Example section high-level diagram
8.2.4 Detailed description diagrams
The detailed description diagrams for each section show all the classes and all the attributes required
to describe the information for that section, and the detail of the conceptual relationships between
those classes.
ISO/TS 20443:2017(E)
Figure 4 — Example detailed description diagram
8.2.5 Relationships between classes
Relationships between classes are described in the context of the (Investigational) Medicinal Product,
and are described simply as associations, with no further qualification as to the role or type of the
association, in order to keep the model simple.
Cardinalities on relationships are given in a single direction only: the direction with the (Investigational)
Medicinal Product always as the direct or indirect source entity. The rationale for this is that the scope
of this document is to describe the (Investigational) Medicinal Product and its associated information;
therefore, having the (Investigational) Medicinal Product always as the source entity brings clarification
and avoids describing complex many-to-many cardinalities that might occur in a reverse direction from
an entity towards the (Investigational) Medicinal Product.
A cardinality of “1” is synonymous with a cardinality of “1.1”.
A cardinality of “1” between entities is reflected in the text as the information for that entity shall be
specified, and that only one set of the entity information shall be given.
8 © ISO 2017 – All rights reserved
ISO/TS 20443:2017(E)
A cardinality of “1.*” between entities is reflected in the text as the information for that entity shall be
specified, and that one or more sets of the entity information shall be given.
A cardinality of “0.1” between entities is reflected in the text as the information for that entity can be
specified, and that one set of the entity information can be given.
A cardinality of “0.*” between entities is reflected in the text as the information for that entity can be
specified, and that one or more sets of the entity information can be given.
Some optional attributes can be elevated to mandatory if some conditions are met. Please see Clause 5.
See ISO 21090 for more information on composition of attributes. A datatype for the data in each
attribute is not specified directly in the model. However, the text description for each attribute indicates
the form in which data should be specified.
8.2.6 Attributes of classes
Attributes of a class are described using an attribute name in the model. The definition, description and
example values for the attribute are given in the text following the model diagram.
An attribute showing no explicit cardinality means that the attribute shall be valued with one value
(this is the equivalent to [1]).
An attribute showing a cardinality of [1.*] means that the attribute shall be valued with one or
more values.
An attribute showing a cardinality of [0.1] means that the attribute can be valued with one value.
An attribute showing a cardinality of [0.*] means that the attribute can be valued with one or more values.
8.2.7 Generalised classes and patterns
There is one use of a generalised class in the diagrams whereby the pattern for a set of information is
described once, but applied for use for several classes. For simplicity, this has not been described by
using the formal UML generalisation/specialisation relationships, but by using a specialised class name.
The detailed representation of an “Organisation”, its “Contact Persons” and its “Other Locations” is
described in Annex G. Wherever information of type “Organisation” with its “Contact Person(s)” and/or
“Other Locations” is required, as for example in the class “Manufacturer/Establishment (Organisation)”
or the “Medicines Regulatory Agency (Organisation)” class, the “(Organisation)” in the class name
indicates that the information shall be described as per the generalised “Organisation” class.
There is also one generalised pattern used several times in the diagrams whereby generic classes
provide the ability to describe something using (unspecified) classification, nomenclature or
identification systems. To do this at the conceptual level, the model shows a class with two attributes:
the first to identify the system itself (a classification, nomenclature or identification system), and the
second to describe the applicable term or value from that system.
9 Information for an authorised Medicinal Product
9.1 General
The main concepts modelled in Figure 3 and described below should apply in order to identify and
characterise an authorised Medicinal Product
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...