ISO/TS 20443:2017

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

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ISO/TS 20443:2017(E)

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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
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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
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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.
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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.
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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).
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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 .
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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
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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 w
...