ISO/TR 18728:2025

Technical
Report
ISO/TR 18728
First edition
Health informatics — Global
2025-12
medicinal product and ingredient
and batch registration as part of
identification of medicinal products
(IDMP)
Informatique de santé — Enregistrement global des
médicaments, des ingrédients et des lots en tant qu'élément de
l'identification des médicaments (IDMP)
Reference number
© ISO 2025
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Published in Switzerland
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and abbreviated terms . 1
3.1 Terms and definitions .1
3.2 Abbreviated terms .2
4 ISO standards on IDMP . . 2
4.1 General .2
4.2 ISO 11615 .2
4.3 ISO 11616 .3
4.4 ISO 11238 .3
4.5 ISO 11239 .3
4.6 ISO 11240 .3
4.7 ISO/TR 14872 .4
4.8 Global response to the ISO standards on IDMP .4
4.9 Supply chain .4
4.9.1 General .4
4.9.2 ISO/IEC 19988 .5
4.9.3 ISO/IEC 19987 . . .5
4.9.4 ISO 16791 .5
4.9.5 Global response to supply chain standards .5
5 Regulations . 5
5.1 General .5
5.2 EU Falsified Medicines Directive .6
5.3 European Commission Implementing Regulation (EU) .6
5.4 Drug Supply Chain Security Act .6
5.5 Track and trace systems in other countries .6
5.6 Summary .6
6 Vision and industry need . 6
7 Current trends . 7
7.1 General .7
7.2 Technology industry .7
7.3 Airline industry .7
7.4 Medical devices .7
8 Current systems . 8
8.1 General .8
8.2 Supply chain .8
8.2.1 General .8
8.2.2 Global trade item number (GTIN®) .8
8.2.3 EPCIS (electronic product code information services).9
8.2.4 Rice traceability .9
8.2.5 Current status for medicinal product identification (MPID) .10
8.2.6 Current status for medicinal product package identification (PCID) .10
8.2.7 Current status for substances and ingredients .10
8.2.8 Current status for medicinal product batch identifier (BAID) .10
8.3 Summary .11
Bibliography .12

iii
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
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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).
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constitute an endorsement.
For an explanation of 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 www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

iv
Introduction
The ISO standards on identification of medicinal products (IDMP) unambiguously define medicinal products
on a global level. Although the standards prescribe the use of global identifiers for substances, dosages, units
of measure, and pharmaceutical products, global identifiers for medicinal products or manufactured items
and batch are not foreseen since the latter is maintained in a distributed (local/regional) manner.
Medicinal product shortages are often caused by manufacturing issues, supply misallocation, and other
factors.
In a regulated market such as for medicinal products, the deliveries of (medicinal) product and ingredients
(and their respective batch) are segmented by markets, sometimes with a limited number of suppliers.
This document discusses the current options for global products and ingredients associated with batch
identifiers registration at global level. It outlines existing solutions for global traceability.

v
Technical Report ISO/TR 18728:2025(en)
Health informatics — Global medicinal product and
ingredient and batch registration as part of identification of
medicinal products (IDMP)
1 Scope
This document showcases existing practices to monitor supply chains as implemented in the healthcare
supply chains, by making use of medicines verification or authentication systems, or both, traceability tools,
safe communication technology solutions, and more.
This document also discusses the potential benefits of expanding the identification of medicinal products
(IDMP) to provide global identifiers for medicinal products, ingredients and batches. It also addresses
potential pathways to a global registration system.
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 22532, Health informatics — Identification of medicinal products — Core vocabulary for the IDMP
1)
Standards
3 Terms, definitions and abbreviated terms
For the purposes of this document, the terms and definitions given in ISO 22532 and the following apply.
ISO and IEC maintain terminology 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 Terms and definitions
3.1.1
batch
lot
specific quantity of a pharmaceutical product or other material 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
1) Under preparation. Stage at the time of publication: ISO/DIS 22532.

3.2 Abbreviated terms
DCID data carrier identifier
EMA European medicines agency
EPCIS electronic product code information services
GSRS global substance registration system
GSID global substance identifier
GTIN® global trade item number
MPID medicinal product identifier
PCID packaged medicinal product identifier
PhPID pharmaceutical product identifier
RFID radio frequency identification
UDI unique device identifier
UMC Uppsala monitoring centre
4 ISO standards on IDMP
4.1 General
Multiple standards have been written to enable the unique identification of medicinal products worldwide
by the pharmaceutical industry. These standards, the majority of which were published in 2012, provide
the framework for harmonizing data and processes to improve drug safety, simplify cross-border drug
prescriptions, enable more focused drug recalls, and increase the usage of the HL7 framework for
development.
4.2 ISO 11615
ISO 11615 provides a mechanism for countries to identify their nationally approved medicinal products in
a standardized way that can be understood globally. These global identifiers are intended to supplement
national identifiers and are recommended to be retained at four different levels:
— medicinal product identifier (MPID), to supplement the existing authorization number;
— packaged medicinal product identified (PCID), to identify each package for sale or supply;
— batch identifier 1 (BAID1), to track batch number on outer packaging;
— batch identifier 2 (BAID2), to track batch number on primary packaging (when not the outer packaging).
There is no recommendation in ISO 11615 for these four level of identifiers to be unique global identifiers.
ISO 11615 does recommend the use of ISO 11238 to define substance terms, the use of ISO 11239 to define
dose forms, and the use of ISO 11240 to define units of measure.
In addition, ISO 11615 provides a mechanism for national authorities to connect the PCID, BAID1, and BAID2
to the supply chain, which in addition to the product name, formulation, dosage, and strength, can also track
quantity, packaging configuration, form, fit, function, or sub-divisions or groupings of packaging:
— data carrier identifier (DCID), to uniquely identify items that are traded.

ISO 11615 acknowledges the prevalence of GS1® and GTIN® as the primary DCID, but recognizes that
multiple systems can be present in certain regions and provides the ability for the company to identify
which system is used and then provide the associated DCID.
4.3 ISO 11616
ISO 11616 provides a mechanism to identify the unique characteristics of a pharmaceutical product in its
administrable form at four levels based on substance term, substance strength, reference strength, and
administrable dose form at both the active substance and the specified substance level:
— pharmaceutical product identifier (PhPID), to uniquely identify the pharmaceutical product.
ISO 11616 recommends that the global PhPID be a unique global identifier different from all domains.
ISO 11616 also recommends the use of ISO 11238 to define substance terms, the use of ISO 11239 to define
dose forms, and the use of ISO 11240 to define units of measure.
4.4 ISO 11238
ISO 11238 outlines how to define substances and specified substances. It also recommends having a global
unique identifier and identifying all terms in English, with associated synonyms for other languages. It also
states that unique identifiers are publicly available and royalty-free.
4.5 ISO 11239
ISO 11239 specifies:
— the data elements, structures and relationships between the data elements required for the exchange of
information, which uniquely and with certainty identify pharmaceutical dose forms, units of presentation,
routes of administration and packaging items (containers, closures and administration devices) related
to medicinal products;
— a mechanism for the association of translations of a single concept into different languages, which is an
integral part of the information exchange;
— a mechanism for the versioning of the concepts to track their evolution;
— rules to help regional authorities to map existing regional terms to the terms created using this document,
in a harmonized and meaningful way.
4.6 ISO 11240
ISO 11240 specifies:
— rules for the usage and coded representation of units of measurement for the purpose of exchanging
information about quantitative medicinal product characteristics that require units of measurement
(e.g. strength) in the human medicine domain;
— requirements for units to provide traceability to international metrological standards;
— rules for the standardized and machine-readable documentation of quantitative composition and
strength of medicinal products, specifically in the context of medicinal product identification;
— the requirements for the representation of units of measurement in coded form;
— structures and rules for mapping between different unit vocabularies and language translations to
support the implementation of ISO 11240, considering that existing systems, dictionaries and repositories
use a variety of terms and codes for the representation of units.
The scope of ISO 11240 is limited to the representation of units of measurement for data.

4.7 ISO/TR 14872
ISO/TR 14872 describes the maintenance of unique identifiers for all IDMP terms and having a process to
manage the IDMP terminologies in a transparent manner. It describes the governance processes within
core and derived maintenance organizations (at the global level) and includes references to the way unique
machine-readable identifiers are used in the supply chain and as outlined in ISO/TS 16791.
4.8 Global response to the ISO standards on IDMP
In response to these global standards, multiple groups, spanning industry, technology providers, consultants
and regulators, have formed to enable these standards to come to fruition.
[15]
— The US and EMA worked closely together to align the substances in a GSRS database in accordance
with the guidance in ISO 11238.
— UNICOM developed trainings and guidance on what IDMP is and how to leverage it in the Health Care
domains.
— Uppsala monitoring centre (UMC) is actively working with countries worldwide to integrate and maintain
GSID’s and global PhPID’s in their own database and establish business rules.
— HL7 international developed corresponding FHIR message for the ISO standard and holds Connectathons
to test feasibility and connectivity.
— EMA began a regional implementation of the ISO standards by mandating the use of data management
services for substances, products, organizations, and referential (SPOR) management services.
— Several regulators such as Brazil, Canada and Switzerland are in the development phase to begin their
own IDMP implementation.
— US FDA has issued guidance calling for a global IDMP approach. FDA has undertaken a project to identify
and prioritize pharmaceutical quality/chemistry, manufacturing and controls (PQ/CMC) information
that would benefit from a structured submission approach. However, this PQ/CMC data standards project
is not FDA’s implementation of the ISO standards on IDMP. The FDA, EMA and UMC established the Global
IDMP Working Group (GIDWIG) to conduct projects that would lead to the global implementation of the
IDMP standards.
— The Pistoia Alliance, a collaborative effort between industry, is running an IDMP Ontology project to
digitalize ISO 11615, in a system-agnostic machine-readable model to ease the IDMP implementation
worldwide.
— SNOMED international is seeking to align the clinical terminology with IDMP.
— PQI utilizes HL7 objects that align with IDMP (substances) and share common concepts with SSG4.
As no guidance calls for the use of a global medicinal product ID, package ID, and batch identifier ID, limited
work has been done to develop a methodology for the same, although the connection between regulatory
and supply chain has been identified as a use case in ISO 16791.
4.9 Supply chain
4.9.1 General
Multiple standards have been written to support the smooth running of the supply chain worldwide.
Organizations such as GS1®, have taken a proactive role to shape the guidance, as they have over 40 years
of experience establishing and implementing best practices to identify, capture and share supply chain
information worldwide. Increasingly, standardization efforts have begun to link both the supply chain and
the medicinal product world, recognizing the need for end-to-end product traceability to improve drug
safety; these efforts have been recognised by numerous countries which have mandated the use of the GS1®
standards.
4.9.2 ISO/IEC 19988
ISO/IEC 19988 defines the version 2.0 of the core business vocabulary (CBV). The goal of ISO/IEC 19988
is to specify the structure of vocabularies and specific values for the vocabulary elements to be utilized
in conjunction with the ISO/IEC 19987 for data sharing both within and across enterprises. The aim is to
standardize these elements across users of EPC Information Services (EPCIS) to improve the understanding
of data contained in EPCIS events.
4.9.3 ISO/IEC 19987
ISO/IEC 19987 defines the version 2.0 of EPCIS. The goal of EPCIS is to enable disparate applications to
create and share visibility event data, both within and across enterprises. Ultimately, this sharing is aimed
at enabling users to gain a shared view of physical or digital objects within a relevant business context.
4.9.4 ISO 16791
ISO 16791 bridges the supply chain and health care requirements to recommend how to identify and label
medicinal products from the point of manufacture of packaged medicinal products to the point of dispensing.
It takes the terminology from ISO 11615 and suggests how to incorporate GTIN® with PCID, MPID, and
PhPID.
ISO 16791 also notes the importance of having a unique medicinal product identifier to maintain the
ability to track and trace worldwide. GTIN® + serialization number provides a unique code for tracking
and verification. ISO 16791 also notes the importance of having master data which includes the regulatory
product information so that the event data can be linked back to the product information.
4.9.5 Global response to supply chain standards
In response to these global standards, multiple groups, spanning industry, technology providers, consultants
and regulators, have taken action to enable these standards to come to fruition.
— The International Council of Medicinal Regulatory Authorities (ICMRA) Supply Chain Project issued a
memo entitled “Recommendations on Alignment of Existing and Planned Track and Trace Systems to
[16]
Allow for Interoperability” in 2017.
[17]
— In 2018, GS1® released the GS1 Regulatory Roadmap articulating the differences between a centralized
track and trace system, which provides a more robust view of the supply chain, and a decentralized point
of dispense verification, which is easier to implement.
— In 2021, the WHO collaboratively wrote a rep
...