kSIST-TS FprCEN ISO/TS 20443:2026

• Abstract:

  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.

• Status: Not Published
• Public Enquiry End Date: 27-Sep-2026
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ITC - Information technology
• Current Stage: 5520 - Unique Acceptance Procedure (UAP) (Adopted Project)
• Start Date: 22-Jul-2026
• Due Date: 09-Dec-2026
• Completion Date: 20-Aug-2026
• Ref Project: FprCEN ISO/TS 20443 - Health informatics - Identification of medicinal products - Implementation for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO/DTS 20443:2026)

• Referred By: SIST EN 50626-2:2023 - Conduit systems buried underground for the protection and management of insulated electrical cables or communication cables - Part 2: Polyethylene (PE), Polypropylene (PP) or Unplasticized poly(vinyl chloride) (PVC-U) conduit systems - Requirements for solid wall conduits, fittings and the system used in special applications
• Effective Date: 09-Feb-2026
• Referred By: SIST EN 15416-5:2025 - Adhesives for load bearing timber structures other than phenolic and aminoplastic - Test methods - Part 5: Determination of minimum pressing time under referenced conditions
• Effective Date: 28-Jan-2026
• Referred By: SIST EN 12814-1:2026 - Testing of welded joints of thermoplastics semi-finished products - Part 1: Bend test
• Effective Date: 28-Jan-2026
• Referred By: SIST EN 17618:2022 - Adhesives - Wood-to-wood adhesive bonds for non-structural applications - Determination of shear strength by compressive loading
• Effective Date: 28-Jan-2026
• Referred By: SIST EN 302-1:2023 - Adhesives for load-bearing timber structures - Test methods - Part 1: Determination of longitudinal tensile shear strength
• Effective Date: 28-Jan-2026
• Referred By: SIST EN 302-6:2023 - Adhesives for load-bearing timber structures - Test methods - Part 6: Determination of the minimum pressing time under referenced conditions
• Effective Date: 28-Jan-2026
• Referred By: SIST EN 302-4:2023 - Adhesives for load-bearing timber structures - Test methods - Part 4: Determination of the effects of wood shrinkage on the shear strength
• Effective Date: 28-Jan-2026
• Referred By: SIST EN 14257:2019 - Adhesives - Wood adhesives - Determination of tensile strength of lap joints at elevated temperature (WATT '91)
• Effective Date: 28-Jan-2026
• Referred By: SIST EN 12814-7:2024 - Testing of welded joints of thermoplastics semi-finished products - Part 7: Tensile test with waisted test specimens
• Effective Date: 28-Jan-2026
• Referred By: SIST EN 12814-2:2021 - Testing of welded joints of thermoplastics semi-finished products - Part 2: Tensile test
• Effective Date: 28-Jan-2026
• Referred By: SIST EN 15416-4:2025 - Adhesives for load bearing timber structures other than phenolic and aminoplastic - Test methods - Part 4: Determination of open assembly time under referenced conditions
• Effective Date: 28-Jan-2026
• Referred By: SIST EN ISO 2411:2024 - Rubber- or plastics-coated fabrics - Determination of coating adhesion (ISO 2411:2024)
• Effective Date: 28-Jan-2026
• Referred By: SIST EN 17467:2022 - Surfaces for sports areas - Test method for the determination of the residual deformation of synthetic or organic infill granules after static load
• Effective Date: 28-Jan-2026
• Referred By: SIST EN 302-3:2023 - Adhesives for load-bearing timber structures - Test methods - Part 3: Determination of the effect of acid damage to wood fibres by temperature and humidity cycling on the transverse tensile strength
• Effective Date: 28-Jan-2026
• Revises: SIST-TS CEN ISO/TS 20443:2018 - 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)
• Effective Date: 28-Jan-2023

Overview

kSIST-TS FprCEN ISO/TS 20443:2026 is a technical specification developed by SIST, aligned with international efforts through ISO and CEN, under the scope of health informatics. This standard supports the unique identification and precise exchange of regulated medicinal product information, focusing specifically on the implementation of ISO 11615 data elements and structures. It serves as a guide for regulators, marketing authorization holders, and healthcare solution providers to ensure global interoperability and consistency for medicinal product identification, from approval through post-marketing and withdrawal phases.

The specification brings together requirements for encoding, structuring, and exchanging medicinal product data in compliance with the broader ISO IDMP framework. It references key interoperability technologies and messaging standards such as HL7 Common Product Model (CPM), Structured Product Labeling (SPL), and HL7 FHIR, thus fostering semantic, syntactic, and technical interoperability across the pharmaceutical and regulatory landscapes.

Key Topics

• Unique Medicinal Product Identification: Provides guidance on structuring data for unambiguous identification, covering medicinal products, ingredients, packaging, and pharmaceutical products.
• Implementation of ISO 11615: Aligns data elements and structures for regulatory and industry exchanges, allowing consistent tracking and management of medicinal products.
• Interoperability Standards: Details use cases for HL7 messaging frameworks, including SPL and FHIR, facilitating the reliable exchange of product data across systems and organizations.
• Controlled Vocabularies: Ensures standardized terminology for products, supporting clear, machine-readable information and reducing ambiguity.
• Information Modelling: Offers structured methodologies for information flow, class relationships, attributes, and data integrity, supporting precise product descriptions and regulatory submissions.
• Regulatory Interactions: Outlines requirements for data exchanges between medicines authorities, pharmaceutical companies, clinical trial sponsors, and other authorized entities.

Applications

The practical value of kSIST-TS FprCEN ISO/TS 20443:2026 is evident in a variety of real-world scenarios, including:

• Regulatory Submissions: Streamlines the preparation and exchange of regulated product information with authorities, supporting activities from initial approval through renewal or withdrawal.
• Pharmacovigilance and Post-marketing Surveillance: Enables consistent tracking of medicinal products for safety monitoring and adverse event reporting, essential for public health.
• Clinical Trials: Supports clear identification of investigational medicinal products, allowing reliable exchange of clinical trial authorizations and reporting information.
• Global Pharmaceutical Supply Chains: Ensures transparent traceability of medicinal products as they move across borders and between stakeholders.
• Health IT System Integration: Facilitates interoperability between regulatory agencies’ databases, pharmaceutical information management systems, and healthcare provider platforms by adopting HL7-based messaging and representation models.
• Data Analytics and FAIR Principles: Supports the collection of findable, accessible, interoperable, and reusable data for advanced analytics, regulatory oversight, and research.

Related Standards

For comprehensive medicinal product identification and exchange, the following ISO and CEN standards are referenced within or closely related to kSIST-TS FprCEN ISO/TS 20443:2026:

• ISO 11615: Identification of medicinal products – Data elements and structures for the unique identification and exchange of regulated medicinal product information.
• ISO 11616: Data elements and structures for pharmaceutical product identification.
• ISO 11238: Data elements for substances in medicinal products.
• ISO 11239: Standards for pharmaceutical dose forms, units of presentation, routes of administration, and packaging.
• ISO 11240: Units of measurement for medicinal products.
• ISO/TS 19844, ISO/TS 20440, ISO/TS 20451: Implementation guidelines for related IDMP standards.
• HL7 SPL, HL7 FHIR, HL7 CPM: Messaging standards for exchange and semantic interoperability.
• ISO/HL7 27953-1 and 27953-2: Adverse event reporting for pharmacovigilance.

These standards together support the broad goal of an internationally harmonized system for the consistent, safe, and effective management of medicinal product information across healthcare, regulatory, and industry domains.

SLOVENSKI STANDARD
01-september-2026
Zdravstvena informatika - Identifikacija medicinskih izdelkov - Uporaba ISO 11615
podatkovnih elementov in struktur za enotno identifikacijo in izmenjavo
predpisanih informacij o medicinskih izdelkih (ISO/DTS 20443:2026)
Health informatics - Identification of medicinal products - Implementation for ISO 11615
data elements and structures for the unique identification and exchange of regulated
medicinal product information (ISO/DTS 20443:2026)
Medizinische Informatik - Identifikation von Arzneimitteln - Implementierungsleitfaden für
ISO 11615 Datenelemente und Strukturen zur eindeutigen Identifikation und zum
Austausch von vorgeschriebenen Arzneimittelinformationen (ISO/DTS 20443:2026)
Informatique de santé - Identification des médicaments - Lignes directrices pour
limplémentation des éléments de données et structures ISO 11615 pour lidentification
unique et léchange dinformations réglementées sur les médicaments (ISO/DTS
20443:2026)
Ta slovenski standard je istoveten z: FprCEN ISO/TS 20443
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.

FINAL DRAFT
Technical
Specification
ISO/DTS 20443
ISO/TC 215
Health informatics — Identification
Secretariat: ANSI
of medicinal products —
Voting begins on:
Implementation for ISO 11615 data
2026-07-16
elements and structures for the
Voting terminates on:
unique identification and exchange
2026-10-08
of regulated medicinal product
information
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/CEN PARALLEL PROCESSING LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO/DTS 20443:2026(en) © ISO 2026

FINAL DRAFT
ISO/DTS 20443:2026(en)
Technical
Specification
ISO/DTS 20443
ISO/TC 215
Health informatics — Identification
Secretariat: ANSI
of medicinal products —
Voting begins on:
Implementation for ISO 11615 data
elements and structures for the
Voting terminates on:
unique identification and exchange
of regulated medicinal product
information
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2026
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO/DTS 20443:2026(en) © ISO 2026

ii
ISO/DTS 20443:2026(en)
Contents Page
Foreword .v
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
3.1 Abbreviations .3
4 Message exchange. 4
4.1 General .4
4.2 Message exchange format .5
4.3 Controlled vocabularies .5
5 Conformance terminology and context as it relates to the ISO standards on IDMP and
their corresponding technical specifications . 6
6 Maintenance of IDMP data elements and IDMP identifiers . 6
6.1 General .6
6.2 Translation and language .7
7 Why standardization of identification of medicinal products is needed . 7
8 General considerations . 7
8.1 Overview .7
8.2 General considerations related to the description of the information modelling
principles and practices .8
8.2.1 Overview .8
8.2.2 Conceptual overview diagrams .9
8.2.3 Section high-level diagrams .10
8.2.4 Detailed description diagrams .10
8.2.5 Relationships between classes .11
8.2.6 Attributes of classes . 12
8.2.7 Generalised classes and patterns . 12
9 Information for an authorised medicinal product .13
9.1 General . 13
9.2 Medicinal product . 15
9.3 Header . 15
9.4 Medicinal product name .16
9.5 Manufacturer - Establishment (Organization).16
9.6 Marketing authorisation .17
9.7 Packaged medicinal product .17
9.8 Pharmaceutical product .18
9.9 Ingredient.19
9.10 Clinical particulars . 20
10 Investigational medicinal product identifier (IMPID) .20
10.1 Conceptual overview of the information for an investigational medicinal product . 20
10.2 Investigational medicinal product . 22
10.3 Clinical trial authorisation . 22
10.4 Investigational medicinal product name . 23
10.5 Header . 23
10.6 Manufacturer - Establishment (Organization).24
10.7 Pharmaceutical product .24
10.8 Investigational packaged medicinal product . 25
10.9 Ingredient. 25
10.10 Clinical particulars . 26

iii
ISO/DTS 20443:2026(en)
11 Conceptual and detailed information models of authorised and investigational
medicinal product .26
Annex A (normative) Medicinal product .31
Annex B (normative) Marketing authorisation .65
Annex C (normative) Packaged medicinal product (including manufactured item and device) .92
Annex D (normative) Ingredient, substance and strength .139
Annex E (normative) Pharmaceutical product and device .163
Annex F (normative) Clinical particulars .172
Annex G (normative) Organization .194
Annex H (normative) Manufacturer - Establishment . 200
Annex I (normative) Investigational medicinal product . 209
Annex J (informative) SPL documents .229
Annex K (informative) HL7® FHIR® Mappings . 248
Bibliography . 266

iv
ISO/DTS 20443:2026(en)
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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
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, in collaboration with
the European Committee for Standardization (CEN) Technical Committee CEN/TC 251, Health informatics, in
accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO/TS 20443:2017) which has been technically
revised.
The main changes are as follows:
— Extensive technical and structural revision of the standard, including more than 70 structural changes
to improve clarity, consistency, and usability.
— Alignment with the latest developments of ISO 11615, including updates to the overall data model and
related concepts.
— Major extension and refinement of the information model through the introduction of new attributes,
associations, and classes, as well as refinement and reallocation of existing elements across pharmaceutical
product, manufactured item, device, ingredient, substance, packaging, and regulatory domains.
— Redesign of the strength representation model, including the introduction of “Strength Type”, “Strength”,
and “Reference Substance” constructs, revised substance-strength associations, and alternative linkage
mechanisms consistent with ISO 11615, while preserving backward compatibility.
— Introduction of interoperability mappings and implementation artefacts, including a new informative
Annex K defining mappings to HL7 FHIR, as well as inclusion of HL7 FHIR (XML/JSON) examples and
updated HL7 SPL snippets.
— Strengthening of model constraints and data integrity through updates to cardinalities, mandatory
elements, and classification structures (e.g. therapeutic indication, population grouping, product domain
classification).
— Clarification and enhancement of existing requirements, including updates to cardinalities, classifications,
and modelling constraints to ensure more precise and consistent interpretation.

v
ISO/DTS 20443:2026(en)
— Addition of informative content, bibliographic references, and explanatory material to support
implementation and understanding.
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.

vi
ISO/DTS 20443:2026(en)
Introduction
1)
This document provides requirements and recommendations for implementing ISO 11615 . It is one of
the five ISO International Standards and four ISO Technical Specifications which together characterise the
basis for the unique and unambiguous identification of medicinal products (IDMP). The ISO documents on
IDMP are: ISO 11615, ISO/TS 20443 (this document), ISO 11616, ISO/TS 20451, ISO 11238, ISO/TS 19844,
ISO 11239, ISO/TS 20440, and ISO 11240.
The primary purpose of 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 this information, unique identifiers are
to be produced in conformance with the standards to support applications where it is important 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 and implementation guides to support practical
implementation within a given region or jurisdiction. ISO/TR 14872 describes core principles for supporting
the development, implementation and ongoing maintenance of IDMP identifiers and terminologies.
The data elements and message specifications described in this document support, at a minimum, the
following interactions within the following scope:
— regulatory medicines authority to regulatory medicines authority;
— pharmaceutical company to regulatory medicines authority;
— sponsor of a clinical trial to regulatory medicines authority;
— regulatory medicines authority to other stakeholders (as applicable);
— regulatory medicines authority to worldwide-maintained data sources.
Unique identifiers produced in conformance with this document are aimed at supporting applications where
it is necessary to reliably identify and trace the use of medicinal products.
1) Third edition under preparation. Stage at the time of balloting: ISO/DIS 11615.

vii
FINAL DRAFT Technical Specification ISO/DTS 20443:2026(en)
Health informatics — Identification of medicinal products —
Implementation for ISO 11615 data elements and structures
for the unique identification and exchange of regulated
medicinal product information
IMPORTANT — The electronic file of this document contains colours which are considered to be
useful for the correct understanding of the document. Users should therefore consider printing this
document using a colour printer.
1 Scope
This document provides technical and business-oriented requirements and recommendations for
2)
implementing ISO 11615 within systems that create, exchange, and process IDMP compliant medicinal
product information. It focuses on the data elements, structures, and message specifications required to
construct and interpret well-formed IDMP messages for regulatory and industry use. The scope covers
interactions involving:
— regulatory authorities;
— pharmaceutical companies and marketing authorisation holders;
— clinical trial sponsors;
— other authorised stakeholders and global data sources.
This document applies to the exchange of medicinal product information needed to ensure unique, consistent,
and traceable identification of medicinal products. Furthermore, to support successful information
3)
exchange, the use of the non-normative HL7® CPM (Common Product Model), the HL7® SPL (Structured
4)
Product Labeling), and HL7® FHIR® are described. References to the use of other relevant standards for
medicinal product information are included in this document to support successful information exchange.
The document does not cover the governance, creation, or maintenance of identifier repositories, nor region
specific regulatory procedures (e.g. marketing authorisation workflows), or internal business processes
and system design for individual organizations, or training materials or domain-specific regulatory
interpretations. Regional implementation guides can be consulted for jurisdiction-specific requirements.
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, Code for individual languages and language groups
ISO 3166-1, Codes for the representation of names of countries and their subdivisions — Part 1: Country code
ISO 8601-1, Date and time — Representations for information interchange — Part 1: Basic rules
2) Third edition under preparation. Stage at the time of balloting: ISO/DIS 11615:2026.
3) HL7 is the registered trademark of Health Level Seven International. This information is given for the convenience of
users of this document and does not constitute an endorsement by ISO of the product named.
4) FHIR is a trademark of HL7®. This information is given for the convenience of users of this document and does not
constitute an endorsement by ISO of the product named.

ISO/DTS 20443:2026(en)
ISO 8601-2, Date and time — Representations for information interchange — Part 2: Extensions
ISO 12639, Graphic technology — Prepress digital data exchange — Tag image file format for image technology
(TIFF/IT)
ISO/TS 19844:2018, Health informatics — Identification of medicinal products (IDMP) — Implementation
guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated
information on substances
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
unique identification and exchange of regulated pharmaceutical product information
ISO/TS 20440, Health informatics — Identification of medicinal products — Implementation guidelines for
ISO 11239 data elements and structures for the unique identification and exchange of regulated information on
pharmaceutical dose forms, units of presentation, routes of administration and packaging
ISO/TS 20451, Health informatics — Identification of medicinal products — Implementation guidelines for
ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical
product information
ISO 21090, Health Informatics — Harmonized data types for information interchange
ISO/HL7 27953-1:2011, Health informatics — Individual case safety reports (ICSRs) in pharmacovigilance —
Part 1: Framework for adverse event reporting
ISO/HL7 27953-2, Health informatics — Individual case safety reports (ICSRs) in pharmacovigilance — Part 2:
Human pharmaceutical reporting requirements for ICSR
3 Terms and definitions
No terms and definitions are listed in this document.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/

ISO/DTS 20443:2026(en)
3.1 Abbreviations
ATC anatomical therapeutic chemical
BAID medicinal product batch identifier
BAID 1 medicinal product batch identifier (outer packaging)
BAID 2 medicinal product batch identifier (immediate packaging)
CDA clinical document architecture
CEN European Committee for Standardisation
CPM common product model
EMA European Medicines Agency, EU
FDA Food and Drug Administration, US
FHIR® Fast Healthcare Interoperability Resources
FLFS fulfills relationship
GTIN® Global Trade Identification Number; a trademark of GS1
GUID globally unique identifier
HL7® Health Level Seven
International Conference on Harmonisation of Technical Requirements for Registration of
ICH
Pharmaceuticals for Human Use
ICSR individual case safety reporting
ID identifier
IDMP identification of medicinal product
IG implementation guide
IMPID investigational medicinal product identifier
IND investigational new drug
INN international nonproprietary name
ISO International Organization for Standardisation
JSON JavaScript object notation
LOINC logical observation identifiers names and codes
MPID medicinal product identifier
NCI National Cancer Institute
NDA new drug application
OID object identifier
OMG object modelling group
ISO/DTS 20443:2026(en)
PCID packaged medicinal product identifier
PCPC personal care products council
PhPID pharmaceutical product identifier
PSUR periodic safety update report
RIM reference information model
SDOs standards development organizations
SME small to medium enterprise
SmPC summary of product characteristics
SPL structured product labeling
Substance ID substance identifier
UDI unique device identification (code)
UML unified modeling language
UUID universally unique identifier
XML extensible markup language
4 Message exchange
4.1 General
HL7® messaging standards have been widely implemented globally. The HL7® V3 architecture messaging
standard deals with a static model of healthcare information as viewed within the scope of HL7® standards
development activities. The HL7® FHIR® (Fast Healthcare Interoperability Resources) specification
5)
defines a set of capabilities for use across the healthcare process, about 157 modular components (called
Resources) that can be assembled into working systems that support the wider healthcare domain. ISO
recognises HL7® as an accredited partner organization for mutually issuing standards. The first mutually
published standard was ISO/HL7 21731.
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.
FHIR® is a specification based on emerging industry approaches, but informed by years of lessons around
requirements, successes and challenges gained through defining and implementing HL7® V2, HL7® v3 and
the RIM, and CDA. FHIR® focuses to simplify implementations, it leverages existing logical and conceptual
models to provide a consistent, easy to implement, and rigorous mechanism for exchanging data between
healthcare applications. FHIR® has built-in mechanisms for traceability to the HL7® RIM and other
important content models. This ensures alignment to HL7®’s previously defined patterns and best practices
without requiring the implementer to have intimate knowledge of the RIM or any HL7® v3 derivations.
5) As per current FHIR® Release #5: https:// hl7 .org/ fhir/

ISO/DTS 20443:2026(en)
6)
HL7® has confirmed that HL7® Version 3 is no longer actively developed and almost all new HL7®
projects have been building upon FHIR®. But some V3-based standards continue to be used in practice.
[7]
For example, CDA (Clinical Document Architecture) which is rooted in HL7® V3 models remains widely
implemented in many national programs and regulatory workflows (e.g. clinical documents, discharge
summaries, structured reports); the pharmacovigilance Individual Case Safety Report (ICSR) standards
(ISO/HL7 27953-1 and ISO/HL7 27953-2) used for adverse event reporting are HL7® V3-based and continue
to be officially reaffirmed and remain valid until at least December 2026 (as per ANSI/HL7 listings); the
HL7® SPL (see Reference [8]) and HL7® CPM (see Reference [9]) are also HL7® V3-based standards
7)
used for regulatory use cases (including IDMP) in one of the ICH regions . The framework described in
ISO/HL7 27953-1 shall apply.
Although not all current HL7® projects are based on FHIR®, nearly all new development, innovation efforts,
and strategic investments at HL7® now converge on FHIR®. This includes emerging interoperability
initiatives, accelerator programs, implementation guides, new tooling such as FHIR® Foundry, and federal
interoperability strategies, all of which overwhelmingly prioritize FHIR®.
The ISO standards on IDMP 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) and the HL7® FHIR®
specification. The IDMP data elements represent a subset of those in the CPM and FHIR®. The use of HL7®
messaging standards will facilitate the integration of IDMP into the broader healthcare community, improve
8)
interoperability through standardized resource-based data exchange, support FAIR data principles , reduce
integration costs and complexity, and provide a future-proof foundation for advanced analytics and decision
support.
4.2 Message exchange format
In the context of this document, the message exchange formats to be utilised as informative reference
in transactions are the HL7® SPL (Structured Product Labeling) and HL7® FHIR®. The HL7® SPL is a
standard message exchange format based on Clinical Document Architecture (CDA) and the HL7® Reference
Information Model (RIM). FHIR® and SPL instances (code snippets) and FHIR® mappings (see Annex K) are
provided in this document to illustrate the representation of an IDMP concept within the HL7® SPL message
exchange format and within HL7® FHIR® specification. Technical conformance criteria for messages will
not be addressed in this document and shall be left to regional guidance and implementations per their
respective requirements. A reference to the most up to date HL7® CPM, HL7 SPL, and HL7® FHIR® reference
9),10)
as a resource for IDMP implementation is accessible on the HL7® portal .
4.3 Controlled vocabularies
A controlled vocabulary is a standardised, predefined set of terms used to describe, categorize and retrieve
information in a consistent and unambiguous way. It ensures that everyone uses the same authorised terms
to refer to the same concepts, improving search accuracy and reducing confusion. Controlled vocabularies:
— ensure terminology consistency in how concepts are named and described (e.g. “oral tablet” is always
coded the same way);
— eliminate ambiguity by ensuring each term refers to only one concept (e.g. regulators and applicants use
the same semantics through medicines’ life cycle);
6) The withdrawal and retirement of V3-based specifications signify the cessation of all maintenance activities, including
the discontinuation of tooling and editorial support, and formally denote that the specification has reached a mature state
and will no longer be subject to further enhancement.
7) US FDA.
8) The FAIR data principles are a set of internationally recognized guidelines designed to ensure that data can be
Findable, Accessible, Interoperable, and Reusable (Reference [10]).
9) https:// www .hl7 .org/
10) https:// hl7 .org/ fhir/
ISO/DTS 20443:2026(en)
— improve search and retrieval (since users do not need to guess which synonyms were used) and reduce
manual interpretation of the information because structured, coded data are machine readable;
— organize knowledge, making systems more navigable and interoperable;
— solve problems of synonyms, homographs and variant spellings by enforcing a one-to-one relationship
between concepts and preferred terms.
The controlled vocabularies are used in many domains, e.g. libraries (cataloguing, subject headings), in
databases and search engines, in knowledge graphs and AI systems (to ensure semantic consistency), in
ontologies and metadata standards, and they are foundational in organising information for retrieval and
supporting the semantic interoperability across systems.
In the regulatory, pharmaceutical and healthcare standards development domain there are many
terms in use to describe basic concepts used for different purposes and in different contexts. The terms
and definitions described in ISO 11615 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 or implementation guides shall be developed to support practical implementation within
[1]
a given region or jurisdiction. ISO/TR 14872 is a technical report that provides a framework for identifying
core principles for the maintenance of identifiers and terms for ISO IDMP standards.
NOTE Harmonization 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.
5 Conformance terminology and context as it relates to the ISO standards on IDMP
and their corresponding technical specifications
— Mandatory: Defining elements necessary for the unique identification of medicinal products per the ISO
IDMP standards and their 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 and pharmaceutical product.
Regional implementation of the ISO IDMP standards and 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 either not absolutely necessary for the unique identification
of medicinal or pharmaceutical products according to the ISO IDMP standards and their technical
specifications, or conditionally mandatory. Regional implementation of the ISO standards on IDMP
may elevate the optional conformance categories to “mandatory” or “conditional” to meet 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.
ISO/DTS 20443:2026(en)
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 can require documents
translated in some or all languages of its member nationalities. In addition, a country with multiple sizeable
sub-populations using multiple languages can require translations into more than one of these languages.
The IDMP standards do not set such requirements. The multilingual make-up of many regions is supported
by HL7® CPM and SPL for multilingual contexts and international exchange of IDMP data. For example,
Annex J specifies how SPL is to be utilised in support of multilingual requirements; also, multi-language
support in FHIR® (localization, internationalization) is available at https:// build .fhir .org/ languages .html
7 Why standardization 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
standardization 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 harmonized 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 harmonized definitions of terminologies and data
sets, which impairs pharmacovigilance, electronic prescription and electronic 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
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