SIST EN ISO 16791:2026

Health informatics - Requirements for international machine-readable coding of medicinal product package identifiers (ISO 16791:2026)

This document provides requirements on identification and labelling of medicinal products from the point of manufacturing of packaged medicinal product to the point of dispensing the product.
This document outlines commonly accepted international practices for automatic identification and data capture (AIDC) barcoding solutions for applications and applies to manufacturers, distributors, healthcare facilities and all parties involved in labelling and distribution of packaged medicinal products. These users can, however, consider the coding interoperability requirements for other AIDC technologies, e.g. radio frequency identification (RFID); that technology is not addressed in this document except as for information.

Medizinische Informatik - Anforderungen für internationale maschinenlesbare Kodierungen von Identifikatoren für Arzneimittelpackungen (ISO 16791:2026)

Dieses Dokument bietet Anforderungen an die Identifizierung und Etikettierung von Arzneimitteln, von der Herstellung des verpackten Arzneimittels bis zur Verabreichung des Produkts.
Dieses Dokument umreißt die allgemein gültigen, internationalen Praktiken für die automatische Erkennung und Datenerfassung (AIDC) mittels Strichcodelösungen für Anwendungen und gilt für Hersteller, Vertriebspartner, Gesundheitseinrichtungen und alle involvierten Beteiligten für die Etikettierung und den Vertrieb von verpackten Arzneimitteln. Diese Anwender können jedoch die Interoperabilitätsanforderungen der Kodierung für andere AIDC Technologien, z. B. Radiofrequenz-Identifikation (RFID) beachten; diese Technologie wird in diesem Dokument nur zu Informationszwecken erwähnt.

Informatique de santé - Exigences relatives au codage international lisible par machine des identifiants d'emballages de médicaments (ISO 16791:2026)

Le présent document spécifie les exigences relatives à l'identification et à l'étiquetage des médicaments, depuis le point de fabrication du médicament emballé jusqu'au point de distribution du produit.
Le présent document décrit les pratiques internationales communément admises pour les solutions de codage à barres d'identification et de capture de données automatiques (AIDC) pour les applications et s'applique aux fabricants, aux distributeurs, aux établissements de santé et à toutes les parties impliquées dans l'étiquetage et la distribution des médicaments emballés. Ces utilisateurs peuvent toutefois tenir compte des exigences d'interopérabilité du codage pour d'autres technologies d’AIDC, par exemple l'identification par radiofréquence (RFID); cette technologie n'est pas traitée dans le présent document, sauf en ce qui concerne l'information.

Zdravstvena informatika - Zahteve za mednarodne strojno berljive kode za pakiranje zdravil (ISO 16791:2026)

Ta dokument določa zahteve za identifikacijo in označevanje zdravil od točke proizvodnje pakiranega zdravila do točke izdaje izdelka.
Ta dokument opisuje splošno sprejete mednarodne prakse za rešitve avtomatske identifikacije in zajema podatkov (AIDC) z uporabo črtne kode za aplikacije in se uporablja za proizvajalce, distributerje, zdravstvene ustanove in vse strani, ki so vključene v označevanje in distribucijo pakiranih zdravil. Ti uporabniki lahko kljub temu upoštevajo zahteve za interoperabilnost kodiranja za druge AIDC tehnologije, npr. radiofrekvenčno identifikacijo (RFID); ta tehnologija v tem dokumentu ni obravnavana, razen kot informacija.

General Information

• Status: Published
• Public Enquiry End Date: 02-Jun-2025
• Publication Date: 28-May-2026
• ICS: 11.120.10 - Medicaments
• ICS: 35.040.50 - Automatic identification and data capture techniques
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ITC - Information technology
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 20-Apr-2026
• Due Date: 25-Jun-2026
• Completion Date: 29-May-2026
• Ref Project: EN ISO 16791:2026 - Health informatics - Requirements for international machine-readable coding of medicinal product package identifiers (ISO 16791:2026)

Relations

• Replaces: SIST-TS CEN ISO/TS 16791:2021 - Health informatics -- Requirements for international machine-readable coding of medicinal product package identifiers (ISO/TS 16791:2020)
• Effective Date: 01-Jul-2026

Overview

SIST EN ISO 16791:2026 establishes international requirements for the identification and labelling of medicinal product packages using machine-readable codes. Developed by the Slovenian Institute for Standardization (SIST) in alignment with ISO and CEN, this standard covers the entire journey of packaged medicinal products-from manufacturing to the point of dispensing. Its primary focus is on the adoption of automatic identification and data capture (AIDC) technologies, especially barcode solutions, to improve traceability, security, and patient safety within the pharmaceutical supply chain.

By ensuring globally harmonized and interoperable data structures for medicinal product package identifiers, ISO 16791:2026 supports stakeholders such as manufacturers, distributors, healthcare providers, and supply chain partners in implementing standardized labelling practices. While RFID and other AIDC technologies are referenced for interoperability, barcoding remains the core application in scope.

Key Topics

• AIDC Barcoding Solutions:
  • Guidance for the implementation of barcode technology across packaged medicinal products.
  • Emphasis on the use of standardized data structures (such as GS1 standards) for global interoperability.
• Unique Package Identification:
  • Requirements for assigning and encoding unique identifiers-including serial numbers, batch/lot numbers, and expiry dates-on all packaging levels.
• Traceability:
  • Enabling forward and backward tracking and tracing of medicinal products throughout the supply chain.
• Combating Falsification:
  • Measures to authenticate and verify the authenticity of medicinal products at various stages to prevent counterfeiting.
• Patient Safety:
  • Enhanced identification and verification at the point of care, reducing the risk of medication errors via machine-readable information.
• Support for Healthcare Systems:
  • Facilitating efficient procurement, stock management, and regulatory compliance through standardized identification protocols.
• Interoperability Considerations:
  • Although not covering RFID in detail, the document addresses compatibility with other AIDC technologies to enable future integration.

Applications

SIST EN ISO 16791:2026 delivers practical value across multiple applications in the healthcare and pharmaceutical sectors:

• Manufacturing:
  • Ensures each package leaving the production line carries a globally unique, machine-readable identifier for regulatory and operational control.
• Distribution Logistics:
  • Boosts efficiency and security by enabling automated scanning for tracking shipments and managing recalls or returns.
• Healthcare Facilities:
  • Automates inventory management, reduces manual entry errors, and streamlines dispensing processes via barcode scanning.
• Pharmacies and Points of Dispensing:
  • Verifies authenticity of medicines before distribution, helping protect patients from falsified or expired products.
• Regulatory Compliance:
  • Supports alignment with global traceability and pharmacovigilance requirements, including those from the World Health Organization or regional authorities like the EU or US FDA.
• Supply Chain Integrity:
  • Enhances the ability to pinpoint and address issues (such as product recalls) rapidly due to full, machine-readable traceability.
• Digitized Information Access:
  • Enables access to electronic product information (ePI) via scanned package codes for up-to-date, authoritative content.

Related Standards

For comprehensive implementation, refer to these associated international standards:

• ISO 11615: Health informatics – Identification of medicinal products – Data elements and structures for the unique identification and exchange of regulated medicinal product information.
• ISO/TS 19256: Health informatics – Requirements for medicinal product dictionary systems for health care.
• GS1 Standards: Global standards for barcoding, serialization, and identification in supply chains.
• ISO/IEC 15418 and ISO/IEC 15420: Technical specifications for barcode and identification architectures.

By adhering to SIST EN ISO 16791:2026, organizations support greater safety, efficiency, and trust within the healthcare supply chain through the standardized, international use of machine-readable package identifiers. This not only fulfills regulatory obligations but also advances global traceability and patient protection.

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2026
Nadomešča:
SIST-TS CEN ISO/TS 16791:2021
Zdravstvena informatika - Zahteve za mednarodne strojno berljive kode za
pakiranje zdravil (ISO 16791:2026)
Health informatics - Requirements for international machine-readable coding of
medicinal product package identifiers (ISO 16791:2026)
Medizinische Informatik - Anforderungen für internationale maschinenlesbare
Kodierungen von Identifikatoren für Arzneimittelpackungen (ISO 16791:2026)
Informatique de santé - Exigences relatives au codage international lisible par machine
des identifiants d'emballages de médicaments (ISO 16791:2026)
Ta slovenski standard je istoveten z: EN ISO 16791:2026
ICS:
11.120.10 Zdravila Medicaments
35.040.50 Tehnike za samodejno Automatic identification and
razpoznavanje in zajem data capture techniques
podatkov
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 16791
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2026
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes CEN ISO/TS 16791:2020
English Version
Health informatics - Requirements for international
machine-readable coding of medicinal product package
identifiers (ISO 16791:2026)
Informatique de santé - Exigences relatives au codage Medizinische Informatik - Anforderungen für
international lisible par machine des identifiants internationale maschinenlesbare Kodierungen von
d'emballages de médicaments (ISO 16791:2026) Identifikatoren für Arzneimittelpackungen (ISO
16791:2026)
This European Standard was approved by CEN on 27 March 2026.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye 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
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16791:2026 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 16791:2026) has been prepared by Technical Committee ISO/TC 215 "Health
informatics" in collaboration with Technical Committee CEN/TC 251 “Health informatics” the
secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by October 2026, and conflicting national standards shall
be withdrawn at the latest by October 2026.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes CEN ISO/TS 16791:2020.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 16791:2026 has been approved by CEN as EN ISO 16791:2026 without any modification.

International
Standard
ISO 16791
Third edition
Health informatics — Requirements
2026-03
for international machine-readable
coding of medicinal product
package identifiers
Informatique de santé — Exigences relatives au codage
international lisible par machine des identifiants d'emballages de
médicaments
Reference number
ISO 16791:2026(en) © ISO 2026
ISO 16791:2026(en)
© ISO 2026
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 16791:2026(en)
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 .7
4 Procedural background . 7
4.1 General .7
4.2 Identification .7
4.3 International machine-readable coding .8
4.4 Medicinal product .8
4.5 Labelling .8
4.6 Package identifier .9
4.7 Serialization .10
5 Usage requirements .10
5.1 General .10
5.2 Traceability .10
5.2.1 Principles .10
5.2.2 Requirements . 12
5.3 Measures to combat falsification of medicines . 12
5.3.1 Principles . 12
5.3.2 Requirements for both approaches . 13
5.3.3 Product authentication .14
5.3.4 Supply chain integrity .14
5.4 Improving patient safety at point of care . 15
5.4.1 Principles . 15
5.4.2 Requirements . 15
5.5 Support of healthcare systems . 15
5.5.1 Principles . 15
5.5.2 Requirements .16
5.6 Procurement and stock management .17
5.6.1 Principles .17
5.6.2 Requirements .17
5.7 Overview of requirements .18
6 Economic aspects .18
6.1 General .18
6.2 Manufacturer perspective .18
6.3 Healthcare provider perspective .19
Annex A (informative) Relationship between PhPID and MPID .20
Annex B (informative) Packaging hierarchy, relationship between MPID, PCID and GTIN® .22
Annex C (informative) Identification of trade items and logistic units .24
Annex D (informative) Examples for package identifier .25
Annex E (informative) Personalized medicine .34
Annex F (informative) Accessing electronic product information (ePI) by scanning the supply
chain unique identifier .35
Bibliography .37

iii
ISO 16791:2026(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 third edition cancels and replaces the second edition (ISO/TS 16791:2020), which has been technically
revised.
The main changes are as follows:
— addition of a definition on electronic product information;
— adjustment of 5.5.1 to reference ePL;
— addition of Annex F.
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
ISO 16791:2026(en)
Introduction
Globally, healthcare regulators, medicinal product suppliers, and healthcare providers, among others,
are facing increased pressure to ensure a more secure and safer supply chain for medicinal products.
The primary objective is to ensure optimal patient safety outcomes. Organizations such as the World
Health Organization (WHO), the European Union and the US Congress, along with many other healthcare
organizations, are also seeking robust systems that will deliver outcomes to enhance overall supply chain
integrity, to prevent product falsification and to improve patient safety, especially at the point of care.
Machine-readable coding is a technology capable of achieving these stated outcomes. Therefore, the core
purpose of this document is to provide requirements for machine-readable coding based on globally
harmonized and interoperable standards for wide scale international implementation, such as GS1 System
or UDI for medical devices.
This document outlines the requirements to implement international machine-readable coding on medicinal
product packages in the healthcare supply chain; this process cannot be isolated from more general
identification practice with medical devices or other categories of products. It assists all stakeholders
implement, use, and optimize automatic identification and data capture (AIDC) technologies in their
respective enterprises with a particular attention to health informatics. In that respect, this document
complements ISO 11615; for example, it provides requirements regarding medicinal product package
identifiers (PCID) and their relation with data carrier identifiers (DCID).
As AIDC offers a wide spectrum of potential solutions, particularly for data carriers such as barcodes, it has
highlighted the importance of properly defining data structures to prevent ambiguity when information is
encoded and captured.
Furthermore, the semantics of data carried can be specified by a number of organizations (also called
“issuing agencies”), some with commercial activities, some with a national emphasis, and others with a
1)
standard development organizations’ objective. This document focuses on the GS1® System of Standards.
The majority of supplies (such as processed food, office supplies, apparels, medical devices and equipment,
medicinal products) in healthcare around the world use the GS1® System of Standards for AIDC as it is
multi-sectorial and a globally implemented system of standards. Interoperability along the supply chain is
easier to achieve once a single system of standards is used in any market, including healthcare.
This document is intended to guide healthcare packaging designers, regulatory affairs specialists, logistics
operators, and others to implement AIDC solutions for healthcare.
NOTE 1 See Reference [34].
NOTE 2 See Reference [35].
1) GS1® is a registered trademark. This information is given for the convenience of users of this document and does not
constitute an endorsement by ISO.

v
International Standard ISO 16791:2026(en)
Health informatics — Requirements for international
machine-readable coding of medicinal product package
identifiers
1 Scope
This document provides requirements on identification and labelling of medicinal products from the point
of manufacturing of packaged medicinal product to the point of dispensing the product.
This document outlines commonly accepted international practices for automatic identification and data
capture (AIDC) barcoding solutions for applications and applies to manufacturers, distributors, healthcare
facilities and all parties involved in labelling and distribution of packaged medicinal products. These users
can, however, consider the coding interoperability requirements for other AIDC technologies, e.g. radio
frequency identification (RFID); that technology is not addressed in this document except as for information.
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 11615, Health informatics — Identification of medicinal products — Data elements and structures for the
unique identification and exchange of regulated medicinal product information
ISO/TS 19256, Health informatics — Requirements for medicinal product dictionary systems for health care
3 Terms, definitions and abbreviated terms
For the purposes of this document, the following terms and definitions apply.
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/
3.1 Terms and definitions
3.1.1
aggregation
packaging aggregation
hierarchical, parent-child relationship between a containing object (i.e. parent) and one or more objects (i.e.
children) which are contained
Note 1 to entry: When the content of a delivery is not homogeneous, aggregation shall be provided by using a univocal
identification of the delivery, such as with a serial shipping container code (SSCC); see Annex C.

ISO 16791:2026(en)
3.1.2
application identifier
AI
GS1® prefix that specifies the meaning and purpose of the data element that follows, as specified in
[33]
ISO/IEC 15418 and GS1® General Specifications
[SOURCE: ISO/IEC 19762:2025, 3.1.1.77, modified — “defines” and “defined” were changed to “specifies” and
“specified”.]
3.1.3
automatic identification and data capture
AIDC
methods or technologies for automatically identifying objects, collecting data about them, and entering that
data directly into computer systems, eliminating manual entry
Note 1 to entry: The methods or technologies typically considered as part of AIDC include barcodes (3.1.9) which can
be linear or 2-dimensional symbols and radio frequency identification (RFID) (3.1.33) tags/chips.
3.1.4
authentication
comparing the attributes of the object itself to what is known about objects of that origin
Note 1 to entry: Attributes include unique identifier besides overt, covert, and/or forensic solutions.
3.1.5
medicinal product batch identifier 1
BAID1
unique identifier (3.1.37) allocated to a specific batch (3.1.7) of a medicinal product (3.1.22), which appears on
the outer packaging (3.1.26) of the medicinal product
Note 1 to entry: It is constructed by using the batch number (3.1.8) assigned by the manufacturer and the expiration
date. This is for indexing purposes and to contribute to improving patient safety by allowing for the unique
identification of a medicinal product at the package level.
Note 2 to entry: BAID1 is market specific.
Note 3 to entry: See 5.2.1.5 for the difference between BAID1 and BAID2, and batch or lot number.
2)
[SOURCE: ISO 11615:— , 3.1.51, modified — Notes 2 and 3 to entry were added.]
3.1.6
medicinal product batch identifier 2
BAID2
unique identifier (3.1.37) allocated to a specific batch (3.1.7) of a medicinal product (3.1.22), which appears on
the immediate packaging, where this is not the outer packaging (3.1.26)
Note 1 to entry: It is constructed by using the batch number (3.1.8) assigned by the manufacturer and the expiration
date. This is for indexing purposes and to contribute to improving patient safety by allowing for the unique
identification of a medicinal product based at the level of the immediate container.
Note 2 to entry: ‘Immediate packaging’ corresponds frequently to ‘primary packaging’. See Annex B.
Note 3 to entry: See 5.2.1.5 for the difference between BAID1 and BAID2, and batch or lot number.
[SOURCE: ISO 11615:—, 3.1.52, modified — Notes 2 and 3 to entry were added.]
2) Under preparation. Stage at the time of publication: ISO/DIS 11615.

ISO 16791:2026(en)
3.1.7
batch
specific quantity of a drug or other material that is intended to have uniform character and quality, within
specified limits, and is produced according to a single manufacturing (3.1.19) order during the same cycle of
manufacturing
Note 1 to entry: See 5.2.1.5 for the difference between BAID1 and BAID2, and batch or lot number.
Note 2 to entry: ‘Lot’ is frequently used as synonym of batch.
[SOURCE: ISO 11615:—, 3.1.8, modified — Notes to entry were added.]
3.1.8
batch number
identifier (3.1.17) assigned to a specific batch (3.1.7) of a medicinal product (3.1.22) or item resulting from a
manufacturing (3.1.19) process at a specific point of time
Note 1 to entry: A batch number permits its manufacturing history to be traced.
Note 2 to entry: A batch number is made of series of ASCII characters.
Note 3 to entry: ‘Lot number’ is frequently used as synonym of batch number.
[SOURCE: ISO 11615:—, 3.1.9, modified — Notes to entry were added.]
3.1.9
barcode
optical machine-readable representation of data, showing data about the object to which it attaches
Note 1 to entry: Originally, barcodes represented data by varying the widths and spacings of parallel lines, and they
can be referred to as linear or one-dimensional (1D). Later they evolved into rectangles, dots, hexagons, and other
geometric patterns in two dimensions (2D). Although 2D systems use a variety of symbols, they are generally referred
to as barcodes as well.
3.1.10
compounded preparation
medicinal products (3.1.22) generally consisting of active substances that can be combined with excipients,
formulated into a dosage form suitable for the intended use
3.1.11
dispense
prepare and give out a medicinal product (3.1.22) in accordance with a prescription
Note 1 to entry: This includes assessing the pharmaceutical appropriateness including decision support.
Note 2 to entry: See ISO/TS 19293.
3.1.12
electronic product information
ePI
authorized, statutory product information for medicines (i.e. SmPC, PL and labelling)
Note 1 to entry: See Reference [47].
3.1.13
global trade item number
GTIN®
number that is used for the unique identification (3.1.15) of trade items worldwide
EXAMPLE 1 GS1® Identification Key, which comprises a GS1® Company Prefix, an Item Reference and Check digit.
EXAMPLE 2 Used to identify trade items such as medicinal products (3.1.22) and medical devices.

ISO 16791:2026(en)
Note 1 to entry: See Annex A for the relationship between medicinal product identifier (MPID) (3.1.23) and medicinal
product package identifier (PCID) (3.1.24).
[SOURCE: ISO/IEC 15420:2025, 3.2 modified — “GS1 identification key” was changed to “number”; “which
may be 8, 12, 13 or 14 digits in length” was removed; Examples and Note 1 to entry were added.]
3.1.14
healthcare system
organization of people, institutions, and resources to deliver healthcare services to meet the health needs of
target populations
3.1.15
identification
way information about an object, such as a trade item, can be found in IT systems using a sequence of
characters
3.1.16
identification schema namespace
container for a set of identifiers (3.1.17) that allows the disambiguation of homonym identifiers residing in
different identification schema
3.1.17
identifier
ID
description that is sufficient to represent an object in a given environment identification schema
Note 1 to entry: This concept is generic and applies to all identifications mentioned in this document.
3.1.18
machine-readable code
code, readable by a machine, that contains information used to establish a relationship between a physical
object such as a medicinal product (3.1.22) package and data sources such as medical, production, logistical
or reimbursement coding systems
3.1.19
manufacturing
process of production from the acquisition of all materials through all processing stages, including final
packaging
3.1.20
marketing authorization
authorization issued from a medicines regulatory agency that allows a medicinal product (3.1.22) to be
placed on the market
[SOURCE: ISO 11615:—, 3.1.40]
3.1.21
marketing authorization holder
MAH
organization that holds the authorization for marketing a medicinal product (3.1.22) in a region or country
[SOURCE: ISO 11615:—, 3.1.41 modified — “or country” was added.]
3.1.22
medicinal product
pharmaceutical product (3.1.29) or combination of pharmaceutical products that may be administered to
human beings for treating or preventing disease, with the aim or purpose of making a medical diagnosis or
to restore, correct or modify physiological functions
Note 1 to entry: The same definition applies for animal health.
Note 2 to entry: Corresponds frequently to “medicines”.

ISO 16791:2026(en)
[SOURCE: ISO 11615:—, 3.1.50, modified — “(or animals)” was removed; the original Notes 1 and 3 to entry
were removed and new Notes to entry were added.]
3.1.23
medicinal product identifier
MPID
identifier allocated to a medicinal product (3.1.22) supplementary to any existing authorization number as
ascribed by a medicines regulatory agency in a region
[SOURCE: ISO 11615:—, 3.1.53, modified — “unique identifier” was changed to “identifier”; Notes to entry
were removed.]
3.1.24
medicinal product package identifier
PCID
identifier allocated to a packaged medicinal product (3.1.28) supplementary to any existing authorization
number as ascribed by a medicines regulatory agency in a region
Note 1 to entry: See Annex D for relationship between medicinal product identifier (MPID) (3.1.23), medicinal product
package identifier (PCID) (3.1.24) and global trade item number (GTIN®) (3.1.13).
[SOURCE: ISO 11615:—, 3.1.55, modified — “unique identifier” was changed to “identifier”; Note 1 to entry
was removed and replaced by a new note.]
3.1.25
object identifier
OID
globally unique value associated with an object to unambiguously identify it
3.1.26
outer packaging
external container in which a medicinal product (3.1.22) is supplied
Note 1 to entry: Corresponds frequently to “secondary packaging” (see Annex B).
[SOURCE: ISO 11615:—, 3.1.57 modified — Note 1 to entry was removed and replaced by a new note.]
3.1.27
packaging hierarchy
relationship between a medicinal product (3.1.22) package and its grouping in larger or smaller quantities
Note 1 to entry: See Annex B for illustration of “primary packaging”, “secondary packaging”, etc.
3.1.28
packaged medicinal product
medicinal product (3.1.22) in a container being part of a package, representing the entirety that has been
packaged for sale or supply
Note 1 to entry: Corresponds frequently to “primary packaging” (see Annex B).
[SOURCE: ISO 11615:—, 3.1.59, modified — Note 1 to entry was added.]
3.1.29
pharmaceutical product
qualitative and quantitative composition of a medicinal product (3.1.22) in the dose form approved for
administration in line with the regulated product information
[SOURCE: ISO 11615:—, 3.1.60, modified — Note 1 to entry was removed.]

ISO 16791:2026(en)
3.1.30
pharmaceutical product identifier
PhPID
identifier for a pharmaceutical product (3.1.29)
[SOURCE: ISO 11615:—, 3.1.61 modified — “unique identifier” was changed to “identifier”.]
3.1.31
pharmacovigilance
science and activities relating to the detection, assessment, understanding and prevention of adverse effects
[23,24,43]
or any other medicine-related problem
Note 1 to entry: Adapted from Reference [43].
3.1.32
pseudo-randomized
sequence of numbers that appears to be statistically random, despite having been produced by a completely
deterministic and repeatable process
3.1.33
radio frequency identification
RFID
wireless non-contact system that uses radio-frequency electromagnetic fields to transfer data from a tag
attached to an object, for the purposes of automatic identification (3.1.15) and tracking
3.1.34
reconstitution
manipulation to enable the use or application of a medicinal product (3.1.22) with a marketing authorization
(3.1.20) (e.g. solving a powder to a solution) in accordance with the instructions given in the summary of
product characteristics or the patient information leaflet
3.1.35
serialization
assigning a unique identifier (3.1.37) (e.g. a number) to an item (e.g. pack, case or pallet)
Note 1 to entry: This identifier is stored on a database along with other information about the item (e.g. manufacturer,
batch info). Serialization typically includes randomly selected, encrypted, numerical or alpha- numeric serial number.
Note 2 to entry: According to Reference [44], ‘unique identifier’ is the safety feature which enables the verification
(3.1.38) of the authenticity and the identification of an individual pack of a medicinal product (3.1.22).
3.1.36
traceability
ability to track forward the movement through specified stage(s) of the extended supply chain and trace
backward the history, application, or location of that which is under consideration
Note 1 to entry: Adapted from Reference [48].
3.1.37
unique identifier
univocal coding
identification (3.1.15) that is unique to a specific instance and cannot be confused with another identification
3.1.38
verification
reading unique identifier (3.1.37) numbers and checking these in a database

ISO 16791:2026(en)
3.2 Abbreviated terms
IDMP identification of medicinal products
IHE integrating the healthcare enterprise
NDC national drug code (from US FDA)
OCR optical character recognition
4 Procedural background
4.1 General
Clause 4 specifies the distinctions between identification and data carriers (machine-readable coding and
its international characters). It then focuses on medicinal product and the characteristics of their physical
packaging in the marketplace.
Supply chain, traceability, and patient safety require appropriate labelling and the use of packaging
identifiers (as described in ISO 11615).
4.2 to 4.7 describe the key components of AIDC in the healthcare context, including the structure of
identifiers (4.2), machine-readable codes (4.3), medicinal products and their packaging hierarchy (4.4),
labelling technologies (4.5), package identifiers (4.6), and serialization practices (4.7), which together
support traceability and patient safety.
4.2 Identification
Identification shall be a unique sequence structured according to a globally agreed architecture or syntax
and may contain inbuilt significance.
EXAMPLE 1 The identifier for one pre-filled syringe of XYZ medicinal product is: 7665431234887. The identifier for
one telephone-service subscription is: 022 592 74 25.
Uniqueness of the identifier is the key to ensuring unambiguous identification. It is important to note that
the same sequence of characters can identify different items or objects belonging to different domains
(or contexts), but each unique object within a single domain (or context) shall also have an unambiguous
identifier. Uniqueness is also governed by the selected identification schema (or namespace) and the domains
(contexts) in which the schema applies. The identification schema rules are therefore paramount.
EXAMPLE 2 7665431234887 uniquely identifies the class pre-filled syringe of XYZ medicinal product in the domain
“GS1”. 022 592 74 25 uniquely identifies a web conference access point in the domain “telephone-service subscription
numbers, Switzerland”.
There are several types of identifiers in computer systems, varying in structure, purpose, governance, etc.
Uniform resource identifiers (URIs) are used for electronically available identifiers.
Uniform resource identifiers (URIs) can be:
— Uniform resource locators (URLs) – which are references to a location and therefore to an identifier in
the source location, such as http:// somewebesite/ products/ identifiers.
— Uniform resource names (URN) – which identify an object regardless of its location and availability,
by means of a value (the identifier of the object) and the namespace (how the identifier is assigned). To
ensure uniqueness and availability of the identifiers, there are two approaches – either a hierarchical
identifier assignment, or a random identifier creation. Illustrative examples:
— Object identifiers (OID), are defined by a naming system with structured (hierarchical), global
governance, to ensure that only one entity can assign identifiers in one space.

ISO 16791:2026(en)
— Universally unique identifiers (UUID), sometimes called globally unique identifiers (GUID), are
practically unique IDs, generated without a global governance. A UUID is randomly generated and
the probability of two systems creating the same UUID is extremely low, so the UUID can also be
considered unique for practical reasons.
EXAMPLE 3 OID < 2.51.1.1 > delimits the domain “GS1 GTIN” in which product identifier 7665431234887 is unique.
OID < 0.0.17.825.0.6.8 > delimits the domain “callingPartyNumber” in which web conference access point 022 592 74
25 is unique.
3)
EXAMPLE 4 In HL7® FHIR® standard, GTINs® can be used to identify a product, OIDs can be used for entities,
and URLs can identify other online resources such as prescriptions or documents (e.g. URL for the domain “GS1 GTIN”
is https:// www .gs1 .org/ 1/ gtinrules// en/ ).
4.3 International machine-readable coding
The manufacturer of the medicinal product shall apply product labelling that incorporates international
machine-readable code. Further, the manufacturer shall ensure any labelling carried out by external
parties along the supply chain (distributor, dispenser etc) applies AIDC and international machine-readable
code (see ISO/IEC 15424, the ISO/IEC 15426 series, ISO/IEC 15459-1, ISO/IEC 15459-2, ISO/IEC 15459-3,
ISO/IEC 15459-4, ISO/IEC 15459-6, ISO/IEC 16022, ISO/IEC 19762). This can be done by contractual
arrangements and vendor controls.
Unique identifier, as described in 4.2, is required when medicinal products are intended to be used in the
international market, if they physically circulate, or if information about them is used across the jurisdictions.
That means that the domain (or context) is not national or regional, but global.
International machine-readable coding is not just limited to packaging identifiers; it also encompasses
attributes such as batch number, expiry date, and serial numbers. Depending on medicinal product’s
characteristics, all of these attributes require semantics in such a way as to allow encoding and then
capturing regardless of the origin of the medicinal products. Application identifiers provide the semantics
of the data carried in an international machine-readable code, and they shall therefore be used uniformly
across the global market.
4.4 Medicinal product
Medicinal products are traded in various outer packaging configurations, between which there is an
established relationship. For example, the pharmaceutical product “Painkiller” has a market authorization
for 100 mg tablets (medicinal product). These tablets can be packed in 10. Packages of 10 tablets can be
bundled by 5; bundles can be grouped into cartons of 12 and cartons can be grouped in shipping cases of 20.
Annex B illustrates these relationships referred to as “packaging hierarchy”. There are numerous complex
situations which are not illustrated in this document but for which the same principles shall apply.
In the packaging hierarchy, each packaging level shall be uniquely identified.
Medicinal products can be authorized with two or more strengths, each being identified using a different
and unique pharmaceutical product identifier (PhPID) and medicinal product ID (MPID) (see Annex A).
“Painkiller” can be marketed in 100 mg and in 200 mg tablets. Each of these strengths corresponds to a
different medicinal product. There will be different packaging hierarchies, one for each strength. Again, for
medicinal product, all levels of packaging require univocal identification.
4.5 Labelling
AIDC has demonstrated its efficiency over several decades, and the use of that technology has enables
significant progresses in data accuracy.
For more than 40 years, standardized optical carriers such as linear barcodes and two-dimensional symbols
have been used by trading partners for AIDC (see ISO 22742). RFID was once considered as a technology
3) HL7® and FHIR® are registered trademarks. This information is given for the convenience of users of this document
and does not constitute an endorsement by ISO.

ISO 16791:2026(en)
that could be used for identification without direct handling and still remains among the possibilities for the
future AIDC widespread adoption. Likewise, trading p
...