prEN ISO 16791

SLOVENSKI STANDARD
01-junij-2025
Zdravstvena informatika - Zahteve za mednarodne strojno berljive kode za
pakiranje zdravil (ISO/DIS 16791:2025)
Health informatics - Requirements for international machine-readable coding of
medicinal product package identifiers (ISO/DIS 16791:2025)
Medizinische Informatik - Anforderungen für internationale maschinenlesbare
Kodierungen von Identifikatoren für Arzneimittelpackungen (ISO/DIS 16791:2025)
Informatique de santé - Exigences relatives au codage international lisible par machine
des identifiants de paquetage de médicaments (ISO/DIS 16791:2025)
Ta slovenski standard je istoveten z: prEN ISO 16791
ICS:
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.

DRAFT
International
Standard
ISO/DIS 16791
ISO/TC 215
Health informatics — Requirements
Secretariat: ANSI
for international machine-readable
Voting begins on:
coding of medicinal product
2025-03-03
package identifiers
Voting terminates on:
2025-07-04
Informatique de santé — Exigences relatives au codage
international lisible par machine des identifiants de paquetage de
médicaments
ICS: 35.240.80
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
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BEING ACCEPTABLE FOR INDUSTRIAL,
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USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
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RECIPIENTS OF THIS DRAFT ARE INVITED
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NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 16791:2025(en)
DRAFT
ISO/DIS 16791:2025(en)
International
Standard
ISO/DIS 16791
ISO/TC 215
Health informatics — Requirements
Secretariat: ANSI
for international machine-readable
Voting begins on:
coding of medicinal product
2025-03-03
package identifiers
Voting terminates on:
Informatique de santé — Exigences relatives au codage
international lisible par machine des identifiants de paquetage de
médicaments
ICS: 35.240.80
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
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Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 16791:2025(en)
ii
ISO/DIS 16791:2025(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 .6
4 Procedural background . 6
4.1 General .6
4.2 Identification .6
4.3 International machine-readable coding .7
4.4 Medicinal product .7
4.5 Labelling .8
4.6 Package identifier .8
4.7 Serialization .9
5 Usage requirements . 9
5.1 General .9
5.2 Traceability .10
5.2.1 Principles .10
5.2.2 Guidelines .11
5.3 Measures to combat falsification of medicines . 12
5.3.1 Principles . 12
5.3.2 Guidelines for both approaches . 13
5.3.3 Product authentication . 13
5.3.4 Supply chain integrity .14
5.4 Improving patient safety at point of care .14
5.4.1 Principles .14
5.4.2 Guidelines .14
5.5 Support of healthcare systems . 15
5.5.1 Principles . 15
5.5.2 Guidelines .16
5.6 Procurement and stock management .16
5.6.1 Principles .16
5.6.2 Guidelines .17
5.7 Overview of guidelines .17
6 Economic aspects . 17
6.1 General .17
6.2 Manufacturer perspective .18
6.3 Healthcare provider perspective .18
Annex A (informative) Relationship between PhPID and MPID . 19
Annex B (informative) Packaging hierarchy, relationship between MPID, PCID and GTIN®.21
Annex C (informative) Identification of trade items and logistic units.23
Annex D (informative) Examples for Package Identifier .24
Annex E (informative) Personalized Medicine .33
Annex F (informative) Accessing electronic product information (ePI) by scanning the supply
chain unique identifier .34
Bibliography .36

iii
ISO/DIS 16791:2025(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 to the previous edition are as follows:
—
The main changes to the previous edition are as follows:
— addition of a definition on ePL 3.1.11
— Adjustment of 5.5.1 to reference ePL of ;
— 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/DIS 16791:2025(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 guidelines for machine-readable coding based on globally harmonized
and interoperable standards for wide scale international implementation.
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.
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 defined 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 particular specification focuses on the GS1® System
of Standards.
The majority of supplies (such as processed food, office supplies, apparels, medical devices and equipment,
medicinal products, etc.) 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 [39].
NOTE 2 See Reference [40].
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
DRAFT International Standard ISO/DIS 16791:2025(en)
Health informatics — Requirements for international
machine-readable coding of medicinal product package
identifiers
1 Scope
This document provides guidelines on identification and labelling of medicinal products from the point of
manufacture of packaged medicinal product to the point of dispensing the product.
This document outlines best practice for AIDC barcoding solutions for applications. Users can, however,
consider the coding interoperability requirements for other AIDC technologies, e.g. Radio Frequency
Identification (RFID).
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 11615:2017, 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 terminological 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
aggregated packaging
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.
3.1.2
application identifier
AI
GS1® prefix that defines the meaning and purpose of the data element that follows, as defined in
ISO/IEC 15418 and GS1® General Specifications
[SOURCE: ISO/IEC 19762:2016, 01.01.82]

ISO/DIS 16791:2025(en)
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 which can be
linear or 2-dimensional symbols and Radio Frequency Identification (RFID) 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 allocated to a specific batch of a medicinal product, which appears on the outer packaging
of the medicinal product
Note 1 to entry: It is constructed by using the batch number 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.
[SOURCE: ISO 11615:2017, 3.1.51]
Note 2 to entry: BAID1 is market specific.
3.1.6
medicinal product batch identifier 2
BAID2
unique identifier allocated to a specific batch of a medicinal product, which appears on the immediate
packaging, where this is not the outer packaging
Note 1 to entry: It is constructed by using the batch number 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.
[SOURCE: ISO 11615:2017, 3.1.52]
Note 2 to entry: ‘immediate packaging’ corresponds frequently to ‘primary packaging’. See Annex B.
3.1.7
batch
lot
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 order during the same cycle of
manufacture
[SOURCE: ISO 11615:2017, 3.1.8 — modified, “lot” was added as a preferred term.]
3.1.8
batch number
lot number
identifier assigned to a specific batch of a medicinal product or item resulting from a manufacturing process
at a specific point of time
[SOURCE: ISO 11615:2017, 3.1.9 — modified, “lot number” was added as a preferred term.]
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.

ISO/DIS 16791:2025(en)
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 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
dispense medication
prepare and give out a medicinal product in accordance with a prescription
Note 1 to entry: This includes assessing the pharmaceutical appropriateness including decision support.
Note 2 to entry: See also ISO/TS 19293:2018.
3.1.11
Electronic product information
ePI
is authorized, statutory product information for medicines (i.e. SmPC, PL and labelling).
Note 1 to entry: from “electronic product information for human medicines in the EU: key principles”, European
Medicines Agency, 2020
3.1.12
global trade item number
2)
GTIN®
number that is used for the unique identification of trade items worldwide
[SOURCE: ISO/IEC 15420:2009, 3.7 — modified, digit length removed.]
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 and medical devices.
Note 1 to entry: See Annex A for the relationship between MPID, PCID, and GTIN®.
3.1.13
healthcare system
organization of people, institutions, and resources to deliver healthcare services to meet the health needs of
target populations
3.1.14
identification
way information about an object, such as a trade item, can be found in IT systems, such as databases
Note 1 to entry: It refers to a sequence of characters (numerals and/or alpha characters). The identifier is intended
to be a unique sequence structured according to a globally agreed architecture or syntax, and can or cannot contain
inbuilt significance.
3.1.15
identification schema namespace
container for a set of identifiers that allows the disambiguation of homonym identifiers residing in different
identification schema
2) GTIN® is a registered trademark. This information is given for the convenience of users of this document and does
not constitute an endorsement by ISO.

ISO/DIS 16791:2025(en)
3.1.16
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.
3.1.17
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 package and data sources such as medical, production, logistical and/or
reimbursement coding systems
3.1.18
manufacturing
manufacture
process of production from the acquisition of all materials through all processing stages, including final
packaging
3.1.19
marketing authorization
authorization issued from a medicines regulatory agency that allows a medicinal product to be placed on
the market
[SOURCE: ISO 11615:2017, 3.1.40]
3.1.20
marketing authorization holder
MAH
organization that holds the authorization for marketing a medicinal product in a region or country
[SOURCE: ISO 11615:2017, 3.1.41— modified, "or country" added.]
3.1.21
medicinal product
pharmaceutical product or combination of pharmaceutical products that may be administered to human
beings for treating or preventing disease, with the aim/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.
[SOURCE: ISO 11615:2017, 3.1.50, — modified, “(or animals)” removed; notes to entry 1 and 2 removed and a
new note 1 to entry added.]
3.1.22
medicinal product identifier
MPID
identifier allocated to a medicinal product supplementary to any existing authorization number as ascribed
by a medicines regulatory agency in a region
[SOURCE: ISO 11615:2017, 3.1.53, — modified, “unique” removed; notes to entry removed.]
3.1.23
medicinal product package identifier
PCID
identifier allocated to a packaged medicinal product supplementary to any existing authorization number as
ascribed by a medicines regulatory agency in a region
[SOURCE: ISO 11615:2017, 3.1.55, — modified, “unique” removed; note to entry removed.]
Note 1 to entry: See Annex D for relationship between MPID, PCID, and GTIN®.

ISO/DIS 16791:2025(en)
3.1.24
object identifier
OID
globally unique value associated with an object to unambiguously identify it
3.1.25
outer packaging
external container in which a medicinal product is supplied
[SOURCE: ISO 11615:2017, 3.1.57 — modified, note to entry removed.]
Note 1 to entry: Corresponds frequently to “secondary packaging” (see Annex B).
3.1.26
packaging hierarchy
relationship between a medicinal product package and its grouping in larger/smaller quantities
Note 1 to entry: See Annex B for illustration of “primary packaging”, “secondary packaging”, etc.
3.1.27
packaged medicinal product
medicinal product in a container being part of a package, representing the entirety that has been packaged
for sale or supply
[SOURCE: ISO 11615:2017, 3.1.59]
Note 1 to entry: Corresponds frequently to “primary packaging” (see Annex B).
3.1.28
pharmaceutical product
qualitative and quantitative composition of a medicinal product in the dose form approved for administration
in line with the regulated product information
[SOURCE: ISO 11615:2017, 3.1.60]
3.1.29
pharmaceutical product identifier
PhPID
identifier for a pharmaceutical product
[SOURCE: ISO 11615:2017, 3.1.61 — modified, “unique” removed.]
3.1.30
pharmacovigilance
science and activities relating to the detection, assessment, understanding and prevention of adverse effects
or any other medicine-related problem
[SOURCE: WHO, Reporting and learning systems for medication errors: the role of pharmacovigilance
centres, 2014, Annex 1]
3.1.31
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 and tracking
3.1.32
serialization
assigning a unique identifier (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, etc). Serialization typically includes randomly selected, encrypted, numerical or alpha- numeric serial number.

ISO/DIS 16791:2025(en)
Note 2 to entry: According to Reference [51], ‘unique identifier’ is the safety feature which enables the verification of
the authenticity and the identification of an individual pack of a medicinal product.
3.1.33
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
[SOURCE: Global Traceability Standard for Healthcare, GS1, 2013, 5.2]
3.1.34
univocal coding
unique identifier
identification that is unique to a specific instance and cannot be confused with another identification
3.1.35
verification
reading unique identifier numbers and checking these in a database
3.2 Abbreviated terms
IHE Integrating the Healthcare Enterprise
INN International Non-proprietary Name
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). Since new processes are in development in many countries to fight
against falsification, reimbursement fraud, etc., 4.7 addresses serialization, namely the unit (or instance)
identification.
4.2 Identification
In this document, “identification” refers to a sequence of characters (numerals and/or alpha characters).
This identifier shall be a unique sequence structured according to a globally agreed architecture or syntax
and may or may not contain inbuilt significance.
EXAMPLE 1 The identifier for one pre-filled syringe of XYZ medication is: 7665431234887. The identifier for one
telephone-service subscription is: 022 592 74 25.
Uniqueness of the identifier (also referred to as ‘univocal coding’) 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

ISO/DIS 16791:2025(en)
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 medication 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.
— 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
Machine-readable coding is the process to transcribe and capture identification from a data carrier such as a
barcode or two-dimensional symbols.
Univocal coding, 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/lot 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 shall therefore be used uniformly across
the global market.
4.4 Medicinal product
Medicinal products are traded in various 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.
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/DIS 16791:2025(en)
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). “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
The term AIDC is used to describe the process of automatically capturing (without manual key entry)
the identifier assigned to a product for a given level of packaging using machine-readable coding. AIDC
shall be delivered using a range of technologies including optical symbols, e.g. barcodes, radio frequency
identification (RFID) technologies, and biometrics.
For more than 40 years, standardized optical carriers such as linear barcodes and two-dimensional symbols
have been used by trading partners for AIDC. RFID was once considered as a technology that could be used
for hands-free mass identification and still remains among the possibilities for the future AIDC widespread
adoption. Likewise, trading partners have not adopted other AIDC solutions, such as OCR and biometrics,
because of lack of efficiencies, ease of encoding, decoding, and the use of proprietary algorithms. However,
the use of AIDC based on standardized optical carriers does offer the possibility for users to attain more
efficient and effective logistics and material management. For medicinal products, the possibility of
implementing AIDC at the point of care given is enabled.
The number of possible optical symbols available needs to be contained and standardized. Effective AIDC
uses globally standardized symbols with standardized globally-agreed data encoded in the symbols. This
ensures overall efficiency, i.e. the same type data structures encoded in a set of pre- defined symbols shall
be used by any geography or economy, regardless of the type products (e.g. food, medicinal products, office
devices, etc.). As a result, manufacturers shall standardize their production processes by using consistent
AIDC symbols and eliminating variability. From a user’s perspective, this increases global interoperability
since the identification schema namespace is widespread.
There are many devices and software solutions available for encoding and decoding the data in the AIDC
symbol. All are capable of delivering a wide variety of solutions because of the use of global standards.
Software and devices ensure that they are focused on delivery standard solutions that are interoperable.
In 2017, IHE released a new profile (“Uniform Barcode Processing), to help software vendors meet these
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requirements .
Mass production requires high quality label printing. In addition to manufacturers selecting the right optical
symbol (data carrier) and correct data for the symbol, suitable software shall ensure that the print quality
of the AIDC symbol is satisfactory for reading purposes. Testing symbol readability is an essential process.
Some ISO deliverables, e.g. the ISO/IEC 15426 series, have been developed for testing and measuring the
readability of barcodes. Manufacturers (labellers) shall further pay particular attention to packaging/label
design so that the placement of labels on packaging ensures that the AIDC process is not compromised. Data
encoded in the symbol should be printed in human readable format to ensure process continuity where
readers may not be available, or by equipment failure.
4.6 Package identifier
There are a number of identification relationships that should be understood for effective AIDC of Medicinal
Products. This includes the relationship between Pharmaceutical Product Identifier (PhPID), Medicinal
Product Identifier (MPID), Packaging Identifier (PCID), Marketing Authorization number, and Global Trade
Item Number (GTIN®). The relationship between Marketing Authorization number and GTIN® varies
depending on regulatory framework. There are two main scenarios:
— The Marketing Authorization number and the GTIN® can be the same (i.e. the same sequence of
characters). Examples of this situation can be observed in the US or in France (see Annex D).

ISO/DIS 16791:2025(en)
NOTE In some countries, such as France or Austria, GTINs® are generated by including a national number
maintained by another authority than the marketing authorization holder. In this circumstance, one uses the
acronym “NTIN” (National Trade Item Number). Usually NTIN correspond to secondary packaging. Primary
packaging and higher levels of packaging are identified by following the normal GTIN® allocation rules.
— A single Marketing Authorization number is delivered by a central Regulator for different markets.
Different GTINs® shall be used to distinguish the different packages of the same medicinal product as
the actual packaging differs from one market to another. An example of this situation is seen in Europe
(i.e. there is central marketing authorization, but there is country specific packaging in the European
Member States). The Marketing Authorization number issued is related to the GTIN® in a database, not
via AIDC.
Annex D illustrates the current scenario in some countries.
The GTIN-14 standard is defined as the unique 14-digit identifier for trade items; it includes, in sequence, the
following:
a) Indicator digit: The indicator digit is a one-digit logistical code, which value can be a zero (0);
b) Country code: The country code is the c
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