ISO/FDIS 16791

ISO/DISFDIS 16791:2025(en)
ISO/TC 215
Secretariat: ANSI
Date: 2025-06-2712-17
Health informatics — Requirements for international machine-
readable coding of medicinal product package identifiers
Informatique de santé — Exigences pour une identification internationale,relatives au codage international
lisible par capture automatique,machine des produits médicinauxidentifiants de paquetage de médicaments
FDIS stage
TThhiis drs draafftt i is s susubbmmiitttteed d ttoo aa ppaarraallellel l vvoottee i inn IISSOO,, CCEEN.N.

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: + 41 22 749 01 11
EmailE-mail: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO/DISFDIS 16791:2025(en)
Contents
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 . 8
4.1 General . 8
4.2 Identification . 8
4.3 International machine-readable coding . 9
4.4 Medicinal product . 9
4.5 Labelling . 9
4.6 Package identifier . 10
4.7 Serialization . 11
5 Usage requirements . 11
5.1 General . 11
5.2 Traceability . 12
5.3 Measures to combat falsification of medicines . 14
5.4 Improving patient safety at point of care . 16
5.5 Support of healthcare systems . 17
5.6 Procurement and stock management . 18
5.7 Overview of requirements . 19
6 Economic aspects . 20
6.1 General . 20
6.2 Manufacturer perspective . 20
6.3 Healthcare provider perspective . 20
Annex A (informative) Relationship between PhPID and MPID . 22
Annex B (informative) Packaging hierarchy, relationship between MPID, PCID and GTIN® . 25
Annex C (informative) Identification of trade items and logistic units . 30
Annex D (informative) Examples for package identifier . 31
Annex E (informative) Personalized medicine. 43
Annex F (informative) Accessing electronic product information (ePI) by scanning the supply
chain unique identifier . 44
Bibliography . 47

This template allows you to work with default MS Word functions and styles. You can use these
if you want to maintain the Table of Contents automatically and apply auto-numbering.
To update the Table of Contents please select it and press "F9".
iii
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee 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'sISO’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 5.5.15.5.1 to reference ePL;
— — addition of Annex FAnnex 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/DISFDIS 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 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 Identificationautomatic identification and Data Capturedata 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 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 standard
11)
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[39].].
NOTE 2 See Reference [35[40].].

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.
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
ISO/DISFDIS 16791:2025(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 AIDCautomatic 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 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 Containerserial shipping container code (SSCC); see
Annex CAnnex C.
3.1.2 3.1.2
application identifier
AI
GS1® prefix that specifies the meaning and purpose of the data element that follows, as specified in
[33 [38]]
ISO/IEC 15418 and GS1® General Specifications
[SOURCE: ISO/IEC 19762:2025, 3.1.1.77]
Note 1 to entry: GTIN® is a registered trademark. This information is given for the convenience of users of
this document, modified — “defines” and does not constitute an endorsement by ISO“defined” were changed
to “specifies” and “specified”.]
3.1.3 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 Identificationradio frequency identification (RFID) (3.1.33)
tags/chips.
3.1.4 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 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 clause 5.2.1.5 See 5.2.1.5 for the difference between BAID1 and BAID2, and batch or lot number.
2)
[SOURCE: ISO 11615:2017,:— , 3.1.51]
, modified — Notes 2 and 3.1.6 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 ‘Immediate packaging’ corresponds frequently to ‘primary packaging’. See Annex BAnnex B.
Note 3 to entry: see clause 5.2.1.5 See 5.2.1.5 for the difference between BAID1 and BAID2, and batch or lot number.
[SOURCE: ISO 11615:2017,:—, 3.1.52]

2)
Under preparation. Stage at the time of publication: ISO/DIS 11615.
ISO/DISFDIS 16791:2025(en)
, modified — Notes 2 and 3.1.7 to entry were added.]
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 clause 5.2.1.5 See 5.2.1.5 for the difference between BAID1 and BAID2, and batch or lot number.
Note 2 to entry: lot ‘Lot’ is frequently used as synonym of batch.
[SOURCE: ISO 11615:2017,:—, 3.1.8, modified, “lot” was — Notes to entry were added as a preferred term.]
3.1.8 3.1.8
batch number
lot 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 ‘Lot number’ is frequently used as synonym of batch number.
[SOURCE: ISO 11615:2017,:—, 3.1.9, modified — Notes to entry were added.]
3.1.9 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
3.1.10 Compounded
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 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 [8]. ISO/TS 19293.
3.1.12 3.1.12
electronic product information
ePI
[55]
authorized, statutory product information for medicines (i.e. SmPC, PL and labelling) )
Note 1 to entry: See Reference [47 [55]].
3.1.13 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.
Note 1 to entry: See Annex AAnnex A for the relationship between medicinal product identifier (MPID) (3.1.23) and
medicinal product package identifier (PCID) (3.1.24).
[SOURCE: ISO/IEC 15420:20092025, 3.7 2 modified, digit — “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 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 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 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 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 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 3.1.19
manufacturing
process of production from the acquisition of all materials through all processing stages, including final
packaging
3.1.20 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 11615:2017,:—, 3.1.40]
ISO/DISFDIS 16791:2025(en)
3.1.21 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 11615:2017,:—, 3.1.41 modified, " — “or country"” was added.]
3.1.22 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 orpurposeor 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 Corresponds frequently to “medicines””.
[SOURCE: ISO 11615:2017,:—, 3.1.50, modified, — “(or animals)” was removed; notesthe original Notes 1 and
3 to entry 1 and 2were removed and a new note 1Notes to entry were added.]
3.1.23 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
[SOURCE: ISO 11615:2017, 3.1.53, modified, “unique” removed; notes to Note 1 to entry removed.]
3.1.24
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
Note 1 to entry: : See Annex DAnnex D for relationship between medicinal product identifier (MPID) (3.1.23), medicinal
product package identifier (PCID) (3.1.24, PCID,) and global trade item number (GTIN®) (3.1.13®.).
[SOURCE: ISO 11615:2017,:—, 3.1.55, modified. Term “Medicinal Product Package Identifier” replaced by
“medicinal product packagemodified — “unique identifier” and “PCID”, “unique” removed as first word of the
definition; note to entrywas changed to “identifier”; Note 1 to entry was removed and replaced by a new note.]
3.1.243.1.25 3.1.25
object identifier
OID
globally unique value associated with an object to unambiguously identify it
3.1.253.1.26 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 BAnnex B).).
[SOURCE: ISO 11615:2017,:—, 3.1.57 modified, note — Note 1 to entry was removed and replaced by a new
note to entry.]
3.1.263.1.27 3.1.27
packaging hierarchy
relationship between a medicinal product (3.1.22) package and its grouping in larger orsmalleror smaller
quantities
Note 1 to entry: See Annex BAnnex B for illustration of “primary packaging”, “secondary packaging”, etc.
3.1.273.1.28 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 BAnnex B).).
[SOURCE: ISO 11615:2017,:—, 3.1.59]
3., modified — Note 1.29 to entry was added.]
3.1.283.1.29
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 11615:2017,:—, 3.1.60], modified — Note 1 to entry was removed.]
3.1.293.1.30 3.1.30
pharmaceutical product identifier
PhPID
identifier for a pharmaceutical product (3.1.29)
[SOURCE: ISO 11615:2017,:—, 3.1.61 modified, — “unique” removed.] identifier” was changed to “identifier”.]
3.1.303.1.31 3.1.31
pharmacovigilance
science and activities relating to the detection, assessment, understanding and prevention of adverse effects
[23,24,43[29, 30, 49] ]
or any other medicine-related problem
[SOURCE:Note 1 to entry: Adapted from Reference [43 [49]]].
3.1.32
Pseudo-randomization
3.1.32 a pseudorandom
pseudo-randomized
sequence of numbers is one that appears to be statistically random, despite having been produced by a
completely deterministic and repeatable process.
ISO/DISFDIS 16791:2025(en)
3.1.33 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
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
3.1.363.1.35 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, etc). Serialization typically includes randomly selected, encrypted, numerical or alpha- numeric serial number.
Note 2 to entry: According to Reference [44[51],], ‘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.).
3.1.373.1.36 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.
[SOURCE:Note 1 to entry: Adapted from Reference [48 [57]]].
3.1.37
univocal coding
3.1.403.1.37
unique identifier
univocal coding
identification (3.1.15) that is unique to a specific instance and cannot be confused with another identification
3.1.413.1.38 3.1.38
verification
reading unique identifier (3.1.37) 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 4Clause 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).
4.2Subclauses 4.2 to 4.74.7 describe the key components of AIDC in the healthcare context, including the
structure of identifiers (4.2(4.2),), machine-readable codes (4.3(4.3),), medicinal products and their packaging
hierarchy (4.4(4.4),), labelling technologies (4.5(4.5),), package identifiers (4.6(4.6),), and serialization
practices (4.7(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.
uniformUniform 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.
ISO/DISFDIS 16791:2025(en)
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.
23)
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 ensuringensure any labelling carried out by external
parties along the supply chain (distributor, dispenser etc) applies AIDC and international machine readable
[17] [18] [19] [20] [21] [22] [23] [24] [25]
code (see , , , , , , , , ).-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.
Univocal codingUnique identifier, as described in 4.24.2,, 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 BAnnex 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 AAnnex 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.

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.
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.
For more than 40 years, standardized optical carriers such as linear barcodes and two-dimensional symbols
[6]
have been used by trading partners for AIDC .(see ISO 22742). RFID was once considered as a technology
that could be used for identification without direct handling 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 (see [16]). ISO/IEC 15423). 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). 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
[37[42] ]
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 shall always be documented,
which includes standard procedures about the control practice, symbol quality and verification frequency.
Some ISO deliverables, e.g. the ISO/IEC 15415, ISO/IEC 15416 or ISO/IEC 15426, have been developed for
testing and measuring the readability of barcodes. Manufacturers (labellers) shall further pay particular
attention to packaging or label design so that the placement of labels on outer 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 might 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 Authorizationmarketing authorization number and
GTIN® varies depending on regulatory framework. There are two main scenarios:
— — The Marketing Authorizationmarketing 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 DAnnex D).).
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.
ISO/DISFDIS 16791:2025(en)
Annex DAnnex 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) a) Indicator digit: The indicator digit is a one-digit logistical code, which value can be a zero (0);).
b) b) Country code: The country code is the country code corresponding to the GS1® member
organization of which the brand or license owner is a member;.
c) c) Brand or license owner code - Company prefix: The brand or license owner code is a code
allocated to the brand owner by the GS1® member organization of which the brand or license owner is a
member;.
d) d) Product code: Product codes are unique numbers. The value for product code is arbitrary and
is at the discretion of the brand or license owner;.
e) e) Check digit: A final digit calculated from the other digits of GS1® GTIN® (and some other
Identification Keys). This digit is used to check that the data has been correctly composed.
4.7 Serialization
The serial number is an attribute of the product identifier (Global Trade Item Number, GTIN®). This means
that the combination GTIN® + + serial number provides the uniqueness required to develop either tracking
or verification, or both, to the ‘instance’ level of the item for a given level of packaging.
NOTE Some regulations refer to “unique identifier”, which corresponds to the combination GTIN® + serial number.
Serial numbers can be either alpha or numeric characters. Alpha characters, as well changing a character set
[10] [11]
(see ISO/IEC 8859-1 and ISO/IEC 10646 ),), require more space in the data carrier, but increase the
numbering capacity with fewer characters. The user community has limited the size of the serial number to a
maximum of 20 characters.
Serial numbers are allocated to secondary or tertiary level packaging and shall not be found on the primary
package (unit of use, i.e. blistered solid forms). A medicinal product marketed in its primary package [i.e.
hospital packaging (bottle) containing hundreds of solid forms] shall have a GTIN® and should be serialized.
When medicinal product packaging is assigned a GTIN® and is serialized by the manufacturer at the time of
production, the combination GTIN® + + serial number shall be stored in a data
...