ISO/TS 16791:2014

TECHNICAL ISO/TS
SPECIFICATION 16791
First edition
2014-04-01
Health informatics — Requirements
for international machine-readable
coding of medicinal product package
identifiers
Informatique de santé — Exigences pour une identification
internationale, lisible par capture automatique, des produits
médicinaux
Reference number
©
ISO 2014
© ISO 2014
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ii © ISO 2014 – All rights reserved

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 Terms . 1
3.2 Abbreviations . 5
4 Procedural background. 6
4.1 General . 6
4.2 Identification . 6
4.3 International machine readable coding . 6
4.4 Medicinal product . 7
4.5 Labelling . 7
4.6 Package identifier . 8
4.7 Serialization . 8
5 Usage requirements . 9
5.1 General . 9
5.2 Traceability . 9
5.3 Measures to combat falsification of medicines .10
5.4 Improving patient safety at point of care .12
5.5 Support of healthcare systems .12
5.6 Procurement and stock management .14
5.7 Overview of the normative options . .15
6 Economic aspects .15
6.1 General .15
6.2 Manufacturer perspective .16
6.3 Healthcare provider perspective .16
Annex A (informative) Relationship between PhPID and MPID (Referencing ISO 11615 and
ISO 11616) .17
Annex B (informative) Packaging hierarchy .18
Annex C (informative) Relationship between MPID, PCID and GTIN .19
Annex D (informative) Examples for Package Identifier .20
Bibliography .22
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
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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).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 215, Health informatics.
iv © ISO 2014 – All rights reserved

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. International organizations such
as the World Health Organization (WHO) and the Council of Europe, 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 Technical Specification is to provide guidance for machine-readable coding based on
globally harmonized and interoperable standards for wide scale international implementation.
This Technical Specification outlines the requirements to implement international machine-readable
coding on medicinal product packages in the healthcare supply chain. It assists all stakeholders implement,
use, and optimize Automatic Identification and Data Capture Identification (AIDC) technologies in their
respective enterprises with a particular attention to Health Informatics. In that respect, it 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
standard development organizations’ objective. This particular specification focuses on the GS1 System
1)
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 Technical Specification is intended to guide healthcare packaging designers, regulatory affairs
specialists, logistics operators, and others to implement AIDC solutions for healthcare.
1) GS1 is a registered trademark. Any trademark used in this document is information given for the convenience
of users and does not constitute an endorsement.
TECHNICAL SPECIFICATION ISO/TS 16791:2014(E)
Health informatics — Requirements for international
machine-readable coding of medicinal product package
identifiers
1 Scope
This Technical Specification provides guidance on identification and labelling of medicinal products
from the point of manufacture of packaged medicinal product to the point of dispensing the product.
This Technical Specification 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, in whole or in part, are normatively referenced in this document and are
indispensable for its application. 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/IEC 15415, Information technology — Automatic identification and data capture techniques — Bar
code symbol print quality test specification — Two-dimensional symbols
ISO/IEC 15416, Information technology — Automatic identification and data capture techniques — Bar
code print quality test specification — Linear symbols
ISO 28219, Packaging — Labelling and direct product marking with linear bar code and two-dimensional
symbols
ISO 22742, Packaging — Linear bar code and two-dimensional symbols for product packaging
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 Terms
3.1.1
application identifier
AI
2)
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 19762-1:2008, 01.01.94]
2) GS1 is a registered trademark. Any trademark used in this document is information given for the convenience
of users and does not constitute an endorsement.
3.1.2
AIDC
automatic identification and data capture
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 bar codes which can be
linear or 2-dimensional symbols and Radio Frequency Identification (RFID) tags/chips.
3.1.3
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.
3.1.4
BAID_1
unique identifier allocated to a specific batch of a medicinal product which appears on the outer
packaging of the medicinal product
3.1.5
BAID_2
unique identifier allocated to a specific batch of a medicinal product which appears on the immediate
packaging (not the outer packaging)
3.1.6
batch
lot
specific manufacturing release of a medicinal product or item by the manufacturer
[SOURCE: ISO 11615:2012, 3.1.7 — modified, “lot” was added as a preferred term.]
3.1.7
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
Note 1 to entry: Batch number permits its manufacturing history to be traced.
Note 2 to entry: Batch number is made of series of ASCII characters.
[SOURCE: ISO 11615:2012, 3.1.8 — modified, “lot number” was added as a preferred term; notes were
added.]
3.1.8
bar code
optical machine-readable representation of data, showing data about the object to which it attaches
Note 1 to entry: Originally bar codes 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 bar codes as well.
3.1.9
dispense medication
prepare and give out a medicinal product in accordance with a prescription
Note 1 to entry: This includes asessing the pharmaceutical appropriateness including decision support.
2 © ISO 2014 – All rights reserved

3.1.10
falsified medicines
fake medicines that pass themselves off as real, authorized medicines
[SOURCE: European Medicines Agency]
Note 1 to entry: It can be contaminated or contain the wrong or no active ingredient. They could have the right
active ingredient but at the wrong dose.
Note 2 to entry: WHO is using the concept of “Spurious/falsely-labelled/falsified/counterfeit (SFFC) medicines”.
3.1.11
3)
GTIN
global trade item number
number that is used for the unique identification 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 pharmaceuticals and medical devices.
Note 1 to entry: See Annex C for the relationship between MPID, PCID, and GTIN.
[SOURCE: ISO/IEC 15420:2009, 3.7 — modified, examples added; note 1 to entry added; digit length
removed.]
3.1.12
healthcare system
organization of people, institutions, and resources to deliver healthcare services to meet the health
needs of target populations
3.1.13
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 can not
contain inbuilt significance.
3.1.14
identification schema
namespace
container for a set of identifiers that allows the disambiguation of homonym identifiers residing in
different identification schema
3.1.15
identifier
ID
description that is sufficient to represent an object in a given environment identification schema
3.1.16
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
3.1.17
manufacturing/manufacture
process of production from the acquisition of all materials through all processing stages, including final
packaging
3) GTIN is a registered trademark. Any trademark used in this document is information given for the convenience
of users and does not constitute an endorsement.
3.1.18
marketing authorization
authorization issued from a Medicines Reulatory Agency that a Medicinal Product may be placed on the
market
[SOURCE: ISO 11615:2012, 3.1.40]
3.1.19
marketing authorization holder
organization that holds the authorization for marketing a medicinal product in a jurisdiction
[SOURCE: ISO 11615:2012, 3.1.38, — modified, “for marketing a medicinal product in a jurisdiction”
added]
3.1.20
medicinal product
any substance or combination of substances that can be administered to human beings for treating
or preventing disease, with the view 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 11615:2012, 3.1.49, — modified, “(or animals” removed; notes 1-2 removed and a new note
1 to entry added.]
3.1.21
MPID
medicinal product identifier
identifier allocated to a medicinal product supplementary to any existing authorization number as
ascribed by a medicines regulatory authority in a jurisdiction
[SOURCE: ISO 11615:2012, 3.1.50, — modified, “unique” removed; note removed.]
3.1.22
PCID
medicinal product package identifier
identifier allocated to a packaged medicinal product supplementary to any existing authorization
number as ascribed by a medicines regulatory agency in a jurisdiction
[SOURCE: ISO 11615:2012, 3.1.53, — modified, “unique” removed; note removed.]
Note 1 to entry: See Annex C for relationship between MPID, PCID, and GTIN.
3.1.23
OID
object identifier
globally unique value associated with an object to unambiguously identify it
3.1.24
outer packaging
external container in which a medicinal product is supplied
Note 1 to entry: Corresponds frequently to “secondary packaging” (see Annex B).
[SOURCE: ISO 11615:2012, 3.1.55 — modified, examples and notes removed; new note added.]
3.1.25
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.
4 © ISO 2014 – All rights reserved

3.1.26
packaged medicinal product
medicinal product 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 11615:2012, 3.1.57 — modified, note 1 to entry added.]
3.1.27
pharmacovigilance
science and activities relating to the detection, assessment, understanding and prevention of adverse
effects or any other medicine-related problem
[SOURCE: WHO]
3.1.28
PhPID
pharmaceutical product identifier
identifier for a pharmaceutical product
Note 1 to entry: Pharmaceutical product: qualitative and quantitative composition of the pharmaceutical product
as administered to the patient in line with the regulated product information.
[SOURCE: ISO 11615:2012, 3.1.60 — modified, “unique” removed; note 1 to entry added.]
3.1.29
RFID
radio frequency identification
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
3.1.30
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.
3.1.31
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, 2009]
3.1.32
verification
reading unique identifier numbers and checking these in a database
3.2 Abbreviations
AIDC Automatic Identification Data Capture
PCID Medicinal Product Package Identifier
GTIN Global Trade Item Number (from GS1)
INN International Non-proprietary Name
NDC National Drug Code (from US FDA)
OID Object Identifier
PhPID identifier for a pharmaceutical product
RFID Radio Frequency Identification
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 Technical Specification, “identification” means the way information about an object such as a
trade item can be found in IT systems such as databases. It 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 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 medication in the domain
“GS1”. 022 592 74 25 uniquely identifies a web conference access point in the domain “telephone-service
subscription numbers, Switzerland”.
Identification is used in data processing and is usually qualified with an Object Identifier (OID), which
corresponds to the data processing domain. Identification is also used in the Automatic Identification
and Data Capture (AIDC) process.
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.
4.3 International machine readable coding
Machine readable coding is the process to transcribe and capture unique identification from a data
carrier such as a bar code or two dimensional symbols.
Unique 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.
6 © ISO 2014 – All rights reserved

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.
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). “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 unique 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. bar codes, radio frequency
identification (RFID) technologies, and biometrics.
For more than 40 years, standardized optical carriers such as linear bar codes 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 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.
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.
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. ISO standards have been developed for testing and measuring the readability of bar
codes. Manufacturers (labellers) shall further pay particular attention to packaging/label design so that
the placement of labels on package 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 the Pharmaceutical Product Identifier
(PhPID), Medicinal Product Identifier (MPID), Packaging Identifier (PCID), Marketing Authorization
number, and Global Trade Item Number (GTIN). The relationship between the Marketing Authorization
number and the 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).
— 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 medicine 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 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 country code corresponding to the GS1 member organization
of which the brand/license owner is a member;
c) Brand/license owner code - Company prefix: The brand/license owner code is a code allocated to
the brand owner by the GS1 member organization of which the brand/license owner is a member;
d) Product code: Product codes are unique numbers. The value for product code is arbitrary and is at
the discretion of the brand/license owner;
e) Check digit: A final digit calculated from the other digits of some GS1 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 tracking and/or
verification to the ‘instance’ level of the item for a given level of packaging.
Serial numbers can be either alpha or numeric characters. Alpha characters, as well changing a character
set (see ISO/IEC 8859-1:1998 and ISO/IEC 10646:2012 in the Bibliography), requires more space in the
data carrier, but increases 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) packaging. A medicinal product marketed in its
primary package [i.e. hospital packaging package (bottle) containing hundreds of solid form] 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 database so that events about
each item shall be recorded by supply chain partners.
8 © ISO 2014 – All rights reserved

5 Usage requirements
5.1 General
Machine readable coding systems (AIDC systems) are both widespread and international. The initial
requirements arose from the need of businesses to implement automated re-ordering from suppliers
(often, wholesalers) and when combined with AIDC at the point of sale, allowed businesses to adopt a
non-specific AIDC schema regardless of product type.
Over the years, AIDC or international machine readable coding has grown in importance. AIDC is now
used for stock management, traceability, patient safety, and in the combat against product falsification.
Clause 5 provides a review of the business processes and normative requirements.
5.2 Traceability
5.2.1 Principles
For the purpose of this Technical Specification, traceability is considered from the point of manufacture
to the finished and packaged medicinal product, ready for supply according to the market authorization.
Traceability ends when the medicinal product has been dispensed, applied, or administered.
Traceability requires identification and other related information about the medicinal product being
captured or exchanged throughout the supply chain.
Traceability can be required at different levels of granularity. Depending on regulatory requirements,
trading partner needs, and business requirements, traceability shall be enabled by product identification
(level one), by production batch and expiry date (level two), and by serial number, (level three). See 5.3
for more information.
NOTE When identification is required at the level of a unique serial number, the term “unique identifier” is
commonly used.
EXAMPLE 1 European Union, Directive 2011/62/EU of the European Parliament and of the Council (…) on the
Community Code relating to medicinal products for human use (…), “unique identifier” in Article 54a, § 2 (a).
As medicinal products are assembled in a packaging hierarchy, identification data shall be labelled in a
machine readable form ready for AIDC on each level of the hierarchy.
Each level of packaging requiring traceability needs a unique identifier (GTIN). The unique identifier
shall never be re-used (this applies to all packaging hierarchies). Batch number and expiry date shall be
consistent/identical on the different levels of the hierarchy.
In some special cases (for example, kits where two or more different items are grouped in a single
secondary packaging), the batch number and expiry date applied to the secondary packaging and higher
levels of packaging refers to the grouping as a whole.
EXAMPLE 2 Sweetdream i.V. in a kit (BAID_1) including a vial with powder (BAID_2) and a second vial with
water for injection (a second BAID_2 level).
5.2.1.1 Repackaging
If for any reason the medicinal product is repackaged along the supply chain channel, this process is
considered a manufacturing step and traceability shall be secured from the original pack to the resulting
‘repackaged’ pack. Subsequently, the re-packager or the local distributor as a contracting party or local
product ‘sponsor’ is legally responsible for the repackaged medicinal product. This change should lead to
a new GTIN (e.g. for changes such as a new leaflet in another language being included in the packaging),
however the assigned lot/batch number and expiry date should remain unchanged.
5.2.1.2 Compounded preparation
Compounded preparations are medicinal products generally consisting of active substances that can be
combined with excipients, formulated into a dosage form suitable for the intended use (with a patient),
where necessary after reconstitution, presented in a suitable and appropriately labelled container. New
identification shall be issued to these products to secure traceability to the final use.
5.2.1.3 Reconstitution
Reconstitution is the manipulation to enable the use or application of a medicinal product with a
marketing authorization (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. The identification of the
separate products that are used to make the final product shall be available and linked to the new
product for traceability of the process.
5.2.2 Normative options
To enable efficient and effective traceability, supply chain partners shall use the same identification
schema or data structure, which includes product identification, and if required, batch identification,
and expiry date or serial number. Medicinal product identifiers across all packaging hierarchies shall
never be re-used. Standardized data carriers shall also be used, not only to ensure reading devices can
be programmed to capture and process data, but also to provide a robust machine readable code for
AIDC that can be processed automatically regardless of product type, its supplier, or its origin.
Several jurisdictions have adopted international machine readable coding for AIDC as a regulatory
requirement.
EXAMPLE 1 France: Notice to human-use medicinal product marketing authorization holders and head
pharmacists of the pharmaceutical establishments cited in article R. 51242 of the French Public Health Code (CSP)
21 February 2007, § 2: “In liaison with the representatives of the pharmaceutical industry, the French Agency for
the Safety of Health Products (AFSSAPS) has selected the principle of switching CIP code, from 7 characters to 13
characters, and from barcode 39 to EAN 128 (combined with ECC.200 Data Matrix marking) as per the EAN.UCC
system” (see www.ansm.sante.fr).
In other jurisdictions, stakeholders have added such a clause in their request for tenders.
EXAMPLE 2 Spain: “Technical Commission for Health Services Purchasing and Logistics (CTCL)”, Product
identification through shared standards would lead to the unification of the bar code and symbol system so that
products could be identified automatically by product suppliers through the use of GS1 codes (…)” (see see www.
ctcl.es/).
There are also healthcare institutions that recommend the use of international machine readable coding
for AIDC for their healthcare product suppliers.
5.3 Measures to combat falsification of medicines
5.3.1 Principles
A falsified medicine is one which is deliberately and fraudulently mislabelled with respect to identity
and/or source. Falsification equally applies to both branded and generic products.
Preventing falsification can involve various techniques on the secondary packaging. Together with the
serialization of each medicinal product pack (i.e. use of a “unique identifier”), these techniques can be -
overt, covert, and/or forensic solutions.
In addition, the user community has recognized that serial numbers shall not be issued sequentially (as
sequential numbers can be predicted by non-authorized persons) but in a pseudo-randomized manner.
Falsifiers face greater difficulty with randomly generated serial numbers. Pseudo-randomized means
that each serial number remains unique but over the range of numbers that is not predictable. Serialized
numbers shall never be reissued.
10 © ISO 2014 – All rights reserved

5.3.1.1 Using serialization
Using the product identifier GTIN and a serial number to create “unique identifier”, there are two main
approaches to fight against medication falsification:
— product authentication;
— supply chain integrity (example with ePedigree).
5.3.1.2 Product authentication
The product shall be authenticated at the end of the supply chain by validating, in a database, the unique
identifier on the medicinal product packaging, besides checking further characteristics (overt, covert,
and/or forensic solutions). In this case, the unique identifier shall have been issued by the manufacturer,
and shall not have already been verified by another supply chain partner. It is assumed that the first
authentication of GTIN and Serial Number corresponds to the authentic item.
Authentication fails if the same unique identifier is verified repeatedly (i.e. more than one instance of
the serialized product exists), or if the unique identifier is not referenced in the database (i.e. the given
instance of the product was never created by the manufacturer).
In the first situation, when several supply chain partners issue a database query for the same unique
identifier, all of the medicinal product packages under review shall be considered suspicious. In the
second scenario, when one or more supply chain partners issue a database query for an unknown unique
identifier, all of the medicinal product packages under review shall be considered suspicious.
5.3.1.3 Supply chain integrity
Supply chain integrity consists of collecting and sharing information of the medicinal product along the
supply chain at each point in the journey, i.e. from the manufacturer to dispensing or administration
of the medicinal product to the patient. At each step in the journey, each event shall be recorded and
linked to the previous and subsequent event. The integrity of the supply chain shall be verified at each
step in detail. Incoming medicinal products, without the integrity of previously recorded steps, shall be
detected and considered as suspicious.
5.3.2 Normative options
Manufacturer representative associations recognize that product serialization and the associated
data processin
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