ISO/TS 16791:2020
(Main)Health informatics — Requirements for international machine-readable coding of medicinal product package identifiers
Health informatics — Requirements for international machine-readable coding of medicinal product package identifiers
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).
Informatique de santé — Exigences pour une identification internationale, lisible par capture automatique, des produits médicinaux
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TECHNICAL ISO/TS
SPECIFICATION 16791
Second edition
2020-09
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/TS 16791:2020(E)
ISO 2020
---------------------- Page: 1 ----------------------
ISO/TS 16791:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/TS 16791:2020(E)
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
Bibliography .............................................................................................................................................................................................................................34
© ISO 2020 – All rights reserved iii---------------------- Page: 3 ----------------------
ISO/TS 16791:2020(E)
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).
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 of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.This document was prepared by Technical Committee ISO/TC 215, Health informatics, in collaboration
with the European Committee for Standardization (CEN) Technical Committee CEN/TC 251, Health
informatics, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna
Agreement).This second edition cancels and replaces the first edition (ISO/TS 16791:2014), which has been
technically revised.The main changes to the previous edition are as follows:
— adjustment of definitions to the latest IDMP standard (ISO 11615), adding definition for aggregation;
— improvement of 5.2.1.4;— improvement of 5.3 with a clear distinction between product authentication and supply chain
integrity;— improvement of Annex D;
— Addition of Annex E.
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 .htmliv © ISO 2020 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/TS 16791:2020(E)
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 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.© ISO 2020 – All rights reserved v
---------------------- Page: 5 ----------------------
TECHNICAL SPECIFICATION ISO/TS 16791:2020(E)
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 termsFor 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 http:// 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 containedNote 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.
3.1.2application identifier
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 2020 – All rights reserved 1
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ISO/TS 16791:2020(E)
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 entryNote 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.
3.1.4authentication
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.
3.1.5medicinal 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 productNote 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 packagingNote 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.
3.1.7batch
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.
2 © ISO 2020 – All rights reserved
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ISO/TS 16791:2020(E)
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
global trade item number
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®.3.1.12
healthcare system
organization of people, institutions, and resources to deliver healthcare services to meet the health
needs of target populations3.1.13
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
cannot 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 schema3.1.15
identifier
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.
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 2020 – All rights reserved 3
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ISO/TS 16791:2020(E)
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 systems3.1.17
manufacturing
manufacture
process of production from the acquisition of all materials through all processing stages, including final
packaging3.1.18
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]
3.1.19
marketing authorization holder
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.]3.1.20
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 functionsNote 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.]3.1.21
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.]
3.1.22medicinal 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®.3.1.23
object identifier
OID
globally unique value associated with an object to unambiguously identify it
4 © ISO 2020 – All rights reserved
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ISO/TS 16791:2020(E)
3.1.24
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).
3.1.25
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.
3.1.26packaged 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).
3.1.27
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]
3.1.28
pharmaceutical product identifier
PhPID
identifier for a pharmaceutical product
[SOURCE: ISO 11615:2017, 3.1.61 — modified, “unique” removed.]
3.1.29
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]3.1.30
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
3.1.31serialization
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.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.
© ISO 2020 – All rights reserved 5---------------------- Page: 10 ----------------------
ISO/TS 16791:2020(E)
3.1.32
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]3.1.33
univocal coding
unique identifier
identification that is unique to a specific instance and cannot be confused with another identification
3.1.34verification
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 schema (or namespace) and the domains (contexts) in which the schema ap
...TECHNICAL ISO/TS
SPECIFICATION 16791
Second edition
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
PROOF/ÉPREUVE
Reference number
ISO/TS 16791:2020(E)
ISO 2020
---------------------- Page: 1 ----------------------
ISO/TS 16791:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii PROOF/ÉPREUVE © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/TS 16791:2020(E)
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
Bibliography .............................................................................................................................................................................................................................34
© ISO 2020 – All rights reserved PROOF/ÉPREUVE iii---------------------- Page: 3 ----------------------
ISO/TS 16791:2020(E)
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).
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 of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.This document was prepared by Technical Committee ISO/TC 215, Health informatics, in collaboration
with the European Committee for Standardization (CEN) Technical Committee CEN/TC 251, Health
informatics, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna
Agreement).This second edition cancels and replaces the first edition (ISO/TS 16791:2014), which has been
technically revised.The main changes compared to the previous edition are as follows:
— adjustment of definitions to the latest IDMP standard (ISO 11615), adding definition for aggregation;
— improvement of 5.2.1.4;— improvement of 5.3 with a clear distinction between product authentication and supply chain
integrity;— improvement of Annex D (Examples for Package Identifier);
— Addition of Annex E.
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 .htmliv PROOF/ÉPREUVE © ISO 2020 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/TS 16791:2020(E)
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 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.© ISO 2020 – All rights reserved PROOF/ÉPREUVE v
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TECHNICAL SPECIFICATION ISO/TS 16791:2020(E)
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, 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 termsFor 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 http:// 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 containedNote 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.
3.1.2application identifier
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]
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ISO/TS 16791:2020(E)
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 entryNote 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.
3.1.4authentication
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.
3.1.5medicinal 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 productNote 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 packagingNote 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.
3.1.7batch
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.
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ISO/TS 16791:2020(E)
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
global trade item number
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®.3.1.12
healthcare system
organization of people, institutions, and resources to deliver healthcare services to meet the health
needs of target populations3.1.13
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
cannot 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 schema3.1.15
identifier
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.
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 2020 – All rights reserved PROOF/ÉPREUVE 3
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ISO/TS 16791:2020(E)
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 systems3.1.17
manufacturing
manufacture
process of production from the acquisition of all materials through all processing stages, including final
packaging3.1.18
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]
3.1.19
marketing authorization holder
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.]3.1.20
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 functionsNote 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.]3.1.21
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.]
3.1.22medicinal 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®.3.1.23
object identifier
OID
globally unique value associated with an object to unambiguously identify it
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ISO/TS 16791:2020(E)
3.1.24
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).
3.1.25
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.
3.1.26packaged 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).
3.1.27
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]
3.1.28
pharmaceutical product identifier
PhPID
identifier for a pharmaceutical product
[SOURCE: ISO 11615:2017, 3.1.61 — modified, “unique” removed.]
3.1.29
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]3.1.30
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
3.1.31serialization
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.Note 2 to entry: According to Reference [50], ‘unique identifier’ is the safety feature which enables the verification
of the authenticity and the identification of an individual pack of a medicinal product.
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ISO/TS 16791:2020(E)
3.1.32
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]3.1.33
univocal coding
unique identifier
identification that is unique to a specific instance and cannot be confused with another identification
3.1.34verification
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...
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