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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Publication Date
28-Sep-2020
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5060 - Close of voting Proof returned by Secretariat
Start Date
06-Aug-2020
Completion Date
06-Aug-2020
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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 .html
iv © 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 terms
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at 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 contained

Note 1 to entry: When the content of a delivery is not homogeneous, aggregation shall be provided by using a

univocal identification of the delivery, such as with a Serial Shipping Container code (SSCC); see Annex C.

3.1.2
application identifier

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
---------------------- Page: 6 ----------------------
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 entry

Note 1 to entry: The methods or technologies typically considered as part of AIDC include barcodes which can be

linear or 2-dimensional symbols and Radio Frequency Identification (RFID) tags/chips.

3.1.4
authentication

comparing the attributes of the object itself to what is known about objects of that origin

Note 1 to entry: Attributes include unique identifier besides overt, covert, and/or forensic solutions.

3.1.5
medicinal product batch identifier 1
BAID1

unique identifier allocated to a specific batch of a medicinal product, which appears on the outer

packaging of the medicinal product

Note 1 to entry: It is constructed by using the batch number assigned by the manufacturer and the expiration

date. This is for indexing purposes and to contribute to improving patient safety by allowing for the unique

identification of a medicinal product at the package level.
[SOURCE: ISO 11615:2017, 3.1.51]
Note 2 to entry: BAID1 is market specific.
3.1.6
medicinal product batch identifier 2
BAID2

unique identifier allocated to a specific batch of a medicinal product, which appears on the immediate

packaging, where this is not the outer packaging

Note 1 to entry: It is constructed by using the batch number assigned by the manufacturer and the expiration

date. This is for indexing purposes and to contribute to improving patient safety by allowing for the unique

identification of a medicinal product based at the level of the immediate container.

[SOURCE: ISO 11615:2017, 3.1.52]

Note 2 to entry: ‘immediate packaging’ corresponds frequently to ‘primary packaging’. See Annex B.

3.1.7
batch
lot

specific quantity of a drug or other material that is intended to have uniform character and quality,

within specified limits, and is produced according to a single manufacturing order during the same

cycle of manufacture
[SOURCE: ISO 11615:2017, 3.1.8 — modified, “lot” was added as a preferred term.]
3.1.8
batch number
lot number

identifier assigned to a specific batch of a medicinal product or item resulting from a manufacturing

process at a specific point of time

[SOURCE: ISO 11615:2017, 3.1.9 — modified, “lot number” was added as a preferred term.]

Note 1 to entry: A batch number permits its manufacturing history to be traced.
Note 2 to entry: A batch number is made of series of ASCII characters.
2 © ISO 2020 – All rights reserved
---------------------- Page: 7 ----------------------
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 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

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 schema
3.1.15
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
---------------------- Page: 8 ----------------------
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 systems
3.1.17
manufacturing
manufacture

process of production from the acquisition of all materials through all processing stages, including final

packaging
3.1.18
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 functions
Note 1 to entry: The same definition applies for animal health.

[SOURCE: ISO 11615:2017, 3.1.50, — modified, “(or animals)” removed; notes to entry 1 and 2 removed

and a new note 1 to entry added.]
3.1.21
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.]

3.1.22
medicinal product package identifier
PCID

identifier allocated to a packaged medicinal product supplementary to any existing authorization

number as ascribed by a medicines regulatory agency in a region

[SOURCE: ISO 11615:2017, 3.1.55, — modified, “unique” removed; note to entry removed.]

Note 1 to entry: See Annex D for relationship between MPID, PCID, and GTIN®.
3.1.23
object identifier
OID
globally unique value associated with an object to unambiguously identify it
4 © ISO 2020 – All rights reserved
---------------------- Page: 9 ----------------------
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.

3.1.26
packaged medicinal product

medicinal product in a container being part of a package, representing the entirety that has been

packaged for sale or supply
[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

3.1.31
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.

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

3.1.34
verification
reading unique identifier numbers and checking these in a database
3.2 Abbreviated terms
IHE Integrating the Healthcare Enterprise
INN International Non-proprietary Name
NDC National Drug Code (from US FDA)
OCR Optical Character Recognition
4 Procedural background
4.1 General

Clause 4 specifies the distinctions between identification and data carriers (machine-readable coding

and its international characters). It then focuses on medicinal product and the characteristics of their

physical packaging in the marketplace.

Supply chain, traceability, and patient safety require appropriate labelling and the use of packaging

identifiers (as described in ISO 11615). Since new processes are in development in many countries to

fight against falsification, reimbursement fraud, etc., 4.7 addresses serialization, namely the unit (or

instance) identification.
4.2 Identification

In this document, “identification” refers to a sequence of characters (numerals and/or alpha characters).

This identifier shall be a unique sequence structured according to a globally agreed architecture or

syntax and may or may not contain inbuilt significance.

EXAMPLE 1 The identifier for one pre-filled syringe of XYZ medication is: 7665431234887. The identifier for

one telephone-service subscription is: 022 592 74 25.

Uniqueness of the identifier (also referred to as ‘univocal coding’) is the key to ensuring unambiguous

identification. It is important to note that the same sequence of characters can identify different items

or objects belonging to different domains (or contexts), but each unique object within a single domain

(or context) shall also have an unambiguous identifier. Uniqueness is also governed by the selected

identification 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 .html
iv 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.
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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 terms
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at 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 contained

Note 1 to entry: When the content of a delivery is not homogeneous, aggregation shall be provided by using a

univocal identification of the delivery, such as with a Serial Shipping Container code (SSCC); see Annex C.

3.1.2
application identifier

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 entry

Note 1 to entry: The methods or technologies typically considered as part of AIDC include barcodes which can be

linear or 2-dimensional symbols and Radio Frequency Identification (RFID) tags/chips.

3.1.4
authentication

comparing the attributes of the object itself to what is known about objects of that origin

Note 1 to entry: Attributes include unique identifier besides overt, covert, and/or forensic solutions.

3.1.5
medicinal product batch identifier 1
BAID1

unique identifier allocated to a specific batch of a medicinal product, which appears on the outer

packaging of the medicinal product

Note 1 to entry: It is constructed by using the batch number assigned by the manufacturer and the expiration

date. This is for indexing purposes and to contribute to improving patient safety by allowing for the unique

identification of a medicinal product at the package level.
[SOURCE: ISO 11615:2017, 3.1.51]
Note 2 to entry: BAID1 is market specific.
3.1.6
medicinal product batch identifier 2
BAID2

unique identifier allocated to a specific batch of a medicinal product, which appears on the immediate

packaging, where this is not the outer packaging

Note 1 to entry: It is constructed by using the batch number assigned by the manufacturer and the expiration

date. This is for indexing purposes and to contribute to improving patient safety by allowing for the unique

identification of a medicinal product based at the level of the immediate container.

[SOURCE: ISO 11615:2017, 3.1.52]

Note 2 to entry: ‘immediate packaging’ corresponds frequently to ‘primary packaging’. See Annex B.

3.1.7
batch
lot

specific quantity of a drug or other material that is intended to have uniform character and quality,

within specified limits, and is produced according to a single manufacturing order during the same

cycle of manufacture
[SOURCE: ISO 11615:2017, 3.1.8 — modified, “lot” was added as a preferred term.]
3.1.8
batch number
lot number

identifier assigned to a specific batch of a medicinal product or item resulting from a manufacturing

process at a specific point of time

[SOURCE: ISO 11615:2017, 3.1.9 — modified, “lot number” was added as a preferred term.]

Note 1 to entry: A batch number permits its manufacturing history to be traced.
Note 2 to entry: A batch number is made of series of ASCII characters.
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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 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

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 schema
3.1.15
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.
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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 systems
3.1.17
manufacturing
manufacture

process of production from the acquisition of all materials through all processing stages, including final

packaging
3.1.18
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 functions
Note 1 to entry: The same definition applies for animal health.

[SOURCE: ISO 11615:2017, 3.1.50, — modified, “(or animals)” removed; notes to entry 1 and 2 removed

and a new note 1 to entry added.]
3.1.21
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.]

3.1.22
medicinal product package identifier
PCID

identifier allocated to a packaged medicinal product supplementary to any existing authorization

number as ascribed by a medicines regulatory agency in a region

[SOURCE: ISO 11615:2017, 3.1.55, — modified, “unique” removed; note to entry removed.]

Note 1 to entry: See Annex D for relationship between MPID, PCID, and GTIN®.
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.

3.1.26
packaged medicinal product

medicinal product in a container being part of a package, representing the entirety that has been

packaged for sale or supply
[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

3.1.31
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.

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

3.1.34
verification
reading unique identifier numbers and checking these in a database
3.2 Abbreviated terms
IHE Integrating the Healthcare Enterprise
INN International Non-proprietary Name
NDC National Drug Code (from US FDA)
OCR Optical Character Recognition
4 Procedural background
4.1 General

Clause 4 specifies the distinctions between identification and data carriers (machine-readable coding

and its international characters). It then focuses on medicinal product and the characteristics of their

physical packaging in the marketplace.

Supply chain, traceability, and patient safety require appropriate labelling and the use of packaging

identifiers (as described in ISO 11615). Since new processes are in development in many countries to

fight against falsification, reimbursement fraud, etc., 4.7 addresses serialization, namely the unit (or

instance) identification.
4.2 Identification

In this document, “identification” refers to a sequence of characters (numerals and/or alpha characters).

This identifier shall be a unique sequence structured according to a globally agreed architecture or

syntax and may or may not contain inbuilt significance.

EXAMPLE 1 The identifier for one pre-filled syringe of XYZ medication is: 7665431234887. The identifier for

one telephone-service subscription is: 022 592 74 25.

Uniqueness of the identifier (also referred to as ‘univocal coding’) is the key to ensuring unambiguous

identification. It is important to note that the same sequence of characters can identify different items

or objects belonging to different domains (or contexts), but each unique object within a single domain

(or
...

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