Health informatics -- Requirements for international machine-readable coding of medicinal product package identifiers (ISO/TS 16791:2020)

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).

Medizinische Informatik - Anforderungen für internationale maschinenlesbare Kodierungen von Identifikatoren für Arzneimittelpackungen (ISO/TS 16791:2020)

Dieses Dokument bietet Leitlinien zur Identifizierung und Etikettierung von Arzneimitteln von der Herstellung des verpackten Arzneimittels bis zur Verabreichung des Produkts.
Es beschreibt bewährte Methoden für AIDC-Strichcodierungslösungen für Anwendungen. Anwender können die Interoperabilitätsanforderungen an die Kodierung jedoch auch auf andere AIDC-Technologien, wie die Identifikation mittels Hochfrequenz (en: Radio Frequency Identification, RFID), übertragen.

Informatique de santé -- Exigences pour une identification internationale, lisible par capture automatique, des produits médicinaux (ISO/TS 16791:2020)

Zdravstvena informatika - Zahteve za mednarodne strojno berljive kode za pakiranje zdravil (ISO/TS 16791:2020)

General Information

Status
Published
Publication Date
06-Dec-2020
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
10-Nov-2020
Due Date
15-Jan-2021
Completion Date
07-Dec-2020

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SLOVENSKI STANDARD
SIST-TS CEN ISO/TS 16791:2021
01-januar-2021
Nadomešča:
SIST-TS CEN ISO/TS 16791:2015
Zdravstvena informatika - Zahteve za mednarodne strojno berljive kode za
pakiranje zdravil (ISO/TS 16791:2020)
Health informatics -- Requirements for international machine-readable coding of
medicinal product package identifiers (ISO/TS 16791:2020)
Medizinische Informatik - Anforderungen für internationale maschinenlesbare
Kodierungen von Identifikatoren für Arzneimittelpackungen (ISO/TS 16791:2020)

Informatique de santé -- Exigences pour une identification internationale, lisible par

capture automatique, des produits médicinaux (ISO/TS 16791:2020)
Ta slovenski standard je istoveten z: CEN ISO/TS 16791:2020
ICS:
35.040.50 Tehnike za samodejno Automatic identification and
razpoznavanje in zajem data capture techniques
podatkov
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST-TS CEN ISO/TS 16791:2021 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TS CEN ISO/TS 16791:2021
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SIST-TS CEN ISO/TS 16791:2021
CEN ISO/TS 16791
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
October 2020
TECHNISCHE SPEZIFIKATION
ICS 35.240.80 Supersedes CEN ISO/TS 16791:2015
English Version
Health informatics - Requirements for international
machine-readable coding of medicinal product package
identifiers (ISO/TS 16791:2020)

Informatique de santé - Exigences pour une Medizinische Informatik - Anforderungen für

identification internationale, lisible par capture internationale maschinenlesbare Kodierungen von

automatique, des produits médicinaux (ISO/TS Identifikatoren für Arzneimittelpackungen (ISO/TS

16791:2020) 16791:2020)

This Technical Specification (CEN/TS) was approved by CEN on 7 September 2020 for provisional application.

The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to

submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard.

CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS

available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in

parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and

United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 16791:2020 E

worldwide for CEN national Members.
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SIST-TS CEN ISO/TS 16791:2021
CEN ISO/TS 16791:2020 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST-TS CEN ISO/TS 16791:2021
CEN ISO/TS 16791:2020 (E)
European foreword

This document (CEN ISO/TS 16791:2020) has been prepared by Technical Committee ISO/TC 215

"Health informatics" in collaboration with Technical Committee CEN/TC 251 “Health informatics” the

secretariat of which is held by NEN.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

This document supersedes CEN ISO/TS 16791:2015.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the

following countries are bound to announce this Technical Specification: Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,

Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of

North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the

United Kingdom.
Endorsement notice

The text of ISO/TS 16791:2020 has been approved by CEN as CEN ISO/TS 16791:2020 without any

modification.
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SIST-TS CEN ISO/TS 16791:2021
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SIST-TS CEN ISO/TS 16791:2021
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
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SIST-TS CEN ISO/TS 16791:2021
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
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SIST-TS CEN ISO/TS 16791:2021
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
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SIST-TS CEN ISO/TS 16791:2021
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
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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
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SIST-TS CEN ISO/TS 16791:2021
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
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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.
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 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
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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 not
...

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