SIST-TS CEN ISO/TS 16791:2015

SLOVENSKI STANDARD
SIST-TS CEN ISO/TS 16791:2015
01-december-2015
Zdravstvena informatika - Zahteve za mednarodne strojno berljive kode za
pakiranje zdravil (ISO/TS 16791:2014)
Health informatics - Requirements for international machine-readable coding of medicinal
product package identifiers (ISO/TS 16791:2014)
Medizinische Informatik - Anforderungen für maschinenlesbare internationale
Kodierungen für Verpackungen von Arzneimitteln (ISO/TS 16791:2014)
Informatique de santé - Exigences pour une identification internationale, lisible par
capture automatique, des produits médicinaux (ISO/TS 16791:2014)
Ta slovenski standard je istoveten z: CEN ISO/TS 16791:2015
ICS:
35.040 Nabori znakov in kodiranje Character sets and
informacij information coding
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST-TS CEN ISO/TS 16791:2015 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 16791:2015

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SIST-TS CEN ISO/TS 16791:2015


CEN ISO/TS 16791
TECHNICAL SPECIFICATION

SPÉCIFICATION TECHNIQUE

September 2015
TECHNISCHE SPEZIFIKATION
ICS 35.240.80
English Version

Health informatics - Requirements for international
machine-readable coding of medicinal product package
identifiers (ISO/TS 16791:2014)
Informatique de santé - Exigences pour une Medizinische Informatik - Anforderungen für
identification internationale, lisible par capture maschinenlesbare internationale Kodierungen für
automatique, des produits médicinaux (ISO/TS Verpackungen von Arzneimitteln (ISO/TS 16791:2014)
16791:2014)
This Technical Specification (CEN/TS) was approved by CEN on 31 August 2015 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 16791:2015 E
worldwide for CEN national Members.

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SIST-TS CEN ISO/TS 16791:2015
CEN ISO/TS 16791:2015 (E)
Contents Page
European foreword . 3

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SIST-TS CEN ISO/TS 16791:2015
CEN ISO/TS 16791:2015 (E)
European foreword
This document (CEN ISO/TS 16791:2015) 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 [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO/TS 16791:2014 has been approved by CEN as CEN ISO/TS 16791:2015 without any
modification.
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SIST-TS CEN ISO/TS 16791:2015
TECHNICAL ISO/TS
SPECIFICATION 16791
First edition
2014-04-01
Health informatics — Requirements
for international machine-readable
coding of medicinal product package
identifiers
Informatique de santé — Exigences pour une identification
internationale, lisible par capture automatique, des produits
médicinaux
Reference number
ISO/TS 16791:2014(E)
©
ISO 2014

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SIST-TS CEN ISO/TS 16791:2015
ISO/TS 16791:2014(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2014
All rights reserved. Unless otherwise specified, 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
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved

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ISO/TS 16791:2014(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 Terms . 1
3.2 Abbreviations . 5
4 Procedural background. 6
4.1 General . 6
4.2 Identification . 6
4.3 International machine readable coding . 6
4.4 Medicinal product . 7
4.5 Labelling . 7
4.6 Package identifier . 8
4.7 Serialization . 8
5 Usage requirements . 9
5.1 General . 9
5.2 Traceability . 9
5.3 Measures to combat falsification of medicines .10
5.4 Improving patient safety at point of care .12
5.5 Support of healthcare systems .12
5.6 Procurement and stock management .14
5.7 Overview of the normative options . .15
6 Economic aspects .15
6.1 General .15
6.2 Manufacturer perspective .16
6.3 Healthcare provider perspective .16
Annex A (informative) Relationship between PhPID and MPID (Referencing ISO 11615 and
ISO 11616) .17
Annex B (informative) Packaging hierarchy .18
Annex C (informative) Relationship between MPID, PCID and GTIN .19
Annex D (informative) Examples for Package Identifier .20
Bibliography .22
© ISO 2014 – All rights reserved iii

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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 on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 215, Health informatics.
iv © ISO 2014 – All rights reserved

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Introduction
Globally, healthcare regulators, medicinal product suppliers, and healthcare providers, among others,
are facing increased pressure to ensure a more secure and safer supply chain for medicinal products.
The primary objective is to ensure optimal patient safety outcomes. International organizations such
as the World Health Organization (WHO) and the Council of Europe, along with many other healthcare
organizations are also seeking robust systems that will deliver outcomes to enhance overall supply chain
integrity, to prevent product falsification and to improve patient safety, especially at the point of care.
Machine readable coding is a technology capable of achieving these stated outcomes. Therefore, the core
purpose of this Technical Specification is to provide guidance for machine-readable coding based on
globally harmonized and interoperable standards for wide scale international implementation.
This Technical Specification outlines the requirements to implement international machine-readable
coding on medicinal product packages in the healthcare supply chain. It assists all stakeholders implement,
use, and optimize Automatic Identification and Data Capture Identification (AIDC) technologies in their
respective enterprises with a particular attention to Health Informatics. In that respect, it complements
ISO 11615.
As AIDC offers a wide spectrum of potential solutions, particularly for data carriers such as barcodes,
it has highlighted the importance of properly defining data structures to prevent ambiguity when
information is encoded and captured.
Furthermore, the semantics of data carried can be defined by a number of organizations (also called
“issuing agencies”), some with commercial activities, some with a national emphasis, and others with a
standard development organizations’ objective. This particular specification focuses on the GS1 System
1)
of Standards .
The majority of supplies (such as processed food, office supplies, apparels, medical devices and
equipment, medicinal products, etc.) in healthcare around the world use the GS1 System of Standards
for AIDC as it is multi-sectorial and a globally implemented system of standards. Interoperability along
the supply chain is easier to achieve once a single system of standards is used in any market, including
healthcare.
This Technical Specification is intended to guide healthcare packaging designers, regulatory affairs
specialists, logistics operators, and others to implement AIDC solutions for healthcare.
1) GS1 is a registered trademark. Any trademark used in this document is information given for the convenience
of users and does not constitute an endorsement.
© ISO 2014 – All rights reserved v

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SIST-TS CEN ISO/TS 16791:2015
TECHNICAL SPECIFICATION ISO/TS 16791:2014(E)
Health informatics — Requirements for international
machine-readable coding of medicinal product package
identifiers
1 Scope
This Technical Specification provides guidance on identification and labelling of medicinal products
from the point of manufacture of packaged medicinal product to the point of dispensing the product.
This Technical Specification outlines best practice for AIDC barcoding solutions for applications. Users
can, however, consider the coding interoperability requirements for other AIDC technologies e.g. Radio
Frequency Identification (RFID).
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 11615, Health informatics — Identification of medicinal products — Data elements and structures for
the unique identification and exchange of regulated medicinal product information
ISO/IEC 15415, Information technology — Automatic identification and data capture techniques — Bar
code symbol print quality test specification — Two-dimensional symbols
ISO/IEC 15416, Information technology — Automatic identification and data capture techniques — Bar
code print quality test specification — Linear symbols
ISO 28219, Packaging — Labelling and direct product marking with linear bar code and two-dimensional
symbols
ISO 22742, Packaging — Linear bar code and two-dimensional symbols for product packaging
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 Terms
3.1.1
application identifier
AI
2)
GS1 prefix that defines the meaning and purpose of the data element that follows, as defined in ISO/IEC
15418 and GS1 General Specifications
[SOURCE: ISO 19762-1:2008, 01.01.94]
2) GS1 is a registered trademark. Any trademark used in this document is information given for the convenience
of users and does not constitute an endorsement.
© ISO 2014 – All rights reserved 1

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3.1.2
AIDC
automatic identification and data capture
methods or technologies for automatically identifying objects, collecting data about them, and entering
that data directly into computer systems, eliminating manual entry
Note 1 to entry: The methods or technologies typically considered as part of AIDC include bar codes which can be
linear or 2-dimensional symbols and Radio Frequency Identification (RFID) tags/chips.
3.1.3
authentication
comparing the attributes of the object itself to what is known about objects of that origin
Note 1 to entry: Attributes include unique identifier besides overt, covert, and/or forensic solutions.
3.1.4
BAID_1
unique identifier allocated to a specific batch of a medicinal product which appears on the outer
packaging of the medicinal product
3.1.5
BAID_2
unique identifier allocated to a specific batch of a medicinal product which appears on the immediate
packaging (not the outer packaging)
3.1.6
batch
lot
specific manufacturing release of a medicinal product or item by the manufacturer
[SOURCE: ISO 11615:2012, 3.1.7 — modified, “lot” was added as a preferred term.]
3.1.7
batch number
lot number
identifier assigned to a specific batch of a medicinal product or item resulting from a manufacturing
process at a specific point of time
Note 1 to entry: Batch number permits its manufacturing history to be traced.
Note 2 to entry: Batch number is made of series of ASCII characters.
[SOURCE: ISO 11615:2012, 3.1.8 — modified, “lot number” was added as a preferred term; notes were
added.]
3.1.8
bar code
optical machine-readable representation of data, showing data about the object to which it attaches
Note 1 to entry: Originally bar codes represented data by varying the widths and spacings of parallel lines, and
can be referred to as linear or one-dimensional (1D). Later they evolved into rectangles, dots, hexagons, and other
geometric patterns in two dimensions (2D). Although 2D systems use a variety of symbols, they are generally
referred to as bar codes as well.
3.1.9
dispense medication
prepare and give out a medicinal product in accordance with a prescription
Note 1 to entry: This includes asessing the pharmaceutical appropriateness including decision support.
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3.1.10
falsified medicines
fake medicines that pass themselves off as real, authorized medicines
[SOURCE: European Medicines Agency]
Note 1 to entry: It can be contaminated or contain the wrong or no active ingredient. They could have the right
active ingredient but at the wrong dose.
Note 2 to entry: WHO is using the concept of “Spurious/falsely-labelled/falsified/counterfeit (SFFC) medicines”.
3.1.11
3)
GTIN
global trade item number
number that is used for the unique identification of trade items worldwide
EXAMPLE 1 GS1 Identification Key which comprises a GS1 Company Prefix, an Item Reference and Check Digit.
EXAMPLE 2 Used to identify trade items such as pharmaceuticals and medical devices.
Note 1 to entry: See Annex C for the relationship between MPID, PCID, and GTIN.
[SOURCE: ISO/IEC 15420:2009, 3.7 — modified, examples added; note 1 to entry added; digit length
removed.]
3.1.12
healthcare system
organization of people, institutions, and resources to deliver healthcare services to meet the health
needs of target populations
3.1.13
identification
way information about an object such as a trade item can be found in IT systems such as databases
Note 1 to entry: It refers to a sequence of characters (numerals and/or alpha characters). The identifier is intended
to be a unique sequence structured according to a globally agreed architecture or syntax, and can or can not
contain inbuilt significance.
3.1.14
identification schema
namespace
container for a set of identifiers that allows the disambiguation of homonym identifiers residing in
different identification schema
3.1.15
identifier
ID
description that is sufficient to represent an object in a given environment identification schema
3.1.16
machine readable code
code, readable by a machine, that contains information used to establish a relationship between a
physical object such as a medicinal product package and data sources such as medical, production,
logistical and/or reimbursement coding systems
3.1.17
manufacturing/manufacture
process of production from the acquisition of all materials through all processing stages, including final
packaging
3) GTIN is a registered trademark. Any trademark used in this document is information given for the convenience
of users and does not constitute an endorsement.
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3.1.18
marketing authorization
authorization issued from a Medicines Reulatory Agency that a Medicinal Product may be placed on the
market
[SOURCE: ISO 11615:2012, 3.1.40]
3.1.19
marketing authorization holder
organization that holds the authorization for marketing a medicinal product in a jurisdiction
[SOURCE: ISO 11615:2012, 3.1.38, — modified, “for marketing a medicinal product in a jurisdiction”
added]
3.1.20
medicinal product
any substance or combination of substances that can be administered to human beings for treating
or preventing disease, with the view of making a medical diagnosis or to restore, correct, or modify
physiological functions
Note 1 to entry: The same definition applies for animal health.
[SOURCE: ISO 11615:2012, 3.1.49, — modified, “(or animals” removed; notes 1-2 removed and a new note
1 to entry added.]
3.1.21
MPID
medicinal product identifier
identifier allocated to a medicinal product supplementary to any existing authorization number as
ascribed by a medicines regulatory authority in a jurisdiction
[SOURCE: ISO 11615:2012, 3.1.50, — modified, “unique” removed; note removed.]
3.1.22
PCID
medicinal product package identifier
identifier allocated to a packaged medicinal product supplementary to any existing authorization
number as ascribed by a medicines regulatory agency in a jurisdiction
[SOURCE: ISO 11615:2012, 3.1.53, — modified, “unique” removed; note removed.]
Note 1 to entry: See Annex C for relationship between MPID, PCID, and GTIN.
3.1.23
OID
object identifier
globally unique value associated with an object to unambiguously identify it
3.1.24
outer packaging
external container in which a medicinal product is supplied
Note 1 to entry: Corresponds frequently to “secondary packaging” (see Annex B).
[SOURCE: ISO 11615:2012, 3.1.55 — modified, examples and notes removed; new note added.]
3.1.25
packaging hierarchy
relationship between a medicinal product package and its grouping in larger/smaller quantities
Note 1 to entry: See Annex B for illustration of “primary packaging”, “secondary packaging”, etc.
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3.1.26
packaged medicinal product
medicinal product in a container being part of a package, representing the entirety that has been
packaged for sale or supply
Note 1 to entry: Corresponds frequently to “primary packaging” (see Annex B).
[SOURCE: ISO 11615:2012, 3.1.57 — modified, note 1 to entry added.]
3.1.27
pharmacovigilance
science and activities relating to the detection, assessment, understanding and prevention of adverse
effects or any other medicine-related problem
[SOURCE: WHO]
3.1.28
PhPID
pharmaceutical product identifier
identifier for a pharmaceutical product
Note 1 to entry: Pharmaceutical product: qualitative and quantitative composition of the pharmaceutical product
as administered to the patient in line with the regulated product information.
[SOURCE: ISO 11615:2012, 3.1.60 — modified, “unique” removed; note 1 to entry added.]
3.1.29
RFID
radio frequency identification
wireless non-contact system that uses radio-frequency electromagnetic fields to transfer data from a
tag attached to an object, for the purposes of automatic identification and tracking
3.1.30
serialization
assigning a unique identifier (e.g. a number) to an item (e.g. pack, case or pallet)
Note 1 to entry: This identifier is stored on a database along with other information about the item (e.g.
manufacturer, batch info, etc). Serialization typically includes randomly selected, encrypted, numerical or alpha-
numeric serial number.
3.1.31
traceability
ability to track forward the movement through specified stage(s) of the extended supply chain and trace
backward the history, application, or location of that which is under consideration
[SOURCE: Global Traceability Standard for Healthcare, GS1, 2009]
3.1.32
verification
reading unique identifier numbers and checking these in a database
3.2 Abbreviations
AIDC Automatic Identification Data Capture
PCID Medicinal Product Package Identifier
GTIN Global Trade Item Number (from GS1)
INN International Non-proprietary Name
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NDC National Drug Code (from US FDA)
OID Object Identifier
PhPID identifier for a pharmaceutical product
RFID Radio Frequency Identification
4 Procedural background
4.1 General
Clause 4 specifies the distinctions between identification and data carriers (machine readable coding
and its international characters). It then focuses on medicinal product and the characteristics of their
physical packaging in the marketplace.
Supply chain, traceability, and patient safety require appropriate labelling and the use of packaging
identifiers (as described in ISO 11615). Since new processes are in development in many countries to
fight
...