EN ISO 21976:2020

Packaging - Tamper verification features for medicinal product packaging (ISO 21976:2018)

This document specifies requirements and provides guidance for the application, use and check of tamper verification features to the packaging of medicinal products.

Verpackung - Merkmale zur Überprüfung von Manipulationen an Arzneimittelverpackungen (ISO 21976:2018)

Dieses Dokument legt Anforderungen fest und enthält Anleitungen zur Anbringung, Verwendung und Prüfung von Merkmalen zur Überprüfung von Manipulationen an Arzneimittelverpackungen.
Die in dem vorliegenden Dokument enthaltenen Grundsätze können entsprechend in anderen Bereichen angewendet werden.

Emballage - Témoins d'effraction pour emballages de médicaments (ISO 21976:2018)

Le présent document définit les exigences et fournit des recommandations pour l'application, l'utilisation et le contrôle des témoins d'effraction sur les emballages de médicaments.
Les principes du présent document peuvent être appliqués dans d'autres secteurs, selon le cas.

Embalaža - Značilnosti preverjanja nedovoljenega poseganja v embalažo za zdravila (ISO 21976:2018)

General Information

• Status: Published
• Publication Date: 13-Oct-2020
• Withdrawal Date: 29-Apr-2021
• ICS: 11.120.99 - Other standards related to pharmaceutics
• ICS: 55.020 - Packaging and distribution of goods in general
• Technical Committee: CEN/TC 261 - Packaging
• Drafting Committee: CEN/TC 261/SC 5 - Primary packaging and transport packaging
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 14-Oct-2020
• Due Date: 28-May-2022
• Completion Date: 14-Oct-2020
• Ref Project: SIST EN ISO 21976:2020 - Packaging - Tamper verification features for medicinal product packaging (ISO 21976:2018)

Relations

• Replaces: EN 16679:2014 - Packaging - Tamper verification features for medicinal product packaging
• Effective Date: 08-Jun-2022

Overview

EN ISO 21976:2020 (identical to ISO 21976:2018) is a CEN-adopted standard that specifies requirements and provides guidance for the application, use and check of tamper verification features for medicinal product packaging. It harmonizes industry practice across Europe and internationally to reduce risk from unauthorized opening or manipulation and to support patient safety and regulatory compliance.

Key topics and technical scope

This standard covers descriptions, functional criteria and verification guidance for a range of tamper verification solutions used on medicinal packaging. Key topics include:

• General requirements: purpose, selection and application of tamper verification features and guidance on how they are intended to be used and checked.
• Categories of features: organized guidance for common packaging formats such as:
  • folding boxes (including glue-closed and specially constructed boxes)
  • sealing labels and tapes
  • film wrappers and sleeves
  • breakable or tear-away closures
  • container inner seals or membranes
  • display blister packs and flexible packaging
  • blow-fill-and-seal (BFS) containers
  • new and emerging technologies
• For each category: a description, criteria of tamper verification and verification approaches (inspection/check procedures).
• Informative annexes: additional background information and bibliography to support implementation.

Practical applications and users

EN ISO 21976:2020 is practical for professionals who design, produce, inspect or regulate medicinal packaging:

• Pharmaceutical manufacturers choosing or specifying tamper verification solutions to meet safety and regulatory expectations.
• Packaging designers and converters developing cartons, seals, blisters, sleeves and tamper labels.
• Contract packagers and CMOs implementing compliant closure and inspection processes.
• Quality assurance and regulatory affairs teams validating packaging integrity and documenting compliance.
• Regulators and inspection bodies seeking a harmonized basis for assessing tamper-verification measures.
• Procurement and supply chain managers evaluating suppliers and materials for tamper-evident performance.

Use cases include selecting an appropriate tamper verification feature for a product presentation, developing routine inspection procedures for release, and demonstrating alignment with regulatory frameworks.

Related standards and context

• EN ISO 21976:2020 supersedes EN 16679:2014 and incorporates ISO 21976:2018 text.
• The standard was developed by ISO/TC 122 (Packaging) and adopted by CEN/TC 261 (Packaging).
• It supports regulatory aims such as those in Directive 2001/83/EC and Directive 2011/62/EU (Falsified Medicines Directive) by promoting harmonized tamper verification practices.

Keywords: tamper verification, tamper-evident, medicinal product packaging, EN ISO 21976:2020, ISO 21976, pharmaceutical packaging standards, tamper verification features.

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2020
Nadomešča:
SIST EN 16679:2015
Embalaža - Značilnosti preverjanja nedovoljenega poseganja v embalažo za
zdravila (ISO 21976:2018)
Packaging - Tamper verification features for medicinal product packaging (ISO
21976:2018)
Verpackung - Merkmale zur Überprüfung von Manipulationen an
Arzneimittelverpackungen (ISO 21976:2018)
Emballage - Témoins d'effraction pour emballages de médicaments (ISO 21976:2018)
Ta slovenski standard je istoveten z: EN ISO 21976:2020
ICS:
11.120.99 Drugi standardi v zvezi s Other standards related to
farmacijo pharmaceutics
55.020 Pakiranje in distribucija blaga Packaging and distribution of
na splošno goods in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 21976
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2020
EUROPÄISCHE NORM
ICS 11.120.99; 55.020 Supersedes EN 16679:2014
English Version
Packaging - Tamper verification features for medicinal
product packaging (ISO 21976:2018)
Emballage - Témoins d'effraction pour emballages de Verpackung - Merkmale zur Überprüfung von
médicaments (ISO 21976:2018) Manipulationen an Arzneimittelverpackungen (ISO
21976:2018)
This European Standard was approved by CEN on 28 September 2020.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

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. EN ISO 21976:2020 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
The text of ISO 21976:2018 has been prepared by Technical Committee ISO/TC 122 "Packaging” of the
International Organization for Standardization (ISO) and has been taken over as EN ISO 21976:2020 by
Technical Committee CEN/TC 261 “Packaging” the secretariat of which is held by AFNOR.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by April 2021, and conflicting national standards shall be
withdrawn at the latest by April 2021.
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 EN 16679:2014.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: 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 21976:2018 has been approved by CEN as EN ISO 21976:2020 without any modification.

INTERNATIONAL ISO
STANDARD 21976
First edition
2018-11
Packaging — Tamper verification
features for medicinal product
packaging
Emballage — Témoins d'effraction pour emballages de médicaments
Reference number
ISO 21976:2018(E)
©
ISO 2018
ISO 21976:2018(E)
© ISO 2018
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: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

ISO 21976:2018(E)
Contents  Page
Foreword .v
Introduction .vi
1  Scope . 1
2  Normative references . 1
3  Terms and definitions . 1
4  General requirements . 2
4.1 Tamper verification features . 2
4.2 Purpose of tamper verification features . 2
4.3 Application and use of tamper verification features . 2
4.4 Check of tamper verification features . 3
5  Categories of tamper verification features . 3
5.1 General . 3
5.2 Folding boxes closed with glue . 3
5.2.1 Description . . . 3
5.2.2 Criteria of tamper verification . 3
5.2.3 Verification . 3
5.3 Specially constructed folding boxes . 4
5.3.1 Description . . . 4
5.3.2 Criteria of tamper verification . 5
5.3.3 Verification . 5
5.4 Sealing labels and tapes . 5
5.4.1 Description . . . 5
5.4.2 Criteria of tamper verification . 6
5.4.3 Verification . 6
5.5 Film wrappers. 7
5.5.1 Description . . . 7
5.5.2 Criteria of tamper verification . 7
5.5.3 Verification . 7
5.6 Sleeves . 7
5.6.1 Description . . . 7
5.6.2 Criteria of tamper verification . 7
5.6.3 Verification . 7
5.7 Breakable or tear-away closure . 8
5.7.1 Description . . . 8
5.7.2 Criteria of tamper verification . 8
5.7.3 Verification . 8
5.8 Container inner seal or membrane . 9
5.8.1 Description . . . 9
5.8.2 Criteria of tamper verification . 9
5.8.3 Verification .10
5.9 Display blister pack .10
5.9.1 Description . . .10
5.9.2 Criteria of tamper verification .10
5.9.3 Verification .11
5.10 Flexible packaging .11
5.10.1 Description . . .11
5.10.2 Criteria of tamper verification .11
5.10.3 Verification .11
5.11 Blow-fill-and-seal-container (BFS) . .12
5.11.1 Description . . .12
5.11.2 Criteria of tamper verification .12
5.11.3 Verification .12
ISO 21976:2018(E)
5.12 New and emerging technologies .13
Annex A (informative) Additional information regarding tamper verification features .14
Bibliography .15
iv © ISO 2018 – All rights reserved

ISO 21976:2018(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 122, Packaging.
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.
ISO 21976:2018(E)
Introduction
Requirements for tamper verification features on medicinal product packaging are emerging and
expanding globally to reduce risk and improve patient safety.
This document is to support the harmonization and implementation of tamper verification features to
the packaging of medicinal products worldwide.
The knowledge and experience gained in EN 16679:2014 has been used for developing this document.
The background for the creation of a European Standard for tamper verification features for medicinal
[6]
product packaging (EN 16679) was the European Directive 2001/83/EC , as amended by Directive
[7]
2011/62/EU , the latter commonly referred to as the “Falsified Medicines Directive” (FMD).
The packaging of medicinal products placed on the market and incorporating tamper verification
features in accordance with this document meets, as an example but not limited to, the requirements
[6] [7]
of Directive 2001/83/EC as amended by Directive 2011/62/EU . Article 54(o) of the Directive
stipulates, that on the outer packaging of certain medicinal products or, where there is no outer
packaging, on the immediate packaging must appear, among others, “a device allowing verification of
whether the outer packaging has been tampered with”.
vi © ISO 2018 – All rights reserved

INTERNATIONAL STANDARD ISO 21976:2018(E)
Packaging — Tamper verification features for medicinal
product packaging
1  Scope
This document specifies requirements and provides guidance for the application, use and check of
tamper verification features to the packaging of medicinal products.
The principles in this document can be applied in other sectors, as appropriate.
2  Normative references
There are no normative references in this document.
3  Terms and definitions
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
falsified medicinal product
medicinal products (3.6) that deliberately/fraudulently misrepresent their identity, composition or
source
[17]
[SOURCE: WHO, Definitions of Substandard and Falsified (SF) Medical Products, 2017 ]
3.2
finished product
authorized medicinal product (3.6) which has undergone all stages of production including packaging in
its final container as it is dispensed, sold or otherwise supplied
3.3
immediate packaging
primary packaging
container or other form of packaging directly in contact with the medicinal product (3.6)
3.4
manufacturing authorization holder
natural or legal person or entity that is authorized for total or partial manufacture
Note 1 to entry: This includes replacement of safety and tamper verification features (3.9) (in accordance with
[6] [7]
Directive 2001/83/EC , Article 47a(1)(b) as amended by Directive 2011/62/EU ).
3.5
market
...