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

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
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Phone: [phone]
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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 .
...