prEN ISO 21976

SLOVENSKI STANDARD
oSIST prEN ISO 21976:2020
01-junij-2020
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: prEN ISO 21976
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
oSIST prEN ISO 21976:2020 en,fr,de

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

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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

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

5.12 New and emerging technologies ..........................................................................................................................................13

Annex A (informative) Additional information regarding tamper verification features ............................14

Bibliography .............................................................................................................................................................................................................................15

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Any feedback or questions on this document should be directed to the user’s national standards body. A

Requirements for tamper verification features on medicinal product packaging are emerging and

This document is to support the harmonization and implementation of tamper verification features to

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

product packaging (EN 16679) was the European Directive 2001/83/EC , as amended by Directive

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

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

This document specifies requirements and provides guidance for the application, use and check of

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

medicinal products (3.6) that deliberately/fraudulently misrepresent their identity, composition or

[SOURCE: WHO, Definitions of Substandard and Falsified (SF) Medical Products, 2017 ]

authorized medicinal product (3.6) which has undergone all stages of production including packaging in

container or other form of packaging directly in contact with the medicinal product (3.6)

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

natural or legal person or entity responsible for placing the medicinal product (3.6) on the market

substance or combination of substances that may be administered to human beings (or animals) for

treating or preventing disease, with the aim/purpose to making a medical diagnosis or to restore,

[SOURCE: ISO 11615:2017, 3.1.50, modified — “Pharmaceutical product” has been replaced by

packaging designed to contain one or more primary packagings together with any protective materials

[SOURCE: ISO 21067-1:2016, 2.2.4, modified — “Outer packaging” has been added as an admitted term.]

unauthorized attempt to open, manipulate or re-use the packaging or elements of it

characteristic(s) allowing verification (3.10) of whether the outer packaging (3.7) of medicinal products

(3.6) or, where there is no outer packaging, the immediate packaging has been opened or tampered with

Note 1 to entry: Tamper verification features may be referred to as “anti-tampering devices”.

confirmation, through the provision of objective evidence, that specified requirements have been

[SOURCE: ISO 9000:2015, 3.8.12, modified — The Notes to entry have been deleted.]

Tamper verification features shall be applied to packaging of medicinal products as required, or may be

Tamper verification features should provide an indication that the packaging of a finished product