Packaging - Tamper verification features for medicinal product packaging

This European Standard specifies requirements and provides guidance for the application, use and check of tamper verification features to the packaging of medicinal products.
NOTE   The packaging of medicinal products placed on the market and incorporating tamper verification features in accordance with this European Standard meets 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 shall appear, among others, "a device allowing verification of whether the outer packaging has been tampered with".
The principles in this European Standard can be applied in other countries and sectors, as appropriate.

Verpackung - Merkmale zur Überprüfung von Manipulationen an Arzneimittelverpackungen

Diese Europäische Norm legt Anforderungen fest und enthält Anleitungen zur Anbringung, Verwendung und Prüfung von Merkmalen zur Überprüfung von Manipulationen an Arzneimittel¬verpackungen.
ANMERKUNG   Die Arzneimittelverpackung, die in Verkehr gebracht wird und Merkmale zur Überprüfung von Manipulationen enthält, die der vorliegenden Europäischen Norm entsprechen, erfüllt die Anforderungen der Richtlinie 2001/83/EG, geändert durch Richtlinie 2011/62/EU. Artikel 54(o) der Richtlinie schreibt vor, dass auf der äußeren Umhüllung bestimmter Arzneimittel oder, falls keine äußere Umhüllung vorhanden ist, auf der Primärverpackung unter anderem "eine Vorrichtung vorhanden sein muss, die es ermöglicht zu überprüfen, ob die äußere Umhüllung manipuliert worden ist".
Die in der vorliegenden Europäischen Norm enthaltenen Grundsätze können entsprechend in anderen Staaten und Bereichen angewendet werden.

Emballage - Témoins d'effraction pour emballages de médicaments

La présente Norme européenne définit les exigences et fournit des préconisations concernant l'application, l'utilisation et le contrôle des témoins d'effraction sur les emballages de médicaments.
NOTE   Les emballages de médicaments commercialisés comportant des témoins d'effraction conformes à la présente Norme européenne satisfont aux exigences de la Directive 2001/83/CE, modifiée par la Directive 2011/62/UE. Le point o) de l'Article 54 de la Directive stipule que l'emballage extérieur ou, à défaut d'emballage extérieur, le conditionnement primaire de certains médicaments doit comporter, entre autres, « un dispositif permettant de vérifier si l’emballage extérieur a fait l’objet d’une effraction ».
Les principes de la présente Norme européenne peuvent être appliqués dans d'autres pays et d'autres secteurs, selon le cas.

Embalaža - Značilnosti preverjanja nedovoljenega poseganja v embalažo za zdravila

Ta evropski standard določa zahteve in vsebuje napotke za uporabo in preverjanje značilnosti preverjanja nedovoljenega poseganja v embalažo za zdravila.
OPOMBA 1 Embalaža za zdravila, dana na trg, z značilnostmi preverjanja nedovoljenega poseganja v embalažo v skladu s tem evropskim standardom izpolnjuje zahteve iz Direktive 2001/83/ES, spremenjene z Direktivo 2011/62/EU. Člen 54(o) Direktive določa, da se na zunanji ovojnini ali, kadar zunanje ovojnine ni, na stični ovojnini zdravil med drugim navede napravo, ki omogoča preverjanje, ali je bila zunanja ovojnina nedovoljeno spremenjena.
OPOMBA 2 Načela tega evropskega standarda je mogoče uporabiti v drugih državah in sektorjih, če je to ustrezno.

General Information

Status
Withdrawn
Publication Date
16-Dec-2014
Withdrawal Date
13-Apr-2025
ICS
03.120.10 - Quality management and quality assurance
 
11.120.10 - Medicaments
 
55.020 - Packaging and distribution of goods in general
Technical Committee
CEN/TC 261 - Packaging
Drafting Committee
CEN/TC 261/SC 5/WG 12 - Marking
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
14-Oct-2020
Completion Date
14-Apr-2025
Ref Project
SIST EN 16679:2015 - Packaging - Tamper verification features for medicinal product packaging

Relations

Replaced By
EN ISO 21976:2020 - Packaging - Tamper verification features for medicinal product packaging (ISO 21976:2018)
Effective Date
08-Jun-2022

Frequently Asked Questions

EN 16679:2014 is a standard published by the European Committee for Standardization (CEN). Its full title is "Packaging - Tamper verification features for medicinal product packaging". This standard covers: This European Standard specifies requirements and provides guidance for the application, use and check of tamper verification features to the packaging of medicinal products. NOTE The packaging of medicinal products placed on the market and incorporating tamper verification features in accordance with this European Standard meets 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 shall appear, among others, "a device allowing verification of whether the outer packaging has been tampered with". The principles in this European Standard can be applied in other countries and sectors, as appropriate.

This European Standard specifies requirements and provides guidance for the application, use and check of tamper verification features to the packaging of medicinal products. NOTE The packaging of medicinal products placed on the market and incorporating tamper verification features in accordance with this European Standard meets 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 shall appear, among others, "a device allowing verification of whether the outer packaging has been tampered with". The principles in this European Standard can be applied in other countries and sectors, as appropriate.

EN 16679:2014 is classified under the following ICS (International Classification for Standards) categories: 03.120.10 - Quality management and quality assurance; 11.120.10 - Medicaments; 55.020 - Packaging and distribution of goods in general. The ICS classification helps identify the subject area and facilitates finding related standards.

EN 16679:2014 has the following relationships with other standards: It is inter standard links to EN ISO 21976:2020. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

You can purchase EN 16679:2014 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.

Standards Content (Sample)


2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.]GUDYLODVerpackung - Merkmale zur Überprüfung von Manipulationen an ArzneimittelverpackungenEmballage - Témoins d'effraction pour emballages de produits médicinauxPackaging - Tamper verification features for medicinal product packaging55.020Pakiranje in distribucija blaga na splošnoPackaging and distribution of goods in general11.020]GUDYVWYHQRYDUVWYHQLMedical sciences and health care facilities in generalICS:Ta slovenski standard je istoveten z:EN 16679:2014SIST EN 16679:2015en,fr,de01-marec-2015SIST EN 16679:2015SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 16679
December 2014 ICS 03.120.10; 11.120.10; 55.020 English Version
Packaging - Tamper verification features for medicinal product packaging
Emballage - Témoins d'effraction pour emballages de médicaments
Verpackung - Merkmale zur Überprüfung von Manipulationen an Arzneimittelverpackungen This European Standard was approved by CEN on 8 November 2014.
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, 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 © 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 16679:2014 ESIST EN 16679:2015

Additional information regarding tamper verification features . 17 Bibliography . 18
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The article discusses the EN 16679:2014 standard, which focuses on tamper verification features for packaging of medicinal products. This standard provides requirements and guidance for the application, use, and checking of these features. It ensures that packaging incorporating tamper verification features complies with Directive 2001/83/EC as amended by Directive 2011/62/EU. This directive states that certain medicinal products must include a device that allows verification of whether the packaging has been tampered with. The principles of this standard can also be applied in other countries and sectors, as needed.

記事タイトル：EN 16679:2014 - 包装 - 医薬品包装の改ざん防止機能 記事内容：このヨーロッパ規格は、医薬品包装の改ざん防止機能の適用、使用、および確認に関する要件とガイダンスを明示しています。 注意事項：このヨーロッパ規格に従って改ざん防止機能を備えた医薬品包装が市場に出回ることは、指令書2001/83/EC（指令書2011/62/EUにより修正）の要件を満たしています。該当する医薬品の外装包装または直接包装には、その他の情報の中に「外装包装が改ざんされていないかを確認するための装置」が表示される必要があります。 このヨーロッパ規格の原則は、必要に応じて他の国や業界にも適用することができます。

기사 제목: EN 16679:2014 - 포장 - 의약품 포장물의 위조 방지 기능 기사 내용: 이 유럽 표준은 의약품 포장물에 대한 위조 방지 기능의 적용, 사용 및 확인에 대한 요구 사항과 지침을 명시합니다. 참고: 이 유럽 표준에 따라 위조 방지 기능을 포함한 의약품 포장물을 시장에 출시한 포장물은 수정된 2001/83/EC 지침에 따르며, 2011/62/EU 지침에 의해 변경되었습니다. 이 지침의 제54조(o)는 특정 의약품의 외부 포장물 또는 주머니 포장물이 외부에서 변경되었는지 확인할 수 있는 "장치" 중 하나가 나타나야 함을 규정합니다. 이 유럽 표준의 원칙은 필요에 따라 다른 국가 및 분야에서도 적용될 수 있습니다.