EN 16679:2014
(Main)Packaging - Tamper verification features for medicinal product packaging
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
Relations
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
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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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