SIST EN 16679:2015
(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 1 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 lit (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 packaging has been tampered with.
NOTE 2 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 produits médicinaux
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
SIST EN 16679:2015
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
EN 16679:2014 (E) 2 Contents Page Foreword .4 Introduction .5 1 Scope .6 2 Terms and definitions .6 3 General requirements .7 3.1 Tamper verification features .7 3.2 Purpose of tamper verification features .7 3.3 Application and use of tamper verification features .7 3.4 Check of tamper verification features .7 4 Categories of tamper verification features .8 4.1 General .8 4.2 Folding boxes closed with glue .8 4.2.1 Description .8 4.2.2 Criteria of tamper verification .8 4.2.3 Verification .8 4.3 Specially constructed folding boxes .9 4.3.1 Description .9 4.3.2 Criteria of tamper verification .9 4.3.3 Verification . 10 4.4 Sealing labels and tapes . 10 4.4.1 Description . 10 4.4.2 Criteria of tamper verification . 10 4.4.3 Verification . 10 4.5 Film wrappers . 11 4.5.1 Description . 11 4.5.2 Criteria of tamper verification . 11 4.5.3 Verification . 11 4.6 Sleeves . 12 4.6.1 Description . 12 4.6.2 Criteria of tamper verification . 12 4.6.3 Verification . 12 4.7 Breakable or tear-away closure . 12 4.7.1 Description . 12 4.7.2 Criteria of tamper verification . 13 4.7.3 Verification . 13 4.8 Display blister pack . 13 4.8.1 Description . 13 4.8.2 Criteria of tamper verification . 13 4.8.3 Verification . 14 4.9 Flexible packaging . 14 4.9.1 Description . 14 4.9.2 Criteria of tamper verification . 14 4.9.3 Verification . 14 4.10 Blow-fill-and-seal-container (BFS) . 15 4.10.1 Description . 15 4.10.2 Criteria of tamper verification . 15 4.10.3 Verification . 15 4.11 New and emerging technologies . 16 SIST EN 16679:2015
EN 16679:2014 (E) 3 Annex A (informative)
Additional information regarding tamper verification features . 17 Bibliography . 18
SIST EN 16679:2015
EN 16679:2014 (E) 4 Foreword This document (EN 16679:2014) has been prepared 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 June 2015, and conflicting national standards shall be withdrawn at the latest by June 2015. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. 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, 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 the United Kingdom. SIST EN 16679:2015
EN 16679:2014 (E) 5 Introduction Directive 2011/62/EU [1], commonly referred to as the “Falsified Medicines Directive” (FMD), amending Directive 2001/83/EC [2], requires safety features for certain medicinal products to provide verification of the “authenticity and identification of individual packs”, and “a device allowing verification of whether the outer packaging has been tampered with”. Directives are implemented into Member States' national legislation. This document is primarily aimed at supporting the implementation of tamper verification features to packaging for medicinal products in the European Union (EU) and European Economic Area (EEA). SIST EN 16679:2015
EN 16679:2014 (E) 6 1 Scope 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. 2 Terms and definitions For the purposes of this document, the following terms and definitions apply. 2.1 dispensing person person authorized or entitled to supply medicinal products to the public 2.2 Falsified Medicines Directive FMD Directive 2011/62/EU 2.3 finished product authorized medicinal product which has undergone all stages of production including packaging in its final container as it is dispensed, sold or otherwise supplied 2.4 immediate packaging primary packaging container or other form of packaging immediately in contact with the medicinal product Note 1 to entry: The term immediate packaging, also known as primary packaging, has been chosen in the context of this European Standard because it is contained in Directive 2001/83/EC. 2.5 manufacturing authorization holder natural or legal person or entity that is authorized for total or partial manufacture, and/or for the various processes of dividing up, packaging or presentation (in accordance with Directive 2001/83/EC, Article 40(2) Note 1 to entry: This includes replacement of safety and tamper verification features (in accordance with Directive 2001/83/EC, Article 47a(1)(b) as amended by Directive 2011/62/EU). 2.6 marketing authorization holder natural or legal person or entity responsible for placing the medicinal product on the market 2.7 outer packaging secondary packaging packaging into which the immediate packaging is placed as it is dispensed or otherwise supplied Note 1 to entry: The term outer packaging, also known as secondary packaging, has been chosen in the context of this standard because it is contained in Directive 2001/83/EC. SIST EN 16679:2015
EN 16679:2014 (E) 7 2.8 tampering unauthorized attempt to open the packaging 2.9 tamper verification feature characteristic(s) allowing verification of whether the outer packaging of medicinal products 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 “devices”, see Directive 2001/83/EC, Article 54(o) as amended by Directive 2011/62/EU. 2.10 verification confirmation, through the provision of objective evidence, that specified requirements have been fulfilled [SOURCE: EN ISO 9000:2005, 3.8.4] 3 General requirements 3.1 Tamper verification features Tamper verification features shall be applied to packaging of certain medicinal products as required in Directive 2001/83/EC as amended by Directive 2011/62/EU. 3.2 Purpose of tamper verification features Tamper verification features should provide an indication that the outer packaging of
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