1、March 2015 Translation by DIN-Sprachendienst.English price group 11No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS
2、11.120.10; 55.020; 03.120.10!%A*l“2300773www.din.deDDIN EN 16679Packaging Tamper verification features for medicinal product packaging;English version EN 16679:2014,English translation of DIN EN 16679:2015-03Verpackung Merkmale zur berprfung von Manipulationen an Arzneimittelverpackungen;Englische F
3、assung EN 16679:2014,Englische bersetzung von DIN EN 16679:2015-03Emballage Tmoins deffraction pour emballages de mdicaments;Version anglaise EN 16679:2014,Traduction anglaise de DIN EN 16679:2015-03www.beuth.deDocument comprises 20 pagesIn case of doubt, the German-language original shall be consid
4、ered authoritative.02.15DIN EN 16679:2015-03 2 A comma is used as the decimal marker. National foreword This document (EN 16679:2014) has been prepared by Technical Committee CEN/TC 261 “Packaging” (Secretariat: AFNOR, France). The responsible German body involved in its preparation was the DIN-Norm
5、enausschuss Verpackungswesen (DIN Standards Committee Packaging), Working Committee NA 115-01-03 AA Markierung, Working Group NA 115-01-03-02 AK Merkmale zur berprfung von Manipulationen an Arzneimittelverpackungen. EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 16679 December 2014 ICS 03.120.
6、10; 11.120.10; 55.020 English Version Packaging - Tamper verification features for medicinal product packaging Emballage - Tmoins deffraction pour emballages de mdicaments Verpackung - Merkmale zur berprfung von Manipulationen an Arzneimittelverpackungen This European Standard was approved by CEN on
7、 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 ma
8、y 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
9、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
10、, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Manageme
11、nt 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 EEN 16679:2014 (E) 2 Contents Page Foreword 4 Introduction .5 1 Scope 6 2 Terms and definitions .6 3 General requirements
12、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 Descrip
13、tion .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 Ve
14、rification 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 t
15、amper 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
16、(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 DIN EN 16679:2015-03 EN 16679:2014 (E) 3 Annex A (informative) Additional information regarding tamper verification features . 17 Bibliography 18 DIN EN 16679:2015-
17、03 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 endorsem
18、ent, 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 an
19、y 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 Repub
20、lic 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. DIN EN 16679:2015-03 EN 16679:2014 (E) 5 Introduction Dire
21、ctive 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
22、 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 Econ
23、omic Area (EEA). DIN EN 16679:2015-03 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 mark
24、et 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 ou
25、ter 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 purpos
26、es 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 o
27、f 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
28、 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, packagi
29、ng 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
30、 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,
31、 has been chosen in the context of this standard because it is contained in Directive 2001/83/EC. DIN EN 16679:2015-03 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 o
32、f 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 confirma
33、tion, 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
34、 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 a finished product has been opened or tampered with (i.e. indicating a possible adulteration or entry of falsified medicin
35、al products into the legitimate supply chain). Tamper verification features limit the ability to replace the contents of genuine packs. Tamper verification features are only one element of the safety features against falsification of the FMD and will not by themselves prevent falsification of medici
36、nal products. 3.3 Application and use of tamper verification features The application of tamper verification features shall not compromise the readability of statutory information. The statutory text on the packaging should remain readable after opening the pack. Applying tamper verification feature
37、s may increase the physical strength needed to open the packaging. 3.4 Check of tamper verification features The tamper verification feature should enable a visual check for its presence and any evidence of tampering (see 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9 and 4.10 for details). The immediate pa
38、ckaging of medicinal products may also provide tamper verification. This serves a different purpose, most significantly to prevent interference with the medicinal product itself and does not meet the tamper verification requirements of Directive 2001/83/EC as amended by Directive 2011/62/EU. However
39、 it also provides another level of protection against tampering but only in combination with additional measures as described. Wholesalers, dispensing persons and other authorized persons may need access to information on the tamper verification features employed on particular products. NOTE Other a
40、uthorized persons include holders of a manufacturing authorization or customs authorities. DIN EN 16679:2015-03 EN 16679:2014 (E) 8 4 Categories of tamper verification features 4.1 General Tamper verification technologies applied on the packaging are under constant evolution. Nine broad categories o
41、f tamper verification features are described in this European Standard (see 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9 and 4.10). Other tamper verification features may exist or be developed and shall meet the requirements of this European Standard as appropriate. The illustrations in Clause 4 are non-e
42、xhaustive. Annex A provides additional information on tamper verification features as listed in 4.2 to 4.10. If there is no outer packaging, the immediate packaging (e.g. bottles and tubes) should be equipped with a tamper verification feature in accordance with 4.4 to 4.10. Tamper verification feat
43、ures shall meet the requirements of Clause 3. The marketing authorization holder shall decide (if legally required) on appropriate tamper verification feature(s) out of the following (see 4.2 to 4.11). This choice may be based on an assessment that takes into account a number of factors including te
44、chnical feasibility, appropriateness, effectiveness, other safety features used on the product, and overall cost. 4.2 Folding boxes closed with glue 4.2.1 Description A glue, e.g. hot melt, polyurethane, dispersion or other glues, or a combination of glues is applied to close the folding box. These
45、boxes may incorporate perforations to facilitate the opening of the pack. 4.2.2 Criteria of tamper verification Folding boxes closed with glue shall be cut or torn to gain access to the product. The box cannot be opened without visual tear-off/ripping-off of the carton board surface and/or other par
46、ts of the folding box. 4.2.3 Verification First time opening of the folding box leads to visible damage of the folding box integrity, for example (see Figure 1 and Figure 2): visible damage of one or more of the flaps (see Figure 1 b) and Figure 1 c); visible damage of perforations (see Figure 2 b)
47、and Figure 2 c); visible damage of other parts of the folding box. DIN EN 16679:2015-03 EN 16679:2014 (E) 9 a) Original condition b) Where the opening of the box has been tried c) Opened Figure 1 Example of a folding box closed with glue a) Original condition b) Where the opening of the box has been
48、 tried c) Opened Figure 2 Example of a folding box with perforations closed with glue 4.3 Specially constructed folding boxes 4.3.1 Description The flaps and the body of the folding box are constructed in such a way that the feature is activated/enabled by inserting the flaps by the manufacturer to
49、close the folding box. First time opening leads to a visible, irreversible change of the folding box appearance in such way, that parts of the flaps or of the folding box are damaged. 4.3.2 Criteria of tamper verification The closure is set up in such a way that, the first time the box is opened, parts of the flaps or of the folding box are ripped off and/or are torn. DIN EN 16679:2015-03 EN 16679:2014 (E) 10 4.3.3 Verification First time opening leads to visible, irreversible damage of the folding box integrity for example (see Figure 3): visi
