1、BSI Standards PublicationBS EN 16679:2014Packaging Tamperverification features formedicinal product packagingBS EN 16679:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 16679:2014. The UK participation in its preparation was entrusted to TechnicalCommittee
2、PKW/0/-/5, Packaging - Product Identification (Braille). A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The B
3、ritish Standards Institution 2014.Published by BSI Standards Limited 2014ISBN 978 0 580 84024 1ICS 03.120.10; 11.120.10; 55.020Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy
4、 Committee on 31 December 2014.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 16679 December 2014 ICS 03.120.10; 11.120.10; 55.020 English Version Packaging - Tamper verification features for medicinal product packaging
5、Emballage - Tmoins deffraction pour emballages de mdicaments Verpackung - Merkmale zur berprfung 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
6、 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
7、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
8、 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, Slovaki
9、a, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means r
10、eserved worldwide for CEN national Members. Ref. No. EN 16679:2014 EBS EN 16679:2014EN 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 Applica
11、tion 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 constructe
12、d 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 1
13、1 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.
14、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
15、 4.11 New and emerging technologies . 16 BS EN 16679:2014EN 16679:2014 (E) 3 Annex A (informative) Additional information regarding tamper verification features . 17 Bibliography 18 BS EN 16679:2014EN 16679:2014 (E) 4 Foreword This document (EN 16679:2014) has been prepared by Technical Committee CE
16、N/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 J
17、une 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 or
18、ganizations 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, Luxembour
19、g, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 16679:2014EN 16679:2014 (E) 5 Introduction Directive 2011/62/EU 1, commonly referred to as the “Falsified Medicines Directive” (FMD), amending Directive 2001
20、/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 l
21、egislation. 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). BS EN 16679:2014EN 16679:2014 (E) 6 1 Scope This European Standard specifies requirements and
22、 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
23、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 th
24、e 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
25、 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 immediat
26、e 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/E
27、C. 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 replaceme
28、nt 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 secondar
29、y 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. BS EN 16679:2014E
30、N 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 Not
31、e 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 9000:2
32、005, 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
33、 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 medicinal products into the legitimate supply chain). Tamper verification features limit the ability to replace the contents of
34、 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 medicinal products. 3.3 Application and use of tamper verification features The application of tamper verification features sh
35、all not compromise the readability of statutory information. The statutory text on the packaging should remain readable after opening the pack. Applying tamper verification features may increase the physical strength needed to open the packaging. 3.4 Check of tamper verification features The tamper
36、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 packaging of medicinal products may also provide tamper verification. This serves a different purpose, most significantly
37、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 it also provides another level of protection against tampering but only in combination with additional measures as desc
38、ribed. Wholesalers, dispensing persons and other authorized persons may need access to information on the tamper verification features employed on particular products. NOTE Other authorized persons include holders of a manufacturing authorization or customs authorities. BS EN 16679:2014EN 16679:2014
39、 (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 of 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).
40、 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-exhaustive. Annex A provides additional information on tamper verification features as listed in 4.2 to 4.10. If there is no o
41、uter 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 features shall meet the requirements of Clause 3. The marketing authorization holder shall decide (if legally required) on approp
42、riate 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 technical feasibility, appropriateness, effectiveness, other safety features used on the product, and overall cost. 4.2 Folding
43、 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 boxes may incorporate perforations to facilitate the opening of the pack. 4.2.2 Criteria of tamper verification Folding boxes
44、 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 parts of the folding box. 4.2.3 Verification First time opening of the folding box leads to visible damage of the folding box in
45、tegrity, 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) and Figure 2 c); visible damage of other parts of the folding box. BS EN 16679:2014EN 16679:2014 (E) 9 a) Original condition
46、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 tried c) Opened Figure 2 Example of a folding box with perforations closed with glue 4.3 Specially constructed folding boxes 4.3.
47、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 close the folding box. First time opening leads to a visible, irreversible change of the folding box appearance in such way, that
48、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. BS EN 16679:2014EN 16679:2014 (E) 10 4.3.3 Verification Fir
49、st time opening leads to visible, irreversible damage of the folding box integrity for example (see Figure 3): visible damage of one or more of the flaps (see Figure 3 b) and Figure 3 c); visible damage of perforations and/or scores/half cuts, if applicable; visible damage of other parts of the folding box. a) Original condition b) Opened c) Condition in which the reclosing of the opened condition shows the first time opening Figure 3 Example of a specially constructed folding box 4.4 Sealing labels and tapes 4.4.1 Description A label or tape (e.g.
