Tamper verification features on medicinal product packaging – … · 2017-11-14 · Tamper verification features on medicinal product packaging – from Europe across the globe

Tamper verification features on medicinal product packaging – from Europe across the globe

Dieter MößnerEdelmann GmbHHeidenheim / Germany

Convenor CEN/TC 261/SC 5/WG 12 “Marking”

Chairman of the Packaging Standards Committee NAVp (www.navp.din.de) at the German Standards Institute DIN(www.din.de)

CPHI Pharma Insight Briefings,CPHI Frankfurt, October 2017

© DIN / © Edelmann Tamper verification features on medicinal product packaging – Dieter Mößner, CPHI Frankfurt, October 2017 Page 1

Information / Legal Disclaimer / Copyright:The contents and the viewpoints of this presentation are personal viewpoints of the presenter. The information given within this presentation has been collected carefully. No warranty or responsibility can be taken over regarding the timeliness, correctness and completeness of the presented information

The information given and the presentation held at the CPHI Pharma Insight Briefings in Frankfurt in October 2017 are only intended for the internal and personal use of the recipients and participants on this day. They are not intended for publication or further distribution. Edelmann GmbH, D-Heidenheim, DIN e.V., D-Berlin and the speaker / presenter do not take over any liability for the timeliness, correctness and completeness of the presented information. Any copyright or other rights are excluded.

The links to authors and information are intended to provide sources for cited information. In any case the indicated sources have to be asked for permission before any use of the information and material.


1) Brief Introduction of packaging standards committee at DIN/Edelmann

2) Why is there a globally increasing demand for tamper verification features on medicinal product packaging?

3) Which tamper verification guidelines / “standards” are available?

4) Why aiming at a European standard? / Process of European Standardisation

5) Results of formal vote / Letter from EU-Commission / Q & A Paper

6) Development of ISO 21976 “tamper verification features for MP packaging”

7) Structure and contents of the forthcoming ISO 21976 /technical characteristics of tamper verification features

8) Conclusions / Recommendations for the practice

Agenda:


The NA 115 Packaging Standards Committee (NAVp) in the German Institute for standardization (DIN) is responsible for the standardization of packaging, transport containers up to 3 m³, packaging systems and unit loads.

It coordinates the German participation in the field of packaging standardization on European and international level and holds secretariats of European and international standardization committees in special fields.

27 active national Working groups that contain approx. 600 German experts do the mirror committee work to 18 European working groups at CEN/TC 261 packaging (www.cen.eu) and to 11 International working groups at ISO/TC 122 „Packaging“, ISO/TC 63 „Glass Containers“ and ISO/TC 51 „Pallets“ (www.iso.org).

Address: DIN German Institute for Standardization, NAVp Packaging standards committee, Mr. Jan-Philip Everding, Burggrafenstrasse 6, D-10787 Berlin/Germany, Tel.: +4930-26012463, Fax: +4930-260142463, E-Mail: [email protected], Internet: www.navp.din.de

1) Introduction: Packaging standards committee at DIN


1) Brief introduction of Edelmann - Overview

Turnover: 300 Mio. € in 2016

5 Mio. folding cartons per year

1,2 Mio. package leaflets per year

2.700 staff members

7 National plants in Germany

9 International plants in France, China,Poland, Hungary, Mexico, India,Brazil and USA

Family owned company


Health Care/Pharmaceutical

OTC Ethical Medicinal Products Diagnostics Generics

Consumer Brands

Tobacco Food and Confectionary Wine and Spirits Consumer Goods Industry

Beauty Care

Perfume Skin Care Cosmetics Make-up Hair Coloration

1) Brief introduction of Edelmann - Markets


Folding Cartons Leaflets Combi Carton

Sicherheit Veredelung

Individual packaging solutions Individual finishing Coding systems Security features

Inserts and outserts Folding and assembly possibilities Booklets Aviation

Integration of leaflets, sachets Carton with inner lining (CEBox) Complex system packaging CEasy

1) Brief introduction of Edelmann - Products


Directive 2011/62/EU amending Directive 2001/83/EC ~ EU-falsified medicines directive (FMD):

The outer packaging of a medicine must contain the following information:

1. „Safety features, that enable distributors and persons, that are allowed to give out medicines to the public, to

– verify the authenticity of the medicine– identify individual pack

2. as well as a device, that allows to verify, if the outer packaging has been manipulated (“tampered with”).

CEN-Standard EN 16679

2) Why is there a globally increasing demand for tamper veri-fication features on medicinal product packaging? EU-FMD

securPharmNational/European Medicines Verification Organisations(NMVO/EMVO)


2 Safety Features

Individual identification feature“unique identifier“

Serial number and further elements (as plain text and Data-Matrix-Code)

Precision in “delegated regulation”

Testing via securPharm and others

Base: EFPIA-Data matrix Project

Anti-Manipulation feature„tamper proof evidence“, better:

„tamper verification feature“

Several possibilities: Glue points, gluing seal, cellophane wrapping, specially constructed folding cartons, new and emerging technologies

Decision by the manufacturer



German medicinesLaw (AMG): Oct. 2012

The EU-FMD/Delegated Regulation will affect- approx. 10,5 Mio. Medicinal products / Year in the EEA- 32 European Countries- Generally Rx-Medicines and some OTC-medicines

09.02.2019 09.02.2025

09.02.2016



Tamper Verification Feature (TVF) from FMD 11th July 2011:- Very general requirement to apply “a device, that allows to verify, if the outer

packaging has been tampered with”- No mandate for the EU-commission to regulate the anti tampering device in

more detail- Decision by the pharmaceutical manufacturer to apply the TVF

Delegated Regulation (published 9th February 2016)- The verification of the integrity of the anti-tampering device shows whether

the packaging has been opened or altered since it left the manufacturer, thereby ensuring that the content of the packaging is authentic.

- Article 10: Verification of the safety featuresWhen verifying the safety features, manufacturers, wholesalers and persons authorized or entitled to supply medicinal products to the public shall verify the following:

(a) the authenticity of the unique identifier;(b) the integrity of the anti-tampering device.

2) Globally increasing demand for tamper verification featureson MP product packaging– Fact base FMD implementation










Agenda:


Code of Practice for the Tamper-Evident Packaging (TEP) of Therapeutic Goods –Australia 2000, update 2017, is voluntary for OTC products without serialisationCode of Federal Regulations, FDA, USA, 1982, update 2016; Subpart G-Packaging and Labelling Control Sec. 211.132 Tamper-evident packaging requirements for over-the-counter (OTC) human drug products, without serialisationEFPIA, 2007: PACKAGING STANDARD FOR COUNTERFEIT RESISTANT PACKAGING AND ITS IMPLEMENTATION INTO INTERNATIONAL SUPPLY CHAINS IN EUROPE. Brazil: ANVISA wanted to provide companies with tamper evident security labels. These would have included a two dimensional barcode and a IUM, see also: rules for the labelling of medicinal products RDC 71 (deleted/changed in 2013):

.

WHO Technical Report Series, No. 902, 2002, Annex 9, Guidelines on packaging for pharmaceutical productsSaudi Arabia: Guidelines on Container Closure Systems, Version 1.3, Draft, 2016PTS-Method PTS-PR 301/2008, Determination of the stiffness of the gluing of the glue flap -> Result: No document fulfils per se the FMD

3) Which tamper verification guidelines/“standards” are available?(Evaluation from 2012 to 2014, Update June 2017)


Code of Practice for the Tamper-Evident Packaging (TEP) of Therapeutic Goods – Australia May 2017, is voluntary for OTC Products without serialisation



Code of Federal Regulations, FDA, USA, 2016; Subpart G-Packaging and Label-ling Control Sec. 211.132 Tamper-evident packaging requirements for OTC prod., for retail sale,stepwise serialisation to start2018-2023

FDA regulations do not mandate a specific type of tamper resistant packaging.

Manufacturers and packagers arefree to use any packaging system as long as the tamper resistantrequirements in the regulation are met.



4) Process of European Standardisation

CEN-Standard = European Standard

e. g. CEN Technical Specification


4) Target of the European standard “tamper verification features”

Why aiming at creating a European standard?The „Delegated regulation“ will not deal with the "Tamper verification feature”. The existing wording in the FMD and in the national laws will remain.

Only a European Standard (EN) has a sufficient grade of acceptance to support the Directive. Only a European Standard is leading to full implementation as national standard - Europe-wide. This also serves the European regulatory purposes of the New Approach.

The target of the forthcoming standard is to eliminate the need for national or European lawmakers to set up further regulations. Based on the FMD a CEN standard shall be created, with which the pharmacist in the legal supply chain can discover in his daily business, if a pack for medicines has already been opened or has been manipulated.

Tamper verification + Serialisation have to be regarded together.


Result Formal Vote FprEN 16679 (Oct. 2014): 20 x Yes, 0 x No, 10 x Abstention, 100% approval. The European standard has been published Dec. 2014. July 2015: The EU-commission confirms EN 16679 as applicable instrument in order to „facilitate the coherent application of tamper verification features on the packaging of medicinal products throughout the Union and, eventually, the correct implementation of the Falsified Medicines Directive.”

5) Results of formal vote / Letter from EU-com / Q & A Paper


Questions & Answers Paper, Version 7,EU-Commission,June 2017

http://ec.europa.eu/health/human-use/falsified_medicines/index_en.htm

4) Results of formal vote / Letter from EU-com / Q & A Paper










Agenda:


a) Some countries outside the EU – e. g. UAE – currently introduce requirements for tamper verification features on pharma packaging. This has stipulated the need to transfer the European standard EN 16679 in to an EN ISO standard = to have one standard (following the model of the Braille EN ISO 17351) and to prevent different requirements and regulations. The New Work Item Proposal to convert EN 16679 into an EN ISO Standard had been successfully accepted at ISO TC 122 packaging in January 2017.

The pharmaceutical manufacturer shall have as many as possible technical solutions to choose from = to apply to the packaging of medicinal products – all of them being accepted and working towards their purpose: “Tamper verification features should provide an indication that the outer packaging of a finished product has been opened or tampered with”. -> Look for national requirements/documents.

Since the EU-Commission has accepted EN 16679 both by letter and by reference in the Q&A document, it is highly recommended to retain the core contents of EN 16679 in the forthcoming ISO standard.



b) ISO Technical Committee 122 (TC 122) packaging (www.iso.org), Secretariat: JISC/ISIRI; Members: 76 national standards institutes, 33 participating und 43 observer countries. Scope: Standardization in the field of packaging with regard to terminology and definitions, packaging dimensions, performance requirements and tests. The first meeting of ISO/TC 122/WG 15 “Tamper verification features for medicinal product packaging” was held 29th & 30th June 2017 at DIN, Berlin. Convenor: Dieter Mößner/Edelmann, ISO TC 122 WG 15 secretariat: Jan-Philip Everding/DIN.

c) Target: ISO 21976 shall be created as an International Standard „Tamper Verification Features (TVF) on medicinal product packaging“. It shall comprise as much as possible existing international requirements regarding TVF on MP packaging. After publication of ISO 21976 this International standard shall be taken over as EN ISO standard. This means: Only One document globally, effective as national standard in 33 Nationals Standards Bodies in Europe and in those NSB’s that take over ISO 21976 as national standard, Timing: 3 Years.

d) Update October 2017: ISO TC 122 has approved via CIB (Committee internal ballot) that ISO 21976 be sent to DIS Inquiry (Draft International Standard) and be published as ISO DIS 21976 on 30th November 2017. DIS Enquiry ends 22nd Feb. 2018. Next meeting of ISO TC 122 WG 15 will take place April 2018 in Stockholm, Vienna or London.

Participation and support of this important standardisation project is highly recommended.

6) ISO 21976 „Tamper Verification Features on medicinal product packaging“ – Process of ISO-Standardisation


a) USA: OTCs (except dermatological, dentifrice, insulin or lozenge products) for retail sale must be packaged in tamper-resistant packaging and be labelled to prominently disclose the tamper-evident features. Additionally, two-piece hard gelatin capsules must be sealed using an acceptable tamper-evident technology. Everything else needs only one TRP feature. -> Different supply chain for prescription drugs in the US. Certain products require

child resistant packaging (https://www.gpo.gov/fdsys/granule/CFR-2012-title16-vol2/CFR-2012-title16-vol2-sec1700-14/content-detail.html). Stepwise serialisation in USA 2018 - 2023

b) Voluntary guidelines/requirements for TVF for OTC’s, e.g. in Australia

c) Serialisation requirements in many countries without requiring TVF, e.g. China, Saudi-Arabia, Korea, etc. Practical application of TVF in these countries.

d) The EU: Requiring serialisation and TVF for Rx products, voluntary for OTC’s, no legal/regulatory specification, European standard EN 16679 available.

-> Task: To combine this “landscape” into an ISO standard “Tamper verification features for medicinal product packaging” at ISO TC 122 WG 15

6) ISO 21976: Overview of regulatory/legal requirements regarding the application of TVF


6) Structure and contents of the Forthcoming International standard ISO DIS 21976 / Contents


a) ScopeThis International Standard specifies requirements and provides guidance for the application, use and check of tamper verification features to the packaging of medicinal products.

b) Tamper verification featuresTamper verification features shall be applied to packaging of medicinal products as required by legislation or may be applied for other situations.

c) Purpose of tamper verification featuresTamper 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 medicinal products into the legitimate supply chain). Tamper verification features limit the ability to replace the contents of genuine packs.

6) Structure and contents of the forthcoming International standard ISO DIS 21976 / Scope + General requirements


a) Flaps of folding boxes closed with glueDescription: 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.

Criteria of tamper verification: Folding boxes closed with glue must 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.

Verification: First time opening of the folding box leads to visible damage of the folding box integrity, for example: - visible damage of one or more of the flaps,- visible damage of perforations,- visible damage of other parts of the folding box

6) Structure and contents of the forthcoming ISO DIS 21976 /technical characteristics of tamper verification features


b) Specially constructed folding boxesDescription: 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.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.Verification: First time opening leads to visible, irreversible damage of the folding box integrity, for example, visible damage of one or more of the flaps, visible damage of perforations and / or scores/half cuts, if applicable, visible damage of other parts of the folding box.



c) Sealing labels and tapes.Description: A label or tape (e.g. from paper, film or laminate) is applied in order to seal the packaging of medicinal products. The packaging to be sealed may incorporate perforations to facilitate the opening of the pack. The sealing label or tape shall provide the integrity of the sealed packaging component. Criteria of tamper verification: Tampering of the sealing label or tape or opening of the packaging shall lead to visible, irreversible damage or change of the packaging and / or of the label or tape. Verification of typical categories of sealing labels or tapes: 1) Fibre-tear seal, 2) Void seal, 3) Seal made with opening strips or perforations, 4) Seal made of fragile material



d) Film wrappersDescription: The product container or part of it is wrapped in film ensuring the product is appropriately sealed. The film must be ripped or broken to gain access to the product. Criteria of tamper verification: Tampering or opening shall lead to visible, irreversible damage or change of the film wrapper and show visible evidence of tampering. Verification: First time opening leads to visible, irreversible damage of the film wrapper and provides the indication that the outer package has been tampered with. The film wrapper cannot be removed and resealed without showing visible evidence of tampering.



e) Further categories of Tamper Verification features are:Sleeves Breakable or tear-away cap

Display blister pack Flexible packaging

Blow-fill-and-seal-container New and emerging technologies



1) Brief Introduction of packaging standards committee at DIN/Edelmann 2) Why is there a globally increasing demand for tamper verification features on medicinal product packaging?3) Which tamper verification guidelines / “standards” are available?4) Why aiming at a European standard? / Process of European Standardisation5) Results of formal vote / Letter from EU-Commission / Q & A Paper6) Development of ISO 21976 “tamper verification features for MP packaging”7) Structure and contents of the forthcoming ISO 21976 /

technical characteristics of tamper verification features8) Conclusions / Recommendations for the practice

a) A layered approach towards pack protectionb) Perform changes for serialisation and TVF in one runc) Combination of tamper verification features with anti-counterfeit featuresd) Higher security by tvf on product and transport packaginge) Plan for tamper verification features and for serialisationf) Qualification and validation

Agenda:


8a) Conclusions / Recommendations for the practice:A layered approach towards pack protection

= Still a need to apply ACF-features on MP packaging

Guarantee the integrity of the original manufacturer’s pack throughout the entire supply chain

Use of overt and covert features to authenticate products

Use of harmonised coding and identification systems for secondary packs

Increased Protection(Patient/Product)

2D Data Matrix or serializedBarcode on 2°pack

Dispensing verification confirmation

Product Integrity

ProductAuthentication

Product Identification


8b) Conclusions / Recommendations for the practice: Perform changes for serialisation and TVF in one run

Human readable: Lot No.: F17L715034Expiry date: 08 / 2018

As Datamatrix Code:PC: 111234568408Lot No.: F17L715034Expiry date: 180800Serial Number: xxxxx

Tamper verification Feature via:Labels?/Varnish free?Gluing / 2 shot?Specially constructed?Foil lamination?

Combine TVF and ACFe.g. security labels or apply preserialized labels

Human readable variable data (now also with serial no + product code)


8c) Recommendations for the practice: Combinationof tamper verification features with anti-counterfeit features

Gluing

Originality labels

Film wrapping

unglued/by design

Closure possibilities

Varnish free areas

Security labels

Holograms

Perforations

ACF-features

combined with


Tamper verification features (tvf) on product and transport packaging

8d) Conclusions / Recommendations for the practice: Higher security by tvf on product and transport packaging

Source: Mr. Kastrup, Meda


8e) Conclusions / Recommendations for the practice: Plan for tamper verification features and for serialisation

Quelle: Hr. Krähenbühl, 3CIntegrity

09.02.2016 09.02.2019


1) Refer in your specification to ISO DIS 21976 (or EN 16679) “Tamper verification features according to ISO DIS 21976 (or EN 16679) – analogous to „Braille according to EN ISO 17351“.

2) Specify the tamper verification features per product/packaging in a way that the general items of the packaging are already specified, (carton board, print, temperature, transport, etc.) and that the specification must only be amended with the item “tamper verification features via e. g. labels, gluing, etc.).

3) Perform some Tests if the Tamper verification feature works and document the tests = a qualification / validation.

4) Prepare these documents for possible inspections by authorities.

8f) Qualification and validation:


Edelmann GmbH Dieter Mößner Steinheimer Strasse 45D-89518 Heidenheim/GermanyTel.: 0049-7321-340-372 Fax: 0049-7321-340-268Mail: [email protected]: www.edelmann.de

Thank you very much for your kind attention.

DIN Deutsches Institut für Normung e.V.Packaging Standards Committee NAVpMr. Jan-Philip EverdingBurggrafenstrasse 6, D-10787 BerlinTel.: 0049-30-2601-2463Fax: 0049-30-2601-42463Mail: [email protected]: www.navp.din.de


Visit Edelmann / Dieter Mößner at the CPHI in Hall 4.2, Booth H 73

Tamper verification features on medicinal product packaging – … · 2017-11-14 · Tamper verification features on medicinal product packaging – from Europe across the globe

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