Waldkirch, Germany. (December 2017) — Pharmaceutical companies have a job on their hands. From February 2019, all medicines in the European Union will have to incorporate a unique identifier and an anti-tamper device. The need for an anti-tamper device means it will no longer be possible to consult the package leaflet. August Faller GmbH & Co. KG has therefore developed the TEAM-Label (tamper-evident and multi-page), combining a seal with a multi-page adhesive label.
Big changes lie ahead for the pharmaceutical sector. On February 9, 2019, Delegated Regulation (EU) 2016/161, supplementing the EU Falsified Medicines Directive 2011/62/EU, enters into force. As well as requiring a unique identifier, European legislators have set out requirements for pharmaceutical products to have tamper-evident packaging. Special devices on drug packaging, such as cuffs, sleeves or seals, will prevent tampering and improve consumer protection. This will enable patients and doctors to quickly and easily see whether drug packaging has already been opened.
This new EU regulation will, however, mean that it will no longer be possible to read the package leaflet for prescription-only medicines without destroying the seal and invalidating the anti-tamper protection. August Faller GmbH & Co. KG has therefore developed the TEAM-Label, which combines a seal with a multi-page adhesive label. Anti-tamper protection is provided by a special self-adhesive strip. This is perforated and glued over the carton’s tuck flap. The laminate is slit using a high-precision two-layer die cut. This ensures that the booklet can be easily opened using the tab provided without damaging the anti-tamper device. For eco-conscious businesses, Faller can also manufacture a laminate-free, paper-only version of the TEAM-Label. This enables the whole pack to be recycled as paper.
Standards-compliant protection and more information
The TEAM-Label provides access to key information from the standard package leaflet on the outside of the package in the form of a multi-page adhesive label. This enables doctors, pharmacists and patients to access this key information without opening the carton. The seal remains unbroken.
The TEAM-Label offers significant cost benefits for pharmaceutical manufacturers. Instead of both a label and a seal, just a single TEAM-Label is applied. The TEAM-Label can be applied using any standard labelling equipment capable of applying tamper-evident labels. By increasing the surface area of the multi-page adhesive label, you can also take care of any multilingual labelling needs. The booklet label can be expanded to up to 32 pages.
Faller manufactures tamper-evident labels for all standard carton sizes. They can be printed in 6 colours front and back, and can be hot stamped to produce a design appropriate to the point of sale, e.g. pharmacies.
Unique identifiers for adhesive labels
August Faller Group can, if required, also apply a unique identifier to the label. Requirements for unique identifiers are complex and require a high level of expertise. One reason for this is the diversity of the paper and plastic film materials and material combinations used for labelling. Similarly, the large number of available coding methods and technical settings for machinery make choosing the ideal material and system a demanding task. August Faller Group boasts many years of experience in this area.
Anti-tamper services and solutions
As a reliable partner to the pharmaceutical sector, August Faller supports its customers in implementing legal requirements correctly. Decades of experience in the pharmaceutical packaging sector enable us to combine expertise from the carton, labelling, printing, consultancy and service fields and to develop custom concepts for our customers. Customers benefit from our technical knowhow at every stage of the production process and receive a custom solution from a single supplier.
Further information available at: www.august-faller.com
Image overview: All photographs: August Faller GmbH & Co. KG
Contact:
Ruess Public T GmbH – Member of Ruess Group
Lindenspürstrasse 22
70176 Stuttgart, Germany
Phone: + 49711 16446-43
Fax: + 49711 16446-11
ariane.walther@ruess-group.com
info@ruess-group.com
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