August Faller: Tamper-Evident Label for Pharma Products

On February 9, 2019, new rules in the EU go into effect requiring a unique identifier and tamper-evident packaging (Delegated Regulation (EU) 2016/161, supplementing the EU Falsified Medicines Directive).

This new EU regulation means 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. To address this, August Faller GmbH & Co. KG has 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, which is perforated and glued over the carton’s tuck flap. The laminate is slit using a high-precision two-layer die cut. This is designed so 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 allows the whole pack to be recycled as paper.

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.

Instead of both a label and a seal, just a single TEAM-Label is applied. The TEAM-Label can be applied using any standard labeling equipment capable of applying tamper-evident labels. By increasing the surface area of the multi-page adhesive label—up to 32 pages—users can also take care of any multilingual labeling needs.

Faller manufactures tamper-evident labels for all standard carton sizes. They can be printed in 6 colors front and back, and can be hot stamped to produce a design appropriate to the point of sale, e.g. pharmacies.

August Faller Group can also apply a unique identifier to the label, where requirements can be difficult to meet because of the diversity of paper and plastic film materials and material combinations used for labeling.