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.
![“Another key [UDI] benefit, because we're calling that product by the same name across the healthcare supply chain… rich and robust data that we can access around supply consumption and utilization rates. One of the buzz terms we've heard during the COVID-19 crisis was what's my burn rate? How fast am I going through gowns, masks, gloves?” – Mike Schiller, Senior Director at AHRMM](https://img.healthcarepackaging.com/files/base/pmmi/all/image/2020/08/UDI.5f4d326e41d53.png?auto=format&fit=crop&h=146&w=340)
