Schreiner MediPharm, provider of specialty pharmaceutical labeling solutions for over 65 years, has introduced BitSecure Mobile, a digital counterfeiting detection system designed to help fight illegal trade in counterfeit medicines. BitSecure Mobile is intended to help in meeting the strict requirements of the EU Directive 2011/62/EU that comes into effect on February 9, 2019, at which time pharma manufacturers must equip secondary packaging units with individual serial numbers and an anti-tampering device that proves the package’s integrity.
The functionality will also help meet regulatory requirements in the U.S. and around the globe. The digital security feature is based on a printed high-resolution, cloud-like random pattern. If anyone attempts to copy the BitSecure pattern, which is only a few square millimeters in size, the printed image suffers a loss in precision and optical details. These differences can be analyzed quantitatively via a smartphone and the respective software to reliably distinguish fraudulent copies from originals. The new app enables authentication via smartphone, and can be executed quickly and flexibly in the field.
This real-time verification is applicable in the pharma sector, where determinations of “fake or real” often must be made at hospitals, pharmacies, or at customs or police. The BitSecure app allows a reliable authentication to be performed easily with the help of a user-friendly, intuitive interface. Additionally, the back-end data management system is integrated in a singular development environment.