Schreiner MediPharm, a Germany-based global provider of specialty pharmaceutical labeling solutions for over 65 years, has introduced BitSecure Mobile, a digital counterfeiting detection solution to help fight illegal trade in counterfeit medicines.

The solution will prove highly useful 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. It will prove similarly useful in the US as regulations continue to be enacted. 

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 highly beneficial for 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 one powerful, future-proof development environment.

“BitSecure Mobile is a great addition to Schreiner MediPharm’s extensive portfolio of innovative analog and digital security solutions for reliable counterfeiting and tampering protection,” said Gene Dul, President of Schreiner MediPharm U.S. “With enforcement deadlines of both US and EU regulations fast-approaching, the easy digital authentication of pharma packaging using a smartphone app comes at an ideal time.”