12 Months, 12 Solutions – Countdown to the EU Falsified Medicines Directive

January Pharma-Security Feature: Security Booklet-Label

Falsified medicines are a lucrative business for criminals. According to the “Pharmaceutical Crime: A Growth Market” research report published by the German Federal Criminal Police Office (BKA) in October 2016, one kilogram of the counterfeit version of a well-known potency-enhancing drug sells for 90,000 euros on average, whereas the price of cocaine is estimated at “merely” 65,000 euros. The serialization of packaging, complemented by anti-counterfeiting labels, helps stop this illegal trade.

Particularly well-suited for protecting patients against falsified medicines and safeguarding the supply chain are labels that combine analog and digital security features as well as being multifunctional. The Security Booklet-Label is a booklet applied to packaging. It enables pharmacists, for instance, to view product information about the medication inside without opening the packaging and thus destroying its integrity. This particularly benefits packaging that must be sealed as of February 9 according to the Falsified Medicines Directive. The bottom layer of the label has an integrated tab that serves as a tamper-evident closure seal and additional first-opening indication – when the seal is opened, an irreversible void effect appears. Additionally, the Security Booklet-Label is equipped with three digital security features:

BitSecure: Clear Product Authentication
The BitSecure copy detection technology is a printed, digital security feature. It is based on a high-resolution random pattern whose delicate details cannot be detected by the naked eye. In an attempt to copy the small random pattern with a size of only a few square millimeters the printed image will suffer a loss in precision and optical details. The differences can be detected via a smartphone app or handheld reader and analyzed using respective software.

KeySecure: Innovative Tracing System
Based on an encrypted, 15-digit alphanumeric code, KeySecure enables the identification and authentication of every individually marked product. The code can be printed in human-readable form or as a 2D code; authentication is performed either by entering the code on the manufacturer’s website, mobile query of the 2D code using a smartphone or by calling the respective hotline.

Label-Integrated NFC Chip: Reliable Authentication
An NFC chip integrated in the label enables digital authentication using smartphones. The NFC chip inconspicuously blends in with the label design and allows for contactless product identification within a few centimeters. Due to the wide-spread use of NFC-capable smartphones, end users can easily and quickly use this function. In addition, it is possible to automatically start an app for product verification.

In our blog series “12 Months, 12 Solutions: The Countdown to the EU Falsified Medicines Directive” over the next twelve months, we will present twelve selected security features that can be used to make medicinal packaging counterfeit-proof.

For more information on Schreiner MediPharm and our innovative Solutions for the Pharmaceutical and Medical Device Industry, please visit: www.schreiner-medipharm.com

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