12 Months, 12 Solutions: The Countdown to the EU Falsified Medicines Directive

On February 9, 2019, EU Directive 2011/62/EU will come into effect. It aims to stop illegal trade in falsified medicines. From then onwards, pharmaceutical manufacturers will have to provide secondary packaging of all medicines placed on the market with an individual serial number as a 2D code for identification as well as an anti-tampering device to prove the integrity of the medicinal packaging. However, this does not yet guarantee reliable counterfeiting protection, which can only be achieved by customized integration of additional authenticity features—in overt, semi-covert, covert or digital form. We want patients to be protected against falsified medicines and pharmaceutical manufacturers to find the best solution for compliance with the legislative directive. In Schreiner MediPharm’s blog series over the next twelve months, we will present twelve selected security features that can be used to make medicinal packaging counterfeit-proof. The countdown is on!


Product pirates often use a simple but perilous method to put falsified medicines on the market: They open the product pack and exchange the contents. If the medicine pack is sealed with a conventional label, product counterfeiters simply cut through it and reapply the seal – this will often go unnoticed by patients. The Cut-Through-Indicator Seal, however, thwarts such tampering attempts.

When it comes to securing the supply chain, digital technologies are playing an increasingly important part in the anti-counterfeiting strategies of pharmaceutical companies. Pharmaceutical manufacturers, distributors/retailers and inspectors must be able to clearly determine on-site.