12 Months, 12 Solutions: The Blog Series on the EU Falsified Medicines Directive 2011/62/EU

Since February 9, 2019 the EU Falsified Medicines Directive 2011/62/EU has been in effect throughout Europe. It requires pharmaceutical manufacturers to provide secondary packaging of prescription medicines with an individual serial number as a 2D code for identification, plus a tamper-evident feature proving that the packaging is intact. This requirement is intended to stop illegal trading of falsified medicines. However, a serialization number alone does not ensure reliable counterfeiting protection, which is only achieved by integrating additional authenticity features – in overt, semi-covert or digital form. In our blog series “12 Months, 12 Solutions: The Countdown to the EU Falsified Medicines Directive” from February 2018 to January 2019, we presented twelve selected security features pharmaceutical manufacturers can use to make their medicine packaging tamper-proof.

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.