With February right around the corner, pharma companies and their packaging designers are scrambling to meet the Falsified Medicines Directive
. As of February 9, 2019
, each prescription drug packaging circulating in the EU must feature a 2D data matrix code enabling wholesalers and pharmacists to track it across the entire value chain. The packages must also be adequately sealed for anti-tampering
purposes. Two early adopters aside, though, it seems EU countries are running out of time.
Early adopters and laggards
Both early adopters
of the Falsified Medicines Directive, Germany and Sweden
were the first to establish the technical system that will be required by the new law. All other EU countries postponed implementing the necessary changes until February 2016 when the delegated act got published. As it took Germany and Sweden approximately two years to launch their systems and get their value chains ready for continuous authentication, the rest of the EU are clearly lagging behind. Pharma players in Belgium, Italy and Greece
, however, are not to worry yet as they must implement the new system by 2022.
Smaller companies struggle the most
Usually not belonging to large-scale pharma industry associations, smaller companies in particular struggle to meet the new directive. Complying with the upcoming Falsified Medicines Directive is a costly and elaborate affair as all serialization efforts
are part of a global undertaking
. Both pharma manufacturers and packaging designers must do all they can to make packaging lines compatible with print machine-readable unique identifiers and tamper-proof closures that meet international guidelines. Meanwhile, the pharma industry faces capacity bottlenecks
among software suppliers, while delivery periods for machinery are extending as well.
Meeting the deadline at all costs
With the costs estimated at 3 to 5 cents per pack
(or 100,000 to 200,000 euros for a single line of packaging), serialization in the pharma industry proves expensive, to say the least. Still, pharma companies and packaging designers must meet the February 9 deadline at all costs, as they will not be allowed to sell their drugs otherwise.
Inspired by European Biotechnology and Interpack