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Falsified Medicines Directive - Long way travelled… still a long way to go…

The 9th of February 2019 looms large on the horizon, in fact the deadline for implementing the provisions of the Falsified Medicines Directive is just 304 days away.
 
What does that mean?
 
In a nutshell, manufacturers need to affix unique serial numbers on the packs that will be authenticated (verified) by pharmacists as they dispense the medicine to the patient. Authentication is via a central repository where the manufacturer uploaded the respective serial numbers. This certifies that the dispensed product is indeed the one produced by the original manufacturer.
 
Why are we doing it?
 
Patient safety. Patients will be sure that the products they receive are authentic, they have not been tampered, falsified or counterfeit.
 
How are we doing it?

Collaboratively. Manufacturers (both originator and generic), wholesalers, pharmacists, hospitals and parallel traders have come together in the first ever stakeholder model (as mandated by the regulation) to develop a secure and robust system.
 
And because the devil is always in the details, it has been a daunting task.
 
Have we had difficulties?
 
You bet. Setting up the political governance; navigating the technical, economic, commercial, data security etc. challenges; securing the funding for the system; bearing in mind the national specificities of Member States – these are some of the small issues we have dealt with on a daily basis. And there is still a long way to go: finalize serialization of packs, build all national systems, connect end-users to the system, pilot and test the system, educate the general public, handle the inevitable false alerts in the very beginning, etc.
 
What about right now? Now, we have to step up our efforts, focus, hurry up and make sure we are ready by 9 February 2019. The deadline will not be pushed back and there will be no exemptions. That much is clear. And there is still a long way to go…

Mihai Rotaru

Mihai Rotaru is Project Manager Market Access in the Economic and Social Affairs team, responsible, among others,...
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