The Falsified Medicines Directives is without a doubt a key step forward in combatting medicine falsification and further guaranteeing patients’ health. AMLIS and EUROPHARM SMC however have concerns with  regard to the unintended consequences the implementation of this Directive has, impacting on the competitiveness of SMEs in the global pharmaceutical industry and more importantly the risk of medicine shortage for patients.
Notably the costs related to the FMD serialisation system are exorbitant and disproportionate for SMEs. At the dawn of the entry into force of the new system, AMLIS and EUROPHARM SMC call upon the EU Commission to adjust the system to help pharmaceutical SMEs to deal with their challenges and to help overcome the societal challenge of medicine scarcity that looms around the corner.