The EU Falsified Medicines Directive (FMD) is designed to prevent entry of falsified medicines into the pharmaceutical supply chain, and requires serialisation legislation be adopted across Europe by February 9, 2019.
With less than a year to go, there are still a number of unknowns surrounding what the directive will mean for industry but according to Fiona Barry – the new editor at GlobalData’s PharmaSource – this should not stop firms from preparing.
“Pharmaceutical manufacturers need to act now to prevent problems ahead of next year’s Falsified Medicines Directive deadlines, like production scheduling clashes and technical and cost challenges,” she told this publication.
“I’m hearing from companies that the directive is expected to increase the cost of goods. It could also lower short-term productivity as the companies will need to take on extra tech support and facility labour.”
As such, Barry said pharma companies should assess their relationships with CMOs “to create a cost-effective process for complying with the FMD, and to ensure a slot in shop floor scheduling before the rush to deadline in 12 months.”
And API makers will also be affected, she continued, as suppliers outside the EU will need to declare compliance with good manufacturing practice (GMP).
“There’s still a lot that’s unknown about how to comply with FMD, like whether or not a sticker alone is an acceptable anti-tamper device, given that patients can easily remove it from packaging. Also, whether over-the-counter products will fall in the scope of the directive is still unclear.”