Dr Ash Ramzan, founder and principal consultant at regulatory affairs consultancy, Woodley BioReg looks at how the key requirements of the Falsified Medicines Directive are being fulfilled by stakeholders and manufacturers.
The Falsified Medicines Directive (FMD, 2001/83/EC as amended to 2011/62/EU), and its delegated regulation EU 2016/161, together set out the requirements that manufacturers of human medicinal products must meet, as part of their legal responsibility.
This applies throughout the EU and responsibilities extend to wholesalers, dealers and parallel importers. Requirements came into force on 9 February 2019, with a number having already been implemented over the past two to three years.