In this online opinion piece, Mark Davison, head of operations in the EU for rfxcel, outlines everything marketing authorisation holders (MAHs) need to know and what is needed for a seamless serialisation process — before regulators remove the right to trade.
EU FMD
The Falsified Medicines Directive (FMD) imposes strict serialisation requirements on pharmaceutical manufacturers, distributors and dispensers. By February 2019, MAHs will need to start uploading serialisation codes for almost all their prescription medicines to the European Medicines Verification Organisation (EMVO) hub for authentication with pharmacists at the point of sale. Those that can’t will simply be unable to sell their products in Europe.