Drastic measures: the Falsified Medicines Directive for marketing authorization holders

In an Expert View piece, Mark Davison, head of operations in the European Union (EU) for software company RFXCEL, outlines everything marketing authorization holders (MAHs) need to know and what you need to do for a seamless serialization process – before regulators remove your right to trade.

The Falsified Medicines Directive (FMD) is fast approaching, with the denouement arriving February 9, 2019, when the directive is fully enforced and the penalties for non-compliance officially come into play.

The MD is an attempt to prevent inauthentic, substandard or harmful medicines entering the supply chain. It imposes strict serialization, traceability and verification requirements on pharmaceutical manufacturers and their associated wholesalers, distributors and contract manufacturers. In particular, it mandates companies to print a unique identifier (UI) on the packaging of prescription medicines. Furthermore, companies aren’t just responsible for the data that goes on the packaging, they’re responsible for submitting it to the central data hub – European Medicines Verification Organization (EMVO) - that will enable pharmacists to authenticate products before they dispense them.