FMD: Falsified Medicines Directive

Directive 2011/62/EU amended Directive 2001/83/EC to prevent falsified medicines entering the legal supply chain. Its best-known element is the safety features in Article 54(o): a unique identifier and an anti-tampering device on the outer packaging of medicines subject to prescription, with exceptions in a white list, and on a black list of non-prescription medicines at risk of falsification. The detailed rules are in Commission Delegated Regulation (EU) 2016/161, which applied from 9 February 2019 across the EU, with Belgium, Greece and Italy allowed until 9 February 2025 because they already had national systems.

The Directive also tightened the rest of the chain. Active substances imported into the EU need a written confirmation from the exporting country that the manufacturer meets GMP standards equivalent to the EU's, unless the country is on the Commission's list of equivalent regimes. Brokers of medicines must register, wholesalers face stricter good distribution practice, and online sellers must display the common EU logo linked to a national register. Manufacturers must report suspected falsification, and Member States must have systems to recall falsified products and to penalise offences.

The verification system built to support the safety features is the European Medicines Verification System, run by the European Medicines Verification Organisation, with national systems in each Member State. Holders upload the unique identifiers of each batch before release and fund the national systems through membership fees. Pharmacies and hospitals verify and decommission the identifier at the point of supply, and wholesalers verify on a risk basis, for example on returns and on products from outside the manufacturer's own channel.

What goes wrong: artwork changes that move the identifier or the human-readable code off the approved position, batches released before the data upload reaches the hub, leaflets and cartons for Member States that need the national reimbursement number, and alerts triggered by scanning errors that nobody investigates. Parallel traders carry their own risks when replacing identifiers, and the holder is pulled in whenever an alert points to one of its codes. Every national organisation also charges the holder an annual fee per product, which is easy to forget when a presentation is discontinued but left registered.