Introduction to the Falsified Medicines Directive
Directive 2011/62/EU, better known as “The Falsified Medicines Directive” or “FMD”, came into force on 2 January 2013, with the aim of preventing falsified medicines from entering the legitimate supply chain in the European Union.
Delegated Regulation (EU) 2016/161 has since supplemented FMD, setting out detailed rules for new safety features to appear on the packaging of prescription-only and some non-prescription medicines to enable them to be verified and authenticated:
- a unique identifier (a 2D data matrix code or barcode) is to be placed on product packaging, to be scanned at fixed points along the supply chain; and
- anti-tamper devices (ATDs) are to be applied to product packaging.
At each stage of the supply chain, products will be inspected to ensure they have not been tampered with, have not previously been dispensed and that the packaging is intact.
The Regulation will apply from 09 February 2019, and Marketing Authorization Holders will by then have to place the above safety features on the packaging of medicines regulated. These obligations are putting additional pressure on all in the pharmaceutical supply chain in the EU, not least parallel traders.
Implications for parallel imports and parallel traders
Parallel traders, who import medicines from lower-price into higher price markets, are considered ‘manufacturers’ under FMD, and will have to bolster their packaging and IT infrastructures. To comply, when a parallel distributor receives packs of medicine from another EU country, they must first remove the unique identifiers and ‘decommission’ these packs from the country of origin’s database. They must then re-package those medicines with new unique identifiers and ATDs, and re-commission them…