The Falsified Medicines Directive (2011/62/EU) (FMD) was introduced in 2011 with the aim of safeguarding the public against medicinal products within the EU whose identity, history or source had been falsified. The FMD requires that the packaging of these products now bears certain safety features, such as a “unique identifier” verifying their authenticity and an “anti-tampering device”.
Parallel importers sought to take advantage of this change in the law to support a complete repackaging of medicinal products imported into Member States, previously only allowed in exceptional circumstances. Pharma companies opposed this, arguing that less invasive methods such as relabelling should be used instead.
In late November 2022, the CJEU handed down four judgments in this complex area, clarifying the extent to which a parallel imported medicinal product can be repackaged.
Amelia Sainsbury explains more in an article for the Wolters Kluwer Trade Mark blog which can be found here.