Impact on medicines and medical devices In brief Medicines and medical devices are subject to the EU’s general product liability rules, including the EU’s Product Liability Directive (PLD). The European Commission’s proposal for a new PLD seeks to make the PLD fit for purpose in the 21st century and address challenges faced by those who have suffered damage to claim compensation. In doing so, the Commission has expanded the scope of the PLD so that…

In brief On 6 October 2022, Advocate General Medina issued an Opinion in three joined appeal cases brought by the European Commission, the EMA and Biogen against Pharmaceutical Works Polpharma. The opinion touches on the concept of global marketing authorization (GMA), and on the principle of mutual recognition of scientific assessments carried out by Member States authorities and EU institutions. In depth This is the first case related to the question of whether an authorized fixed combination…