Link: https://curia.europa.eu/jcms/upload/docs/application/pdf/2024-03/cp240046en.pdf

Languages available: es cs de en fr it hu pl pt ro

PRESS RELEASE No 46/24

Luxembourg, 14 March 2024

Judgment of the Court in Case C-291/22 P | D & A Pharma v Commission and EMA

Marketing authorisations for medicinal products: the European Medicines Agency (EMA) must ensure that the experts it consults do not have a conflict of interest

The EMA cannot avoid this obligation of objective impartiality by requiring the applicant to prove the bias of the committee member concerned

The laboratory D & A Pharma filed an application with the European Medicines Agency (EMA) for marketing authorisation for Hopveus, a medicinal product derived from sodium oxybate. That active substance is indicated to combat alcohol dependence in the medium and long term.

(...)