COURT OF JUSTICE OF THE EU / Health

Court finds a university hospital cannot be considered a ‘pharmaceutical undertaking’ and its experts can therefore participate in EMA’s activities

Brussels, 22/06/2023 (Agence Europe)

On Thursday 22 June , the Court of Justice of the European Union (CJEU) annulled the decision of the General Court of the European Union, (Joined Cases 6/21 P and C-16/21 P) which had found that the experts of theEuropean Medicines Agency (EMA) could have been impartial in the negative opinion issued on the marketing authorisation application by Pharma Mar for the orphan drug ‘Aplidin’.

In July 2018, the Commission had relied on an EMA opinion to refuse to grant marketing authorisation...