Action brought on 21 October 2024 – Novartis Europharm v Commission

(Case T-547/24)

(C/2025/396)

Language of the case: English

Parties

Applicant: Novartis Europharm Ltd (Dublin, Ireland) (represented by: C. Schoonderbeek and B. Jong, lawyers)

Defendant: European Commission

Form of order sought

The applicant claims that the Court should:

Plea in law and main arguments

In support of the action, the applicant relies on a single plea in law.

Violation of the conditions for the grant of generic marketing authorisations as set out in Article 10(1) of Directive 2001/83/EC (1) read in conjunction with Article 11 of that Directive and Article 3(3) of Regulation (EC) No 726/2004 (2).

(1)  Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001, L 311, p. 67).

(2)  Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ 2004, L 136, p. 1).