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Case T-547/24: Action brought on 21 October 2024 – Novartis Europharm v Commission
ECLI:EU:UNKNOWN:62024TN0547
62024TN0547
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Official Journal of the European Union
EN
C series
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C/2025/396
27.1.2025
(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:
—annul the decision of the European Commission, the Defendant, of 22 August 2024 C(2024) 6053 final granting marketing authorisation under Regulation (EC) No 726/2004 for ‘Nilotinib Accord – nilotinib’, a medicinal product for human use; and
—order the Commission to pay the costs.
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).
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).
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).
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ELI: http://data.europa.eu/eli/C/2025/396/oj
ISSN 1977-091X (electronic edition)
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