Дело T-***/**: *****************, Определение от **.**.2024 г.

Текст

... – Application for suspension of operation of a measure – No urgency)

In Case T‑1181/23 R,

Mylan Ireland Ltd, established in Dublin (Ireland), represented by K. Roox, T. De Meese, J. Stuyck and C. Dumont, lawyers,

applicant,

v

European Commission, represented by A. Spina and E. Mathieu, acting as Agents,

defendant,

THE PRESIDENT OF THE GENERAL COURT

makes the following

Order

1. By its application based on Articles 278 and 279 TFEU, the applicant, Mylan Ireland Ltd, seeks suspension of the operation of Commission Implementing Decision C(2023) 8920 final of 13 December 2023 revoking Commission Implementing Decision C(2022) 3252 final of 13 May 2022 granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency (OJ 2004 L 136, p. 1), as amended, for ‘Dimethyl fumarate Mylan – dimethyl fumarate’, a medicinal product for human use (‘the contested decision’).

Background to the dispute and forms of order sought by the parties

2. The applicant is a pharmaceutical company which develops and markets medicinal products, including the generic medicinal product ‘Dimethyl fumarate Mylan – dimethyl fumarate’ (‘DMF Mylan’), indicated for the treatment of multiple sclerosis.

3. On 28 February 2012, Biogen Idec Ltd filed an application with the European Medicines Agency (EMA), pursuant to Article 4(1) of Regulation No 726/2004, for a marketing authorisation (‘MA’) for the medicinal product ‘Tecfidera – ...