Дело T-***/**: *****************, Съдебно решение от **.**.2020 г.

Текст

... Commission decision refusing authorisation — Regulation (EC) No 726/2004 — Scientific evaluation of the risks and benefits of a medicinal product — Committee for Medicinal Products for Human Use — Objective impartiality)

In Case T‑594/18,

Pharma Mar, SA, established in Colmenar Viejo (Spain), represented by M. Merola and V. Salvatore, lawyers,

applicant,

v

European Commission, represented by L. Haasbeek and A. Sipos, acting as Agents,

defendant,

APPLICATION pursuant to Article 263 TFEU for annulment of Commission Implementing Decision C(2018) 4831 final of 17 July 2018 refusing marketing authorisation under 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) for Aplidin — plitidepsin, a medicinal product for human use,

THE GENERAL COURT (Sixth Chamber),

composed of A. Marcoulli (Rapporteur), President, S. Frimodt Nielsen and R. Norkus, Judges,

Registrar: P. Cullen, Administrator,

having regard to the written part of the procedure and further to the hearing on 12 March 2020,

gives the following

Judgment

Background to the dispute

1. The applicant, Pharma Mar, SA, is a company operating in the oncology research sector. On 16 November 2004, it obtained designation of the medicinal product Aplidin, the active substance of which is plitidepsin, as an orphan medicinal product for the treatment of multiple myeloma, a serious cancer of the bone marrow, pursuant to Regulation (EC) No 141/2000 ...