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Case T-594/18: Judgment of the General Court of 28 October 2020 — Pharma Mar v Commission (Medicinal products for human use — Application for marketing authorisation for the medicinal product Aplidin — plitidepsin — 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)
ECLI:EU:UNKNOWN:62018TA0594
62018TA0594
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11.1.2021
Official Journal of the European Union
C 9/13
(Case T-594/18) (<span class="oj-super oj-note-tag">1</span>)
(Medicinal products for human use - Application for marketing authorisation for the medicinal product Aplidin — plitidepsin - 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)
(2021/C 9/19)
Language of the case: English
Parties
Applicant: Pharma Mar, SA (Colmenar Viejo, Spain) (represented by: M. Merola and V. Salvatore, lawyers)
Defendant: European Commission (represented by: L. Haasbeek and A. Sipos, acting as Agents)
Re:
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.
Operative part of the judgment
The Court:
1.Annuls 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, for Aplidin — plitidepsin, a medicinal product for human use;
2.Orders the Commission to pay the costs.
(<span class="oj-super">1</span>) OJ C 445, 10.12.2018.