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Case T-211/18: Judgment of the General Court of 19 December 2019 — Vanda Pharmaceuticals v Commission (Medicinal products for human use — Application for marketing authorisation for the medicinal product Fanaptum — iloperidone — Commission refusal decision — Regulation (EC) No 726/2004 — Scientific evaluation of the risks and benefits of a medicinal product — Obligation to state reasons — Manifest error of assessment — Proportionality — Equal treatment)
ECLI:EU:UNKNOWN:62018TA0211
62018TA0211
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24.2.2020
Official Journal of the European Union
C 61/25
(Case T-211/18) (*)
(Medicinal products for human use - Application for marketing authorisation for the medicinal product Fanaptum - iloperidone - Commission refusal decision - Regulation (EC) No 726/2004 - Scientific evaluation of the risks and benefits of a medicinal product - Obligation to state reasons - Manifest error of assessment - Proportionality - Equal treatment)
(2020/C 61/30)
Language of the case: English
Parties
Applicant: Vanda Pharmaceuticals Ltd (London, United Kingdom) (represented by: M. Meulenbelt, B. Natens, A. S. Melin and C. Muttin, lawyers)
Defendant: European Commission (represented by: L. Haasbeek and A. Sipos, acting as Agents)
Re:
Application pursuant to Article 263 TFEU seeking the annulment of (i) the Commission Implementing Decision C(2018) 252 final of 15 January 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 the medicinal product for human use Fanaptum — iloperidone, and (ii) the opinion and the assessment report of the Committee for Human Medicinal Products of the European Medicines Agency (EMA) of 9 November 2017.
Operative part of the judgment
The Court:
1.Dismisses the action;
2.Orders Vanda Pharmaceuticals Ltd to pay the costs.
(*) Language of the case: English.
ECLI:EU:C:2020:140
* * *
(1) OJ C 190, 4.6.2018.