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Case T-556/20: Judgment of the General Court of 2 March 2022 — D & A Pharma v Commission and EMA (Medicinal products for human use — Application for conditional marketing authorisation for the medicinal product Hopveus — sodium oxybate — Decision of refusal by the Commission — Regulation (EC) No 726/2004 — Procedure — Committee for Medicinal Products for Human Use — Request for consultation of a specific scientific advisory group — Impartiality of members of an ad hoc committee of experts — Manifest errors of assessment — Equal treatment)
ECLI:EU:UNKNOWN:62020TA0556
62020TA0556
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Valentina R., lawyer
16.5.2022
Official Journal of the European Union
C 198/36
(Case T-556/20) (*)
(Medicinal products for human use - Application for conditional marketing authorisation for the medicinal product Hopveus — sodium oxybate - Decision of refusal by the Commission - Regulation (EC) No 726/2004 - Procedure - Committee for Medicinal Products for Human Use - Request for consultation of a specific scientific advisory group - Impartiality of members of an ad hoc committee of experts - Manifest errors of assessment - Equal treatment)
(2022/C 198/51)
Language of the case: French
Parties
Applicant: Debregeas et associés Pharma (D & A Pharma) (Paris, France) (represented by: N. Viguié and D. Krzisch, lawyers)
Defendants: European Commission (represented by: G. Wils and A. Sipos, acting as Agents), European Medicines Agency (represented by: S. Marino, S. Drosos, C. Bortoluzzi and H. Kerr, acting as Agents)
Re:
By its action on the basis of Article 263 TFEU, the applicant seeks annulment of the Commission’s Implementing Decision of 6 July 2020 refusing marketing authorisation for Hopveus — sodium oxybate, a medicinal product for human use, 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).
Operative part of the judgment
The Court:
1.Dismisses the action;
2.Orders Debregeas et associés Pharma (D & A Pharma) to pay the costs.
(*) Language of the case: French.
(1) OJ C 371, 3.11.2020
ECLI:EU:C:2022:140