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Case T-733/17: Judgment of the General Court of 16 May 2019 — GMPO v Commission (Medicinal products for human use — Article 3(1)(b) of Regulation (EC) No 141/2000 — Definition of ‘significant benefit’ — Availability of orphan medicinal products — Article 5(12)(b) of Regulation No 141/2000 — Commission decision to remove a medicinal product from the Register of Orphan Medicinal Products — Error of assessment — Error of law — Legitimate expectations)
ECLI:EU:UNKNOWN:62017TA0733
62017TA0733
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8.7.2019
Official Journal of the European Union
C 230/31
(Case T-733/17) (<span class="super note-tag">1</span>)
(Medicinal products for human use - Article 3(1)(b) of Regulation (EC) No 141/2000 - Definition of ‘significant benefit’ - Availability of orphan medicinal products - Article 5(12)(b) of Regulation No 141/2000 - Commission decision to remove a medicinal product from the Register of Orphan Medicinal Products - Error of assessment - Error of law - Legitimate expectations)
(2019/C 230/38)
Language of the case: English
Parties
Applicant: GMP-Orphan (GMPO) (Paris, France) (represented by: M. Demetriou QC, E. Mackenzie, Barrister, L. Tsang and J. Mulryne, Solicitors)
Defendant: European Commission (represented by: K. Petersen and A. Sipos, acting as Agents)
Re:
Action pursuant to Article 263 TFEU seeking the partial annulment of Commission Implementing Decision C(2017) 6102 final of 5 September 2017 granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for ‘Cuprior-trientine’, a medicinal product for human use, in so far as the Commission decided, in Article 5 of that decision, that that medicinal product no longer satisfied the criteria laid down in Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ 2000 L 18, p. 1) to be registered as an orphan medicinal product and that the European Union Register of Orphan Medicinal Products should be updated accordingly.
Operative part of the judgment
The Court:
1.Dismisses the action;
2.Orders GMP-Orphan (GMPO) to pay the costs, including those incurred in the proceedings for interim measures.
(<span class="note">1</span>) OJ C 13, 15.1.2018.