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Case T-549/19: Judgment of the General Court of 23 September 2020 — Medac Gesellschaft für klinische Spezialpräparate v Commission (Medicinal products for human use — Orphan medicinal products — Application for marketing authorisation for the medicinal product Trecondi-treosulfan — Decision to remove a medicinal product from the Register of Orphan Medicinal Products — Article 3(1)(b) of Regulation (EC) No 141/2000 — Concept of ‘satisfactory method’ — Article 5(12)(b) of Regulation No 141/2000 — Error of law)

ECLI:EU:UNKNOWN:62019TA0549

62019TA0549

September 23, 2020
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16.11.2020

Official Journal of the European Union

C 390/33

(Case T-549/19) (<span class="oj-super oj-note-tag">1</span>)

(Medicinal products for human use - Orphan medicinal products - Application for marketing authorisation for the medicinal product Trecondi-treosulfan - Decision to remove a medicinal product from the Register of Orphan Medicinal Products - Article 3(1)(b) of Regulation (EC) No 141/2000 - Concept of ‘satisfactory method’ - Article 5(12)(b) of Regulation No 141/2000 - Error of law)

(2020/C 390/47)

Language of the case: German

Parties

Applicant: Medac Gesellschaft für klinische Spezialpräparate mbH (Wedel, Germany) (represented by: P. von Czettritz, lawyer)

Defendant: European Commission (represented by: B.-R. Killmann and A. Sipos, acting as Agents)

Re:

Action under Article 263 TFEU seeking the partial annulment of Commission Implementing Decision C(2019) 4858 final of 20 June 2019 granting marketing authorisation for the medicinal product for human use Trecondi-treosulfan.

Operative part of the judgment

The Court:

1.Annuls Article 5 of European Commission Implementing Decision C(2019) 4858 (final) of 20 June 2019 granting marketing authorisation for the medicinal product for human use ‘Trecondi-treosulfan’;

2.Orders the Commission to pay the costs, including those relating to the interim proceedings.

(<span class="oj-super">1</span>) OJ C 337, 7.10.2019.

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