# C_2013233EN.01000902.xml

| 10.8.2013 | EN | Official Journal of the European Union | C 233/9 |
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10.8.2013

EN

Official Journal of the European Union

C 233/9

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Judgment of the General Court of 4 July 2013 — Laboratoires CTRS v Commission

(Case T-301/12) (1)

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(Medicinal products for human use - Application for authorisation to market the medicinal product Orphacol - Commission decision refusing to grant authorisation - Regulation (EC) No 726/2004 - Directive 2001/83/EC - Well-established medicinal use - Exceptional circumstances)

2013/C 233/16

Language of the case: English

Parties

Parties

Applicant: Laboratoires CTRS (Boulogne-Billancourt, France) (represented by: K. Bacon, Barrister, M. Utges Manley and M. Barnden, Solicitors)

Applicant:

Defendant: European Commission (represented by: E. White, M. Šimerdová and L. Banciella, acting as Agents)

Defendant:

Interveners in support of the applicant: Czech Republic (represented by: M. Smolek and D. Hadroušek, acting as Agents); Kingdom of Denmark (represented by: V. Pasternak Jørgensen and C. Thorning, acting as Agents); French Republic (represented by: D. Colas, F. Gloaguen and S. Menez, acting as Agents); Republic of Austria (represented by: C. Pesendorfer and A. Posch, acting as Agents); United Kingdom of Great Britain and Northern Ireland (represented: initially by S. Behzadi-Spencer, acting as Agent, and subsequently by C. Murrel, and finally by L. Christie, acting as Agents, and by J. Holmes, Barrister)

Interveners in support of the applicant:

Intervener in support of the defendant: Republic of Poland (represented: initially by B. Majczyna and M. Szpunar, and subsequently by B. Majczyna, acting as Agents)

Intervener in support of the defendant

Re:

Re:

Application for annulment of Commission Implementing Decision C(2012) 3306 final of 25 May 2012 refusing a marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for ‘Orphacol — Cholic acid’, an orphan medicinal product for human use.

Operative part of the judgment

Operative part of the judgment

The Court:

| 1. | Annuls Commission Implementing Decision C(2012) 3306 final of 25 May 2012 refusing a marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for ‘Orphacol — Cholic acid’, an orphan medicinal product for human use; |
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1.

Annuls Commission Implementing Decision C(2012) 3306 final of 25 May 2012 refusing a marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for ‘Orphacol — Cholic acid’, an orphan medicinal product for human use;

| 2. | Orders the European Commission to bear its own costs and those incurred by Laboratoires CTRS; |
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2.

Orders the European Commission to bear its own costs and those incurred by Laboratoires CTRS;

| 3. | Orders the Czech Republic, the Kingdom of Denmark, the French Republic, the Republic of Austria, the Republic of Poland and the United Kingdom of Great Britain and Northern Ireland to bear their own costs. |
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3.

Orders the Czech Republic, the Kingdom of Denmark, the French Republic, the Republic of Austria, the Republic of Poland and the United Kingdom of Great Britain and Northern Ireland to bear their own costs.

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(1)  OJ C 250, 18.8.2012.

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