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Document 62011CB0477
Case C-477/11 P: Order of the Court of 14 May 2012 — Sepracor Pharmaceuticals (Ireland) Ltd v European Commission (Appeals — Regulation (EC) No 726/2004 — Medicinal products for human use — Active substance ‘eszopiclone’ — Marketing authorisation — Procedure — Statement of position by the Commission — Status of ‘new active substance’ — Concept of ‘actionable measure’ )
Case C-477/11 P: Order of the Court of 14 May 2012 — Sepracor Pharmaceuticals (Ireland) Ltd v European Commission (Appeals — Regulation (EC) No 726/2004 — Medicinal products for human use — Active substance ‘eszopiclone’ — Marketing authorisation — Procedure — Statement of position by the Commission — Status of ‘new active substance’ — Concept of ‘actionable measure’ )
Case C-477/11 P: Order of the Court of 14 May 2012 — Sepracor Pharmaceuticals (Ireland) Ltd v European Commission (Appeals — Regulation (EC) No 726/2004 — Medicinal products for human use — Active substance ‘eszopiclone’ — Marketing authorisation — Procedure — Statement of position by the Commission — Status of ‘new active substance’ — Concept of ‘actionable measure’ )
OJ C 303, 6.10.2012, p. 6–6
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
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6.10.2012 |
EN |
Official Journal of the European Union |
C 303/6 |
Order of the Court of 14 May 2012 — Sepracor Pharmaceuticals (Ireland) Ltd v European Commission
(Case C-477/11 P) (1)
(Appeals - Regulation (EC) No 726/2004 - Medicinal products for human use - Active substance ‘eszopiclone’ - Marketing authorisation - Procedure - Statement of position by the Commission - Status of ‘new active substance’ - Concept of ‘actionable measure’)
2012/C 303/10
Language of the case: English
Parties
Appellant: Sepracor Pharmaceuticals (Ireland) Ltd (represented by: I. Dodds-Smith, solicitor, D. Anderson QC, and J. Stratford, barrister)
Other party to the proceedings: European Commission (represented by: M. Wilderspin and M. Šimerdová, acting as Agents)
Re:
Appeal brought against the order of the General Court (Fourth Chamber) of 4 July 2011 in Case T-275/09 P Sepracor Pharmaceuticals v Commission, dismissing as inadmissible an application for the annulment of the Commission’s decision of 6 May 2009 finding, in the context of the procedure for granting marketing authorisation for the medicinal product ‘Lunivia’, produced by the appellant, that the active substance ‘eszopiclone’, which it contains, does not constitute a new active substance within the meaning of Article 3(2)(a) of Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ 2004 L 136, p. 1) — Concept of actionable measure
Operative part of the order
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1. |
The appeal is dismissed. |
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2. |
Sepracor Pharmaceuticals Ltd is ordered to pay the costs. |