CELEX: 62011CO0477
Language: en
Date: 2012-05-14 00:00:00
Title: Order of the Court (Eighth Chamber) 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 (Eighth Chamber) of 14 May 2012 —Sepracor Pharmaceuticals v Commission(Case C‑477/11 P)
      Appeal — 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’
      Actions for annulment — Actionable measures — Meaning — Measures producing binding legal effects — Letter from the Commission setting out its position as to the steps to be taken in response to the opinion of the Committee
         for Medicinal Products for Human Use of the European Medicines Agency — Not included (Art. 263 TFEU; European Parliament and Council Regulation No 726/2004, Art. 10(2)) (see paras 51-58, 60, 61)
      
      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 
      
         
                  1.
               
               
                  
               
               
                  	The appeal is dismissed.
               
            
         
                  2.
               
               
                  
               
               
                  	Sepracor Pharmaceuticals Ltd is ordered to pay the costs.