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Action for annulment – Medicinal products for human use – Active substance eszopiclone – Marketing authorisation – Refusal of recognition as a new active substance – Act not amenable to review – Inadmissibility
Actions for annulment – Actionable measures – Concept – Measures producing binding legal effects – Letter from the Commission setting out its position as to the action to be taken following the opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency – Not included (Art. 230, fourth para., EC; European Parliament and Council Regulation No 726/2004, Art. 10(2)) (see paras 15, 17-18, 20, 23-24, 31-32, 35)
ACTION for annulment of the decision in the letter of the Commission addressed to the applicant on 6 May 2009 in the context of the procedure for authorising the placing on the market of Lunivia, inasmuch as it concerns classification of the active substance eszopiclone.
1.The action is dismissed as inadmissible.
2.Sepracor Pharmaceuticals (Ireland) Ltd is ordered to pay the costs.