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Order of the President of the Court of First Instance of 24 April 2009. # Nycomed Danmark ApS v Agence européenne des médicaments (EMEA). # Application for interim measures - Marketing authorisation for a medicinal product - Ultrasound echocardiographic imaging agent for diagnostic purposes (perflubutane) - Refusal by the EMEA to grant a waiver from the obligation to submit a paediatric investigation plan - Application for suspension of operation of a measure and interim measures - No urgency. # Case T-52/09 R.
ECLI:EU:T:2009:117
62009TO0052
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(Case T-52/09 R)
Application for interim measures – Marketing authorisation for a medicinal product – Ultrasound echocardiographic imaging agent for diagnostic purposes (perflubutane) – Refusal by the EMEA to grant a waiver from the obligation to submit a paediatric investigation plan – Application for suspension of operation of a measure and interim measures – No urgency
1. Application for interim measures – Suspension of operation of a measure – Interim measures – Conditions for granting – Prima facie case – Urgency – Serious and irreparable damage – Cumulative nature – Order of examination and method of verification – Discretion of the judge dealing with the application for interim relief (Arts 225 EC, 242 EC and 243 EC; Rules of Procedure of the Court of First Instance, Art. 104(2)) (see paras 37-40)
3. Application for interim measures – Conditions for admissibility – Application – Formal requirements – Summary of the pleas establishing a prima facie case for the interim measures applied for (Arts 242 EC and 243 EC; Rules of Procedure of the Court of First Instance, Arts 104(2) and 109) (see paras 61-62)
6. Application for interim measures – Suspension of operation of a measure – Interim measures – Conditions for granting – Urgency – Account to be taken of a lack of diligence on the part of the applicant (Arts 242 EC and 243 EC; Rules of Procedure of the Court of First Instance, Art. 104(2)) (see para. 82)
Re:
APPLICATION, first, for suspension of the operation of the EMEA’s decision of 28 November 2008 rejecting the application for a product-specific waiver concerning perflubutane and, secondly, for the grant of interim measures.
Operative part
1. The application for interim measures is dismissed.