Order of the President of the Court of First Instance of 24 April 2009 – Nycomed Danmark v EMEA
(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)
2. Application for interim measures – Suspension of operation of a measure – Interim measures – Conditions for granting – Serious and irreparable damage – Burden of proof –Materialisation of the damage dependent on future and uncertain events(Arts 242 EC and 243 EC; Rules of Procedure of the Court of First Instance,Art. 104(2)) (see paras 59-60)
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)
4. Application for interim measures – Suspension of operation of a measure – Conditions for granting – Serious and irreparable damage – Financial loss –Damage which may subsequently be made good by compensation or by means of an action for damages (Arts 235 EC, 242 EC and 288 EC; Rules of Procedure of the Court of First Instance, Art. 104(2)) (see paras 70-73)
5. Application for interim measures – Suspension of operation of a measure – Interim measures – Conditions for granting – Urgency – Serious and irreparable damage – Financial loss – Situation which could jeopardise the existence of the applicant company (Arts 242 EC and 243 EC; Rules of Procedure of the Court of First Instance, Art. 104(2)) (see paras 74-80)
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.