Orders (Information) nº T-52/09 of Court of First Instance of the European Communities, April 24, 2009

• Resolution Date: April 24, 2009
• Issuing Organization: Court of First Instance of the European Communities
• Decision Number: T-52/09

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...