Order of the President of the General Court of 19 August 2019 –
BASF v Commission

(Case T‑472/19 R)

(Interim measures — Medicinal product — Marketing authorisation —Omega-3 acid ethyl esters — No urgency)

1.      Application for interim relief — Suspension of operation of a measure — Interim measures — Conditions for granting — Prima facie case — Urgency — Serious and irreparable damage — Cumulative nature — Balancing of all the interests involved — Order of examination and method of verification — Discretion of the court hearing the application for interim relief

(Arts 256(1), 278 and 279 TFEU; Rules of Procedure of the General Court, Art. 156(4))

(see paras 11-14)

2.      Application for interim relief — Suspension of operation of a measure — Interim measures — Conditions for granting — Urgency — Serious and irreparable damage — Burden of proof — Purely hypothetical damage based on the happening of future and uncertain events — Insufficient to demonstrate urgency

(Arts 278 and 279 TFEU)

(see paras 17, 18)

3.      Application for interim relief — Suspension of operation of a measure — Interim measures — Conditions for granting — Urgency — Serious and irreparable damage — Burden of proof — Financial loss — Obligation to provide concrete and precise indications, supported by detailed documentary evidence — Situation liable to endanger the existence of the applicant company

(Arts 278 and 279 TFEU; Rules of Procedure of the General Court, Art. 156(4))

(see paras 19-21)

4.      Application for interim relief — Formal requirements — Submission of applications — Brief summary of the pleas in law on which the application is based — Pleas in law not set out in the application and pleadings — General reference to other documents — Inadmissibility

(Arts 278 and 279 TFEU; Rules of Procedure of the General Court, Art.156(4) and (5))

(see para. 22)

Re:

Application pursuant to Articles 278 TFEU and 279 TFEU for the grant of interim measures to suspend the operation of the Commission Implementing Decision of 6 June 2019 concerning, in the framework of Article 31 of Directive 2001/83/EC, the marketing authorisations of medicinal products for human use containing ‘Omega-3 acid ethyl esters’ for oral use in secondary prevention after myocardial infarction (C(2019) 4336 final).

Operative part

1. The application for interim measures is dismissed.

2. The costs are reserved.