Orders nº T-472/19 of Tribunal General de la Unión Europea, August 19, 2019

• Resolution Date: August 19, 2019
• Issuing Organization: Tribunal General de la Unión Europea
• Decision Number: T-472/19

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

In Case T-472/19 R,

BASF AS, established in Oslo (Norway), represented by E. Wright, A. Rusanov and H. Boland, lawyers,

applicant,

v

European Commission, represented by L. Haasbeek and A. Sipos, acting as Agents,

defendant,

APPLICATION pursuant to Articles 278 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 of the European Parliament and of the Council, 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),

THE PRESIDENT OF THE GENERAL COURT

makes the following

Order

Background to the dispute, procedure and forms of order sought

1 The applicant, BASF AS, is part of BASF, a global group of chemical companies.

2 According to the applicant, it is the marketing authorisation holder for, inter alia, the omega-3-acid ethyl ester medicinal products Omacor and Zodin.

3 Omacor was approved in 1995. The therapeutic indication relating to the treatment in secondary prevention after myocardial infarction was approved in 2001.

4 In 2003, a marketing authorisation was granted for the medicinal product Zodin, which is identical in all aspects to Omacor.

5 On 15 March 2018, the Kingdom of Sweden initiated a procedure pursuant to Article 31 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67).

6 That procedure resulted in the Commission Implementing Decision of 6 June 2019 concerning, in the framework of Article 31 of Directive 2001/83/EC of the European Parliament and of the Council, 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; ‘the contested decision’).

7 By virtue of the contested decision, Member States are, in essence, required to remove, from the existing marketing authorisations for medicinal products such as Omacor and Zodin, the therapeutic indication of use in secondary prevention after myocardial infarction.

8 By application lodged at the Court Registry on 9 July 2019, the applicant brought an action for annulment of the contested decision.

9 By a separate document lodged at the Court Registry on the same day, the applicant brought the present application for interim measures, in which it claims, in essence, that the President of the General Court should:

- suspend the operation of the contested decision in its entirety or in so far as the applicant is affected;

- order the Commission to pay the costs.

10 In its observations on the application for interim measures, lodged at the Court Registry on 29 July 2019, the Commission contends that the President of the General Court should:

- dismiss the application for interim measures;

- order the applicant to pay the costs.

Law

11 It is apparent from reading Articles 278 and 279 TFEU together with Article 256(1) TFEU...