Language of document :

Judgment of the General Court of 23 September 2020 – BASF v Commission

(Case T-472/19) 1

(Medicinal products for human use – Marketing authorisation for medicinal products for human use containing omega-3 acid ethyl esters – Variation of the terms of the authorisation – First paragraph of Article 116 of Directive 2001/83/EC – Manifest error of assessment – Proportionality)

Language of the case: English


Applicant: BASF AS (Oslo, Norway) (represented by: E. Wright, Barrister, and H. Boland, lawyer)

Defendant: European Commission (represented by: L. Haasbeek and A. Sipos, acting as Agents)


Application pursuant to Article 263 TFEU for annulment of Commission Implementing Decision C(2019) 4336 final of 6 June 2019 concerning, in the framework of Article 31 of Directive 2001/83/EC of the European Parliament and of the Council, marketing authorisations of medicinal products for human use containing ‘Omega-3 acid ethyl esters’ for oral use in secondary prevention after myocardial infarction.

Operative part of the judgment

The Court:

Dismisses the action;

Orders BASF AS to pay the costs, including the costs relating to the interlocutory proceedings.


1 OJ C 305, 9.9.2019.