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Case T-472/19: Judgment of the General Court of 23 September 2020 — BASF v Commission (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)

ECLI:EU:UNKNOWN:62019TA0472

62019TA0472

September 23, 2020
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Valentina R., lawyer

Official Journal of the European Union

C 390/32

(Case T-472/19) (<span class="oj-super oj-note-tag">1</span>)

(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)

(2020/C 390/45)

Language of the case: English

Parties

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)

Re:

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:

1.Dismisses the action;

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

(<span class="oj-super">1</span>) OJ C 305, 9.9.2019.

* * *

Language of the case: English

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