Official Journal of the European Union

EN

C series

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C/2025/1118

(Case T-666/24)

(C/2025/1118)

Language of the case: English

Parties

Applicant: Teva Pharma BV (Haarlem, Netherlands) (represented by: C. Lindenthal and A. Säurig, lawyers)

Defendant: European Medicines Agency

Form of order sought

The applicant claims that the Court should:

—annul EMA’s decision EMA/391476/2024 Rev.1 of 28 October 2024, granting a third party, under Regulation No 1049/2001 of the European Parliament and of the Council, (1) access to a document from a scientific advice procedure for the medicinal product Ferric carboxymaltose, subject to certain redactions;

—prohibit EMA to disclose the document without the redactions as proposed in Annex 18; and

—order that the costs of the proceedings be borne by the defendant.

Pleas in law and main arguments

In support of the action, the applicant relies on two pleas in law.

1.First plea in law, alleging that EMA misapplied the law as it decided to disclose information extracted from EMA’s scientific advice in breach of Article 4(2) of Regulation No. 1049/2001. The information at issue constitutes commercially confidential information and as such needs to be redacted.

2.Second plea in law, alleging that the outcome of a proper balancing of interests, as required by law according to the last half sentence of Article 4(2) of Regulation No. 1049/2001, would have demanded a decision not to release the information at issue without the further redactions proposed by the Applicant.

(1) Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ 2001 L 145, p. 43).

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ELI: http://data.europa.eu/eli/C/2025/1118/oj

ISSN 1977-091X (electronic edition)

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