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Valentina R., lawyer
(Interim relief - Medicinal products for human use - Marketing authorisation - Application for interim measures - Application for injunction - Lack of urgency)
(2023/C 338/34)
Language of the case: English
Applicant: Zaklady Farmaceutyczne Polpharma S.A. (Starogard Gdański, Poland) (represented by: K. Roox, T. De Meese, J. Stuyck, M. Van Nieuwenborgh and C. Dumont, lawyers)
Defendant: European Commission (represented by: E. Mathieu and C. Valero, acting as Agents)
By its application based on Articles 278 and 279 TFEU, the applicant seeks, in essence, first, suspension of operation of the decision of the European Commission contained in its letter of 17 March 2023, by which the Commission requires it to comply with the protection period for the reference medicinal product Tecfidera — Dimethyl fumarate as regards the placing on the market of the medicinal product Dimethyl fumarate Polpharma — Dimethyl fumarate (‘DMF Polpharma’) and to give written undertakings to that effect and any subsequent decision or act extending or replacing the contested measure, in so far as they concern it, and, second, an injunction requiring the Commission to refrain from taking any other measures which would amount to a withdrawal of the marketing authorisation enjoyed by it or a prohibition on placing DMF Polpharma on the market.
1.The application for interim measures is dismissed.
2.The costs are reserved.