This document is an excerpt from the EUR-Lex website
Document 62023TB0278
Case T-278/23 R: Order of the President of the General Court of 24 July 2023 — Zentiva and Zentiva Pharma v Commission (Interim relief — Medicinal products for human use — Marketing authorisation — Application for interim measures — Application for injunction — Lack of urgency)
Case T-278/23 R: Order of the President of the General Court of 24 July 2023 — Zentiva and Zentiva Pharma v Commission (Interim relief — Medicinal products for human use — Marketing authorisation — Application for interim measures — Application for injunction — Lack of urgency)
Case T-278/23 R: Order of the President of the General Court of 24 July 2023 — Zentiva and Zentiva Pharma v Commission (Interim relief — Medicinal products for human use — Marketing authorisation — Application for interim measures — Application for injunction — Lack of urgency)
OJ C 338, 25.9.2023, p. 29–29
(BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
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25.9.2023 |
EN |
Official Journal of the European Union |
C 338/29 |
Order of the President of the General Court of 24 July 2023 — Zentiva and Zentiva Pharma v Commission
(Case T-278/23 R)
(Interim relief - Medicinal products for human use - Marketing authorisation - Application for interim measures - Application for injunction - Lack of urgency)
(2023/C 338/38)
Language of the case: English
Parties
Applicants: Zentiva k.s. (Prague, Czech Republic), Zentiva Pharma GmbH (Frankfurt am Main, Germany) (represented by: K. Roox, T. De Meese and J. Stuyck, lawyers)
Defendant: European Commission (represented by: E. Mathieu, L. Haasbeek and A. Spina, acting as Agents)
Re:
By their application based on Articles 278 and 279 TFEU, the applicants seek, in essence, first, suspension of operation of Commission Implementing Decision C(2023) 3067 final of 2 May 2023 amending Commission Implementing Decision C(2014) 601 final of 30 January 2014 granting marketing authorisation (‘MA’) for the medicinal product for human use Tecfidera — Dimethyl fumarate under Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency (OJ 2004 L 136, p. 1), as amended, and any subsequent decision or act extending or replacing the contested decision in so far as they concern them, and, second, an injunction requiring the European Commission to refrain from taking any other measures which would amount to a withdrawal of the MAs enjoyed by them or a prohibition on placing generic Dimethyl fumarate products on the market.
Operative part of the order
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1. |
The application for interim measures is dismissed. |
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2. |
There is no longer any need to rule on the application to intervene submitted by Biogen Netherlands BV or on the application for confidential treatment submitted by Zentiva k.s. and Zentiva Pharma GmbH. |
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3. |
The costs relating to the proceedings for interim relief are reserved. |
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4. |
Each party shall bear its own costs relating to the application to intervene submitted by Biogen Netherlands. |