Order of the General Court of 11 December 2023 – UY v Commission
(Case T-108/23) 1
(Action for annulment – Medicinal products for human use – Directive 2001/83/EC – Marketing authorisation for the medicinal product Spikevax – COVID-19 vaccine – No interest in bringing proceedings – Lack of direct concern – Lack of individual concern – Inadmissibility)
Language of the case: German
Parties
Applicant: UY (represented by: R. Holzeisen, lawyer)
Defendant: European Commission (represented by: E. Mathieu and M. Noll-Ehlers, acting as Agents)
Re:
By his action based on Article 263 TFEU, the applicant seeks the annulment (i) of Commission Implementing Decision C(2022) 7163 final of 3 October 2022 granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for ‘Spikevax – elasomeran’, a medicinal product for human use and repealing Decision C(2021) 94 final, (ii) of Commission Implementing Decision C(2021) 5686 final of 23 July 2021 amending the conditional marketing authorisation granted by Implementing Decision C(2021) 94 final of 6 January 2021 for ‘Spikevax – COVID-19 mRNA Vaccine (nucleoside modified)’, a medicinal product for human use, (iii) of Implementing Decision C(2021) 94 final granting a conditional marketing authorisation under Regulation (EC) No 726/2004 for ‘COVID-19 Vaccine Moderna – COVID-19 mRNA Vaccine (nucleoside modified)’, a medicinal product for human use, (iv) of the last sentence of point 2.1. of Part IV of Annex I to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67), and (v) of the Annex to Commission Directive 2009/120/EC of 14 September 2009 amending Directive 2001/83 as regards advanced therapy medicinal products (OJ 2009 L 242, p. 3).
Operative part of the order
1. The action is dismissed as inadmissible.
2. There is no longer any need to rule on the application to intervene submitted by the European Parliament.
3. UY shall bear his own costs and pay those incurred by the European Commission.
4. The Parliament shall bear its own costs.
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1 OJ C 155, 2.5.2023.