Order of the General Court of 11 December 2023 – UY v Commission
(Case T-109/23) 1
(Action for annulment – Medicinal products for human use – Directive 2001/83/EC – Marketing authorisation for the medicinal product ‘Comirnaty – COVID-19 mRNA vaccine (nucleoside modified)’ – COVID-19 vaccine – No interest in bringing proceedings – No direct concern – No 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 its action under Article 263 TFEU, the applicant seeks the annulment of (i) Commission Implementing Decision C(2022) 7342 final of 10 October 2022 granting marketing authorisation for ‘Comirnaty – tozinameran, COVID-19 mRNA vaccine (nucleoside modified)’, a medicinal product for human use, under Regulation (EC) No 726/2004 of the European Parliament and of the Council and repealing Decision C(2020) 9598 final, (ii) Commission Implementing Decision C(2021) 4034 final of 31 May 2021, amending the conditional marketing authorisation for ‘Comirnaty – COVID-19 mRNA Vaccine (nucleoside modified)’, a medicinal product for human use, granted by Implementing Decision C(2020) 9598 final, (iii) Commission Implementing Decision C(2020) 9598 final of 21 December 2020, granting a conditional marketing authorisation under Regulation (EC) No 726/2004 for ‘Comirnaty – COVID-19 mRNA (nucleoside-modified) vaccine’, a medicinal product for human use, (iv) the last sentence of paragraph 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) 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
The action is dismissed as inadmissible.
There is no longer any need to adjudicate on the European Parliament’s application for leave to intervene.
UY shall bear its own costs and to pay those incurred by the European Commission.
The Parliament shall bear its own costs.
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1 OJ C 155, 2.5.2023.