Information;Order — ECLI:EU:T:2023:813
Date: 2023-12-11
Language of the case: German
Court formation: Fifth Chamber
Subject matter: Public health
Procedure: Action for annulment - inadmissible

Order of the General Court (Fifth Chamber) of 11 December 2023 – UY v Commission (Case T‑109/23) ( 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 ) 1. Action for annulment – Time limits – Mandatory – Examination by the EU judicature of its own motion (Art. 263, sixth para., TFEU; Rules of Procedure of the General Court, Art. 60) (see paragraph 19) 2. Action for annulment – Actionable measures – Acts intended to have legal effects – Concept (Art. 263 TFEU) (see paragraph 24) 3. Action for annulment – Jurisdiction of the EU judicature – Claims for a declaratory judgment – Inadmissibility (Art. 263 TFEU) (see paragraph 27) 4. Action for annulment – Interest in bringing proceedings – Action brought by an applicant who is not an addressee of the contested act – Admissibility – Condition – Measure producing binding legal effects vis-à-vis the applicant – Commission decision granting a conditional marketing authorisation for a COVID-19 vaccine – Measure not bringing about a change in the applicant’s legal position – No interest in bringing proceedings (Art. 263, fourth para., TFEU) (see paragraphs 31-35, 40, 41) 5. Action for annulment – Natural or legal persons – Measures of direct and individual concern to them – Direct concern – Criteria – Commission decision granting a conditional marketing authorisation for a COVID-19 vaccine – Applicant not directly affected (Art. 263, fourth para., TFEU) (see paragraphs 43-48) 6. Action for annulment – Natural or legal persons – Measures of direct and individual concern to them – Commission decision granting a conditional marketing authorisation for a COVID-19 vaccine – Action brought by individuals relying on a violation of fundamental rights – Not individually concerned (Art. 263, fourth para., TFEU) (see paragraphs 49-53) 7. Action for annulment – Natural or legal persons – Concept of ‘regulatory act’ within the meaning of the fourth paragraph of Article 263 TFEU – Any act of general application other than legislative acts – Commission decision granting a conditional marketing authorisation for a COVID-19 vaccine – Not included (Art. 263, fourth para., TFEU) (see paragraphs 54-56) 8. Fundamental rights – Right to effective judicial protection – Review of legality of EU measures – Procedures – Protection of that right by the EU judicature or by the national courts according to the legal nature of the contested measure (Arts 263, 267 and 277 TFEU) (see paragraphs 58, 59) 9. Action for annulment – Natural or legal persons – Interest in bringing proceedings – Conditions – Reading in the light of the fundamental right to effective judicial protection – Commission decision granting a conditional marketing authorisation for a COVID-19 vaccine – Refusal of national courts to question the validity of that decision in preliminary ruling proceedings – No impact on the need to establish locus standi (Art. 263, fourth para., TFEU) (see paragraphs 61, 62) Operative part 1. The action is dismissed as inadmissible. 2. There is no longer any need to adjudicate on the European Parliament’s application for leave to intervene. 3. UY shall bear its own costs and to pay those incurred by the European Commission. 4. The Parliament shall bear its own costs.