Order of the General Court (Eighth Chamber) of 14 January 2022 –

Alauzun and Others v Commission and EMA

(Case T‑418/21)

(Action for annulment – Medicinal products for human use – Amendment to the conditional marketing authorisation for the medicinal product for human use Comirnaty – Act not open to challenge – Preparatory act – No interest in bringing proceedings – No direct concern – Act not of individual concern – Non-regulatory act – Inadmissibility)

1. Action for annulment – Actionable measures – Concept – Measures producing binding legal effects – Preparatory measures – Precluded – Opinion of the European Medicines Agency (EMA) – Inadmissibility (Art. 263 TFEU) (see paras 23, 25, 26)

2. Action for annulment – Admissibility criteria – Action against the author of the contested measure – Application for annulment of the opinion of the European Medicines Agency (EMA) – Inadmissibility (Art. 263 TFEU; Commission Regulation No 1234/2008, Arts 16 and 17(2)) (see paras 28, 29)

3. 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 paras 28-32, 37, 38)

4. Action for annulment – Natural or legal persons – Measures of direct and individual concern to them – Whether directly concerned – Criteria – Commission decision granting a conditional marketing authorisation for a COVID-19 vaccine – Applicant not directly affected (Art. 263, fourth para., TFEU) (see paras 45, 46, 51)

5. 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 paras 55-59)

6. Action for annulment – Natural or legal persons – Concept of ‘regulatory act’ within the meaning of the fourth paragraph of Article 263 TFEU – Any measure of general application other than legislative acts – Commission decision granting a conditional marketing authorisation for a COVID-19 vaccine – Precluded (Art. 263, fourth para., TFEU) (see paras 60, 61)

7. 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 (Art. 19(1) TEU; Arts 263, 267 and 277 TFEU) (see paras 63-68)

Re:

Application under Article 263 TFEU for annulment, first, of Commission Implementing Decision C(2021) 4034 final of 31 May 2021 amending the conditional marketing authorisation granted by Implementing Decision C(2020) 9598 final for ‘Comirnaty – COVID-19 mRNA Vaccine (nucleoside modified)’, a medicinal product for human use, and, second, of the EMA’s opinion of 28 May 2021.

Operative part

1. The action is dismissed as inadmissible.