62021TO0632_INF
Order of the General Court (Eighth Chamber) of 1 March 2022 –Agreiter and Others v Commission
(Case T‑632/21)
(Action for annulment – Medicinal products for human use – Amendment of the conditional marketing authorisation for Spikevax, a medicinal product for human use – COVID-19 mRNA Vaccine (nucleoside modified) – No interest in bringing proceedings – Lack of direct concern – Lack of individual concern – Inadmissibility)
1.
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 amending the 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 20-24, 29, 30)
2.
Action for annulment – Natural or legal persons – Measures of direct and individual concern to them – Whether directly concerned – Criteria – Commission decision amending the conditional marketing authorisation for a COVID-19 vaccine – Applicant not directly affected
(Art. 263, fourth para., TFEU)
(see paras 32-34, 38, 39, 41)
3.
Action for annulment – Natural or legal persons – Measures of direct and individual concern to them – Individual concern – Commission decision amending the 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 42-46)
4.
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 amending the conditional marketing authorisation for a COVID-19 vaccine – Not included
(Art. 263, fourth para., TFEU)
(see paras 47, 48)
Operative part
1.
The action is dismissed as inadmissible.
2.
There is no longer any need to adjudicate on the application for leave to intervene submitted by Moderna Biotech Spain SL.
3.
Ms Karin Agreiter and the other applicants whose names are listed in the Annex shall pay the costs.
4.
Moderna Biotech Spain shall bear its own costs related to the application for leave to intervene.