62021TO0464_INF
Order of the General Court (Eighth Chamber) of 7 February 2022 –Faller and Others v Commission
(Case T‑464/21)
(Action for annulment – Medicinal products for human use – Variation of the conditional marketing authorisation for the Comirnaty medicinal product for human use – No legal interest in bringing proceedings – No direct concern – No 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 25-29, 34, 35)
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 37-39, 43, 44, 46)
3.
Action for annulment – Natural or legal persons – Measures of direct and individual concern to them – 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 47-51)
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 52, 53)
Re:
Application under Article 263 TFEU seeking annulment 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.
Operative part
1.
The action is dismissed as inadmissible.
2.
There is no longer a need to adjudicate on the applications to intervene submitted by TR and the other persons whose names are set out in Annex II, by YI and the other persons whose names are set out in Annex II, by EW and the other persons whose names are set out in Annex II, and by Mr Arnošt Komárek and the other persons whose names are set out in Annex II.
3.
Ms Sonja Faller and the other applicants whose names are set out in Annex I are ordered to pay the costs.
4.
TR and the other persons whose names are set out in Annex II, YI and the other persons whose names are set out in Annex II, EW and the other persons whose names are set out in Annex II, and Mr Komárek and the other persons whose names are set out in Annex II shall each bear their own costs relating to the applications to intervene.