62021TO0267_INF
Order of the General Court (Eighth Chamber) of 9 November 2021 –Amort and Others v Commission
(Case T‑267/21)
(Action for annulment – Medicinal products for human use – Conditional marketing authorisation for the medicinal product for human use ‘COVID-19 Vaccine Janssen – COVID-19 vaccine (Ad26.COV2-S [recombinant])’ – No interest in bringing proceedings – Lack of direct concern – Lack of individual concern – Non-regulatory act – 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 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 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 granting a conditional marketing authorisation for a COVID-19 vaccine – Applicant not directly affected
(Art. 263, fourth para., TFEU)
(see paras 37-39, 44, 45, 48)
3.
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 49-53)
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 granting a conditional marketing authorisation for a COVID-19 vaccine – Precluded
(Art. 263, fourth para., TFEU)
(see paras 54, 55)
Re:
Application under Article 263 TFEU for annulment of Commission Implementing Decision C(2021) 1763 (final) of 11 March 2021 granting a conditional marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for ‘COVID-19 Vaccine Janssen – COVID-19 vaccine (Ad26.COV2-S [recombinant])’, a medicinal product for human use, as amended and supplemented.
Operative part
1.
The action is dismissed as inadmissible.
2.
There is no longer any need to adjudicate on the applications for leave to intervene submitted by TF, TG, TH and TI, by TR and the other persons whose names are set out in Annex II and by VH and the other persons whose names are set out in Annex II.
3.
Ms Heidi Amort and the other persons whose names are set out in Annex I shall pay the costs.
4.
TF, TG, TH and TI, TR and the other persons whose names are set out in Annex II and VH and the other persons whose names are set out in Annex II shall each bear their own costs relating to the applications for leave to intervene.