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Document 62021TO0096

    Order of the General Court (Eighth Chamber) of 9 November 2021.
    Heidi Amort and Others v European Commission.
    Action for annulment – Medicinal products for human use – Conditional marketing authorisation for the medicinal product for human use ‘Comirnaty – COVID-19 mRNA (nucleoside-modified) vaccine’ – No legal interest in bringing proceedings – No direct concern – No individual concern – Non-regulatory act – Inadmissibility.
    Case T-96/21.

    Court reports – general – 'Information on unpublished decisions' section

    ECLI identifier: ECLI:EU:T:2021:804

     Order of the General Court (Eighth Chamber) of 9 November 2021 –
    Amort and Others v Commission

    (Case T‑96/21)

    (Action for annulment – Medicinal products for human use – Conditional marketing authorisation for the medicinal product for human use ‘Comirnaty – COVID-19 mRNA (nucleoside-modified) vaccine’ – No legal interest in bringing proceedings – No direct concern – No 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 29-33, 38, 39)

    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 41-43, 48, 49, 52)

    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 53-57)

    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 58, 59)

    5. 

    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; Charter of Fundamental Rights of the European Union, Art. 47)

    (see paras 64-67)

    Re:

    Application based on Article 263 TFEU seeking annulment of European Commission Implementing Decision C(2020) 9598 (final) of 21 December 2020, granting a conditional marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for ‘Comirnaty – COVID-19 mRNA (nucleoside-modified) vaccine’, a medicinal product for human use, as amended and supplemented.

    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 Roberta Riccio and Alessandra Rizzotto, by Gheorghe Piperea, by TN, by TF, TG, TH and TI, by Jean Gouezo and the other persons whose names are set out in Annex II, by VV, by Stefano Del Gaudio and the other persons whose names are set out in Annex II, by TO, TP and TQ, by TR and the other persons whose names are set out in Annex II, by VH and the other persons whose names are set out in Annex II, by Dieter Achtschin and the other persons whose names are set out in Annex II, by VW, and by BioNTech Manufacturing GmbH and Pfizer Inc.

    3.

    Ms Heidi Amort and the other persons whose names are set out in Annex I are ordered to pay the costs.

    4.

    Roberta Riccio and Alessandra Rizzotto, Gheorghe Piperea, TN, TF, TG, TH and TI, Jean Gouezo and the other persons whose names are set out in Annex II, VV, Stefano Del Gaudio and the other persons whose names are set out in Annex II, TO, TP and TQ, TR and the other persons whose names are set out in Annex II, VH and the other persons whose names are set out in Annex II, Dieter Achtschin and the other persons whose names are set out in Annex II, VW and BioNTech Manufacturing GmbH and Pfizer Inc. shall each bear their own costs relating to the applications to intervene.

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