# C_2021368EN.01003901.xml

| 13.9.2021 | EN | Official Journal of the European Union | C 368/39 |
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13.9.2021

EN

Official Journal of the European Union

C 368/39

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Action brought on 30 July 2021 — Faller and Others v Commission

(Case T-464/21)

(2021/C 368/55)

Language of the case: German

Parties

Applicant: Sonja Faller (Brixen, Italy) and 74 other applicants (represented by: R. Holzeisen, lawyer)

Defendant: European Commission

Form of order sought

The applicants claim that the Court should annul the contested implementing decision, as supplemented and amended.

Pleas in law and main arguments

In support of the action against Commission Implementing Decision of 31 May 2021 amending the conditional marketing authorisation granted by Decision C(2020) 9598 (final) for ‘Comirnaty — COVID-19-mRNA Vaccine (nucleoside modified)’, a medicinal product for human use, the applicants rely on the following pleas in law.

| 1. | First plea in law, alleging that the contested implementing decision infringes Article 2(1) and (2) of Regulation (EC) No 507/2006. (1) Simply on account of the fact that children are at zero risk if they become infected with SARS-CoV-2, there cannot be a positive risk-benefit balance for healthy children. The use of the experimental substance at issue based on genetic technology is thus grossly contrary to EU law. Furthermore, the WHO and the EU have not duly recognised the crisis situation as a public health threat. |
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1.

First plea in law, alleging that the contested implementing decision infringes Article 2(1) and (2) of Regulation (EC) No 507/2006. (1) Simply on account of the fact that children are at zero risk if they become infected with SARS-CoV-2, there cannot be a positive risk-benefit balance for healthy children. The use of the experimental substance at issue based on genetic technology is thus grossly contrary to EU law. Furthermore, the WHO and the EU have not duly recognised the crisis situation as a public health threat.

| 2. | Second plea in law, alleging that the contested implementing decision infringes Article 4 of Regulation (EC) No 507/2006 on account of:






  — | the absence of a positive risk-benefit balance, as defined in Article 1(28a) of Directive 2001/83/EC; (2) |
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2.

Second plea in law, alleging that the contested implementing decision infringes Article 4 of Regulation (EC) No 507/2006 on account of:

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the absence of a positive risk-benefit balance, as defined in Article 1(28a) of Directive 2001/83/EC; (2)

| — | the failure to meet the requirement under Article 4(1)(b) of Regulation (EC) No 507/2006, since the applicant is not in a position to provide the comprehensive clinical data; |
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the failure to meet the requirement under Article 4(1)(b) of Regulation (EC) No 507/2006, since the applicant is not in a position to provide the comprehensive clinical data;

| — | the failure to meet the requirement under Article 4(1)(c) of Regulation (EC) No 507/2006, since there are no unmet medical needs that will be fulfilled by the authorised medicinal product; |
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the failure to meet the requirement under Article 4(1)(c) of Regulation (EC) No 507/2006, since there are no unmet medical needs that will be fulfilled by the authorised medicinal product;

| — | the failure to meet the requirement under Article 4(1)(d) of Regulation (EC) No 507/2006. |
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the failure to meet the requirement under Article 4(1)(d) of Regulation (EC) No 507/2006.

| 3. | Third plea in law, alleging infringement of Regulation (EC) No 1394/2007, (3) Directive 2001/83/EC and Regulation (EC) No 726/2004. (4) |
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3.

Third plea in law, alleging infringement of Regulation (EC) No 1394/2007, (3) Directive 2001/83/EC and Regulation (EC) No 726/2004. (4)

| 4. | Fourth plea in law, alleging gross infringement of Articles 168 and 169 TFEU and Articles 3, 35 and 38 of the EU Charter. |
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4.

Fourth plea in law, alleging gross infringement of Articles 168 and 169 TFEU and Articles 3, 35 and 38 of the EU Charter.

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(1)  Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ 2006 L 92, p. 6).

(2)  Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67).

(3)  Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ 2007 L 324, p. 121).

(4)  Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ 2004 L 136, p. 1).

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