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Joined Cases C-6/21 P and C-16/21 P: Judgment of the Court (Third Chamber) of 22 June 2023 — Federal Republic of Germany (C-6/21 P), Republic of Estonia (C-16/21 P) v Pharma Mar SA, European Commission (Appeal — Public health — Medicinal products for human use — Regulation (EC) No 726/2004 — Refusal of a marketing authorisation for the medicinal product for human use — Aplidin — plitidepsin — European Medicines Agency (EMA) — Impartiality of experts from a scientific advisory group (SAG) — Policy of the European Medicines Agency on the handling of competing interests of scientific committees’ members and experts — Concept of ‘pharmaceutical company’ — Scope of the exclusion for ‘research organisations’ — Concept of ‘rival products’)
ECLI:EU:UNKNOWN:62021CA0006
62021CA0006
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Official Journal of the European Union
C 278/3
(Joined Cases C-6/21 P and C-16/21 P) (*)
(Appeal - Public health - Medicinal products for human use - Regulation (EC) No 726/2004 - Refusal of a marketing authorisation for the medicinal product for human use - Aplidin — plitidepsin - European Medicines Agency (EMA) - Impartiality of experts from a scientific advisory group (SAG) - Policy of the European Medicines Agency on the handling of competing interests of scientific committees’ members and experts - Concept of ‘pharmaceutical company’ - Scope of the exclusion for ‘research organisations’ - Concept of ‘rival products’)
(2023/C 278/03)
Language of the case: English
Parties
Appellants: Federal Republic of Germany (C-6/21 P) (represented initially by J. Möller and S. Heimerl, and subsequently J. Möller and P.-L. Krüger, acting as Agents), Republic of Estonia (C-16/21 P) (represented by: N. Grünberg, acting as Agent)
Other parties to the proceedings: Pharma Mar SA (represented by: M. Merola and V. Salvatore, avvocati), European Commission (represented by: L. Haasbeek and A. Sipos, acting as Agents)
Interveners in support of the applicant (C-6/21 P): Kingdom of the Netherlands (represented by: M.K. Bulterman, J. Langer and C.S. Schillemans, acting as Agents), European Medicines Agency (EMA) (represented by: S. Drosos, H. Kerr and S. Marino, acting as Agents)
Interveners in support of the applicant (C-16/21 P): Federal Republic of Germany (represented initially by J. Möller and S. Heimerl, and subsequently J. Möller and D. Klebs, and, lastly, J. Möller and P.-L. Krüger, acting as Agents), Kingdom of the Netherlands (represented by: M.K. Bulterman, J. Langer and C.S. Schillemans, acting as Agents), European Medicines Agency (EMA) (represented by: S. Drosos, H. Kerr and S. Marino, acting as Agents)
Operative part of the judgment
The Court:
1.Sets aside the judgment of the General Court of the European Union of 28 October 2020, Pharma Mar v Commission (T 594/18, not published, EU:T:2020:512);
2.Refers Case T 594/18 back to the General Court of the European Union;
3.Reserves the costs.
(*) Language of the case: English.
(1) OJ C 110, 29.3.2021.
(2) OJ C 148, 26.4.2021.
ECLI:EU:C:2023:140