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Case T-628/19: Action brought on 20 September 2019 – Teva v Commission and EMA
ECLI:EU:UNKNOWN:62019TN0628
62019TN0628
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11.11.2019
EN
Official Journal of the European Union
C 383/67
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(Case T-628/19)
(2019/C 383/76)
Language of the case: English
Parties
Applicant: Teva BV (Haarlem, Netherlands) (represented by: T. de la Mare, QC, R. Mehta, Barrister and G. Morgan, Solicitor)
Defendants: European Commission and European Medicines Agency
Form of order sought
The applicant claims that the Court should:
—annul Commission’s Implementing Decision C (2019)5393 final of 11 July 2019 refusing marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) for ‘Cabazitaxel Teva – cabazitaxel’ (‘the decision’) insofar as it applies to the applicant, and
—order the defendants to pay the applicant’s costs.
Pleas in law and main arguments
In support of the action, the applicant relies on three pleas in law.
1.First plea in law, alleging that the Commission failed correctly to apply the concept of a ‘global marketing authorisation’ within the meaning of Directive 2001/83 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), in particular the concept of a ‘derivative’ medicinal product in Article 10(2)(b) thereof.
2.Second plea in law, alleging that the Commission and the EMA breached the principle of procedural fairness and the applicant’s right to good administration, in particular by reversing the burden of proof on generic applicants for marketing authorisations contrary to the requirements of the EU legislation in this field.
3.Third plea in law, alleging that by this conduct, the Commission also breached the principle of equal treatment, by treating the applicant differently to the holder of the marketing authorisation for Jevtana®/docetaxel.
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(1) 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)