Request for a preliminary ruling from the Conseil d’État (France) lodged on 14 February 2024 - EG Labo Laboratoires Eurogenerics SAS and Theramex France SAS v Agence nationale de sécurité du médicament et des produits de santé (ANSM) and Biogaran SAS
(Case C-118/24, Laboratoires Eurogenerics and Theramex France)
Language of the case: French
Referring court
Conseil d'État
Parties to the main proceedings
Applicants: EG Labo Laboratoires Eurogenerics SAS, Theramex France SAS
Defendant: Agence nationale de sécurité du médicament et des produits de santé (ANSM), Biogaran SAS
Other parties to the proceedings: Eli Lilly Nederland BV, Lilly France SAS
Questions referred
Should Articles 28 and 29 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 1 be interpreted as meaning that a court of a Member State involved in a decentralised marketing authorisation procedure without being the reference Member State, which has jurisdiction to hear an action brought against that decision granting marketing authorisation taken by the competent authority of that Member State in accordance with what the Court held in its judgment of 14 March 2018, Astellas Pharma (C-557/16), is competent, in such a case, to verify that the decentralised procedure was conducted in compliance with the provisions of Directive 2001/83/EC and that the placing of the medicinal product on the market does not present a potential serious risk to public health within the meaning of Article 29(1) of that directive?
Should Article 10 of Directive 2001/83/EC be interpreted as meaning that it precludes a marketing authorisation from being granted to a chemical medicinal product in accordance with the simplified procedure laid down in Article 10(1) of that directive where the reference medicinal product is a biological medicinal product?
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1 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).