Judgment_paragraph 5 · 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 (C-118/24)

5Article 6(1) of that directive provides:‘No medicinal product may be placed on the market of a Member State unless [an MA] has been issued by the competent authorities of that Member State in accordance with this Directive or an authorisation has been granted in accordance with 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)], read in conjunction with Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use [and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83 and Regulation No 726/2004 (OJ 2006 L 378, p. 1)] and Regulation 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 and Regulation No 726/2004 (OJ 2007 L 324, p. 121)].…’

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 (C-118/24)

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