CELEX:62021CJ0438: Judgment of the Court (Fourth Chamber) of 16 March 2023.#European Commission and Others v Pharmaceutical Works Polpharma S.A.#Appeal – Public health – Medicinal products for human use – Directive 2001/83/EC – Regulation (EC) No 726/2004 – Application for marketing authorisation for a generic version of the medicinal product Tecfidera – Decision of the European Medicines Agency (EMA) not to validate the application for marketing authorisation – Earlier European Commission decision taking the view that Tecfidera was not covered by the same global marketing authorisation as Fumaderm – Previously authorised combination medicinal product – Subsequent marketing authorisation for a component of the combination medicinal product – Assessment of the existence of a global marketing authorisation.#Joined Cases C-438/21 P to C-440/21 P.
21 March, 2023
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