Европейский Союз · cjeu_case

Judgment of the General Court (Seventh Chamber, Extended Composition) of 5 May 2021.#Pharmaceutical Works Polpharma S.A. v European Medicines Agency.#Medicinal products for human use – Application for marketing authorisation for a generic version of the medicinal product Tecfidera – Decision of the EMA not to validate the application for marketing authorisation – Previous decision of the Commission taking the view that Tecfidera – Dimethyl fumarate was not covered by the same global marketing authorisation as Fumaderm – Plea of illegality – Admissibility – Previously authorised combination medicinal product – Subsequent marketing authorisation for a component of the combination medicinal product – Assessment of the existence of two different global marketing authorisations – Manifest error of assessment.#Case T-611/18.

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