General Court 5 May 2021, Case T-611/18: Judgment of the General Court of 5 May 2021 — Pharmaceutical Works Polpharma v EMA (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)

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