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

Reports of Cases

published in the electronic Reports of Cases (Court Reports - general)

• (Appeal Case before the Court of Justice C-438/21 P)