Decoding the Tecfidera Case: The Court of Justice of the European Union’s Verdict on the ‘Same Global Marketing Authorisation’

Headnote: 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 (official headnote)

Author: Pramiti Parwani