Zentiva and Zentiva Pharma challenge Commission Implementing Decision amending the marketing authorisation granted for ‘Tecfidera — Dimethyl fumarate’

Today, official publication has been made of an action for annulment brought by Zentiva and Zentiva Pharma against Commission, concerning the Commission Implementing Decision C(2023)3067(final) of 2 May 2023  amending the marketing authorisation granted by Decision C(2014)601(final) for ‘Tecfidera — Dimethyl fumarate’, a medicinal product for human use: Zentiva and Zentiva Pharma v Commission (Case T-278/23).

The applicants present eight pleas in law to support their action.

Firstly, they claim that the Commission failed to adhere to the time limit for obtaining an extension of market protection as required by Regulation EC No. 726/2004.

The second plea alleges that the Commission misinterpreted the scope of a previo