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Trajan Shipley
28th September 2021
Consumer, Health & Environment Data, Tech & IP Justice & Litigation

Three appeals published against General Court’s annulment of EMA decision rejecting application for marketing authorisation on the grounds of data protection

Three appeals against the General Court’s judgment in Pharmaceutical Works Polpharma v EMA (T-611/18) have been published in the Official Journal. The appeals have been brought by the European Commission, Biogen Netherlands BV and the European Medicines Agency (EMA).

In the contested judgment, as previously reported here, the General Court, sitting in Extended Composition, upheld an action for annulment against an EMA decision not validating Polpharma’s marketing authorisation application for Dimethyl Fumarate (DMF), a generic version of Tecfidera. The contested decision refused to validate the application by considering that the reference product allegedly benefits from regulatory data protection.

The EMA had rejected a fo


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