BRUSSELS THREATENS ITALY WITH COURT ACTION OVER GENERIC DRUG AUTHORISATIONS

BY KEITH NUTHALL THE EUROPEAN Commission is threatening Italy with legal action at the European Court of Justice (ECJ) over a restriction it imposes on generic drug manufacturers. Italian law prevents them from filing marketing authorisation requests before the penultimate year of a patent's expiry which Brussels says breaks EU genetic medicine legislation. "As a result of this law, and of the lengthy procedure to secure the authorisation for marketing, manufacturers of generic products are placed at a disadvantage," said a Commission note. ...


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