Intercept Pharma Ltd and another company v European Medicines Agency

European Union – Community institutions. The applicant companies had commenced proceedings seeking annulment of a decision of the European Medicines Agency (ASK-40399 of 15 May 2018), granting to a third party, pursuant to Regulation (EC) No 1049/2001, access to a document containing information submitted in the context of an application for marketing authorisation for the medicinal product 'Ocaliva'. The General Court of the European Union dismissed the applicants' action, deciding that the applicants had failed to show that the report at issue fell within the exceptions regarding public access to European Parliament, Council and Commission documents set out in the first and second indents of art 4(2) of that regulation, namely the 'commercial interests' provisions and protection of court proceedings.

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