PTC Therapeutics International Ltd v European Medicines Agency

European Union – Information. The applicant pharmaceutical company, established in Ireland, had been granted, a conditional marketing authorisation (MA) for the medicinal product 'Translarna'. The applicant subsequently sought, pursuant to Regulation (EC) No 1049/2001, annulment of the European Medicines Agency's decision to grant a third party access to the main clinical study which had been conducted prior to the granting of the conditional MA. The General Court of the European Union dismissed the applicant's action on the basis that the pleas relied on by the applicant were not justified for the purposes of art 4 of that regulation.

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