Judgment — ECLI:EU:T:2015:373
Date: 2015-06-11
Language of the case: English
Court formation: Seventh Chamber
Subject matter: Public health
Procedure: Action for annulment - successful
Origin: France

Summary of Product Characteristics and the Assessment Report for Cholic Acid FGK, which according to the applicant form an integral part of the contested decision, contained extensive references to the efficacy as well as references to the safety of Cholic Acid FGK in the therapeutic indications for which Orphacol was authorised. In support of the action, the applicant relies on a single plea in law, alleging infringement of Article 8(1) of Regulation No 141/2000, as the Commission has, by granting a marketing authorisation for Cholic Acid FGK on the terms set out in the Summary of Product Characteristics and the Assessment Report, circumvented the applicant’s market exclusivity, since the terms upon which the marketing authorisation for Cholic Acid FGK was granted imply, in substance, that Cholic Acid FGK is also authorised for the two therapeutic indications for which Orphacol is authorised. ____________ ____________ 1 Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ 2000 L 18, p. 1).