Diritto amministrativo europeo

EMA’s appeals against interim measures are dismissed by Court of Justice

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The Vice-President of the Court of Justice of the European Union has dismissed two appeals by the European Medicines Agency (EMA) against interim orders of the President of the General Court, thus upholding the suspension of the release of certain documents requested by third parties under Regulation (EC) No 1049/2001, the so-called “Transparency Regulation”. In December 2015, two court cases were brought against EMA by PTC Therapeutics and Intervet. The two companies challenged EMA’s decisions to release the requested documents in accordance with the Transparency Regulation and EMA’s 2010 policy on access to documents. Both companies argue that the release of the requested documents would infringe their right to protect commercially confidential information contained in their marketing authorisation applications. The Agency respects the orders of the Vice-President of the Court of Justice received in early March 2017 and will not release the concerned documents until the General Court rules on the main cases. The orders in the interim measures proceedings do not pre-empt the judicial decision on the two main cases. In the meantime, EMA will continue to process requests for access to documents concerning medicinal products in accordance with the Transparency Regulation and its 2010 policy on access to documents.

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