16.11.2015 |
EN |
Official Journal of the European Union |
C 381/42 |
Order of the President of the General Court of 1 September 2015 — Pari Pharma v EMA
(Case T-235/15 R)
((Application for interim measures - Access to documents - Regulation (EC) No 1049/2001 - Documents held by the EMA concerning information submitted by an undertaking as part of its application for authorisation to place a medicinal product on the market - Decision to grant a third party access to the documents - Application for suspension of operation of a measure - Urgency - Prima facie case - Weighing up of interests))
(2015/C 381/50)
Language of the case: English
Parties
Applicant: Pari Pharma GmbH (Starnberg, Germany) (represented by: M. Epping and W. Rehmann, lawyers)
Defendant: European Medicines Agency (EMA) (represented by: T. Jabłoński, N. Rampal Olmedo, A. Rusanov and S. Marino, acting as Agents)
Intervener in support of the defendant: Novartis Europharm Ltd (Camberley, United Kingdom) (represented by: C. Schoonderbeek, lawyer)
Re:
Application, in essence, for the suspension of operation of Decision EMA/271043/2015 of the EMA of 24 April 2015, granting to a third party, pursuant to Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ 2001 L 145, p. 43), access to certain documents containing information submitted in the context of an application for marketing authorisation for the medicinal product Vantobra.
Operative part of the order
1. |
The operation of Decision EMA/271043/2015 of the European Medicines Agency (EMA) of 24 April 2015 is suspended, in so far as that decision grants a third party access, pursuant to Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents, to the assessment report (EMA/CHMP/702525/2014) concerning the similarity of Vantobra with Cayston and TOBI Podhaler and the assessment report (EMA/CHMP/778270/2014) concerning the clinical superiority of Vantobra over TOBI Podhaler. |
2. |
The EMA is ordered not to disclose the two reports mentioned in point 1. |
3. |
Novartis Europharm Ltd’s request for access to the full case file is rejected. |
4. |
The costs are reserved. |