# C_2015381EN.01004201.xml

| 16.11.2015 | EN | Official Journal of the European Union | C 381/42 |
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16.11.2015

EN

Official Journal of the European Union

C 381/42

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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

Parties

Applicant: Pari Pharma GmbH (Starnberg, Germany) (represented by: M. Epping and W. Rehmann, lawyers)

Applicant:

Defendant: European Medicines Agency (EMA) (represented by: T. Jabłoński, N. Rampal Olmedo, A. Rusanov and S. Marino, acting as Agents)

Defendant:

Intervener in support of the defendant: Novartis Europharm Ltd (Camberley, United Kingdom) (represented by: C. Schoonderbeek, lawyer)

Intervener in support of the defendant:

Re:

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

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. |
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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. |
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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. |
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3.

Novartis Europharm Ltd’s request for access to the full case file is rejected.

| 4. | The costs are reserved. |
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4.

The costs are reserved.

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