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Case T-729/15 R: Order of the President of the General Court of 20 July 2016 — MSD Animal Health Innovation and Intervet international v EMA (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)
ECLI:EU:UNKNOWN:62015TB0729
62015TB0729
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Valentina R., lawyer
12.9.2016
Official Journal of the European Union
C 335/48
(Case T-729/15 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))
(2016/C 335/63)
Language of the case: English
Parties
Applicants: MSD Animal Health Innovation GmbH (Schwabenheim, Germany) and Intervet international BV (Boxmeer, Netherlands) (represented by: P. Bogaert, lawyer, B. Kelly and H. Billson, Solicitors, J. Stratford QC, and C. Thomas, Barrister)
Defendant: European Medicines Agency (EMA) (represented by: T. Jabłoński, N. Rampal Olmedo, A. Spina, A. Rusanov and S. Marino, acting as Agents)
Re:
Application based on Articles 278 TFEU and 279 TFEU, in essence, for the suspension of operation of Decision EMA/785809/2015 of the EMA of 25 November 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 veterinary medicinal product Bravecto.
Operative part of the order
1.The operation of Decision EMA/785809/2015 of the European Medicines Agency (EMA) of 25 November 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 toxicity study reports C 45151/28-day dermal (6 hours semi-occlusive) toxicity study in wistar rats, C 45162/28-day oral (gavage) toxicity study in wistar rats, and C 88913/28-day dermal (6 hours semi-occlusive) toxicity study in wistar rats..
2.The EMA shall not disclose the reports mentioned in point 1.
3.Costs are reserved.