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Document 62015TA0718
Case T-718/15: Judgment of the General Court of 5 February 2018 — PTC Therapeutics International v EMA (Access to documents — Regulation (EC) No 1049/2001 — Document held by the EMA and submitted in the context of the application for marketing authorisation for the medicinal product Translarna — Decision to grant a third party access to the document — Exception relating to the protection of commercial interests — No general presumption of confidentiality)
Case T-718/15: Judgment of the General Court of 5 February 2018 — PTC Therapeutics International v EMA (Access to documents — Regulation (EC) No 1049/2001 — Document held by the EMA and submitted in the context of the application for marketing authorisation for the medicinal product Translarna — Decision to grant a third party access to the document — Exception relating to the protection of commercial interests — No general presumption of confidentiality)
Case T-718/15: Judgment of the General Court of 5 February 2018 — PTC Therapeutics International v EMA (Access to documents — Regulation (EC) No 1049/2001 — Document held by the EMA and submitted in the context of the application for marketing authorisation for the medicinal product Translarna — Decision to grant a third party access to the document — Exception relating to the protection of commercial interests — No general presumption of confidentiality)
OJ C 104, 19.3.2018, p. 30–30
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
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19.3.2018 |
EN |
Official Journal of the European Union |
C 104/30 |
Judgment of the General Court of 5 February 2018 — PTC Therapeutics International v EMA
(Case T-718/15) (1)
((Access to documents - Regulation (EC) No 1049/2001 - Document held by the EMA and submitted in the context of the application for marketing authorisation for the medicinal product Translarna - Decision to grant a third party access to the document - Exception relating to the protection of commercial interests - No general presumption of confidentiality))
(2018/C 104/38)
Language of the case: English
Parties
Applicant: PTC Therapeutics International Ltd (Dublin, Ireland) (represented initially by: C. Thomas, Barrister, G. Castle, B. Kelly, H. Billson, Solicitors, and M. Demetriou QC, and, subsequently, by C. Thomas, M. Demetriou, G. Castle and B. Kelly)
Defendant: European Medicines Agency (EMA) (represented by: T. Jabłoński, A. Spina, S. Marino, A. Rusanov and N. Rampal Olmedo, acting as Agents)
Intervener in support of the applicant: European Confederation of Pharmaceutical Entrepreneurs (Eucope) (represented by: D. Scannell, Barrister, and S. Cowlishaw, Solicitor)
Re:
Action under Article 263 TFEU for the annulment of Decision EMA/722323/2015 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 a document containing information submitted in the context of an application for marketing authorisation for the medicinal product Translarna.
Operative part of the judgment
The Court:
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1. |
Dismisses the action; |
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2. |
Orders PTC Therapeutics International Ltd to bear its own costs and to pay those incurred by the European Medicines Agency (EMA), including those relating to the application for interim measures; |
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3. |
Orders the European Confederation of Pharmaceutical Entrepreneurs (Eucope) to bear its own costs. |