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Case T-33/17: Judgment of the General Court of 25 September 2018 — Amicus Therapeutics UK and Amicus Therapeutics v EMA (Access to documents — Regulation (EC) No 1049/2001 — Documents held by the EMA and submitted as part of the request for authorisation to place the medicinal product Galafold on the market — Decision to grant a third party access to a document — Exception relating to the protection of commercial interests — No general presumption of confidentiality)
ECLI:EU:UNKNOWN:62017TA0033
62017TA0033
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12.11.2018
Official Journal of the European Union
C 408/48
(Case T-33/17) (*)
((Access to documents - Regulation (EC) No 1049/2001 - Documents held by the EMA and submitted as part of the request for authorisation to place the medicinal product Galafold on the market - Decision to grant a third party access to a document - Exception relating to the protection of commercial interests - No general presumption of confidentiality))
(2018/C 408/60)
Language of the case: English
Parties
Applicants: Amicus Therapeutics UK Ltd (Gerrards Cross, United Kingdom) and Amicus Therapeutics, Inc. (Cranbury, New Jersey, United States) (represented by: L. Tsang, J. Mulryne, Solicitors, and F. Campbell, Barrister)
Defendant: European Medicines Agency (EMA) (represented by N. Rampal Olmedo, S. Marino, A. Spina, A. Rusanov and T. Jabłoński, acting as Agents)
Re:
Action under Article 263 TFEU for the annulment of EMA Decision ASK-22072 of 14 December 2016, 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 a request for marketing authorisation for the medicinal product Galafold.
Operative part of the judgment
The Court:
1.Dismisses the action;
2.Orders Amicus Therapeutics UK Ltd and Amicus Therapeutics, Inc. to pay the costs.
(*)
Language of the case: English.
ECLI:EU:C:2018:140
* * *