23.9.2019
EN
Official Journal of the European Union
C 319/17
Judgment of the Court (Eighth Chamber) of 29 July 2019 — European Medicines Agency v Shire Pharmaceuticals Ireland Ltd, European Commission
(Case C-359/18 P) (1)
(Appeal - Regulation (EC) No 141/2000 - Orphan medicinal products - Article 5 - Application for designation of a medicinal product as an ‘orphan medicinal product’ - Validation - Existence of a prior marketing authorisation (MA) for the same medicinal product)
(2019/C 319/17)
Language of the case: English
Parties
Appellant: European Medicines Agency (represented by: initially by S. Marino, S. Drosos, T. Jabłoński and A. Spina, Agents, and subsequently by S. Marino, S. Drosos and T. Jabłoński, Agents)
Other parties to the proceedings: Shire Pharmaceuticals Ireland Ltd (represented by: G. Castle, Solicitor, D. Anderson QC and M. Birdling, Barrister and by S. Cowlishaw, Solicitor), European Commission (represented by: K. Petersen and A. Sipos, Agents)
Operative part of the judgment
The Court:
1.
Dismisses the appeal;
2.
Orders the European Medicines Agency (EMA) to bear its own costs and to pay the costs incurred by Shire Pharmaceuticals Ireland Ltd;
3.
Orders the European Commission to bear its own costs.
(1) OJ C 294, 20.8.2018
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