Language of document :

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)

Language of the case: English


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