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Case C-359/18 P: Judgment of the Court (Eighth Chamber) of 29 July 2019 — European Medicines Agency v Shire Pharmaceuticals Ireland Ltd, European Commission (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)

ECLI:EU:UNKNOWN:62018CA0359

62018CA0359

July 29, 2019
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23.9.2019

Official Journal of the European Union

C 319/17

(Case C-359/18 P) (*)

(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.

(*) Language of the case: English.

(1) OJ C 294, 20.8.2018

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