EU & Human Rights

EMA v Shire Pharmaceuticals Ireland (Public health - Application for designation of a medicinal product as an 'orphan medicinal product' - Judgment)

[2019] EUECJ C35918PCourt of Justice of the European Union (including the General Court)2019

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(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)

APPEAL under Article 56 of the Statute of the Court of Justice of the European Union, brought on 1 June 2018,

European Medicines Agency (EMA), represented initially by S. Marino, S. Drosos, T. Jabłoński and A. Spina, acting as Agents, and subsequently by S. Marino, S. Drosos and T. Jabłoński, acting as Agents,

Shire Pharmaceuticals Ireland Ltd, established in Dublin (Ireland), represented by G. Castle, Solicitor, D. Anderson QC and M. Birdling, Barrister and by S. Cowlishaw, Solicitor,

composed of F. Biltgen, President of the Chamber, J. Malenovský and C.G. Fernlund (Rapporteur), Judges,

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