Court of Justice (Eighth Chamber) 29 July 2019, C-359/18 P (European Medicines Agency v Shire Pharmaceuticals Ireland Ltd.)

JUDGMENT OF THE COURT (Eighth Chamber) 29 July 2019 (*) (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) In Case C‑359/18 P APPEAL under Article 56 of the Statute of the Court of Justice