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