General Court 22 March 2018, Case T-80/16: Judgment of the General Court of 22 March 2018 — Shire Pharmaceuticals Ireland v EMA (Medicinal products for human use — Validation of an application for designation as an orphan medicinal product — Significant benefit — EMA decision refusing to validate an application for designation as an orphan medicinal product — Article 3(1)(b) and Article 5(1), (2) and (4) of Regulation (EC) No 141/2000)

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