Judgment of the Court (Eighth Chamber) of 29 July 2019 — EMA v Shire Pharmaceuticals Ireland
(Case C‑359/18 P)(1)
(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)
Approximation of laws — Uniform legislation — Medicinal products for human use — Orphan medicinal products — Procedure for designating a medicinal product as an orphan medicinal product — Existence of a prior marketing authorisation for the same medicinal product — Sponsor seeking orphan designation for a second medicinal product in respect of the same therapeutic indication — Obligation to establish that the second medicinal product is of significant benefit to patients in relation to the first medicinal product
(European Parliament and Council Regulation No 141/2000, Arts 3(1) and 5(2)
(see para. 31)
Operative part
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.
1 OJ C 294, 20.8.2018.