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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)
ECLI:EU:UNKNOWN:62016TA0080
62016TA0080
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Official Journal of the European Union
C 166/27
(Case T-80/16) (<span class="super note-tag">1</span>)
((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))
(2018/C 166/34)
Language of the case: English
Parties
Applicant: Shire Pharmaceuticals Ireland Ltd (Dublin, Ireland) (represented by: D. Anderson QC, M. Birdling, barrister, G. Castle and S. Cowlishaw, solicitors)
Defendant: European Medicines Agency (EMA) (represented by: T. Jabłoński, N. Rampal Olmedo and M. Tovar Gomis, acting as Agents)
Intervener in support of the defendant: European Commission (represented by: K. Petersen and A. Sipos, acting as Agents)
Re:
Application pursuant to Article 263 TFEU seeking the annulment of the EMA decision of 15 December 2015 refusing to validate the application submitted by Shire Pharmaceuticals Ireland for designation of Idursulfase-IT as an orphan medicinal product.
Operative part of the judgment
The Court:
1.Annuls the decision of the European Medicines Agency (EMA) dated 15 December 2015 refusing to validate the application submitted by Shire Pharmaceuticals Ireland Ltd seeking the designation of Idursulfase-IT as an orphan medicinal product;
2.Orders the EMA to bear its own costs, as well as those of Shire Pharmaceuticals Ireland;
3.Orders the European Commission to bear its own costs.
(<span class="note"> <a id="ntr1-C_2018166EN.01002701-E0001" href="#ntc1-C_2018166EN.01002701-E0001">*1</a> </span>) OJ C 136, 18.4.2016.