Shire Pharmaceuticals Ireland Ltd v European Medicines Agency

European Union – Medicinal products. Shire Pharmaceuticals Ireland Ltd (Shire) successfully applied for annulment of the European Medicines Agency's (EMA) decision refusing to validate Shire's application seeking the designation of Idursulfase-IT as an orphan medicinal product. The General Court of the European Union held, among other things, that the EMA could not refuse to validate that application on the ground that Shire had already obtained a marketing authorisation for the orphan medicinal product Elaprase, which contained the same active substance as Idursulfase-IT which had led it to conclude that the application had failed to satisfy the requirement laid down in art 5(1) of Regulation No (EC) 141/2000.

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