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Shire v EMA: Clarification on orphan designation for products with the same active substance

24/04/2018

On 22 March 2018 the EU General Court handed down its judgment in Case T-80/16 Shire Pharmaceuticals Ireland Ltd v European Medicines Agency (EMA). The case centred around whether a new medicinal product can obtain orphan designation when it has the same active...

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Authors

Portrait ofFionnuala Rice
Fionnuala Rice
Senior Associate
London