FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

EMA Advises Drug Companies How to Transfer Orphan Designations

Nov. 17, 2017
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In what seems to be part of the lead up to the departure of the UK from the European Union, the European Medicines Agency laid out how sponsors holding orphan drug designations should go about transferring their EMA registrations from one country to another.

The EMA document — a checklist for sponsors seeking transfers of the designations — does not mention the Brexit withdrawal. The EMA clarified earlier this year that drug companies that hold the designations must be based in the European Economic Area, which includes the EU countries plus Norway, Liechtenstein and Iceland.

In accordance with the UK’s 2016 vote to quit the EU and the UK government’s adoption of a schedule, the agency is planning for the UK’s departure by March 30, 2019. Exactly how the transition will play out is under negotiation.

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