Orphan designation: marketing authorisation

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The European Medicines Agency (EMA) is responsible for the scientific evaluation of marketing authorisation applications for all orphan medicines in the European Economic Area (EEA), as they fall under the mandatory scope of the centralised procedure.

United Kingdom’s (UK) withdrawal from the European Union (EU) (new)

EMA has published important information to help users of the centralised procedure prepare for the expected consequences of 'Brexit', including their obligations related to establishment within the EEA. For more information, see UK’s withdrawal from the EU.

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Sponsors of designated orphan medicines at the marketing authorisation stage should also consider the regulatory information in the sections below:

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