Orphan designation: post-authorisation

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The pages listed below are relevant for sponsors of medicines that have obtained orphan designation and are at the post-authorisation stage of the product lifecycle.

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

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 European Economic Area (EEA). For more information, see UK’s withdrawal from the EU.

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

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