On May 2, EMA released a Q&A document
in response to the United Kingdom’s
withdrawal from the European Union.
This document covers procedures for marketing
authorization holders currently established
in the United Kingdom, orphan
designation procedures, role of Qualified
Persons, etc. EMA expects to update this
document in the future.
In addition, a recent meeting of EMA’s
Management Board covered how the
Agency will handle the UK’s plans to exit
the European Union. The Agency is working
on the assumption that the UK will be
considered a third country outside the EU
and European Economic area as of March
30, 2019, and will continue to participate
in all formal meetings and retain its speaking
and voting rights.