We have previously reported on how the European Medicines Agency (EMA) has issued statements about the possible implications of Brexit. CMDh has now also issued a similar statement aimed specifically at MAHs
We note with interest that the guidance for switching the Reference Member States (RMS) has also been updated. The MAH can only request for the change of RMS in exceptional circumstances. CMDh have agreed that a justified reason for such a request may now include where the “RMS has triggered Article 50 of the Treaty of the European Union”. Of particular interest is the suggestion that the RMS status could be switched back to the original RMS, if an exemption allowing them continual participation in EU regulatory procedures is negotiated by that MS and the EU.
If you would like to discuss your specific requirements relating to the UK’s withdrawal from the EU, please contact us on Contact PharmaLex or call +44 (0)1628 530554.