The United Kingdom has formally left the European Union on 31 January 2020 and has become a third country to the EU.

A transition period, during which EU pharmaceutical law as laid out in the ‘Acquis Communautaire’ continued to be applicable to the UK, has ended on 31 December 2020.

As of 1 January 2021, the Protocol on Ireland/Northern Ireland is applicable and has an impact on marketing authorisations for medicinal products in the UK with respect to Northern Ireland.

The CMDh, the European Commission and the EMA have prepared guidance on the impact of the withdrawal of the UK from the EU and the applicability of the IE/NI Protocol.