On 29 March 2017, the United Kingdom (UK) submitted its request to leave the European Union ("BREXIT") to the European Council. In accordance with Article 50 of the Treaty on European Union, the UK left the Union on 31 January 2020 and became a third country. A transition period began on 1 February 2020 and ended on 31 December 2020.

In some cases, authorisation holders have not yet fulfilled their obligations and the authorisation holder, batch release, batch control, QPPV and PSMF are still located in the UK in their authorisation dossiers (exception: according to the Ireland/Northern Ireland Protocol, batch control and batch release for the EEA market may continue to take place in Northern Ireland). These products therefore do not currently comply with EU legislation and corresponding changes must be submitted immediately!

Batch control/release in the UK (with the exception of Northern Ireland) is no longer permitted and such batches may no longer be placed on the market; batches already marketed are not affected by this.

If several batch control/release sites (in the UK and the EU/EEA) have been authorised, the sites located in the UK must be removed from the authorisation dossiers as quickly as possible - now that the transition period has ended.

Further information and FAQs on BREXIT can be found at

FAQs CMDh: http://www.hma.eu/535.html

FAQs CMDv: http://www.hma.eu/542.html