BREXIT – End of transition period
On 29 March 2017 the United Kingdom (UK) submitted a notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union (“BREXIT”). UK left the European Union on 31 January 2020 and became a third country. A transition period began on February 1st 2020 and ended on December 31st 2020.
Some Marketing Authorisation Holders have not yet fulfilled their obligation to transfer the Marketing Authorisation Holder, batch release, batch control, QPPV and PSMF from the UK to the EU (exception: according to the Ireland/Northern Ireland Protocol, batch control and batch release for the EEA market may still take place in Northern Ireland). These medicinal products are therefore currently not in compliance with EU legislation and the variations must be submitted immediately!
Batches that are controlled and/or released by UK sites are not allowed to be placed on the market (with the exception of sites located in Northern Ireland); batches, which are already marketed, are not affected by this.
If multiple sites of batch control/batch release (in UK and EU/EEA) have been approved, the UK sites – now after the end of the transition period – must be removed from the marketing authorisations as soon as possible.
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