Brexit: the United Kingdom’s withdrawal from the European Union
End of Transition Period
The United Kingdom (UK) formally left the European Union (EU) on 31 January 2020 and became a third country. The ratified withdrawal agreement established a transition period, which ended on 31 December 2020. During the transition period, EU pharmaceutical law as laid out in the ‘acquis communautaire’ continued to be applicable to the whole of UK.
With the end of the transition period, as of 01 January 2021, EU pharmaceutical law as laid out in the ‚acquis communautaire‘ applies to and in the UK in respect of Northern Ireland only – based on the provisions of the Protocol on Ireland / Northern Ireland. The Northern Ireland Legislative Assembly may vote four years after the start of the Protocol on 1 January 2021 to the continued application of the Protocol.
After UK left the EU on 31 January 2020, it stopped participating in EU institutions and the decision making of the EU. This implies, that UK may neither act as leading authority (RMS, Rapporteur or Co-Rapporteur) in European procedures nor that anyone representing, appointed or nominated by the UK may participate in European scientific committees or working parties anymore.
Impact of Brexit: Notes for Marketing Authorisation Holders and Applicants
The United Kingdom’s withdrawal from the European Union and the provisions of the Protocol on Ireland / Northern Ireland have direct impact on the holders of national or European marketing authorisations.
Pharmaceutical companies had until 31 December 2020 to ensure that veterinary medicines complied with EU law in order to remain on the EU market by making the necessary changes.
Further information and guidance on the legal requirements can be found here:
- EMA: The United Kingdom's withdrawal from the EU
- EMA: Brexit-related guidance for companies
- CMDv website on Brexit
Brexit preparedness of BVL
In order to systematically address the challenges of Brexit, BVL has established an internal project organisation. It was and is BVL's main objective to ensure the availability of veterinary medicinal products at any time. BVL increased its capacities and expands its activities within the European network further: particularly in the areas of assessment and licensing, pharmacovigilance as well as post-marketing. During the fourth circle of Benchmarking of European Medicines Agencies (April 2018), BVL’s Brexit activities were positively emphasised. In total, BVL again achieved excellent benchmarking result (4.4 on average), which demonstrates that BVL is one of the leading European regulatory authorities of medicinal products.
Furthermore, BVL is prepared to take on additional new applications for centralized and MR or DC procedures, in order to reduce potential bottlenecks within the European network.