Welcome to the BIA Brexit Portal
This website contains guidance on the UK's future relationship with the EU for biotech businesses and the life sciences sector.
There is continuing uncertainty about the potential nature of the future relationship with Europe and trade with the rest of the world. Our aim is to provide access to relevant advice and information so that businesses can make informed decisions and prepare appropriately.
MHRA is holding a series of webinars on their guidance for EU Exit and the end of the transition period on 31 December 2020. The sessions run from 19 October to 29 October.
MHRA has changed its guidance batch testing. The new wording makes clear that batch testing from Europe will only be accepted until 1 January 2023. There is more information in Steve Bates' blog from 28 September.
BEIS is running a webinar targeted at the life sciences industry to help businesses prepare for the end of the transition period. The webinar takes place at 11am on Tuesday 27 October.
The British Chambers of Commerce have published an update of its Brexit guidance dashboard containing 26 questions that remain unanswered ahead of the end of the transition period.
Our latest BIA Brexit webinar from the 23 September is available on the Bioindustry Association Youtube channel
Key links and updates from that webinar are available here:
- Government's Reasonable Worst Case Scenario for borders at the end of the transition period
- Letter to businesses about new trade arrangements
- The letter from Steve Oldfield to medicines suppliers
- MHRA post-transition period information
- HMRC introductory videos:
The Transition Period
The UK left the EU on 31 January 2020. Under the terms of the Withdrawal Agreement a transition period is now in effect which runs from 1 February to 31 December 2020.
During this period medicines and devices regulation will stay aligned with the EU. There are no changes to market access, licensing, packaging, batch release and testing, however there are some changes to the status of the MHRA. For more details please refer to the regulation and IP page of this site.
The deadline for extending the transition period passed on 1 July 2020. At the meeting of the Withdrawal Agreement Joint Committee on 12 June 2020, the UK confirmed it would not extend the transition period. A subsequent joint statement made clear that the period would not be extended. A House of Commons briefing paper sets out the legal and procedural hurdles to extending the transition period if the position of the UK and EU changes. However, currently the transition period will end on 1 January 2021.
The government’s plan means that UK life sciences businesses need to be ready for the additional costs and time of increased trade friction and the potential for extra regulatory processes from 1 January 2021.
The UK's future relationship with the EU
Negotiations are now underway between the UK and EU on the terms of a future relationship. The UK Government has published its objectives for these negotiations and the EU Commission has also published a set of negotiating directives which were agreed with EU member states.
We want to see early progress in the negotiations to secure a pragmatic and business-friendly trading relationship between the UK and the EU.
Disappointingly for our sector, which had called for a deep and close future relationship, the Government’s vision is not as ambitious as we had hoped for. However, the Government has recognised the need to seek agreement in areas vital for the continued operation of our sector.
The BIA will continue to work closely with the Government to secure the UK’s place as a globally competitive biotech hub for the benefit of patients and the broader economy through these and other trade negotiations.