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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.
Key guidance
- Latest DHSC letter to suppliers [NEW]
- Government transition support website
- MHRA end of transition guidance
- Border Operating Model
- Letter to VAT registered businesses on new trade arrangement
- Steve Oldfield letter on supply
- MHRA Article 41 guidance (supplying medicines in NI)
- Trader Support Service (for moving goods in and out of NI)
- Using personal data after the transition period
- MHRA batch testing guidance
- Registering to book emergency freight capacity (more details on 16 Nov)
- MHRA letter to Marketing Authorisation Holders to inform of actions the MHRA is plannign to take concerning Centrally Authorised Products
- MHRA guidance on varying marketing authorisations after 1 January 2021
- MHRA gudiance on new assessment routes from 1 January 2021
- NIBSC guidance for manufacturers of biological medicines - independent batch release in the UK from 1 January 2021
Latest updates
DHSC has published a new letter to suppliers. It provides an update on plans and preparations ahead of the end of the transition period with the EU.
Additionally, the Department for Business, Energy and Industrial Strategy (BEIS) has recently published guidance that may be of relevant. Links to this guidance is as follows:
- The new page on placing manufactured goods on the NI market can be found here: https://www.gov.uk/guidance/placing-manufactured-goods-on-the-market-in-northern-ireland-from-1-january-2021
- The equivalent page on placing on the GB market (including new unfettered access provisions) can be found here: https://www.gov.uk/guidance/placing-manufactured-goods-on-the-market-in-great-britain-from-1-january-2021
- More information and support from BEIS on trading with the EU, including past and future webinars, is available on this page: https://www.gov.uk/guidance/help-and-support-if-your-business-trades-with-the-eu#webinars-for-businesses-by-sector
If you are interested in receiving the Office for Life Sciences Bulletin each Friday or gaining access to the DHSC eXchange platform, with resources relating to Brexit and the end of transition, then please email Tim Windle at twindle@bioindustry.org with your name and email address.
Our latest BIA Brexit webinar is available on the Bioindustry Association Youtube channel
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 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.