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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.
Our aim is to provide access to relevant advice and information so that businesses can make informed decisions and prepare appropriately.
BIA Brexit - Key Links
- Steve Oldfield's April 2021 letter to medicines suppliers
- 2 February Michael Gove letter to EU Commission
- EU Commission response to UK extension of NI Protocol grace periods
- Taskforce on Innovation, Growth and Regulatory Reform
- CER UK Services publication
- Horizon Europe
- Future BIA Events
Key guidance
- BIA Post-Brexit tax guide
- DIT Trade with the UK tool for businesses exporting good to the UK
- DIT Check How to Export Goods tool for UK exporters
- Letter from Ed Argar on the UK-EU Trade and Cooperation Agreement
- Guidance on data protection and copyright
- Application of the Union’s pharmaceutical acquis in markets historically dependent on medicines supply from or through Great Britain (N Ireland, Malton) after the end of the transition period
- Letter from Steve Oldfield on the National Supply Disruption Response
- MHRA Brexit FAQs
- Claim a waiver on tariffs for goods moving from GB to NI
- MHRA Guidance on MAH and QPPV location
- EU Unilateral declaration on Northern Ireland and medicines
- EMA Brexit-related guidance on the NI Protocol
- Latest DHSC letter to suppliers
- 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
Consultation on future UK batch testing regime
To allow the medicines sector to continue to focus on the pandemic, and to protect the supply of medicines to UK patients, the UK Government has introduced a two-year notice period of any changes to the current position of continued recognition of EU/EEA batch testing. This will also provide time for a comprehensive review of the future batch testing strategy for the UK. Continued recognition of EU/EEA batch testing will not be ending on 1 January 2023. For more information, please read the MHRA guidance here.
A deal has been agreed
Government guidance for businesses
- The Brexit checker tool (gov.uk/transition) is the best place for businesses to start and provides users with a list of personalised actions they need to take.
- Gov.uk alerts (https://www.gov.uk/help/update-email-notifications) Sign up and create an account to get alerts when changes are made to relevant guidance.
- The Local Communications Toolkit (https://www.gov.uk/government/collections/uk-transition-campaign-communications-resources) provides campaign material to be used for promoting the actions citizens and businesses need to take. For further information please contact uktcampaignqueries@cabinetoffice.gov.uk.
- Guidance for UK nationals living in the EU (https://www.gov.uk/guidance/living-in-europe).
- Resources for traders on border readiness:
- Step by step guides for importing (https://www.gov.uk/prepare-to-import-to-great-britain-from-january-2021) and exporting (https://www.gov.uk/prepare-to-export-from-great-britain-from-january-2021).
- Video guides for importing (https://www.youtube.com/watch?v=OZ6or0d6Cxk) and exporting (https://www.youtube.com/watch?v=5aTiYjB2R4c).
- Process flows for importing (https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/910155/How_to_import_goods_from_the_EU_into_GB_from_January_2021.pdf) and exporting (https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/927051/How_to_export_goods_from_GB_into_the_EU_from_January_2021.pdf)
For any further queries please contact the business support helpline (https://www.gov.uk/business-support-helpline), use the EU Transition Trade and Industry Forum (https://transition-forum.service.cabinetoffice.gov.uk) or sign up for a range of webinars (https://www.gov.uk/guidance/help-and-support-if-your-business-trades-with-the-eu).
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 was in effect from 1 February to 31 December 2020.
During this period medicines and devices regulation remained aligned with the EU. There wereno changes to market access, licensing, packaging, batch release and testing, however there were some changes to the status of the MHRA.
The Transition Period has now ended.
The UK's future relationship with the EU
At the beginning of negotiation, the UK Government published its objectives and the EU Commission has also published a set of negotiating directives which were agreed with EU member states.
The BIA's objective was to see negotiations 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 was not as ambitious as we had hoped for. However, the Government recognised the need to seek agreement in areas vital for the continued operation of our sector.
While mutual recognition was not included in the final agreement, 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.