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

Key guidance

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

Read our analysis here

Government guidance for businesses

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.