Guidance

The life sciences sector and preparing for Brexit

Your business may need to make changes before the UK leaves the EU.

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Get ready for Brexit on 31 October. This page tells you how to prepare for Brexit. It will be updated if anything changes, including if a deal is agreed.

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Visit Get ready for Brexit to find more detailed guidance on policy changes relevant to your sector.

Regulation and standards

Preparing for changes to the way medicines, medical devices and clinical trials will be regulated

If the UK leaves the EU without a deal, the UK’s involvement in the European regulatory network will end. The Medicines and Healthcare products Regulatory Agency (MHRA) will take on the EU’s current regulatory functions for medicines and devices in the UK.

Maintaining EU/EEA market access for medicines

To place a medicine on the EU market, the Market Authorisation Holders (MAHs) and applicants must be established in the EU/EEA. The Qualified Person for Pharmacovigilance (QPPV) and the Pharmacovigilance System Master File must be based in the EU/EEA.

Read the European Medicines Agency (EMA) guidance to find out more. See below for requirements for placing a medicine on the UK market.

Maintaining EU/EEA market access for medical devices and In Vitro Diagnostic Devices (IVDs)

Where required by EU law, devices should be CE marked, the technical files held by an EU Notified body, and an authorised representative appointed in the EU.

Registration with individual Competent Authorities may be required for access to individual member-state markets.

After the UK leaves the EU, conformity assessment carried out by UK notified bodies, designated by the UK Competent Authority, will not be recognised in the EU.

Any European presence of a UK notified body, designated by a European competent authority, will be in compliance with EU law after Brexit. Certificates held with that European presence will be valid – you should discuss directly with your UK notified body if this affects you.

Read the European Commission guidance to find out more.

Maintaining UK market access for medicines

To place a medicine on the market after the UK leaves the EU, the MAH and QPPV can initially be UK or EU/EEA based, but the MAH and QPPV must be established in the UK by the end of 2020.

Where the MAH is not established in the UK on exit day, a UK-based contact must be in place within 4 weeks of Brexit.

All Centrally Authorised Products (CAPs) will be converted into UK market authorisations on 31 October 2019.

Read further information on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal.

After Brexit, to market a new product in the UK, an initial MA application will need to be submitted to the MHRA and will go through a national assessment.

Maintaining UK market access for devices and IVDs

Devices for the UK market must be CE marked in compliance with EU law by either an EU notified body or a UK Conformity Assessment body (for devices CE marked before we leave the EU).

Any changes to this in the future will be subject to consultation with industry and your business will be given time to implement any new requirements.

In addition, devices for the UK market need to be registered with the MHRA according to the timetable set out in the further guidance.

Where a manufacturer is based outside of the UK, registration must be done by a nominated UK Responsible Person.

Read the Regulating medical devices in the event of a no deal scenario guidance for more information.

Clinical trials

The UK will continue to recognise existing clinical trial authorisations – for regulatory and ethics approvals – and your business will not need to re-apply. The MHRA and ethics committees will continue to authorise UK clinical trial authorisation applications.

Read the guidance on How medicines, medical devices and clinical trials would be regulated if there’s no Brexit deal for more information on manufacturing human medicines in the UK and EU.

Please also regularly check the MHRA website for new detailed guidance.

Preparing for changes to batch testing recognitions

To make sure there will be a continual supply of medicines, the UK will continue to accept batch testing of human medicines carried out in countries named on a list set out by the MHRA. On exit day, this list would include EU countries, other EEA countries and those third countries with which the EU has an MRA.

The UK will also continue to accept batch testing of Investigational Medicinal Products (IMPs) – substances being used in clinical trials – manufactured in EU and EEA states. There will be no change to the present arrangements for batch testing of IMPs manufactured in third countries.

Please read batch testing medicines if there’s no Brexit deal to find out more about manufacturing human medicines in the UK and EU.

The UK will continue to recognise Qualified Person (QP) certification from the EU/EEA after the UK leaves the EU, for medicines manufactured in the EU/EEA or manufactured in a third country but imported into the UK from the EU/EEA.

Importing and exporting

Preparing for disruption to trade at the UK-EU border

  1. Get a UK EORI number (this starts with GB) so you can continue to import or export goods and apply for authorisations that will make customs processes easier for you.

  2. Decide if you want to hire an import-export agent, or make the declarations yourself.

  3. Contact the organisation that moves your goods (for example, a haulage firm) to find out what information they need to make the declarations for your goods, or if you will need to make them yourself.

Read the guidance on simplified customs procedures for trading with the EU if we leave without a deal.

Find further information in HMRC’s advice for businesses trading with the EU.

Preparing to move goods between Ireland and Northern Ireland

If the UK leaves the EU without a deal, goods moving between Ireland and Northern Ireland will face different procedures compared to other UK-EU trade. This approach will apply until longer-term arrangements are made.

Read the guidance on customs procedures and VAT for goods moving between Ireland and Northern Ireland.

Preparing for changes to existing trade agreements

Check the way you currently trade with non-EU countries. When the UK leaves the EU the way you access existing favourable arrangements with these countries may change. Changes may be different for each country.

Read the guidance on changes to trading with non-EU countries that have a free trade agreement with the EU.

Preparing for changes to import tariffs

If the UK leaves the EU without a deal, the UK would implement a temporary tariff regime. This would apply for up to 12 months while a full consultation, and review on a permanent approach, is undertaken.

Under the temporary tariff regime the majority of UK imports would be tariff-free.

In certain sectors, tariffs would be maintained to support the most sensitive agricultural industries, the automotive sector, vulnerable industries exposed to unfair global competition, and to maintain the UK government’s commitment to developing countries.

Check the temporary rates of customs duty on imports after Brexit.

Your employees

Employing EU, EEA and Swiss citizens

Right to work checks

You should continue to carry out the same right to work checks on all EU/EEA and Swiss citizens, by using their passport or national identity card, until January 2021.

You will not need to distinguish between EU/EEA and Swiss citizens who were resident in the UK before or after the UK leaves the EU.

Find out how to check an applicant’s right to work and read the guidance on employing EU, EEA and Swiss citizens after Brexit.

EU/EEA and Swiss citizens living in the UK before the UK leaves the EU

If the UK leaves the EU without a deal, EU/EEA and Swiss citizens who are resident in the UK before the UK leaves the EU will be able to apply to the EU Settlement Scheme to get settled or pre-settled status. This will mean they can continue to live, work and study in the UK.

EU/EEA and Swiss citizens must apply by 31 December 2020 if the UK leaves the EU without a deal.

You can use the EU Settlement Scheme guidance for employers to give further information to your employees.

EU/EEA and Swiss citizens who arrive in the UK after the UK leaves the EU

If the UK leaves the EU without a deal, EU, EEA and Swiss citizens arriving in the UK from Exit Day to 31 December 2020 can continue to come to the UK, to live, work and study without applying for a visa in advance.

After free movement ends, if they want to stay for longer than 3 months, they can read the guidance on staying in the UK to find out what they’ll need to do.

Irish citizens can continue to live, work and study in the UK, just as before.

From 1 January 2021, a new skills-based immigration system will launch.

For non-EU nationals, Brexit will not affect the application process for work visas.

Business travel

Check the guidance for travellers visiting the EU to find out what you need to do when going abroad for work.

Personal data

Data protection

Your business will need to make sure it follows data protection law if the UK leaves the EU without a deal.

If you operate across the EU or exchange personal data with organisations in the EEA, there may be changes that you need to make before the UK leaves the EU.

Read the 6 step process and the data protection guidance from the Information Commissioner’s Office (ICO).

You can also check if you can use Standard Contractual Clauses (SCCs) for transfers from the EEA to the UK.

Trade associations

UK Bioindustry Association
The Association of the British Pharmaceutical Industry
The Association of British HealthTech Industries

Published 28 February 2019
Last updated 14 March 2019 + show all updates
  1. Updated with information on the temporary tariff regime.
  2. First published.