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The latest guidance on the implications of a no-deal Brexit

Last updated on 11 Apr 2019

The Government has agreed with the EU a further extension of the Article 50 period to 31 October 2019.

It has been clear that delivering the deal negotiated with the EU remains its top priority, and for more than two years it has been implementing a significant programme of work to ensure that the UK is prepared to leave the EU.

If the UK leaves the EU before 31 October 2019 it will be with a deal, and we will share any relevant information for the health and social care research system as soon as it becomes available.

In 2018, the government published a series of 106 technical notices setting out information to allow businesses and citizens to understand what they would need to do in a no deal scenario so they can make informed plans and preparations. At that time, the HRA highlighted the aspects most relevant to health and social care research.

On this page, we will highlight further updates and additional guidance published more recently to help organisations prepare for a no-deal EU Exit, as well as our own guidance on aspects of planning which are within our regulatory remit.

Handing amendments in the case of a no-deal Brexit


The HRA published new guidance on 6 March 2019. The guidance sets out some of the changes which may need to be made to studies in the event of a no-deal scenario, and whether they constitute substantial amendments.

The full guidance can be read here.


The MHRA has recently published guidance on substantial amendments to a clinical trial if the UK leaves the EU with no deal.

Read the guidance here.

Transferring research data between countries in the event of a no-deal Brexit


NHS England has published a set of questions and answers for the health and social care community on ensuring continued access to, processing and sharing of data after EU Exit. It has confirmed that this guidance applies to personal data flows for the purpose of health and social care research (please see the final question).

This guidance complements DHSC guidance which can be read in full on the gov.uk website. Of particular note is page 13, which includes more detail on maintaining data flows.

There is further advice on maintaining data flows in guidance published by the Information Commissioner's Office, details of which can be found in our news story from December 2018.

Clinical trials of medicinal products and clinical investigations of medical devices


The Medicine and Healthcare products Regulatory Agency (MHRA) published new guidance on registration of Clinical Trials for Investigational Medicinal Products (CTIMPs) and publication of summary results in the event of a no deal EU Exit.

More information about how and when the registration of trials may be deferred can be found on our Research Registration page.

Supplies for clinical trials:

"We are working with organisations running clinical trials and have requested these organisations to consider their supply chains for clinical trials ahead of an EU exit date. We have requested that they ensure contingency arrangements are in place for their supplies. Supplies for clinical trials are transported in small quantities and usually via airfreight."

Stephen Hammond, Minister of State for Health, 25 February 2019

Clinical trials and clinical investigations:

“Organisations should […] continue to participate in and/or recruit patients to clinical trials and clinical investigations from the EU exit date, unless they receive information to the contrary from a trial sponsor, organisation managing the trial or investigation, or from formal communications.”

Clinical Trial Regulation:

"For EU-wide trials, the new EU Clinical Trial Regulation (CTR) will not be in force in the EU on 29 March 2019 and so will not be incorporated into UK law. However, the Government has stated the UK will align where possible with the CTR without delay when it does come into force in the EU, subject to usual parliamentary approvals. This will provide certainty for organisations conducting trials in the UK."

Department of Health and Social Care, 21 December 2018

The Minister's full statement to the House of Commons on plans for the continuity of medicines and medical products in the event of a no-deal Brexit can be read on the gov.uk website.

The DHSC guidance can be read in full on the gov.uk website. Of particular note are pages 12 and 13.

The government also published guidance on clinical trials in a no deal scenario in the summer, more details of which can be found in news story from August 2018. 

Clinical investigations:

"The UK will continue to recognise existing clinical investigation approvals – both for regulatory and ethics approvals – and there will be no need to re-apply. UK clinical investigation applications will continue to be authorised by the MHRA and ethics committees as they are presently."

Clinical Trials of investigational medicinal products:

"If there’s no deal, the UK’s current participation in the European regulatory network for clinical trials would end, and the MHRA would take on the responsibilities for the UK that are currently undertaken through the EU system. The UK will continue to recognise existing approvals – both for regulatory and ethics approvals – and there will be no need to re-apply."

New EU regulations:

"Through the no deal statutory instrument, which will amend the Medical Devices Regulations 2002, the UK will have a regulatory system in place on 30 March 2019, which will mirror all the key elements contained in Regulations 2017/745 on medical devices (MDR) and 2017/746 on in vitro diagnostic medical devices (IVDR) and which will be brought into force in line with the transitional timetable being followed by the EU for the full application of those two Regulations."

MHRA, 3 January 2019

The MHRA guidance can be read in full on the gov.uk website. Of particular note are sections 2.4, 2.6 and 3.

Supplies for clinical trials:

"The Government has put in place a range of contingency measures to support continuity of supply, including clinical trial supplies, to NHS and Adult Social Care providers in the event of the UK leaving the EU without a deal, and I want to thank the industry and sponsors of clinical trials for their positive engagement with our contingency planning programme.

"While we have every confidence that these measures, coupled with your actions, will enable the continued supply of goods and services to health and social care providers once out of the EU, it is important that we are all fully prepared to respond to any supply disruption incidents that may arise."

Steve Oldfield, Chief Commercial Officer, DHSC, 26 March 2019

As part of its Operational Response Centre, DHSC has set up a National Supply Disruption Response (NSDR). The NSDR processes will monitor the supply situation and co-ordinate actions to address supply disruption incidents that occur after the UK has exited the EU where normal procedures are unable to provide a resolution.

Clinical trials and clinical investigations:

"The Department of Health and Social Care (DHSC) has communicated widely with industry (via trade associations), the NHS and charities (via Association of Medical Research Charities), and Universities, and has emphasised that organisations running clinical trials and clinical investigations in the UK should consider their supply chains for supplies (including Investigational Medicinal Products, devices/in-vitro diagnostics devices, advanced therapy medicinal products, radioisotopes and other clinical consumables) to ensure appropriate arrangements are in place to assure supplies in the event of any possible border delays."

Department of Health and Social Care, 27 March 2019

EU research and innovation funding schemes

"The Government has guaranteed funding committed to UK organisations for certain EU funded projects in the event of a ‘no deal’ scenario. This includes the payment of awards where UK organisations successfully bid directly to the EU while we remain in the EU, and the payment of awards where UK organisations are able to successfully bid to participate as a third country after EU Exit, until the end of 2020.

"This means that successful bids for EU programme funding until the end of 2020 will receive their full financial allocation for the lifetime of the project"

Department of Health and Social Care, 21 December 2018


This page has been produced to flag the most relevant sections of the most recent guidance for health and social care researchers, sponsors and funders, but the HRA cannot replicate the whole of these documents here. We recommend that you follow the links above to read the guidance in full.

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