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Brexit

Read our latest guidance, updates and FAQs on Brexit.

Last updated: March 2021

Read our guidance on EORI numbers and clinical trial supplies.

On 22 December 2020 the JRO updated its position statement on our UCL clinical trials portfolio in relation to Brexit.

The update includes reference to the Northern Ireland Protocol – the current position is that Northern Ireland will remain in compliance with EU legislation and comply with EU requirements with respect to medicinal products and medical devices.

It also sets out information on freight services to support the uninterrupted delivery of medicines and medicinal products. 

The Department of Health and Social Care (DHSC) has released guidance to sponsors of clinical trials, to ensure all patients taking part in clinical trials and clinical investigations continue to have access to medicines and medical products.

Read the full DHSC guidance.

FAQs

I have an existing UCL sponsored study with a European site. Do I need to do anything?

If the study in question is a CTIMP study, please follow these JRO guidelines.

If the study is a non-CTIMP study and UCL is the data controller with European sites processing data on UCL’s behalf, UCL Research Ltd need to be a legal representative in the EU.  Assigning additional representatives in the EU does not require an amendment to be notified in the UK. Similarly, no amendment is required in the UK to establish any arrangements solely in relation to the study’s management and conduct outside the UK that do not affect the approved UK study. Sponsorship of the relevant study will remain with UCL.  UCL’s insurance will cover UCL Research Limited and the activities that it will carry out in the EU. There are no extra processes for insurance that need to be taken by researchers for trials that have EU sites.

The UK Government has announced that the Treaty agreed with the EU will allow personal data to flow freely from the EU (and EEA) to the UK, until adequacy decisions have been adopted, or for no more than six months.  JRO is in constant contact with regulators in the UK and will update as soon as more information becomes available.

I am planning a new study with EU site, what will change for my approval? 

If the proposed trial is a CTIMP please follow these JRO guidelines.

For non-CTIMP studies with European sites and where a site is processing personal data on behalf of the sponsor (UCL), UCL Research Ltd need to be mentioned as a legal representative in the EU.  UCL will still be listed as a sponsor. We advise to contact JRO in advance to check any insurance implications for planned European site.

The treaty agreed with the EU will allow personal data to flow from EU and EEA to the UK, until adequacy decisions have been adopted, or for no more than six months. However, please contact JRO for advice for data flow after then period so it can be incorporated in the trial/study design.

I am a site for a study sponsored by an EU organisation, do I need to do anything?

CTIMPs will already have a Sponsor or legal representative in the UK or EEA for existing trials. All UK regulatory approvals in place will still be valid in the UK. If you are processing data as a site the EU sponsor will continue as normal due to the Statutory Instrument being in place.

For studies other than CTIMPs, the UK Policy Framework does not require a UK legal representative of the lead Sponsor (or any co-Sponsor). If you are processing data as a site and to EU sponsor will continue as normal due to the Statutory Instrument being in place.

UK has, on a transitional basis, deemed the EU and EEA States to be adequate to allow for data flows from the UK.

I am planning to be a site for an EU sponsored study. What will change for my approval? 

CTIMPs will need a Sponsor or legal representative in the UK or EEA. The Sponsor or legal representative is responsible for making submissions to the competent authority and get regulatory approvals.   There is no change.

For studies other than CTIMPs, the UK Policy Framework does not require a UK legal representative of the lead Sponsor (or any co-Sponsor).  The EU sponsor is responsible for making submission to competent authority and get regulatory approvals.   There is no change in the process.

I am sending or planning to send data or samples into the EU - what do I need to do?

Data or samples can be sent to the EU however Standard Contractual Clauses (SCC) needs to be implemented in the contracts with EU entity to ensure free flow of data. Please contact the JRO contracts team for advice. Read more details here under the section on GDPR.

I am going to receive data / samples from EU for analysis – what I need to do?

For data the Treaty agreed with the EU will allow personal data to flow freely from the EU (and EEA) to the UK, until adequacy decisions have been adopted, or for no more than six months from 1 January 2021.  JRO is in contact with regulators and will update researchers when new details are available.

The EU sponsor of my trial is asking about EORI number. What is EORI number and where can I find it?

You can find details about EORI numbers here.

I have heard about a transition period. What is it?

The UK government has agreed a Treaty with the EU that will allow personal data to flow freely from the EU (and EEA) to the UK, until adequacy decisions have been adopted, or for no more than six months. This will enable organisations across all sectors to continue to freely receive data from the EU (and EEA). The UK has, on a transitional basis, deemed the EU and EEA EFTA States to be adequate to allow for data flows from the UK.

With the UK leaving the EU, there are changes required for some establishments to update their HTA licences so that they can continue to receive tissues and cells for human application from the EU, or send tissues and cells intended for human application to the EU. The HTA Licence variations must be in place by 30 June 2021.  Both UCL and UCLH HTA license holders are aware of the changes and are working with HTA to put necessary steps in place.

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