Clinical trials

Updated 08 April 2021
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After the expiry of the transition period ending on 31 December 2020, the UK is no longer an EU member state and therefore has community status as a third country.

Special rules apply to Northern Ireland (the IE/NI Protocol) after expiry of the transition period on 31 December 2020. The IE/NI Protocol provides that Article 13 of Directive 2001/20/EC applies to and in the United Kingdom in respect of Northern Ireland.

More specifically, this means inter alia the following:

  • EU rules for good manufacturing practice of investigational medicinal products apply in Northern Ireland.
  • An investigational medicinal product manufactured in Northern Ireland and shipped to the EU is not an imported investigational medicinal product.
  • An investigational medicinal product shipped from Great Britain to Northern Ireland is an imported investigational medicinal product.
  • The qualified person may be established in Northern Ireland.

The above IE/NI Protocol means that batch release by the United Kingdom in respect of Northern Ireland is not recognised in the EU.

The complete text can be found here:https://ec.europa.eu/info/sites/info/files/brexit_files/info_site/clinical-trials_en.pdf


Questions and answers on clinical trials related to Brexit


Manufacture

My IMP is released in the UK. What should I do?

After a no-deal Brexit, the IMP is to be released to the EU in an EU country. You will therefore need to submit a substantial amendment with updated documentation. The QP declaration must also be updated.

My IMP is manufactured in the UK. What should I do?

After a no-deal Brexit, the IMP is to be imported to the EU. You will need to find an importer and a batch releaser as well as prepare a QP declaration. 

Is retesting (analytical control) mandatory if already carried out in the UK?

No. Contrary to marketed medicinal products, retesting (analytical control) in the EU is not mandatory if the products have already been tested and released (cf. directive 2003/94/EC, article 11(2) – analytical control) in the UK. 

 

Sponsor etc.

What should I do if the legal representative is established in the UK when the sponsor is from a third country (e.g. the USA)?

A new legal representative must be appointed. The EudraCT form must be updated and submitted as a substantial amendment.

What should I do if the sponsor is established in the UK?

A legal representative must be appointed, and the EudraCT form must be updated and submitted as a substantial amendment.

The European Commission notified stakeholders on the outcome of Brexit in relation to clinical trials on 6 September 2018: Notice to stakeholder on Brexit and Clinical Trials

VHP procedures in preparation and in case of a no-deal Brexit

VHP and Brexit

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