Clinical trials

Updated 18 December 2020
EU flag

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.20

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 (see section A of this notice);
  • the qualified person may be established in Northern Ireland (see section A.2.2. of this notice).

However, the IE/NI Protocol excludes the possibility for the United Kingdom in respect of Northern Ireland to

  • participate in the decision-making and decision-shaping of the Union;21
  • invoke the country of origin principle or mutual recognition.22

More specifically, this means inter alia the following:

  • An official batch release by the United Kingdom in respect of Northern Ireland is not recognised in the EU.

Please find more information 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 Brexit, the IMP is to be released to the EU in a 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 Brexit, the IMP is then to be imported to the EU. You will need to find an importer and a batch releaser as well as prepare a QP declaration. A substantial amendment must therefore be submitted with the update of the documentation.

Is mandatory to re-test (analytic control) if already carried out in a third country?

Retesting (analytical control) in the EU is not mandatory if already carried out in the third country. As of the withdrawal date, these rules will apply to investigational medicinal products imported from the United Kingdom to the EU.

What is the procedure of IMP batches, which were released in the UK before UK withdrawal but were imported to EU 27 after Brexit? 

IMPs which are imported from the UK after Brexit, 2019 need to be batch released by a QP in the EU27. Retesting of an IMP, if already tested and released in the UK, is not necessary. No need for retesting in the EU 27.

What is the procedure of IMP batches, which were released in the UK AND arrived to the EU27 before Brexit?

These batches were not imported so no new batch release should take place in EU 27.

If second shipment of an IMP takes place after Brexit from an identical batch that had been already released in UK and imported to EU 27 before Brexit, does this additional shipment requires also re-release in EU 27?

Yes, it requires a release in the EU27 due to the import (at physically crossing the border)

Does IMPs that were released in the UK after Brexit will require re-testing in EU27?

No, re-testing of IMPs already tested and released (technical release complete) in the UK will not be necessary.
 

Sponsor etc.

What should I do if the legal representative is domiciled 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 domiciled in the UK?

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

Primary September The EU-Commission published information to Stakeholders: Brexit's significance in relation to Clinical Trials

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

VHP and Brexit

Did you get answers to your questions?

Please tell us how we can improve our website? Please note that we do not answer questions asked via this feature.


...

You have to accept marketing cookies to watch video content

Update consent