Clinical trials

11 September 2018, Updated 21 December 2018
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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.
 

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

 

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