Procedures for Clinical Trials in the case of No-Deal-Brexit

In the absence of a withdrawal agreement with corresponding transitional arrangements at European level, the United Kingdom will be regarded as a third country from date of Brexit.

This will have the following consequences for clinical trials:

Clinical Trials with Sponsor or Legal Representative in the UK

Until date of Brexit all sponsors based in the UK have to nominate a legal representative in the EEA. Legal representatives for the EEA residing in the UK must be replaced by legal representatives residing in the EEA.

According to the CT-1 Guidance Document of the European Commission (Eudralex Volume 10), changes to the sponsor or legal representative are typically considered substantial. However, the BASG will accept changes within the same organisation (concerning legal form or place of residence) as non-substantial, provided these changes are clearly described in the cover letter.

An amendment may be submitted for several clinical trials at the same time if adequate reference is provided. However, processing, decision, and billing (for substantial amendments) are performed separately for each clinical trial. The amendment can be submitted separately or combined with other changes.

It is sufficient for the amendment to have been submitted to the BASG before the Brexit date. The amendment does not have to be approved at that time. If the European Medicines Agency (EMA) has not adapted the EudraCT application form by then for the necessary changes (i.e. submission of a legal representative to a UK sponsor), follow-up notifications are also possible.

For clinical trials which have not initiated the required changes by date of Brexit, corrective measures will be initiated in accordance with §41c Austrian Medicines Act (AMG) as amended and the sponsors will be requested to submit the respective amendments.

Clinical trials with IMP release by an EU QP (qualified person) in the UK

All investigational medicinal products released by a competent person (QP) in the UK that are imported into the EEA by date of Brexit do not require further approvals and can be used in clinical trials.

Investigational products that are still in the UK after date of Brexit require a new release by an EU QP for import. This is a formal release, new testing is not required. The addition or change of a QP is a substantial amendment, unless within the same organisation (see above). Until date of Brexit the BASG recommends to add another EU QP. The removal of the UK QP after the Brexit date is non-substantial and not subject to timelines.

The European Commission has explicitly stated that in the case of a "No-Deal-Brexit", member states are not allowed to introduce national transitional regulations contrary to European law.

Notification for clinical trials in UK in EudraCT

For studies conducted in the EU, the provisions for clinical trials conducted in third countries will apply in the future. As a result, notifications in EudraCT will only required if the clinical trial is part of a paediatric investigation plan.

For all clinical trials that have the deadline for publication of results by date of Brexit (= one year after the end of the trial, unless otherwise specified), the obligation to enter results in EudraCT remains.

Created: 07.12.2015

© Austrian Federal Office for Safety in Health Care
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