The below update is posted on EudraCT What’s New section, on December 07, 2020. The information is not new as such, and all the points that have been published so far regarding the Brexit and the action required therefore, are reported in a summary format. The sponsor is required to make changes to the Clinical Trial Application (CTA) as mentioned below:
From January 1st, 2021, for all clinical trials recorded in EudraCT that are ongoing in the EU/EEA:
- Sponsors established in the United Kingdom prior to 31 Dec 2020, must as of 1 January 2021 be legally established in the EU/EEA or have a Legal representative who is legally established in the EU/EEA.
- Legal representatives established in the United Kingdom prior to 31 December 2020 can no longer act as a legal representative of a UK sponsor as of 1 January 2021.
- Qualified persons established in the United Kingdom other than in Northern Ireland can no longer certify batch-release of an IMP for use in EU/EEA as of 1 January 2021 and must be established either in the EU/EEA or in Northern Ireland.
Sponsors are requested to update these requirements in sections B.1, B.2 and/or D.9.2 of the Clinical Trial Application (CTA) form, as appropriate, using the EudraCT application (click on “EudraCT number, CTA & Login for posting results”, then “load -> EEA CTA”, add the CTA XML file, perform the changes and save the CTA file locally). The amended XML file of the CTA will then need to be submitted to all the relevant National Competent Authorities where the trial is submitted/ongoing.
Please note that it is already possible for sponsors to modify the XML file of their CTAs with the following:
- Update section B.1 with a sponsor based in EU/EEA
- Update section B.2 with a EU/EEA legal representative for third country sponsors having a legal representative based in UK
- Update section D.9 with a Qualified Person based in EU/EEA
In addition, from January 1st, 2021 sponsors will be able to perform the following changes in the CTA:
- Update section B.2 with a EU/EEA legal representative, for trials with sponsors based in UK
- Update section D.220.127.116.11 specifying “Northern Ireland” in the country field
When submitting the updated XML file of the CTA to the National Competent Authority, the sponsor is requested to make a reference to the relevant substantial amendment form already submitted.