Procedures for Clinical Trials after the Brexit
Since 1 February 2020, the United Kingdom has withdrawn from the European Union and has become a “third country” .The Withdrawal Agreement provides for a transition period ending on 31 December 2020. Since no extension was requested as of July 1 2020, there is no possibility for further extension beyond that date.
Therefore, sponsors of clinical investigations and performance studies conducted in the EU Member States are reminded of the legal situation applicable after the end of the transition period.
- Clinical investigations and performance studies with the sponsor in UK require a legal representative for the sponsor in the Union.
- Where the legal representative of the sponsor in the Union was previously based in the UK, this must be changed to a legal representative in the Union.
- For clinical investigations and performance studies with products with CE-marking the same rules as for the Austrian market apply.
These changes should be submitted to the BASG as a substantial amendment. A non-substantial notification is sufficient if the change of responsible persons takes place within the same, already approved company (e.g. company XY UK to company XY DE).