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Since 1 February 2020, the United Kingdom has withdrawn from the European Union and has become a “third country” .The Withdrawal Agreement provides for a transition period ending on 31 December 2020.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 trials conducted in the EU Member States are reminded of the legal situation applicable after the end of the transition period as described in the Commission Brexit readiness notice regarding Clinical Trials.

  • Clinical trials with 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
  • The Qualified Person for the release of the investigational medicinal product must be based in the Union (EU Qualified Person). Investigational medicinal products used in clinical trials cannot be imported until their batch release has been certified by a qualified person in the EU.

For further information, please refer to the notice of the European Commission.

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).

Joint technical notice by the European Commission, EMA and HMA


Further inquiry note