Changes in clinical trials due to Brexit

In clinical trials, the legal representative of the sponsor and Manufacturing/ Importation Authorisation (MIA) holder responsible for the release of the investigational medicinal product (IMP) as well as the Qualified Person need to be based in an EU/EEA member state. Therefore, these operators in UK need to be relocated to an EU/EEA member state before Brexit date, March 29th, 2019. Fimea will consider these changes as regulatory changes and recommends submission of the information without delay. Information concerning the same change in several trials may be submitted within one submission. After Brexit, Fimea will take action in trials that have not been subject of this information.

After Brexit, new IMP batches from UK need to be released in an EU/EEA member state. In addition, the batches that have not been released in UK before Brexit, need to be released in an EU/EEA member state. Companies that import from UK to EU/EEA member state and also companies responsible for IMP batch certification and release are required to have MIA license.

IMP batch certifications that have been performed in UK before Brexit will be valid after Brexit.