Submission of new clinical trial applications will no longer be possible after 31 January 2023 under the EU CT Directive for any EEA country
This means:
- For an ongoing clinical trial under the EU CT Directive, new requests for clinical trial authorizations to include further EEA countries are not possible after 30-January-2023
- To add new EEA countries to an ongoing clinical trial under EU Directive after this date, you must first transition the trial to the EU CTR and then submit additional EEA countries following the EU CTR procedure