Submission of applications under the Directive during the transitional period

Tukija considers applications submitted in accordance with the Clinical Trials Directive (2001/20/EC) and the Clinical Trials Regulation (536/2014) in its meetings.

However, the due date policy related to Tukija's meeting schedule only applies to applications submitted in accordance with the Clinical Trials Directive, as applications under the CTR have separate date policy in CTIS.

The application is considered duly submitted when it includes all the required documents. In this case, the application will proceed to the meeting in accordance with the due date policy. Incomplete applications must be completed by the due date of the specific meeting. Starting from 1 September 2022, no other separate due date is given for completing the application.