Submission of the application
Tukija has switched to electronic transactions on 1 January 2021. Under the headings you will find electronic application forms. Forms only work with Chrome or Firefox browsers.
Between 31 January 2022 and 31 January 2023, sponsors of clinical trials may choose to submit their new applications for clinical trials in accordance with the Clinical Trials Directive (2001/20 / EC) through national application procedures or the EU Clinical Trials Regulation (536/2014). ) through the CTIS (Clinical Trials Information System; EU portal and database).
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 below mentioned due date policy only applies to applications submitted in accordance with the Clinical Trials Directive, as applications under the CTR have separate due 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.
The establishment of a biobank is conditional on the positive statement of Tukija. Tukija provides its opinion within 60 days of receiving the application.