CASubmissionOfApplication object

Responsible for study submission

Legal representative domiciled in the respective country

Guidance on submission of application

Information on the application procedure including a list of required documents to be appended to the notification is provided in Section 6 -8 of Regulation 2/2012.
Details on notification procedure available on FIMEA website in section: Supervision > Clinical Drug Trials > Notification of a clinical trial - EudraCT

Applicable national legal framework/ Reference

Section 6 -8 of Regulation 2/2012

Additional Information

If radiation is used in the clinical investigation:
A safety license issued by STUK is required, unless the practice is specifically exempted. Instructions for applying safety license are available at STUK website. The license should be valid before trial commencement.
Submission of trial notification to Fimea is needed if the clinical trial includes radioactive material, e.g. diagnostic product.