What should be noted when submitting to Fimea the documents for the ongoing trials?
The new documents should be accompanied with the track change versions of the updated documents. When necessary, the updated version of the EudraCT-form, the Substantial Amendment form and/or the End of the Trial-form should also be submitted.
Please remember to add cover letter, and to specify therein:
* what clinical trial is this submission for (Klnro, EudraCT number)?
* the content of the submission (appendices)
* is the substantial amendment in question
* are the same documents being submitted or have they been submitted before for any other clinical trial(s) (if yes, please specify into which trial(s)
* the details for the contact person
* if there are other issues concerning evaluation or if evaluation is needed urgently
Fimea is to be notified of substantial amendments only, for the definition please see the Reg. 8-2019 for the clinical trials.