Notification for Clinical Trials with Medicinal Products
The sponsor or the sponsor’s legal representative in the European Community, must submit a notification, or a request for authorization (special products), of a clinical trial on medicinal product before the commencement of the trial. If the person submitting the notification is not the sponsor or his legal representative, the notification must be accompanied by a letter in which the sponsor authorizes the party submitting the notification to act on his behalf. A multi-centre trial is considered a single trial on which one complete notification must be filed.
The notification shall be completed in Finnish, Swedish, or English using the EudraCT system. The completed notification form shall be saved as an electronic file on a CD and sent together with a signed printout of the form to Fimea. After checking the information, the Agency shall submit it to the official EudraCT database. Documents to be appended to the notification are listed in Regulation 2/2012. In the event that an EudraCT number has already been obtained for notification to be made to the Competent Authority of another state, the same number shall be used. In case of any uncertainty, Fimea will decide whether a notification for a clinical trial on medicinal products should be submitted.
Notification is not needed if the study in question is non-interventional trial.
If no additional clarifications is requested, Fimea authorizes clinical trials within 60 days. If Fimea cannot approve study conduct, the sponsor is asked for further clarifications. The request for further clarification is made in writing within 60/90 days of the commencement of processing to the party submitting the notification. The sponsor may amend its trial protocol to rectify any deficiencies observed.