Notification of Protocol Amendment and Study Completion

In case the amendments to the protocol are made, a Substantial Amendment Notification form, should be filled in. If Fimea does not request any further clarification of the amendment notification within 35 days of receiving it, the Agency has accepted the amendment.

Declaration of the End of Clinical Trial, should be filled within 90 days of study completion. If an international trial ends in Finland earlier than elsewhere, a separate notification must be made of study termination in Finland as well as at the end of the entire trial.

The both forms, a Sustantial Amendment Notification and Declaration of the End of Clinical Trial will be found in European Comission websites.

Fimea must also be provided with a summary of study results. These forms may be filled in electronically on the EMA website but Fimea requires submission of signed paper printouts. If the study has no EudraCT number, the EudraCT forms shall be used but with the number provided by Fimea (KL number) serving as the notification ID number. If the trial is not initiated, Fimea must be notified of the decision and the reasons for it in writing within 90 days. If the trial has been interrupted, authorities must be notified of interruption and of the respective reason within 15 days using the form “Notification of amendment”. The same form must be used to notify authorities of re-commencement of the trial.