Competent Authority

Notification for Clinical Trials on Medicinal Products

The Competent Authority for Interventional Clinical Trials with Medicinal Products in Finland is the Finnish Medicines Agency, FIMEA. Fimea must be notified, regardless of whether the investigational medicinal product has marketing authorization or not. Notification process is different comparing Clinical Trials on Medicinal Products and Clinical Trials on Medicinal Products containing Genetically Modified Organisms (GMOs).

In case of combination trials involving both medicinal products and medical devices, the Competent Authorities, Valvira and Fimea, must be consulted in advance to clarify which authority will review the application.

For year 2015 the fee for notification of Clinical Trials on Medicinal Products is 2200€. Authorization relating to clinical drug trials involving gene therapy or containing genetically modified organisms is 2500€. The fees are reviewed on yearly basis.

Waivers

A waiver of the processing fee may be requested with respect to a notification relating to clinical trial on a medicinal product conducted by an individual investigator, a trial team, an university institute, an university hospital clinic or the National Institute for Health and Welfare without outstanding financing or with financing by a non-profit corporation. An informal statement that the investigation will not receive any outside financing must be attached to the notification.