Notification for Clinical Trial containing Genetically Modified Organisms

If the investigational product contains genetically modified organisms (e.g. vaccines containing live genetically modified viruses or bacteria having no marketing authorization), a notification or application for their deliberate release should also be submitted to the Board of Gene Technology  which is the Competent Authority in Finland regarding the use of genetically modified organisms, in accordance with the Gene Technology Act. The deliberate release of GMOs into the environment is carried out as so-called field trials (also referred to as deliberate release for any other purpose than for placing on the market).  Deliberate release has to be authorized, and it requires thorough risk assessment of any possible health or environmental effects of the GMO. The use of such investigational product is accepted only if there is no harm to human health or environment based on risk evaluation. Public consultation is always included in the process of application. Consultation takes 60 days. At the moment there is no specific form for the process. The Board of Gene Technology has 120 days to deal with the application including the consultation period if there are no requests for further information.For medicinal products containing gene therapy, somatic cell therapy, or genetically modified organisms, without any additional clarifications requested, the processing time is 90 days, but written authorization must be obtained before the start of a clinical trial.

The application fee for the deliberate release of GMOs is 3300€ and notification or application for the contained use of GMOs between 375€ and 1310€.