Clinical gene therapy trials with genetically modified organisms are classified into contained use or deliberate release depending on the characteristics of the GMO and the trial setting. Relevant notification or application is submitted to the Board for Gene Technology as stated in Gene Technology Act (377/1995). Separate from the notification process under the Board for Gene Technology (environmental aspects) a different review is conducted by the Finnish Medicines Agency concerning the medicinal aspects of the trial. Ethical opinion is given by a subcommittee on Medical Research Ethics. The Finnish Medicines Agency's responsibilities are to maintain and promote the safety and safe use of medicinal products, medical devices and blood products.
(Last reviewed by the Competent Authority: 4 May 2010)