The Gene Technology Act regulates all aspects of activities with GMOs including gene therapy products. The competent authorities for GMO in Norway is the Ministry of the Environment, represented by the Directorate for Nature Management and the Ministry of Health and Care Services represented by the Directorate for Health and Social Affairs.
The procedures for clinical trials that are deliberate releases are described in the Act and the Regulations relating to Impact Assessment pursuant to the Act. See also related laws, guidelines and regulation documents.
(Last reviewed by the Competent Authority: 7 June 2011)