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Gene Therapy Legislation in Norway

All clinical trials in Norway must be approved by the Norwegian Medicines Agency (NoMA). The NoMA is the national, regulatory authority for new and existing medicines and the supply chain. The agency is responsible for supervising the production, trials and marketing of medicines. It approves medicines and monitors their use, and ensures cost-efficient, effective and well-documented use of medicines. The inspectorate also supervises the supply-chain. NOMA also regulate prices and trade conditions for pharmacies.
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)