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Gene Therapy Legislation in Denmark

Gene therapy trials with products containing GMOs are subject to the Danish Environment and Gene Technology Act. The rules are contained in the Danish Working Environment Authority’s (DWEA) Executive Order on gene technology and working environment. Notifications of gene therapy projects are to be submitted to the Danish Working Environment Authority. The quality of the investigation and the safety of the patient during the clinical trial are evaluated by the Danish Medicines Agency. The Danish Medicines Agency assumes the role as competent authority with respect to the technical aspects of clinical investigations of medical devices from the Scientific Ethical Committee System. There is a requirement for authorisation, from the DMA, for the clinical investigation of medical devices on human subjects. Both procedures (Danish Working Environment Authority and Danish Medicines Agency) run independently and the application forms are separated.