Seek approval from several authorities

Approval from different authorities is required before the clinical trial can start. The authorities below co-operate to facilitate the approval processes under the different regulations.

• The Norwegian Medicines Agency (Statens legemiddelverk) 
• The Norwegian Directorate for Health (Helsedirektoratet) 

Applicants can submit their applications under all regulations at the same time to the shared address: GMO@legemiddelverket.no

Limitations for this guidance document

The scope if this guidance document concerns applications for clinical trials with medicinal products (MPs) that contain or consist of genetically modified organisms (GMO-MPs) for use in humans. Clinical trials where the clinical trial subject (treated patient) leaves the contained use facility after treatment are regarded as deliberate release.