Guide Clinical trials with GMOs in medicinal products

+ The responsible authority for approval of deliberate release of GMOs in clinical trials has recently been temporarily transferred from the Norwegian Environment Agency to the Norwegian Medicines Agency, on the 15th of November 2021. Applicants should still contact the Norwegian Medicines Agency via gmo@legemiddelverket.no

See also the Norwegian Medicines Agency's website

– Lukk

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.