Deadlines

Norwegian authorities shall make a decision within 90 working days of receipt of an application.

Clock-stop

A clock stop is introduced in the case further information is requested from the applicant.

Public consultation

Pursuant to the Gene Technology Act all applications for deliberate release are subject to public consultation. Clinical trials with medicinal products containing or consisting of GMOs, where the clinical trial subject leaves the contained use facility after treatment, are regarded as deliberate release.

Questions related to the application

Questions and inquiries about the application and the application process can be sent to: 

GMO@legemiddelverket.no

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