Regulationhttps://legemiddelverket.no/english/clinical-trials/regulation-relating-to-clinical-trials-on-medicinal-products-for-human-use-Regulation419Clinical Trials are mainly regulated by international and national laws and the European Directive 2001/20/EC, wich is fully implemented in the Norwegian Regulation relating to clinical trials on medicinal products for human use.
Applicationhttps://legemiddelverket.no/english/clinical-trials/application-for-an-authorisation-of-a-clinical-trialApplicationHow should a application be submitted and what information should be included.417
Amendmentshttps://legemiddelverket.no/english/clinical-trials/amendmentsAmendmentsThe Norwegian medicines Agency (NoMA) has, due to temporary lack of resources, changed its practice related to answering submissions of substantial amendments. 420The Norwegian medicines Agency (NoMA) has changed its practice related to answering submissions of substantial amendments.