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 for a period not sent a written answer to Sponsors applying for approval of substantial amendments. The situation has however changed, and we are now in most cases able to give a written answer. 420The Norwegian medicines Agency (NoMA) has changed its practice related to answering submissions of substantial amendments.

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