Regulation 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.
Application to submit an application and what type of information to include417
Amendments 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.
Amendments due to COVID-19 due to COVID-19​Changes to a Clinical Trial that can be defined as safety measures as a result of covid-19 preparedness can be implemented prior to approval from the Norwegian Medicines Agency (NoMA).2426
Compassionate use program use programThe Norwegian Medicines Agency evaluates and approves applications for the compassionate use program (CUP). 1621CUP is an arrangement manufacturers can use to make a medicinal product without granted marketing authorization (MA) available for a group of patients.
Import of medicinal products for clinical studies in Norway of medicinal products for clinical studies in NorwayGeneral guideline regarding persission to import medicinal products for clinical studies in Norway. The guideline also covers the permission to export such products.1498

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