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 should a application be submitted and what information should be included.417
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.
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

​Fant du det du lette etter?