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.

​Fant du det du lette etter?