| Regulation | https://legemiddelverket.no/english/clinical-trials/regulation-relating-to-clinical-trials-on-medicinal-products-for-human-use- | Regulation | | 419 | Clinical 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 | https://legemiddelverket.no/english/clinical-trials/application-for-an-authorisation-of-a-clinical-trial | Application | How to submit an application and what type of information to include | 417 | |
| Amendments | https://legemiddelverket.no/english/clinical-trials/amendments | Amendments | The 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. | 420 | The Norwegian medicines Agency (NoMA) has changed its practice related to answering submissions of substantial amendments. |
| Amendments due to COVID-19 | https://legemiddelverket.no/english/clinical-trials/management-of-clinical-trials-in-relation-to-covid-19 | Amendments 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 | https://legemiddelverket.no/english/clinical-trials/compassionate-use-program | Compassionate use program | The Norwegian Medicines Agency evaluates and approves applications for the compassionate use program (CUP). | 1621 | CUP 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 | https://legemiddelverket.no/english/import-wholesaling-and-retailing/import-of-medicinal-products-for-clinical-studies-in-norway | Import of medicinal products for clinical studies in Norway | General guideline regarding persission to import medicinal products for clinical studies in Norway. The guideline also covers the permission to export such products. | 1498 | |
| New clinical trials regulation (EU Regulation No. 536/2014) | https://legemiddelverket.no/english/clinical-trials/new-clinical-trials-regulation | New clinical trials regulation (EU Regulation No. 536/2014) | Information regarding the new regulation, Clinical Trials Information System (CTIS) and transition period | 2886 | Information regarding the new regulation, Clinical Trials Information System (CTIS) and transition period |
