| 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 |
| 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, which 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 | Information regarding the submission of a Clinical Trial Application | 417 | Information regarding the submission of a Clinical Trial Application |
| Notification of Amendments to a Clinical Trial | https://legemiddelverket.no/english/clinical-trials/amendments | Notification of Amendments to a Clinical Trial | Substantial Amendments to a Clinical Trial must be sent to the Norwegian Medicines Agency for approval. Non-substantial amendments do not require approval. | 420 | Substantial Amendments to a Clinical Trial must be sent to the Norwegian Medicines Agency for approval. Non-substantial amendments do not require approval. |
| 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 authorisation (MA) available for a group of patients. |
| 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 | |
| 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 | |
