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New Clinical Trials Regulation (EU Regulation No. 536/2014)https://legemiddelverket.no/english/clinical-trials/new-clinical-trials-regulationNew Clinical Trials Regulation (EU Regulation No. 536/2014)Information regarding the new Regulation, Clinical Trials Information System (CTIS) and transition period 2886Information regarding the new Regulation, Clinical Trials Information System (CTIS) and transition period
Regulationhttps://legemiddelverket.no/english/clinical-trials/regulation-relating-to-clinical-trials-on-medicinal-products-for-human-use-Regulation419Clinical 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.
Applicationhttps://legemiddelverket.no/english/clinical-trials/application-for-an-authorisation-of-a-clinical-trialApplicationInformation regarding the submission of a Clinical Trial Application417Information regarding the submission of a Clinical Trial Application
Notification of Amendments to a Clinical Trialhttps://legemiddelverket.no/english/clinical-trials/amendmentsNotification of Amendments to a Clinical TrialSubstantial Amendments to a Clinical Trial must be sent to the Norwegian Medicines Agency for approval. Non-substantial amendments do not require approval.420Substantial Amendments to a Clinical Trial must be sent to the Norwegian Medicines Agency for approval. Non-substantial amendments do not require approval.
Compassionate Use Programhttps://legemiddelverket.no/english/clinical-trials/compassionate-use-programCompassionate 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 authorisation (MA) available for a group of patients.
Amendments due to COVID-19https://legemiddelverket.no/english/clinical-trials/management-of-clinical-trials-in-relation-to-covid-19Amendments 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 Norwayhttps://legemiddelverket.no/english/import-wholesaling-and-retailing/import-of-medicinal-products-for-clinical-studies-in-norwayImport 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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