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Contact ushttps://legemiddelverket.no/english/contact-usContact us445Telephone, e-mail addresses, how to visity us, list of Norwegian holidays.
About ushttps://legemiddelverket.no/english/about-usAbout usOur goals and tasks, our departments, the Norwegian pharmaceutical system.418
Regulatory affairshttps://legemiddelverket.no/english/regulatory-affairsRegulatory affairsA medicinal product must be granted a valid Marketing Authorisation (MA) by the Norwegian Medicines Agency (NoMA) prior to marketing in Norway. 70
Clinical trialshttps://legemiddelverket.no/english/clinical-trialsClinical trialsClinical 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.71
Import, wholesaling and retailing of medicineshttps://legemiddelverket.no/english/import-wholesaling-and-retailingImport, wholesaling and retailing of medicines69
Pharmacovigilancehttps://legemiddelverket.no/english/pharmacovigilancePharmacovigilancePharmacovigilance is an important tool for ensuring safe and effective drugs. The purpose is to gather information about safety in clinical use and shorten the time until the safety profile of a drug is well known.72
Price and reimbursementhttps://legemiddelverket.no/english/price-and-reimbursementPrice and reimbursementThe Norwegian Medicines Agency is responsible for setting maximum prices on prescription-only-medicines. The Agency also evaluates and decides whether a medicine should be reimbursed by the National Insurance Scheme. 73
Scientific and regulatory advicehttps://legemiddelverket.no/english/scientific-and-regulatory-advice-for-the-development-of-a-medicinal-productScientific and regulatory adviceThe Norwegian Medicines Agency (NoMA) offers advice regarding the development of human and veterinary medicinal products.435
Appeal against an administrative decisionhttps://legemiddelverket.no/english/appeal-against-an-administrative-decisionAppeal against an administrative decision446Legal basis and notification form.
Veterinary medicinehttps://legemiddelverket.no/english/veterinary-medicineVeterinary medicineInformation from the Norwegian Medicines Agency.981