About ushttps://legemiddelverket.no/english/about-usAbout usOur goals and tasks, our departments, contact information, the Norwegian pharmaceutical system.418
Appeal against an administrative decisionhttps://legemiddelverket.no/english/appeal-against-an-administrative-decisionAppeal against an administrative decision446
Clinical Trialshttps://legemiddelverket.no/english/clinical-trialsClinical TrialsClinical Trials are mainly regulated by international and national laws, and the European Regulation EU No 536/2014, which is fully implemented in the Norwegian Regulation relating to Clinical Trials on Medicinal Products for Human Use.71Regulation, Compassionate Use, Application, Amendments.
Contact ushttps://legemiddelverket.no/english/about-us/contactContact us445Telephone, e-mail addresses, how to visit us, list of Norwegian holidays.
Covid-19: Vaccines and medicineshttps://legemiddelverket.no/english/covid-19-and-medicinesCovid-19: Vaccines and medicinesIn the EU, several vaccines are currently approved.2504
Database - approved and marketed pharmaceuticalshttps://legemiddelverket.no/english/database-approved-and-marketed-pharmaceuticalsDatabase - approved and marketed pharmaceuticals"Legemiddelsøk" displays information about market authorisation, prices, reimbursement and more.1116
Import, wholesaling and retailing of medicineshttps://legemiddelverket.no/english/import-wholesaling-and-retailingImport, wholesaling and retailing of medicines69Personal import, dispensing regulation, release of vaccines and blood products, wholesaling in Norway for the products and facilities covered by the MIA.
Medical deviceshttps://legemiddelverket.no/english/medical-devicesMedical devicesThe Norwegian Medicines Agency is competent authority for medical devices, and has administrative and advisory responsibilities related to legislation and supervisory authority over manufacturers, distributors and notified bodies. 1577Legislation, regulatory information, reporting of serious incidents.
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.72Pharmacovigilance legislation, new pharmacovigilance database, transfer of case safety reports.
Public funding and pricinghttps://legemiddelverket.no/english/public-funding-and-pricingPublic funding and pricingThe Norwegian Medicines Agency is responsible for setting maximum prices on prescription-only-medicines. The Agency also evaluates and decides whether a medicine should be publicly funded.1934Maximum price, horizon scanning, single technology assessment (STA), introduction to the Norwegian health care system.
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. 70Fees, templates, submission of applications, notification of market interruption.
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 and medical devices.435
Veterinary medicinehttps://legemiddelverket.no/english/veterinary-medicineVeterinary medicineInformation from the Norwegian Medicines Agency.981

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