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 Directive 2001/20/EC, wich is fully implemented in the Norwegian Regulation relating to clinical trials on medicinal products for human use.71Information about regulation, application and amendments.
Contact ushttps://legemiddelverket.no/english/about-us/contactContact us445Telephone, e-mail addresses, how to visit us, list of Norwegian holidays.
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/regulatory-affairs/medical-devicesMedical devicesAs of 1st of January 2018 administrative and advisory responsibilities related to medical devices will be transferred from the The Norwegian Directorate of Health to The Norwegian Medicines Agency.447The Norwegian Medicines Agency will be the competent authority for medical devices from 1st of January 2018.
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.
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. 73Maximum price, HTA, general reibursement scheme, about 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. 70
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
Veterinary medicinehttps://legemiddelverket.no/english/veterinary-medicineVeterinary medicineInformation from the Norwegian Medicines Agency.981

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