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.
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
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 medicines69Information about personal import, dispensing regulation, release of vaccines and blood products, wholesaling in Norway for the products and facilities covered by the MIA.
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