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/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 adverse 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.
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
Strategic Review and Learning Meeting CHMP – PDCO – CAT Oslo 2018https://legemiddelverket.no/english/strategic-review-and-learning-meeting-chmp-pdco-cat-oslo-2018Strategic Review and Learning Meeting CHMP – PDCO – CAT Oslo 2018The Norwegian Medicines Agency (NoMA) are pleased to welcome you to the strategic review and learning meeting to be held in Oslo on May 7 to 9, 2018.1641Registration, practical information, agenda.
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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