Reported suspected adverse reactions of covid-19 vaccines suspected adverse reactions of covid-19 vaccinesThe Norwegian Medicines Agency publishes overviews of suspected adverse reactions associated with corona vaccination in Norway. From week 43 the overviews will usually be published fortnightly on Thursday or Friday.2840
About us usOur goals and tasks, our departments, contact information, the Norwegian pharmaceutical system.418
Appeal against an administrative decision against an administrative decision446
Clinical Trials TrialsClinical Trials are mainly regulated by international and national laws, and the European Directive 2001/20/EC, which is fully implemented in the Norwegian Regulation relating to Clinical Trials on Medicinal Products for Human Use.71Regulation, Compassionate Use, Application, Amendments.
Contact us us445Telephone, e-mail addresses, how to visit us, list of Norwegian holidays.
Covid-19: Vaccines, medicines and medical devices Vaccines, medicines and medical devicesEmergency preparedness for the health service has been increased in Norway due to covid-19. 2504
Database - approved and marketed pharmaceuticals - approved and marketed pharmaceuticals"Legemiddelsøk" displays information about market authorisation, prices, reimbursement and more.1116
Import, wholesaling and retailing of medicines, 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 devices 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.
Pharmacovigilance 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 pricing 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 affairs 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 advice and regulatory adviceThe Norwegian Medicines Agency (NoMA) offers advice regarding the development of human and veterinary medicinal products.435
Veterinary medicine medicineInformation from the Norwegian Medicines Agency.981

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