About us | https://legemiddelverket.no/english/about-us | About us | Our goals and tasks, our departments, contact information, the Norwegian pharmaceutical system. | 418 | |
Appeal against an administrative decision | https://legemiddelverket.no/english/appeal-against-an-administrative-decision | Appeal against an administrative decision | | 446 | |
Clinical Trials | https://legemiddelverket.no/english/clinical-trials | Clinical Trials | Clinical 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. | 71 | Regulation, Compassionate Use, Application, Amendments. |
Contact us | https://legemiddelverket.no/english/about-us/contact | Contact us | | 445 | Telephone, e-mail addresses, how to visit us, list of Norwegian holidays. |
Covid-19: Vaccines and medicines | https://legemiddelverket.no/english/covid-19-and-medicines | Covid-19: Vaccines and medicines | In the EU, several vaccines are currently approved. | 2504 | |
Database - approved and marketed pharmaceuticals | https://legemiddelverket.no/english/database-approved-and-marketed-pharmaceuticals | Database - approved and marketed pharmaceuticals | "Legemiddelsøk" displays information about market authorisation, prices, reimbursement and more. | 1116 | |
Import, wholesaling and retailing of medicines | https://legemiddelverket.no/english/import-wholesaling-and-retailing | Import, wholesaling and retailing of medicines | | 69 | Personal import, dispensing regulation, release of vaccines and blood products, wholesaling in Norway for the products and facilities covered by the MIA. |
Medical devices | https://legemiddelverket.no/english/medical-devices | Medical devices | The 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. | 1577 | Legislation, regulatory information, reporting of serious incidents. |
Pharmacovigilance | https://legemiddelverket.no/english/pharmacovigilance | Pharmacovigilance | 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. | 72 | Pharmacovigilance legislation, new pharmacovigilance database, transfer of case safety reports. |
Public funding and pricing | https://legemiddelverket.no/english/public-funding-and-pricing | Public funding and pricing | The 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. | 1934 | Maximum price, horizon scanning, single technology assessment (STA), introduction to the Norwegian health care system. |
Regulatory affairs | https://legemiddelverket.no/english/regulatory-affairs | Regulatory affairs | A medicinal product must be granted a valid Marketing Authorisation (MA) by the Norwegian Medicines Agency (NoMA) prior to marketing in Norway.
| 70 | Fees, templates, submission of applications, notification of market interruption. |
Scientific and regulatory advice | https://legemiddelverket.no/english/scientific-and-regulatory-advice-for-the-development-of-a-medicinal-product | Scientific and regulatory advice | The Norwegian Medicines Agency (NoMA) offers advice regarding the development of human and veterinary medicinal products and medical devices. | 435 | |
Veterinary medicine | https://legemiddelverket.no/english/veterinary-medicine | Veterinary medicine | Information from the Norwegian Medicines Agency. | 981 | |