​​​​Our goals:

  • Ensure that medicines are safe and effective. 
  • Ensure that the population has access to medicines regardless of ability to pay.
  • Ensure the correct medicinal  and economical use of medicines.
  • Ensure the use of cost-effective medicines.

Our tasks:

Assessment of medicines:

  • Assess medicines and issue market authorisations.
  • Assess clinical trials.

Administration of the pharmaceutical distribution chain

  • Authorise the manufacturing, import, sale and distribution of medicines.
  • Classify products as medicines, narcotics or doping substances.
  • Authorise the use of medicines that don’t have market authorisation.
  • Administer the narcotics and doping regulations and authorise the import and export of narcotics.

Pharmacoeconomics:

  • Determine the price of prescription medicines.
  • Determine medicines that should be included in the general reimbursement scheme.
  • Evaluate cost effectiveness of medicines used in the specialist health service.
  • Charge fees as regards revenues from sale of medicines,  offer operational  support and freight reimbursement to pharmacies in addition to preparing pharmacy statistics.

Supervision:

  • Pharmacovigilance
  • Supervise clinical trials
  • Supervise manufacturers, blood banks, importers, wholesalers and pharmacies
  • Supervise the marketing of medicines
  • Handle medicines safety alerts 
  • Batch release
  • Conduct laboratory analyses

Medical information:

  • Provide information on correct medicinal and sound economical  use of medicines to doctors and other prescribers.
  • Provide information regarding regulations and procedures to MA holders, manufacturers, importers, wholesalers and pharmacies.
  • Provide the general public with advice on the safe use of medicines.

​International cooperation:

  • Represent Norway in EU scientific committees and working parties, and other international bodies such as the United Nations and EDQM.
  • Make assessments of medicines on behalf of The European Medicines Agency.
  • Take part in the development of European medicines regulations.

Publisert: 27.06.2016