Our goals and tasks

NOMA is an agency under the Ministry of Health and Care Services.

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.

• Ensure that medical devices placed on the market and put into service in Norway meet the regulatory requirements

Our tasks

Assessment of medicines

• Assess medicines and issue market authorisations.

• Assess clinical trials regarding medicines and medical devices

• 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 safety deficiencies regarding medicines and medical devices

• 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.

Medical devices

• Administer, interpret and enforce the medical devices legislation.

• Provide information and guidance regarding the medical devices regulations to manufacturers, importers, wholesalers and users.

• Monitoring of the market and the actors involved.

International cooperation

• Represent Norway in EU scientific committees and working parties, and other international bodies such as the United Nations and EDQM.

• Participate in the European co-operation between Competent Authorities for medical devices, EU committees and working groups.

• Make assessments of medicines on behalf of The European Medicines Agency.

• Take part in the development of European medicines and medical devices regulations.