Sideinnhold
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.
