Main areas of responsibility include processes related to advisory services to general practitioners, medical safety, epidemiology, product information, price control, regulation of personal import of medical products and approvals for exemption from market authorisations. The area has five units.
Unit for Regulatory Affairs 2
The unit is responsible for regulatory functions/tasks taking place after a drug has received marketing authorization, such as changes, renewals and dispute resolutions (referrals).
Unit for Product Information
The unit provides marketing authorisations and approves product information (SPC), patient information leaflets (PILs) and labeling in all regulatory procedures. Other tasks include implementing the "sunset clause" in Norway and updating databases with medicinal product information.
Unit for Correct Use of Medicinal Products
The unit is responsible for the proper use of pharmaceutical products:
- Advisory services to general Practitioners
- Safety Information, surveillance of pharmaceutical products and responsibility for the national safety registry
- Supervising advertisement of pharmaceutical products
- Approval exemptions
- Generic substitution
- Private import and the regulatory framework guiding international travel with pharmaceutical products
Unit for Pharmacovigilance
The unit is responsible for evaluating safety documentation before and after granting marketing authorisation, and assessing risk minimization measures for pharmaceuticals already in the market. The unit represents Norway in the committee for monitoring of pharmaceuticals (Pharmacovigilance Risk Assessment Committee, PRAC).
Unit for Pricing and Electronic Prescription Support
The unit regulates the pricing of prescription drugs, monitors the distribution chain (pharmacies and wholesalers), provides operational support to pharmacies and reimburses shipping costs to patients who cannot visit the pharmacies themselves.
The unit administers and quality assures drug information and interactions-data in NOMA’s information service (FEST). Some of the responsibilities include cooperation with external experts on quality of interaction-data, and information exchange with the pharmacy information system (Farmalogg) and The Norwegian Health Economics Administration (HELFO). The unit collaborates with the Directorate for e-health in the production of information in the e-prescription chain, and with users of the drug information system FEST (healthcare workers, suppliers of journals, veterinarians, hospitals etc.)