Goals and tasks of the Norwegian Medicines Agency
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Changes
- : Paragraph headings have been adjusted. Minor language improvements have been added.
- : The text has been updated with information regarding NOMA's responsibility for supply security and preparedness, as well as new tasks related to health economics and blood, cells, and tissues. It has also been adjusted concerning supervisory tasks and medical devices. The section on disinfectants has been removed as other agencies have taken over most of the regulatory responsibility for these types of products.
The Norwegian Medical Products Agency (NOMA) is the competent authority for medicinal products and medical devices. This includes responsibility for supply security and preparedness, supervision, guidance, and international cooperation.
Page contents
The Norwegian Medical Products Agency (NOMA) ensures timely and equal access to effective medicinal products and medical devices. We monitor safety and contribute to better use of these products. Furthermore, we support research and innovation. We are responsible for national security og supply and preparedness for medical products.
NOMA operates under the Ministry of Health and Care Services and has approximately 400 employees.
Our tasks are as follows:
Approval of medicinal products
- Assess medicinal products for humans and animals regarding quality, safety, and efficacy
- Review applications for marketing authorisation (MA) for the sale of medicinal products in Norway, as well as approve the summary of product characteristics (SPC), package leaflets, and labelling
- Evaluate applications for changes to approved medicinal products
- Assess applications for clinical trials of medicinal products
Medical devices
- Administer laws and regulations concerning medical devices
- Develop and interpret regulations
- Evaluate notifications of clinical trials of medical devices and performance studies of in vitro diagnostic (IVD) devices
- Maintain a register of Norwegian manufacturers and authorised representatives of medical devices (The Device Register)
- Designate notified bodies
- Issue export certificates
Supply chain administration
- Issue authorisations for manufacturing, import, wholesaling, and distribution of medicinal products
- Approve blood banks and organisations handling cells and tissues
- Classify medicinal products, medical devices, doping substances, narcotics, etc.
- Administer the regulations on narcotics and doping, and issue permits for the import and export of narcotic medicinal products
- Process applications for compassionate use of medicinal products
- Handle applications for exemptions from CE-marking for medical devices
- Respond to notifications of drug shortages to mitigate their impact on the Norwegian market
Health economics
- Set prices for prescription medicines for humans and contribute to the lowest possible price for medicines
- Manage the procurement of medicines and vaccines funded by the National Insurance Scheme
- Conduct health technology assessments (HTA) of medicinal products and medical devices
- Decide which medicines qualify for general reimbursement
- Collect fees related to the sale of medicinal products, provide operational support to pharmacies, and compile pharmacy statistics
Security of supply and preparedness
- Monitor and analyse the supply situation for medicinal products in Norway
- Maintain oversight of supply chains and stock levels for infection control equipment and medicinal products
- Manage the national emergency stockpile for infection control equipment and medicinal products
Supervision and Monitoring
- Monitor adverse reactions and other unintended effects of use og medicines
- Monitor adverse events related to blood transfusions and handling of cells and tissues
- Inspection of:
- entities conducting clinical trials
- MA holders, manufacturers, blood banks, importers, wholesalers, and pharmacies
- entities advertising medicinal products and medical devices
- medical devices, including the devices themselves, manufacturers, authorised representatives, importers, distributors, and notified bodies
- Monitor controlled substances (including narcotics) in Norway
- Analyse and release blood products and vaccines for human use (batch release)
- Address notifications of quality defects in medicinal products
- Handle reports of serious incidents and safety measures related to medical devices
- Conduct laboratory testing of medicinal products
Information and guidance
- Provide guidance to doctors and other prescribers on the safe and socio-economically appropriate use of medicinal products
- Offer information to pharmacies/retailers, medicinal product wholesalers, importers, and the industry regarding regulations and case processing
- Inform the public on better use of medicinal products by providing information on safety/adverse reactions, the general reimbursement scheme, new medicines, and updates on existing medicines
- Support innovation by offering guidance during the development of medicinal products and medical devices
- Provide guidance and information on the regulatory framework for medical devices
International tasks
- Participate in European medicinal product cooperation, represent Norway in EU scientific committees and working groups, and conduct expert assessments on behalf of the European network
- Represent Norway in other international organisations and forums, including the UN, EDQM, and Nordic cooperation forums
- Participate in European cooperation on medical devices within EU Commission committees and working groups, as well as other regulatory collaborations
- Conduct expert assessments and evaluations on behalf of the European medicines network
- Contribute to the development of European regulations for medicinal products and medical devices