Organisational chart and departments
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NOMA consists of 24 units placed in five areas of responsibility (departments).
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Leadership
The strategic leadership consists of Director General Audun Hågå and five strategic directors.
Strategic leadership
General Director
Strategic director, medicinal product assessment
Strategic director, regulatory affairs and better use of medicines
Strategic director, health economics and analysis
Strategic director, medicines supply (chain) and medical devices
Strategic director, organisational governance and development
Department for medicinal product assessment
The department is responsible for processes that give patients quick access to new, effective and safe medicines for humans and animals, and for promoting innovation and good research in the pharmaceutical area. The department consists of five units:
Clinical trials and innovation
Areas of expertise:
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Approval and follow-up of clinical trials
-
Regulatory guidance
Head of unit
MA - human products
Areas of expertise:
- Investigation of medicines effectiveness in MA assessments for human pharmaceuticals
Head of unit
MA - human and veterinary products
Areas of expertise:
- Investigation of medicines effectiveness in MA assessments for human and veterinary pharmaceuticals
- Investigation of drug safety and environmental impact in MA assessments for veterinary pharmaceuticals
Head of unit
Pharmaceutical quality
Areas of expertise:
- Investigation of chemical and biological quality of pharmaceuticals in MA assessments
Head of unit
Pharmaceutical safety
Areas of expertise:
-
Investigation of drug safety in MA assessments for human pharmaceuticals
Head of unit
Department for regulatory affairs and better use of medicines
The department contributes to medicines being used correctly based on the needs of patients, healthcare personnel and society. The department also coordinates applications and changes linked to marketing authorization (MT) and product information.
The department is responsible for distributing structured drug data to, among other things, the e-prescription scheme and hospitals. The department consists of five units:
Regulatory affairs before MA
Areas of expertise:
- Coordination of new MA assessment assignments in all procedures
Head of unit
Regulatory affairs after MA
Areas of expertise:
- Coordination of existing MA assessment assignments in all procedures
Head of unit
Medicinal product information
Areas of expertise:
- Issuance of market authorisations
- Approval of Norwegian product information for pharmaceuticals
Head of unit
Distribution of data on medicinal products
Areas of expertise:
- Prescription and information support (FEST)
- SPOR programme
- NoMA medicine database
Head of unit
Better use of medicines
Areas of expertise:
- Adverse drug reactions
- Medical advice
- E-cigarettes
- Private import of medicines
- Hemovigilance
Head of unit
Department for health economics and analysis
The department has, among other things, responsibility for assessments of medical products for public funding (health technology assessments, HTA), setting prices for medicines, financial analyzes and changing medicines in pharmacies. The department consists of five units:
HTA and general reimbursement
Areas of expertise:
- HTA of pharmaceuticals funded by the National Insurance Scheme
Head of unit
HTA hospital medicines
Areas of expertise:
- STA of pharmaceuticals financed by the regional health authorities, except cancer pharmaceuticals
Head of unit
HTA cancer medicines
Areas of expertise:
- STA of cancer pharmaceuticals
Head of unit
HTA medical devices
Areas of expertise:
- Single technology assessments of medical devices
Head of unit
Price regulation and market analysis
Areas of expertise:
- Price regulation of pharmaceuticals
- Pharmaceutical statistics and analysis
- Pharmacy accounting
- Sector fees
- Operational support for pharmacies
- Shipping reimbursement
Head of unit
Department for medicines supply (chain) and medical devices
The department contributes to an adequate supply of safe medicines and administer the product regulations for medical equipment. The department is also responsible for the laboratory services and supervises the actors in the supply chain. The department consists of five units:
Inspections and narcotic drugs regulation
Areas of expertise:
- Inspection of supply chain
- Certificate for import/export of narcotics
- Administration of the narcotics regulations
- Advertising supervision
Head of unit
Authorisations and security of supply
Areas of expertise:
- Prevention and management of medicine shortages
- Authorisations for companies within the pharmaceutical supply chain
Head of unit
Laboratory quality control
Areas of expterise:
- Analysis of pharmaceuticals
- Official authority batch release of blood products and human vaccines
Head of unit
Medical devices - market surveillance
Areas of expertise:
- Supervise medical devices; products, manufacturers and distributors
- Follow up on incidents with medical devices
Head of unit
Medical devices - development and notified body
Areas of expertise:
-
Designation and oversight of notified bodies
-
Regulatory development for medical devices
-
Classification, clinical trials, and innovation support for medical devices
Head of unit
Department for organisational governance and development
The department provides services that are used by the entire organization. The department consists of four units:
Finance and legal affairs
Areas of expertise:
- Legal advice
- Hearings
- Payroll
- Invoicing
Head of unit
Communication
Areas of expertise:
- Press service
- Internal communication
- Webpage
- Social media
Head of unit
IT
Areas of expertise:
- Administration of IT systems
- Contact with operational and development suppliers
- Technical support
HR and organisational development
Areas of expertise:
- Recruitment
- Competence development