Organisational chart and departments
Published:
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Updated:
Changes
- : Added new information as NOMA has been reorganised with å new department for supply chain security and preparedness as well as new units within other departments.
- : Changed head of unit for HTA hospital medicines.
- : Organisational chart has been updated. The position as organisational development leader has been terminated.
- : Updated with two new acting head of units.
- : Updated with adjusted organisation chart and information about new strategic director for medicines supply chain and medical devices.
- : Updated organisation chart and new information about units.
- : Information updated as new Director General Trygve Ottersen took office.
- : Updated organisation chart.
NOMA consists of 27 units placed in six areas of responsibility (departments).
Page contents
Leadership
The strategic leadership consists of Director General Trygve Ottersen and six strategic directors. The strategic leadership is supported by the Office of the Director, headed by a chief of staff.
Strategic leadership
Director General
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
Acting strategic director, supply chain security and preparedness
Carl-Axel Hagen
Strategic director, Organisational governance and development
Chief of staff
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
Responsibilities:
-
Approval and follow-up of clinical trials
-
Regulatory guidance
Head of unit
MA - human products
Responsibilities:
- Investigation of medicines effectiveness in MA assessments for human pharmaceuticals
List of employees in this unit
Head of unit
MA - human and veterinary products
Responsibilities:
- 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
List of employees in this unit
Head of unit
Pharmaceutical quality
Responsibilities:
- Investigation of chemical and biological quality of pharmaceuticals in MA assessments
List of employees in this unit
Head of unit
Pharmaceutical safety
Responsibilities:
-
Investigation of drug safety in MA assessments for human pharmaceuticals
List of employees in this unit
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
Responsibilities:
- Coordination of new MA assessment assignments in all procedures
List of employees in this unit
Head of unit
Regulatory affairs after MA
Responsibilities:
- Coordination of existing MA assessment assignments in all procedures
List of employees in this unit
Head of unit
Medicinal product information
Areas of expertise:
- Issuance of market authorisations
- Approval of Norwegian product information for pharmaceuticals
List of employees in this unit
Head of unit
Better use of medicines
Areas of expertise:
- Adverse drug reactions
- Medical advice
- Private import of medicines
- Biovigilance
List of employees in this unit
Head of unit
Department for health technology assessment
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:
General reimbursement 1
Responsibilities:
- Assessment of medicinal products considered for reimbursement under the National Insurance Scheme (“blue prescription”)
- Tasks leading up to the initiation of a health technology assessment (HTA), including requests for HTAs, guidance/pre-submission meetings, and recruitment of clinical experts.
Head of unit
General reimbursement 2
Responsibilities:
- Assessment of medicinal products considered for reimbursement under the National Insurance Scheme.
- Tasks following the completion of a health technology assessment (HTA), such as engaging the Norwegian Hospital Procurement Trust in negotiations, following up reimbursement prices, updating reimbursement criteria, and assessing wider societal impacts in cases exceeding DMP’s decision-making authority.
- Developing systems for financing vaccines.
- Conducting comprehensive reviews of therapeutic areas covered by the National Insurance Scheme.
Head of unit
Hospital - cancer diseases
Responsibilities:
- Health technology assessments (HTAs) of medical products for cancer treatment.
- Health technology assessments of medical devices within the New Methods system.
Head of unit
Unit for hospital - rare diseases
Responsibilities:
- Health technology assessments (HTAs) of advanced therapy medicinal products (ATMPs) and medicinal products for rare diseases.
- Promoting the development of international cooperation in Europe and the Nordic region.
Head of unit
Hospital - chronic diseases
Responsibilities:
- Health technology assessments (HTAs) of products for chronic diseases and large patient populations.
- Health technology assessments without submitted documentation.
Head of unit
Department for supply chains and medical devices
The department contributes to an adequate supply of safe medicines and administer the product regulations for medical devices. The department is also responsible for the laboratory services and supervises the actors in the supply chain. The department consists of five units:
Inspection
Responsibilities:
- Inspection of the medicinal products supply chain
- Follow-up of reports of quality defects in medicinal products
- Inspection of promotional activites regarding medicinal products
Head of unit
Authorisations and narcotic drug regulations
Responsibilities:
- Authorisation of entities in the medicinal product supply chain
- Authorisation of blood establishments and establishments handling cells and tissues
- Certificates for the import and export of narcotic drugs
- Administration of narcotics legislation
Head of unit
Laboratory quality control
Responsibilities:
- Analysis of pharmaceuticals
- Official authority batch release of blood products and human vaccines
List of employees in this unit
Head of unit
Medical devices - market surveillance
Responsibilities:
- Supervise medical devices; products, manufacturers and distributors
- Follow up on incidents with medical devices
List of employees in this unit
Head of unit
Medical devices - development and notified body
Responsibilities:
-
Designation and oversight of notified bodies
-
Regulatory development for medical devices
-
Classification, clinical trials, and innovation support for medical devices
List of employees in this unit
Head of unit
Department for supply chain security and preparedness
The department is responsible for NOMA’s emergency preparedness, analysing the supply situation for medical products, and coordinating measures to ensure security of supply. It is also responsible for financial policy instruments, including pharmacy finances, price regulation and procurement. The department comprises two units:
Unit 1
Head of unit
Unit 2
Acting strategic director, supply chain security and preparedness
Carl-Axel Hagen
Department for organisational governance and development
The department provides services that are used by the entire organization. The department consists of four units:
Governance and finance
Responsibilities:
- Payroll
- Invoicing
- Organisational governance
- Quality management
- Data privacy
List of employees in this unit
Head of unit
Legal affairs
Responsibilities:
- Legal advise
- Hearings
Head of unit
Communication
Responsibilities:
- Press service
- Internal communication
- Webpage
- Social media
List of employees in this unit
Head of unit
HR
IT-management and security
Responsibilities:
- Operation and management of NOMA's IT systems
- IT security work at DMP
Acting head of unit
Grete Strand
Data and digitalisation
Responsibilities:
- Development of NOMA's IT systems
- Managing and improving how the systems are used to share data with our partners. This includes distributing structured medicinal product data to services such as the national e-prescription system and hospitals.
Head of unit