This change came into force on 1 January 2024. The English name of the directorate is the Norwegian Medical Products Agency (NOMA).
"Compared with the Norwegian Medicines Agency, the new directorate has an expanded portfolio of responsibilities within emergency preparedness and public financing of medical products. We take on more duties and establish closer partnerships with both existing and new stakeholders. We will be even more of a professional contributor to policy formulation in our field," says Director General Audun Hågå.
The new directorate also has duties associated with the approval of operators that handle blood, cells and tissue.
See also: Practical information about the transition
Enhanced emergency preparedness for medical products
During 2023, the Norwegian Government presented a parliamentary report on health preparedness. NOMA assumes overall responsibility for the security of supply and emergency preparedness of medical products. This includes monitoring the supply chains, an enhanced role in product procurement, and management of emergency stockpiles.
“The COVID-19 pandemic demonstrated how medical products have a complex and vulnerable supply chain. New emergency preparedness functions have since been established in Europe, which in turn have created a need for enhanced national coordination. Against this backdrop, the directorate assumes system responsibility in Norway for emergency preparedness and the security of supply of medical products," Hågå says.
Among other things, this includes closer dialogue with stakeholders and strengthened international cooperation. Cooperation with the European Medicines Agency (EMA) and the Health Emergency Preparedness and Response Authority (HERA) will be particularly important.
Norway’s most important specialist group within health economics
Medicines and health technology are rapidly developing, and the industry is forward-looking. More products being available improves the quality of people’s lives, however also poses a complex economic challenge for public budgets. NOMA is Norway's most important specialist group within health technology assessments (HTA), with approximately 70 employees with this as their field of expertise. The directorate is also responsible for cost-benefit assessments of all medical products, including vaccines and medical devices.
“An increasing number of cost-benefit assessments are being prepared, while at the same time, the documentation we receive is becoming more complex. Our objective is to strike a good balance between ensuring robust cost-benefit assessments and being efficient in our assessment processes. It is therefore necessary that we continually evaluate how this work is carried out. A large and attractive specialist group will ensure that we develop and remain at the forefront," Hågå says.
In addition to methodological assessments, the directorate has an expanded responsibility for market insight and the work on procuring vaccines. This also involves the establishment of a specialist group within procurement processes for medicines and vaccines that are financed by the Norwegian National Insurance Scheme (Folketrygden), vaccines for vaccination programmes, and medicines for the emergency stockpile in Norway. This includes the use of innovative public procurement processes to ensure access to medical products.
New visual profile
The visual profile of DMP features a hexagon as a central element and will be visible in various ways. The hexagon is a basic shape commonly found in nature and molecular structures, including many pharmaceuticals. Therefore, the hexagon serves well as a symbol for our field of expertise.
Our logo is dynamic and flexible, adaptable for various uses, much like DMP, which aims to share knowledge and be in motion. Our profile combines small and large hexagons to illustrate that we consider both the overall picture and details. We will consider the broader picture while simultaneously delving into details and being explorative.