NOMA’s role in supply chain security and preparedness

The role of NOMA is threefold. First, NOMA holds the overarching responsibility for ensuring national supply chain security and preparedness for medicinal products and medical devices. The agency also carries out specific tasks related to these areas, such as coordinating the distribution of infection control equipment during pandemics or other crises. Additionally, many of NOMA's broader functions contribute to supply chain security and preparedness, making this a key element embedded throughout the agency's activities. 

Overarching responsibility 

NOMA holds an overarching and comprehensive responsibility for national supply chain security and preparedness for medicinal products and medical devices, entailing an operational and coordinating responsibility nationally.  

Key tasks related to this responsibility include:

• Monitore: The agency shall monitor the status and developments of supply security chain and preparedness. This includes overseeing the supply chains and stockpiles for infection control equipment and medicines.
• Coordinate national stakeholders: The agency facilitates coordination among key national stakeholders. It leads the Supply Chain Security and Preparedness Committee for Medical Products and participates in the Health Preparedness Council, led by the Ministry of Health and Care Services.
• Coordinate measures: The agency helps coordinate various measures that can be implemented to ensure robust supply chain security and preparedness.
• International cooperation: NOMA represents Norway in various Nordic and European forums, including those focused on procurement and stockpiling. It contributes to ensuring that the collaboration between national and international actors is well-coordinated. 

Specific tasks 

Beyond its overarching responsibility, NOMA has a range of specific tasks related to storage, procurement, and restrictions. 

Storage: The agency monitors the national stockpiles of infection control equipment and medicines. It ensures that pharmaceutical wholesalers fulfill their obligations to maintain emergency reserves for primary healthcare services (as stipulated in § 5 of the Wholesaler Regulations). Additionally, the agency assesses purchases and manages withdrawals from the national stockpile of antiviral medications. In the event of a pandemic or crisis necessitating the use of emergency stockpiles for infection control equipment, the agency takes direct control of these reserves. 

Procurement: NOMA coordinates the use of the government’s procurement efforts  to ensure reliable access to medicines, vaccines, and medical devices. It is responsible for collaborating with the EU on joint procurement initiatives. 

Restrictions: If there is a risk to the supply of medicines in Norway, NOMA has the authority to impose restrictions on pharmacies and wholesalers regarding the sale and distribution of medicines ( Pharmacy Regulations §38 and Wholesaler Regulations §15). Furthermore, NOMA can impose restrictions on wholesalers to limit parallel exports of medicines ( Wholesaler Regulations §16). 

Supply chain security and preparedness in core activities  

Most of NOMA’s core activities also contribute to supply chain security and preparedness. These include, among others, the approval of clinical trials,  authorisation of new medicinal products, designation of notified bodies for medical devices, pharmacovigilance, inspections, issuing authorisations, and setting medicine prices. 

NOMA is also actively engaged in preventing and managing medicine shortages, an effort closely linked to its preparedness for major emergencies and extraordinary events.