The National Competent Authorities (NCAs) play a crucial role in European cooperation on the European Medicines Verification System (EMVS). The Danish NCA is the Danish Medicines Agency. The role of the NCA is not only national, but part of a common European responsibility to protect patients from falsified medicines.

Why is collaboration important?

Cross-country coordination
NCAs contribute to the harmonisation of processes and guidelines, so that FMD is implemented uniformly throughout the EU.

Monitoring and regulation
The authority ensures that the system works in accordance with applicable legislation and handles alerts and incidents in close dialogue with other NCAs. This means that DMVO is also audited by the Danish Medicines Agency on an equal footing with other players in the pharmaceutical supply chain in Denmark.

Strengthened patient safety
By actively participating in the EMVS network, NCAs support a secure supply chain and rapid response to potential risks not only in their own country, but across Europe.

EMVS is only strong when all parties work together. The NCAs’ role in the EMVS collaboration is both strategic and operational. This means that the authority participates in a number of activities that ensure a harmonised and effective implementation of FMD. In practice, this is done through:

Participation in European working groups and forums
The Danish Medicines Agency is represented in EMVO’s governance structure and in technical and regulatory working groups. Here, the authority contributes to the development of common guidelines, decisions on certain system changes and coordination of new requirements from NCAs.

Coordination and knowledge sharing with other NCAs
The NCA engages in an ongoing dialogue with colleagues in other EU countries to exchange experiences, best practices and solutions to common challenges. This ensures that Denmark is in line with European standards and can respond quickly to new issues.

Contribution to governance and compliance
The Danish Medicines Agency monitors that the DMVS operates in accordance with legislation and the EMVS rules. The agency has access to reporting tools that provide insight into alerts, incidents, and system performance, supporting a proactive approach to risk management.

Handling incidents and alerts
When alerts occur in the system, the Danish Medicines Agency collaborates with DMVO and other NCAs to analyse causes, make decisions and ensure that the supply chain remains secure.