The delegation of the Ministry of Health visited the Swedish Medical Products Agency

The delegation of the Ministry of Health of Ukraine headed by Deputy Minister for European Integration Maryna Slobodnichenko paid a working visit to Uppsala (Sweden) to familiarize itself with the work of the Swedish Medicines Agency (Läkemedelsverket). The visit took place at the invitation of Björn Eriksson, MD, Director General of the Agency.

The purpose of the trip is to familiarize and engage the experience of European partners in the structure, model, and practice of pharmacovigilance regulation of medicines, medical devices and cosmetic products that will be regulated by the new state control body (SCB) in Ukraine.

At the request of the Swedish Medical Products Agency representatives, the Deputy Minister presented the experience of managing crises and shortages of medical products during a full-scale invasion and martial law.

“Ukraine’s healthcare system is in crisis and facing new challenges caused by a full-scale war. However, despite everything, we see how the medical system has withstood and countered the threat and attacks of russia. Given the new challenges faced by the global community, there is a need to build further capacity and ability of countries to support crisis management. Therefore, this experience of Ukraine’s development and struggle is useful for global regulators. That is why we are focused on close and effective cooperation with our European partners,” said Maryna Slobodnichenko, Deputy Minister for European Integration.

During the meeting, the following issues were discussed:

• main activities and powers of the Swedish Medical Products Agency;
• personnel management;
• financing structure and fees;
• procedures for regulating medical devices and cosmetics;
• national procedure for regulating medicines;
• information systems;
• regulation and inspection of pharmacies.

During the visit, representatives of the Ukrainian side also met with the Director General of the Agency, Björn Eriksson, visited and familiarized themselves with the work of the official laboratory for quality control of medicines under the Swedish regulator, and as guests of honor joined the Director General's Dialogue - the annual report of the Agency to the employees.

During the visit, the Ministry of Health delegation and representatives of the Agency discussed possible steps of cooperation to share experience and regulatory practices. The meeting was joined by the International Department of the Ministry of Health and Social Affairs of the Kingdom of Sweden representatives.

The MoH delegation also visited the Uppsala Monitoring Center (UMC). “It is inspiring to see Ukraine’s commitment to strengthening its pharmacovigilance and regulatory systems in a challenging environment,” the UMC partners wrote about the meeting with the Ukrainian delegation.

The main areas of further development to strengthen the Ukrainian healthcare system include harmonization of Ukrainian legislation with EU legislation, creation of a single regulatory authority, localization of pharmaceutical production in Ukraine, development of clinical trials, digital integration with the EU, etc.

For reference. The Ukrainian delegation, headed by Deputy Minister for European Integration Maryna Slobodnichenko, also included representatives of the Ministry of Health of Ukraine, the State Expert Center and the SAFEMed/USAID project during the working visit to Uppsala, Sweden. The Ministry expresses its gratitude to the SAFEMed/USAID project for the support and assistance in organizing the visit.