Participation in a working visit to the Republic of Poland

Roman Isaienko, Head of the State Service of Ukraine on Medicines and Drugs Control (SMDC), as a member of the delegation headed by Deputy Minister of Health of Ukraine Maryna Slobodnichenko, participated in a working visit to Warsaw to discuss European integration processes in the pharmaceutical industry during a trilateral meeting with representatives of the Swedish Medical Products Agency and the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.

This meeting was a continuation of the discussions on further cooperation to support Ukraine’s accession to the European Union, which began in December last year and was held at the invitation of the President of the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Mr. Grzegorz Cessak.

The delegates also visited the National Medicines Research Institute, whose most important tasks include medicines and medical devices quality control. The Institute together with other European control laboratories is a laboratory network that in cooperation with the European Directorate for the Quality of Medicines & Healthcare oversees the safety and quality of medicines in the EU.

In order to implement the previous agreements and formalize the intentions for future cooperation, the following bilateral documents were signed: The Memorandum of Cooperation between the Ministry of Health of Ukraine and the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (Urząd Rejestracji PL, WM and PB), as well as the Memorandum of Cooperation between the Ministry of Health of Ukraine and the Swedish Medical Products Agency (Läkemedelsverket).

According to the signed documents, the main issues of cooperation will include training and expert components in the pharmaceutical sector, sharing of best practices and legal norms, in particular in regulating circulation of medicines and medical devices. In turn, the implementation of such cooperation will contribute to strengthening the human resources potential in the negotiation process, which began on June 25, 2024, to further improve the national regulatory framework in accordance with the negotiation framework for Ukraine’s and Moldova’s EU membership prepared by the European Commission.

During the visit to the Chief Pharmaceutical Inspectorate of Poland, the parties discussed cooperation on Ukraine’s accession to the EU, assistance of Polish colleagues in developing regulations on production and import licensing of medicines, wholesale licensing, pharmacy licensing, medicines quality control and emergency response procedures.