Strengthening cooperation with partners

At the invitation of Mr. Grzegorz Cessak, President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of Poland, Head of the State Service of Ukraine on Medicines and Drugs Control (SMDC), Roman Isaienko together with Mykhailo Babenko, Director of the State Enterprise “State Expert Center of the Ministry of Health of Ukraine” and representatives of the USAID/SAFEMed project made a working visit to the Republic of Poland to discuss further cooperation in support of Ukraine’s accession to the European Union.

During the meeting, colleges had discussed the level of adaptation Ukrainian law to the EU normative documents, namely: regulations and procedures on the quality of medicines, conducting inspections on good manufacturing practice and good distributional practice. Among the issues raised, special attention was paid to the legal norms and rules for applying a unified identification code to secondary packaging, and to the medical device requirements, conditions for putting them into circulation and/or exploitation, and conducting a compliance assessment procedure.

At the same time, Head of the State Service of Ukraine on Medicines and Drugs Control informed the representatives of the Polish Office about Ukraine’s experience in legislative activities aimed at ensuring compliance with the requirements of good manufacturing practice (GMP) and good distribution practice (GDP), introduced the participants to the changes in the regulatory system and the state of European standards implementation in the pharmaceutical sector, development of the control laboratory system in Ukraine, improving the methods of medicines and medical devices control, expending international cooperation in the mentioned spheres.

The parties also discussed the possibility of initiate an EU technical assistance project within the framework of the EU Twinning institution-building instrument to adapt Ukrainian legislation on state supervision (control) to the EU legislation and improve the institutional capacity of the SMDC/Ukraine.