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The Ministry of Health and business representatives discussed ways to optimize procedures for obtaining GMP certificates

25 January 2024

The European Business Association has sent a letter to the Ministry of Health of Ukraine regarding issues arising during the procedures for confirming compliance of the conditions for the production of medicines with the requirements of good manufacturing practice under international standards (GMP certificates). Such standards cover requirements for personnel, equipment, premises, control, storage, packaging, labeling, shipment, and distribution of medicinal products. In Ukraine, GMP certification is conducted by the State Service of Ukraine on Medicines and Drugs Control.

Together with business representatives, they discussed the possibilities of optimization (deregulation) to prevent risks associated with the supply of medicines to Ukraine.

“We take into account the position of the business; we hear the business and are open to discussing problematic issues. The Ministry of Health is ready to consider proposals from all participants of the pharmaceutical market and work out ways to solve problems together with the state control body - the State Service of Ukraine on Medicines and Drugs Control. The main priority of the Ministry of Health of Ukraine is to provide Ukrainians with high-quality, safe and effective medicines,” said Minister of Health Viktor Liashko.

According to the letters received, there are currently some delays in obtaining GMP certificates. This makes it difficult to plan a schedule for a timely supply of medicines to Ukraine.

The meeting resulted in the development of solutions to the problems raised, as well as the discussion of clear approaches to the control of medicines and obtaining GMP conclusions following European legislation and the provisions of the new Law of Ukraine “On Medicines”.