This was discussed during the meeting of Health Minister Viktor Lyashko with the Ambassador of the European Union to Ukraine Katarina Maternova.
“The pharmaceutical industry in Ukraine has great potential and is very competitive. Full entry into the European market will give a powerful impetus to the further development of the industry and the possibility of increasing production volumes for widespread export; European citizens will receive a range of quality medicines at competitive prices. We hope that the creation of a pharmaceutical visa-free regime will contribute to the economic development of the industry and the state,” said Minister of Health Viktor Lyashko.
GMP certification (Good Manufacture Practice) is confirmation of compliance of the production conditions of medicines with the requirements of good manufacturing practice according to international standards, which cover requirements for personnel, equipment, premises, control, storage, packaging, labeling, shipment and distribution of medicines. In Ukraine, GMP certification is carried out by the State Service of Ukraine for Medicines and Drug Control.
Now, in order to enter the EU market, Ukrainian pharmaceutical companies need to undergo double GMP checks, first in Ukraine and then at the level of EU member states. This significantly complicates the sale of Ukrainian medicines in European countries, and also affects the significant rise in prices of drugs, which makes Ukrainian pharmaceutical products uncompetitive in the EU market.
The parties also discussed issues of reforms in the pharmaceutical industry, in particular, the creation of a unified regulatory body to control the circulation of medicines, which will be created through the reorganization of the State Medical Service. It is important for Ukraine to involve EU experts to assess the compliance of such a regulator with international standards.
The issues of Ukraine’s inclusion in European networks, such as the register of medical devices in the EU and the register of verification of medicines, remain important.
In addition, it is planned to deepen cooperation on the implementation of a joint project to support mental health. In particular, Ukraine is counting on expert assistance from the EU in creating a mental support program for young Ukrainians.
Let us recall that the Ministry of Health previously reported that the recognition of GMP certificates will allow Ukrainian pharmaceutical companies to export their products to the EU market with fewer regulatory barriers, and therefore will contribute to the development of the pharmaceutical industry in Ukraine.
