On July 5, 2020, Law No. 644-IX "On Amending Certain Laws of Ukraine Regarding the Elimination of Artificial Bureaucratic Barriers and Corruption Factors in the Health Care Sphere" entered into force.
This law makes it possible to carry out all procedures related to the registration of generics during the patent protection of the original drug.
Among other things, this law introduces the so-called "Bolar rule", according to which it is considered a violation of the rights arising from a patent, the import into the customs territory of Ukraine in the manner prescribed by law of goods manufactured using the invention (utility model) for research and / or use of the invention (utility model) in studies conducted with the aim of preparing and presenting information for the registration of a medicinal product. It is expected that this norm will help accelerate the process of introducing generic medicines to the Ukrainian market. Also, Law No. 644-IX improves the prohibition of the export of donated blood and its components outside Ukraine.