17.06.2020

On June 2, 2020, the Ukrainian parliament adopted a draft law amending certain laws of Ukraine regarding the elimination of artificial bureaucratic barriers and corruption factors in the healthcare sector.

According to the new rules, will not be recognized as a violation of patent rights the import into the customs territory of Ukraine of goods manufactured using the invention (utility model) for research and/or use of the invention (utility model) in studies conducted to prepare and submit information for the registration of a pharmaceutical product.

Also, the applicant’s link to the registration information of the original pharmaceutical product and its use in the registration materials submitted for the registration of another pharmaceutical product containing the same active substance as the original product will not be considered disclosure and unfair commercial use of the information.

Thus, pharmaceutical companies will be able to apply for registration of their generic medicines before the patent protection period for the original drugs expires, which will save them up to two years for introductions generics to the Ukrainian market.

In addition, the law introduces a permit to import vaccines for military personnel and civilian personnel of Ukrainian peacekeeping missions abroad without registering it, simplifies the import of narcotic and psychotropic drugs into Ukraine, and limits the export of donated blood and its components.