President of Ukraine Volodymyr Zelenskyy signed the Law "

The document establishes the possibility of accelerated state registration of vaccines or other medical immunobiological preparations for the specific prevention of coronavirus disease (COVID-19) in the event of such a decision by the central executive authority, which ensures the formation and implementation of state policy in the field of healthcare, with the aim of emergency medical.

Such a decision on accelerated state registration is made, in particular, if there is data on the successful conduct of preclinical trials / studies, separate phases of clinical trials / studies.; if authorization for emergency use has been granted by the competent authority of the USA, Great Britain, Swiss Confederation, Japan, Australia, Canada, People's Republic of China, India or under a centralized procedure by the competent authority of the European Union, or the vaccine or other medical immunobiological product has been re-qualified by the World Health Organization. It is separately stipulated that the drug should not be developed in the aggressor state.

In addition, the known and potential benefits of drugs must outweigh the known risks..

The registration certificate of a vaccine or medications that have passed the state registration procedure under an obligation for emergency medical use is issued for a period of one year with the possibility of renewal for another year. After the fulfillment of all the obligations provided by the applicant within the prescribed period, the validity of the registration certificate can be extended up to five years.

Inf. Official website of the President of Ukraine.