Adopted the Law of Ukraine “On Amendments to Certain Legislative Acts of Ukraine Concerning the Prevention of Coronavirus Disease (COVID-19)”

Information Department
Published on 04 December 2020, at 16:00

The law shortens the terms of:

- approval of protocols of clinical trials of drugs for the treatment of coronavirus disease (COVID-19), vaccines or other medical immunobiological drugs for the specific prevention of coronavirus disease (COVID-19) and significant amendments thereto;

- examination of registration materials of these drugs and materials for making changes to them;

- decision-making on state registration or refusal to state registration of such medicinal products, as well as decision on making changes to such registration materials or refusal to make changes.

It is also specified that these provisions may apply only if such drugs, vaccines and immunobiologicals are registered with the competent authority of the United States of America, Great Britain, the Swiss Confederation, Japan, Australia, Canada, China, Israel, India, Mexico, Brazil. Either registered under the centralized procedure by the competent authority of the European Union, or undergo clinical trials in these countries (in one or more such countries).

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