11:24 30.01.2021

Zelensky signs law on possibility of accelerated registration of COVID-19 vaccines

2 min read
Zelensky signs law on possibility of accelerated registration of COVID-19 vaccines

President of Ukraine Volodymyr Zelensky signed the law on amendments to Ukraine's law No. 1159-IX on medicines regarding the state registration of medicines under obligations for emergency medical use, which the Verkhovna Rada adopted on January 29.

"The document establishes the possibility of accelerated state registration of vaccines or other immunobiological medicines for the specific prevention of coronavirus (COVID-19) disease in the event of such a decision being made by the central executive authority, which ensures the formation and implementation of government policy in the healthcare, for the purpose of emergency medical use with taking into account certain obligations," the presidential press service said.

The decision on accelerated state registration is made, in particular, if there is data on the successful conduct of preclinical trials or studies, individual phases of clinical trials or studies; if authorization for emergency use has been granted by the competent authority of the United States, UK, Swiss Confederation, Japan, Australia, Canada, China, India or under a centralized procedure by the competent authority of the European Union, or the vaccine or other immunobiological medicine has been re-qualified by the World Health Organization.

"It is separately stipulated that the medicine should not be developed in the aggressor state," the presidential press service said.

A registration certificate for a vaccine or medications that have passed the state registration procedure under the obligation for emergency medical use is issued for a period of one year with the possibility of renewal for another year.

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