RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of February 8, 2021 No. 95

Some questions of state registration of vaccines or other medical immunobiological supplies for specific prevention of sharp respiratory disease of COVID-19, of SARS-CoV-2, caused by coronavirus under the obligation for the emergency medical application

According to article 9-2 of the Law of Ukraine "About medicines" the Cabinet of Ministers of Ukraine decides:

1. Approve the Procedure for state registration of vaccines or other medical immunobiological supplies for specific prevention of sharp respiratory disease of COVID-19, of SARS-CoV-2, caused by coronavirus under the obligation for the emergency medical application which is applied.

2. Determine that:

the question of responsibility of producers of vaccines or other medical immunobiological supplies for specific prevention of sharp respiratory disease of COVID-19, of SARS-CoV-2, caused by coronavirus delivered within the COVAX mechanism, and also the requirement to texts of instructions about application of such vaccines and marking of packagings of such vaccines primary and secondary (in the presence) are regulated by the arrangements signed by Ukraine within the COVAX mechanism. Carrying out expert evaluation of ratio "advantage/risk" and checks of registration materials on their authenticity in case of state registration of vaccines or other medical immunobiological supplies for specific prevention of sharp respiratory disease of COVID-19, of SARS-CoV-2, caused by coronavirus under the obligation for the emergency medical application which are planned to delivery to Ukraine on the COVAX mechanism is performed by the state company "State Expert Centre of the Ministry of Health of Ukraine" on a grant basis;

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