RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of December 29, 2021 No. 1446

Some questions of state registration of medicines, vaccines or other medical immunobiological supplies for treatment and/or 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 medicines, vaccines or other medical immunobiological supplies for treatment and/or 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 medicines, vaccines or other medical immunobiological supplies for treatment and/or specific prevention of sharp respiratory disease of COVID-19, of SARS-CoV-2, of the delivered within the COVAX mechanism, and also the requirement to texts of instructions for application and marking of such packagings of medicines primary and secondary (in the presence), vaccines or other medical immunobiological supplies caused by coronavirus are regulated by the arrangements signed by Ukraine within the COVAX mechanism. Expert evaluation of ratio "advantage/risk" and check of registration materials concerning their authenticity in case of state registration of such medicines, vaccines or other medical immunobiological supplies which are planned to delivery to Ukraine on the COVAX mechanism and also expert evaluation in case of prolongation of effective period of the registration certificate and in case of modification of registration materials are carried out by the state company "State Expert Centre of the Ministry of Health of Ukraine" on free basis;

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