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;

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, development and/or production of which are performed in the country which is officially acknowledged Ukraine as the state aggressor, it is forbidden.

2-1. During the period of action of warlike situation and/or within six months from the date of the termination or cancellation of warlike situation to extend the term of application, import and address in the territory of Ukraine 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, effective period of registration certificates on which expired during action of warlike situation and/or within six months from the date of the termination or cancellation of warlike situation, by prolongation of effective period of the registration certificate on such medicine, vaccine or other medical immunobiological supply for one year from expiry date of the registration certificate and/or effective period of warlike situation, and/or within six months from the date of the termination or cancellation of warlike situation, with introduction of data on prolongation of effective period of the registration certificate on such medicine, vaccine or other medical immunobiological supply 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, in the State register of medicines of Ukraine.

Information on the extended validity of the registration certificate updated in the State register of medicines of Ukraine on medicine, vaccine or other medical immunobiological supply determined in paragraph one of Item 2-1 of this resolution certifies action of state registration of such medicine, vaccine or other medical immunobiological supply and does not require issue new or replacements of the existing registration certificate.

To owners of registration certificates from the date of the termination or cancellation of warlike situation, but no later than six months from the date of the termination or cancellation of warlike situation to submit to the state company "State Expert Centre of the Ministry of Health of Ukraine" the letter on prolongation of action of the registration certificate of the registered medicine, vaccine or other medical immunobiological supply 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.

3. Declare invalid the 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" (The Official Bulletin of Ukraine, 2021, No. 15, the Art. 584).

Approved by the Resolution of the Cabinet of Ministers of Ukraine of December 29, 2021 , No. 1446

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

General part

1. This Procedure establishes the mechanism of carrying out 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 (further - state registration of medicines and medical immunobiological supplies for the emergency application).

2. State registration of medicines and medical immunobiological supplies for the emergency application is performed by the Ministry of Health based on the statement and the motivated conclusion of the state company "State Expert Centre of the Ministry of Health of Ukraine" (further - the Center) by results of expert evaluation of ratio "advantage/risk" and checks of registration materials of medicines and medical immunobiological supplies concerning their authenticity taking into account certain obligations (except vaccines or other immunobiological medicines which are made in Ukraine with complete cycle or products of "in bulk").

The Ministry of Health performs state registration of medicines and medical immunobiological supplies for the emergency application in the absence of exhaustive clinical data on their safety and efficiency and on condition of accomplishment of such requirements:

the known and potential advantage of medicines and medical immunobiological supplies in case of their use for treatment and/or prevention of sharp respiratory disease of COVID-19, of SARS-CoV-2, caused by coronavirus prevails the known and potential risks of use of such medicines and medical immunobiological supplies;

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