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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;

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, development and/or production of which are performed in the state recognized by the Verkhovna Rada of Ukraine the state aggressor it is forbidden.

Prime Minister of Ukraine

D. Shmygal

Approved by the Resolution of the Cabinet of Ministers of Ukraine of February 8, 2021 , No. 95

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

1. This Procedure establishes the mechanism of carrying out 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 (further - medicines (medical immunobiological supplies), under the obligation for the emergency medical application (further - state registration of medicine (medical immunobiological supply) for the emergency application).

2. State registration of medicines (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 medicine (medical immunobiological supply) on their authenticity taking into account certain obligations.

The Ministry of Health performs state registration of medicine (medical immunobiological supply) for the emergency application in the absence of exhaustive clinical data concerning safety and efficiency of medicine (medical immunobiological supply) applied to prevention, diagnostics and treatment of sharp respiratory disease of COVID-19, of SARS-CoV-2, caused by coronavirus but in case of accomplishment of the following requirements:

it is known also the potential advantage of vaccines or other medical immunobiological supplies in case of their use for prevention of sharp respiratory disease of COVID-19, of SARS-CoV-2, caused by coronavirus exceeds the known and potential risks of use of such vaccines or other medical immunobiological supplies;

the applicant - the legal entity or physical person bearing responsibility for quality, safety and efficiency of vaccine or other medical immunobiological supply for specific prevention of sharp respiratory disease of COVID-19, of SARS-CoV-2 caused by coronavirus (further - the applicant), shall provide to the Center exhaustive data after completion of the corresponding clinical trials.

3. In the statement for state registration of medicine (medical immunobiological supply) under obligations for the emergency medical application (further - the application for state registration for the emergency application) constituted in the form given in appendix 1, which is submitted to the Ministry of Health by the applicant obligations of the applicant in the relation are specified:

carrying out post-registration researches on safety with risks concerning the medicine (medical immunobiological supply) registered for the emergency application;

carrying out post-registration researches on efficiency if the understanding of disease or clinical methodology indicates the need of essential review of the previous efficiency evaluations.

4. For the emergency application in the Center are enclosed to the application for state registration:

1) the document confirming the decision on provision of permission to the emergency application or on registration on certain conditions in the respective country or registration under certain condition with competent authority of the European Union (or other identical in fact decisions according to the applicable legislation of the United States of America, Great Britain, the Swiss Confederation, Japan, Australia, Canada, People's Republic of China, India or according to the centralized procedure competent authority of the European Union according to the national legal system of the country provision of permission or the European Union) for date of filing of application about state registration for the emergency medical application, certified by the signature of the applicant or the representative authorized by it;

2) the valuation report of medicine (medical immunobiological supply) constituted by regulatory body of the country in which medicine (medical immunobiological supply) it is registered (in the presence if such document is provided according to the legislation of the respective country; in case of lack of such document in the statement for state registration for the emergency medical application the corresponding mark becomes);

3) the document by assessment and risk management approved by the decision on provision of permission to the emergency application or on registration on certain conditions in the respective country by competent authority of the European Union (in the presence if such document is provided according to the legislation of the respective country; in case of lack of such document in the statement for state registration for the emergency application the corresponding mark becomes);

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