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ORDER OF THE GOVERNMENT OF THE REPUBLIC OF KAZAKHSTAN

of December 15, 2020 No. 850

About approval of Rules of temporary state registration of vaccines against coronavirus of COVID-19, made in the Republic of Kazakhstan

According to the subitem 9) of article 6 of the Code of the Republic of Kazakhstan of July 7, 2020 "About health of the people and health care system" and Item 1 of the Presidential decree of the Republic of Kazakhstan of March 16, 2020 "About measures for ensuring social and economic stability" the Government of the Republic of Kazakhstan DECIDES: No. 286

1. Approve the enclosed Rules of temporary state registration of vaccines against coronavirus of COVID-19, made in the Republic of Kazakhstan.

2. This resolution becomes effective from the date of its first official publication.

Prime Minister of the Republic of Kazakhstan

A. Mamin

Approved by the Order of the Government of the Republic of Kazakhstan of December 15, 2020 No. 850

Rules of temporary state registration of vaccines against coronavirus of COVID-19, made in the Republic of Kazakhstan

Chapter 1. General provisions

1. These rules of temporary state registration of vaccines against coronavirus of COVID-19, made in the Republic of Kazakhstan (further - Rules), are developed according to the subitem 9) of article 6 of the Code of the Republic of Kazakhstan of July 7, 2020 "About health of the people and health care system" (further - the Code), Item 1 of the Presidential decree of the Republic of Kazakhstan of March 16, 2020 No. 286 "About measures for ensuring social and economic stability" and determine procedure for carrying out temporary state registration of vaccines against coronavirus of COVID-19, made in the territory of the Republic of Kazakhstan for production of pilot and production lot (further - vaccine).

2. In these rules the following basic concepts are used:

1) state body in the sphere of drug circulation and medical products - the state body performing management in the sphere of drug circulation and medical products, control of drug circulation and medical products (further - state body);

2) the state expert organization in the sphere of drug circulation and medical products - the subject of the state monopoly performing production economic activity in the field of health care on safety, efficiency and qualities of medicines and medical products (further - the state expert organization);

3) vaccines - the medicines for specific prevention of infectious diseases rendering preventive effect through immune system;

4) commission of experts - the collegiate organ created in the state expert organization on consideration of documents and adoption of the conclusion about safety, quality and efficiency of vaccines;

5) the applicant - the physical or legal entity, competent to submit the application for temporary state registration of vaccines against coronavirus of COVID-19, made in the Republic of Kazakhstan;

6) the central commission on bioethics - the independent expert body under authorized body in the field of health care which is carrying out bioethical expertize of the documents connected with carrying out medical researches at stage of their planning, during the course of performance and after completion for the purpose of safety and protection of the rights of participants of medical researches.

Chapter 2. Procedure for temporary state registration of vaccines against coronavirus of COVID-19, made in the Republic of Kazakhstan

3. For temporary state registration of vaccines the applicant submits in the state expert organization the application and the list of documents in form according to appendices 1 and 2 to these rules.

4. For review of the documents submitted by the applicant the state expert organization within 1 (one) working day from the date of registration of a statement creates the commission of experts consisting from:

1) specialists and experts of the state expert organization;

2) representatives of the central commission on bioethics;

3) representatives, specialists and experts of the medical organizations;

4) representatives, specialists and experts of the profile organizations performing activities in the field of medicine, biology, microbiology, immunology and epidemiology.

5. The structure of commission of experts affirms the order of the head of the state expert organization.

As the chairman of commission of experts person not below the deputy manager of the state expert organization acts. The total quantity of members of Commission of experts is odd.

Any intervention in activities of Commission of experts is not allowed.

In case of equality of votes the voice of the chairman is decisive.

Inclusion in structure of Commission of experts, and also attraction for other form of participation in work of Commission of experts of persons who are representatives of the applicant and also persons which directly or indirectly were taking part in preparation and (or) development of vaccine is not allowed.

6. The commission of experts within 10 (ten) working days performs assessment of completeness of the submitted documents and their consideration with respect for the principles of independence, objectivity.

In case of availability of questions or notes to the submitted documents, the state expert organization sends to the applicant no more than 1 (one) working day from the date of registration of a statement, the official request (in any form) about need of provision of additional explanation and (or) elimination of the revealed notes in full in time which is not exceeding 3 (three) working days in time.

In cases of representation by the applicant of incomplete document package, and also not elimination of notes of commission of experts in the terms provided by this Item, the commission of experts issues the negative conclusion.

7. Results of holding meeting of commission of experts are drawn up by the relevant protocol and signed by all members of commission of experts.

8. Following the results of consideration and discussion the commission of experts within 1 (one) working day creates the conclusion about safety, quality and efficiency of vaccine in form according to appendix 3 to these rules.

9. The state body based on the conclusion about safety, quality and efficiency of vaccine provided by commission of experts within 1 (one) working day makes the decision on temporary state registration of vaccine for a period of 9 (nine) months or refusal in temporary state registration of vaccine.

10. In case of the positive decision the state body within 1 (one) working day issues to the applicant the temporary registration certificate in form according to appendix 4 to these rules.

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