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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 COVID-19 coronavirus

(as amended on 23-09-2021)

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 COVID-19 coronavirus.

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 COVID-19 coronavirus

Chapter 1. General provisions

1. These rules of temporary state registration of vaccines against COVID-19 coronavirus (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 COVID-19 coronavirus 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;

7) modification of the registration file of vaccine - the procedure performed based on examination of the changes made to the registration file of vaccine during effective period of the temporary registration certificate.

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.

The meeting of commission of experts is considered competent if at it there are at least two thirds of total number of members of commission of experts, the video or audio recording of meetings is conducted. Results of meeting of commission of experts are drawn up by the relevant protocol which is signed by all members of commission of experts.

Decisions of commission of experts are made by vote by a majority vote from number of the members of commission of experts who are present at meeting.

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

The member of commission of experts is not authorized to transfer voting power to the other person, including other member of commission of experts.

The member of commission of experts who did not agree with opinion of the majority is authorized within a day from the moment of the end of meeting to give in writing the special opinion for attaching to the protocol.

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

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 18 (eighteen) months or on 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.

11. In case of the negative decision the state body within 1 (one) working day informs in written (any) form of the applicant on refusal in temporary state registration of vaccine with indication of causes of failure.

The basis for refusal is the negative conclusion of commission of experts.

12. The medical application on voluntary basis of the vaccines which received the temporary registration certificate before provision by the applicant in state body of reports of the I-II phases of clinical trials and the interim statement III of phase of the researches conducted with inclusion at least 50 (fifty) % of the subjects of research provided by the protocol of clinical trial, except for the medical application which is carried out within clinical trials is not allowed.

13. During medical application of vaccines within the conducted clinical trial or medical application of the vaccines on voluntary basis which received the temporary registration certificate by results of the I-II phases of clinical trials and the interim statement III of phase of the researches conducted with inclusion at least 50 (fifty) % of the subjects of research provided by the protocol of clinical trial state body makes the decision on suspension or cancellation of action of the temporary registration certificate in cases:

1) identifications and (or) data acquisition about emergence of undesirable reactions of vaccine;

2) identifications and (or) data acquisition about adverse ratio "advantage risk" of vaccine;

3) availability of the become effective judgment on violation of exclusive rights of the third parties on the invention or useful model.

During action of the temporary registration certificate the applicant submits complete reports of the I-II phases of clinical trials and the interim statement III of phase of the researches conducted with inclusion at least 50 (fifty) % of the subjects of research provided by the protocol of clinical trial.

14. After effective period of the temporary registration certificate the applicant represents to commission of experts the results of clinical trials on safety, quality and efficiency of vaccine received during action of the temporary registration certificate.

15. The commission of experts within 7 (seven) working days considers the data provided by the applicant.

In case of positive results of clinical trials of vaccine about its medical application, the applicant owning the temporary registration certificate undergoes the procedure of examination and state registration of medicines and medical products according to requirements of article 23 of the Code.

Chapter 3. Procedure for issue of the temporary registration certificate to the vaccines against COVID-19, coronavirus made outside the Republic of Kazakhstan

16. State body, considering epidemiological situation in the Republic of Kazakhstan, sends inquiry to the state expert organization for need of verification of presence of registration of vaccine for the country of the producer and compliance of the production site of the producer of vaccine to requirements of GMP.

The state expert organization within 3 working days from the date of registration of request from state body checks and analyzes the available information from open official, Internet resources and other sources information about:

1) registration of vaccine in the country of the producer of the applicant;

2) compliance of the production site of the producer of vaccine to requirements of GMP.

Following the results of the carried-out works the expert organization sends to state body the conclusion of the state expert organization about availability/lack of registration of vaccine in the country of the producer and compliance/discrepancy of the production site to requirements of GMP.

17. The temporary registration certificate to the vaccines against COVID-19, coronavirus made outside the Republic of Kazakhstan is issued on condition of availability of the relevant decision of the Interdepartmental commission on non-admission of origin and spread of koronovirusny infection in the territory of the Republic of Kazakhstan (the order of the Prime Minister of the Republic of Kazakhstan of January 27, 2020 to No. 10-r) and based on the conclusion of the state expert organization about availability of registration of vaccine in the country of the producer and compliance of the production site to requirements of GMP.

18. The temporary registration certificate is issued for a period of up to 8 (eight) months.

Chapter 4. Procedure for modification of the registration file of the vaccines having the temporary registration certificate

19. During action of the temporary registration certificate the applicant for modification of the registration file provides in the state expert organization:

1) the statement on modification of the registration file of vaccine in form according to appendix 5 to these rules;

2) documents according to the list of the changes made to the registration file of vaccine according to appendix 6 to these rules.

The state expert organization performs registration of a statement in day of receipt and submits the arrived documents to commission of experts.

20. The commission of experts within 10 (ten) working days from the date of document transfer for consideration 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 commission of experts directs to the applicant no more than 1 (one) working day from the date of document transfer to consideration, 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.

21. Following the results of consideration and discussion of the statement and documents the commission of experts within 1 (one) working day creates the conclusion about modification of the registration file of vaccine in form according to appendix 7 to these rules.

In cases of representation by the applicant of incomplete document package, and also elimination of the notes revealed by commission of experts in incomplete amount in the terms provided by this Item, the commission of experts issues the negative conclusion.

In cases of provision by the applicant of the statement and document package conforming to requirements of these rules commission of experts the positive conclusion is issued.

22. The state body based on the conclusion provided by commission of experts within 1 (one) working day makes the decision on modification of the registration file, with issue of the updated temporary registration certificate in form according to appendix 4 to these rules, or on refusal in modification of the registration file of vaccine.

Appendix 1

to Rules of temporary state registration of vaccines against COVID-19 coronavirus

See Appendix No. 1 (39Kb In original language)

 

Appendix 2

to Rules of temporary state registration of vaccines against COVID-19 coronavirus

The list of the documents submitted for temporary state registration of vaccines for producers of the Republic of Kazakhstan

No. of payment order

Name of documents

1

2

Part I General documentation *

IA1.

In case of production in the territory of the Republic of Kazakhstan – notarially attested certificate of GMP (in the presence). In case of production on the basis of transfer (transfer) of complete cycle or part of production and engineering procedures – notarially attested certificate of GMP.

I A2.

Copy of the state license for pharmaceutical activities (notarially attested)

I A3.

Appendix to the license

I A4.

If several producers participate in production process documents of Items of IA2, _a 3, _A4 are submitted on all participants of production

I A5.

The license agreement (agreement) on the production right (before expiration of the patent for original medicine) (in the presence)

I A6.

Notarially attested copy of the security document for the invention or useful model of original medicine (it is represented the patentee of the security document), the security document for the trademark (in the presence)

I A8.

The document confirming quality of ready-made product of three series (the certificate of the analysis, the protocol of the analysis) which one series matches series of sample of the medicine given on registration

I AND 9.

The document on prion safety on substances of animal origin from the producer

1. B.3.

The text of marking for primary and secondary packagings, stickers, labels in the Kazakh and Russian languages

Part II Chemical, pharmaceutical and biological documentation *

II

Content

II AND

Structure

II AND 1

High-quality and quantitative composition of medicine (active, excipients)

II AND 2

The document confirming quality of packaging and corking materials of ready-made product

II AND 3

Pharmaceutical development (description of AFS, excipients, medicine development, production process development, compatibility of components, surplus, stability, microbiological purity)

II IN

Data on production:

II IN 1

production formula

II IN 2

description of the production technology

II IN 3

control in production process (operational control)

II WITH

control methods of initial materials

II WITH 1

active substance

II WITH 1.1

The document confirming quality of active agent of three series (the certificate of the analysis of substance from the producer, the protocol of the analysis, the analytical passport)

II WITH 2

excipients

II WITH 2.1

quality certificates on excipients

II WITH 3

packaging material (primary and secondary package)

II WITH 3.1

quality certificates of packaging material with application of documents, regulating their quality

II D

methods of quality control of intermediate products (if necessary)

II E

specification of quality and technique of control of ready-made product

II E 1

the regulating document of the producer on quality control and safety of medicine in electronic form in the format "PDF" and (or) "doc", the explanatory note to it

II E 2

validation of techniques of testing of medicine *

II F

results of testing of stability at least than 3 (three) months **

II N

data of control on animals

II L.

the additional information confirming quality (if necessary)

Part III. Pharmacological and toxicological documentation

III.

Content

III AND.

Data on toxicity (sharp and chronic), (medical immunobiological supply – toxicity in case of single introduction and introduction of repeated doses)

3RD CENTURY.

Influence on reproductive function

III PAGE.

Data on embriotoksichnost and teratogennost

III D.

Data on mutagenicity (in the presence)

III E.

Data on carcinogenicity (in the presence)

III F.

Pharmakodinamika (for medical gene and biological supplies – results of research of reaktogennost)

III G.

Pharmacokinetics (for medical immunobiological supplies – results of specific activity)

III H.

Data on local irritant action (for medical immunobiological supplies – results of research of immunogenicity)

III Q.

The additional information confirming safety (if necessary)

Part IV. Clinical documentation ***

IV.

Content

IV AND.

Data on clinical pharmacology (pharmakodinamika, pharmacokinetics)

IV IN

Clinical, immunological efficiency

IV WITH

Diagnostic efficiency

IV D

Results of clinical trials (testing), including reports of preclinical researches, the interim statements I-II of phases of clinical trials

IV D1

Data of post-registration experience (in the presence)

IV E

The additional information confirming efficiency

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