ORDER OF THE GOVERNMENT OF THE REPUBLIC OF KAZAKHSTAN

of April 15, 2021 No. 244

About modification and amendments in the 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"

The government of the Republic of Kazakhstan DECIDES:

1. Bring in the 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" the following changes and amendments:

state heading in the following edition:

"About approval of Rules of temporary state registration of vaccines against COVID-19 coronavirus";

state Item 1 in the following edition:

"1. Approve the enclosed Rules of temporary state registration of vaccines against COVID-19 coronavirus.";

in Rules of temporary state registration of vaccines against coronavirus of COVID-19, made in the Republic of Kazakhstan, approved by the specified resolution:

state heading in the following edition:

"Rules of temporary state registration of vaccines against COVID-19 coronavirus";

state Item 1 in the following edition:

"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).";

add Item 2 with the subitem 7) of the following content:

"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.";

state Item 5 in the following edition:

"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.";

state Item 9 in the following edition:

"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.";

add with Chapter 3 following of content:

"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.";

add with Chapter 4 following of content:

"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.";

to state 1 right upper corner in annex in the following edition:

"Appendix 1

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

to state the right upper corner in annex 2 in the following edition:

"Appendix 2

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

appendix 3 and 4 to the specified Rules to be reworded as follows according to appendices 1 and 2 to this resolution;

add with appendices 5, 6 and 7 to the specified Rules according to appendices 3, 4 and 5 to this resolution.

2. This resolution becomes effective from the date of its signing and is subject to obligatory official publication.

Appendix 1

to the Order of the Government of the Republic of Kazakhstan of April 15, 2021 No. 244

Appendix 3

to Rules of temporary state registration of vaccines against COVID-19 coronavirus Conclusion about safety, quality and efficiency of vaccine

Conclusion about safety, quality and efficiency of vaccine

     1. The commission of experts reports results of examination on safety, quality and efficiency of vaccine for the purposes of temporary state registration in the Republic of Kazakhstan:

Number and date of the request
The trade name of vaccine (with indication of dosage form, dosage, concentration and amount of filling, quantity of doses in packaging for medicine)
Manufacturing organization, manufacturing country, holder of the temporary registration certificate
Conclusion of commission of experts (positive or negative)

     2. Conclusion (positive): materials and the documents of the registration file on vaccine submitted for temporary state registration in the Republic of Kazakhstan conform to requirements of Rules of temporary state registration of vaccines against COVID-19 coronavirus (further – Rules).

     The vaccine (the trade name of vaccine with indication of dosage form, dosage, concentration and amount of filling, quantity of doses in packaging) can be registered in the Republic of Kazakhstan for a period of 18 (eighteen) months.

     Conclusion (negative): materials and the documents of the registration file on vaccine submitted for temporary state registration in the Republic of Kazakhstan do not conform to the established requirements of Rules.

     The vaccine (the trade name of vaccine with indication of dosage form, dosage, concentration and amount of filling, quantity of doses in packaging) cannot be registered in the Republic of Kazakhstan.

     Head of commission of experts
     ____________      ________________________________________________
      signature                      First name, middle initial, last name (in the presence)
     Members of commission of experts
     ____________      ________________________________________________
      signature                      First name, middle initial, last name (in the presence)
      ____________       ________________________________________________
      signature                      First name, middle initial, last name (in the presence)
     ____________      ________________________________________________
      signature                      First name, middle initial, last name (in the presence).";

 

Appendix 2

to the Order of the Government of the Republic of Kazakhstan of April 15, 2021 No. 244

Appendix 4

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

Form

Coat of arms of the Republic of Kazakhstan

Ministry of Health of the Republic of Kazakhstan

The temporary registration certificate of RK-BP - No. _________

1.	Name of the holder of the registration certificate
2.	Country of the holder of the registration certificate
that medicine is registered and allowed for use in medical practice in the territory of the Republic of Kazakhstan (information on the registered medicine)
3.	Trade name of medicine
4.	For producers the trade name for export
5.	International unlicensed name (in the presence)
6.	Dosage form
7.	Dosage
8.	Packing
9.	Code анатомо - therapeutic and chemical classification
10.	Composition of active agents
11.	Storage duration
12.	Procedure for leave (according to the recipe, without recipe)

Information on producer of medicine

№	Organization type or site of production	Name of the organization	Country
1.	Producer
2.	Packer

Date of temporary state registration from "___" ______ 20 ___ years No. _____ decisions.

Really to "____" ______ 20 ___ years.

First name, middle initial, last name (in the presence) head of state body (or authorized person)

The medical application of the vaccines which received the temporary registration certificate on voluntary basis in the presence of reports of the I-II phases of clinical trials and the interim statement III of phase of researches which is carried out with inclusion at least 50 (fifty) % of the subjects of research provided by the protocol of clinical trial is allowed.

Appendix 3

to the Order of the Government of the Republic of Kazakhstan of April 15, 2021 No. 244

Appendix 5

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

Form

The statement on modification of the registration file of vaccine

1.

Trade name

in Kazakh

in Russian

in English

2.

International unlicensed name

in Kazakh

in Russian

in English

3.

Dosage form

in Kazakh

in Russian

4.

Dosage (concentration) (it is filled in the presence, the amount is filled in packaging)

concentration is specified for liquid, soft and gaseous dosage forms

5.

Анатомо - therapeutic and chemical classification

code

the name in Kazakh

the name in Russian

6.

Introduction methods

7.

Packaging (the list of values is filled in)

№

Type (primary or secondary)

Name

Size (in the presence)

Amount (in the presence)

Quantity of units in packaging

Short description

1)

Primary

2)

Intermediate (in the presence)

3)

Secondary

4)

Barcode of secondary package (GTIN) (Dzhitin) (in the presence)

specify barcode for each dosage (concentration)

8.

Complete high-quality and quantitative structure (the list of values is filled in)

№ of payment order

Substance type (active or auxiliary)

Name

Quantity per unit of dosage form

The regulating document regulating quality, or pharmacopeia with indication of year of the edition

The producer, the country and the address of the production site (for active agents)

It is controlled by the International committee on control of drugs (it is noted in the presence)

Availability of toxic agents (it is noted in the presence)

Wild-growing or cultivated (for medicinal vegetable raw materials) and the place of growth

Sign of human or animal origin (it is noted in the presence)

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