Unofficial translation
Footnote. Title as amended by the resolution of the Government of the Republic of Kazakhstan dated 15.04.2021 No. 244.In accordance with subclause 9) of article 6 of the Code of the Republic of Kazakhstan dated July 7, 2020 "On Public Health and Healthcare System" and clause 1 of the Decree of the President of the Republic of Kazakhstan dated March 16, 2020 No. 286 "On measures to ensure socioeconomic stability" the Government of the Republic of Kazakhstan HEREBY ORDERS:
1. To approve the attached Rules of temporary state registration of vaccines against Covid-19.
Footnote. Paragraph 1 as amended by the resolution of the Government of the Republic of Kazakhstan dated 15.04.2021 No. 244.2. This resolution shall come into force from the date of its first official publication.
Prime Minister of the Republic of Kazakhstan |
A. Mamin |
Approved by the Resolution of the Government of the Republic of Kazakhstan dated December 15, 2020 No. 850 |
The Rules of temporary state registration of vaccines against Covid-19
Footnote. The title as amended by the resolution of the Government of the Republic of Kazakhstan dated 15.04.2021 No. 244.
Chapter 1. General Provisions
1. These rules of temporary state registration of vaccines against Covid-19 (hereinafter referred to as the Rules) are developed in accordance with subparagraph 9) of Article 6 of the Code of the Republic of Kazakhstan dated July 7, 2020 “On the health of the people and healthcare system” (hereinafter - the Code), paragraph 1 of the Decree of the President of the Republic of Kazakhstan dated March 16, 2020 No. 286 “On measures to ensure socio-economic stability” and determine the procedure for conducting temporary state registration of vaccines against Covid-19 for production of an experimental and industrial bunch (hereinafter - the vaccine).
Footnote. Paragraph 1 as amended by the resolution of the Government of the Republic of Kazakhstan dated 15.04.2021 No. 244.2. In these Rules, the following basic concepts are used:
1) a state body in the field of circulation of pharmaceuticals and medical devices - a state body that exercises leadership in the field of circulation of pharmaceuticals and medical devices, control over the circulation of pharmaceuticals and medical devices (hereinafter referred to as the state body);
2) a state expert organization in the field of circulation of pharmaceuticals and medical devices - a state monopoly entity carrying out production and economic activities in the field of public health to ensure the safety, efficiency and quality of pharmaceuticals and medical devices (hereinafter referred to as the state expert organization);
3) vaccines - medicinal products for specific prophylaxis of infectious diseases, providing a preventive effect through the immune system;
4) expert commission – a collegial body, created in a state expert organization, for consideration of documents and making a conclusion on the safety, quality and efficacy of vaccines;
5) an applicant – an individual or legal entity entitled to apply for temporary state registration of coronavirus COVID-19 vaccines produced in the Republic of Kazakhstan;
6) central bioethics commission – an independent expert body under the authorized body in the field of health, conducting a bioethical examination of documents related to the conduct of medical research, at the stage of their planning, during their implementation and after completion in order to ensure the safety and protection of the rights of participants in medical research;
7) amendments to the registration dossier of the vaccine - the procedure carried out on the basis of an examination of the changes made to the registration dossier of the vaccine during the validity period of the temporary registration certificate.
Footnote. Paragraph 2 as amended by the resolution of the Government of the Republic of Kazakhstan dated 15.04.2021 No. 244.Chapter 2. Procedure for temporary state registration of coronavirus COVID-19-vaccines produced in the Republic of Kazakhstan
3. For temporary state registration of vaccines, the applicant shall submit to the state expert examination an application and a list of documents in the form, according to Appendices 1 and 2 to these Rules.
4. To consider the documents submitted by the applicant, the state expert organization, within 1 (one) business day from the date of registration of the application, shall form an expert commission, consisting of:
1) specialists and experts of the state expert organization;
2) representatives of the central bioethics commission;
3) representatives, specialists and experts of medical organizations;
4) representatives, specialists and experts of specialized organizations operating in the field of medicine, biology, microbiology, immunology and epidemiology.
5. The structure of the expert commission is approved by order of the head of the state expert organization.
The chairman of the expert commission is a person not lower than the deputy head of the state expert organization. The total number of members of the expert commission is odd.
The meeting of the expert commission is considered competent if at least two-thirds of the total number of members of the expert commission is present, a video or audio recording of meetings is made. The results of the meeting of the expert commission are drawn up by the relevant protocol, which is signed by all members of the expert commission.
The decisions of the expert commission are made by voting by a majority vote of the number of members of the expert commission present at the meeting.
With the equality of votes, the chairman's voice is decisive.
A member of the expert commission is not authorized to transfer the right to vote to another person, including another member of the expert commission.
A member of the expert commission, who did not agree with the opinion of the majority, is authorized within a day from the date of end of the meeting to submit in writing his special opinion for introduction to the protocol.
Any interference in the activities of the expert commission is not allowed.
It is not allowed to include in the expert commission, as well as the involvement of persons who are representatives of the applicant, as well as persons who directly or indirectly participated in the preparation and (or) development of the vaccine, for a different form of participation in the work of the expert commission.
Footnote. Paragraph 5 as amended by the resolution of the Government of the Republic of Kazakhstan dated 15.04.2021 No. 244.6. The expert commission within 10 (ten) working days shall assess the completeness of the submitted documents and their consideration in compliance with the principles of independence, objectivity.
If there are any questions or comments to the submitted documents, the state expert organization shall send the applicant, within a period of not more than 1 (one) business day from the date of registration of the application, an official request (in any form) about the need to provide additional clarification and (or) eliminate the identified comments in in full within a period not exceeding 3 (three) working days.
In cases where the applicant submits an incomplete package of documents, as well as the failure to eliminate the comments of the expert commission within the time limits provided for by this paragraph, the expert commission shall issue a negative opinion.
7. The results of the meeting of the expert commission shall be drawn up by the appropriate protocol and signed by all members of the expert commission.
8. Based on the results of consideration and discussion, the expert commission, within 1 (one) working day, shall form a conclusion on the safety, quality and effectiveness of the vaccine in the form according to Appendix 3 to these Rules.
9. The state body, on the basis of the conclusion on the security, quality and efficiency of the vaccine, submitted by the expert commission, within 1 (one) working day, decides on temporary state registration of the vaccine for a period of 18 (eighteen) months or refuses the temporary state registration of the vaccine.
Footnote. Paragraph 9 as amended by the resolution of the Government of the Republic of Kazakhstan dated 15.04.2021 No. 244.10. In case of a positive decision, the state body within 1 (one) working day shall issue a temporary registration certificate to the applicant in the form according to Appendix 4 to these Rules.
11. In the event of a negative decision, the state body within 1 (one) working day shall notify the applicant in writing (arbitrary) of the refusal of the temporary state registration of the vaccine, indicating the reasons for the refusal.
The grounds for the refusal shall be the negative conclusion of the expert commission.
12. Medical use on a voluntary basis of vaccines that have received a temporary registration certificate before the applicant submits to the state body reports of phases I-II of clinical trials and an interim report of phase III of studies conducted with the inclusion of at least 50 (fifty)% of research subjects provided for by the protocol of the clinical trial shall not be allowed , except for medical use conducted within the framework of clinical trials.
13. In the course of medical use of vaccines in the framework of an ongoing clinical trial or medical use of vaccines on a voluntary basis, who have received a temporary marketing authorization based on the results of phases I-II clinical trials and an interim report of phase III studies conducted with the inclusion of at least fifty (50)% of research subjects stipulated by the clinical trial protocol, the state body shall make a decision to suspend or cancel the validity of the temporary marketing authorization in cases:
1) revealing and (or) obtaining data on the occurrence of adverse vaccine reactions;
2) revealing and (or) obtaining data on the unfavorable benefit-risk ratio of the vaccine;
3) the presence of a court decision that has entered into force on the violation of the exclusive rights of third parties to an invention or utility model.
During the period of validity of the temporary registration certificate, the applicant shall submit full reports of phases I - II of clinical trials and an interim report of phase III of studies conducted with the inclusion of at least 50 (fifty)% of the research subjects provided for by the protocol of the clinical trial.
14. Upon the expiration of the temporary registration certificate, the applicant shall submit to the expert commission the results of clinical studies on the safety, quality and efficacy of the vaccine obtained during the validity period of the temporary registration certificate.
15. The expert commission within 7 (seven) working days shall consider the information submitted by the applicant.
In case of positive results of clinical trials of a vaccine on its medical use, the applicant, who owns a temporary registration certificate, shall undergo the examination procedure and state registration of medicines and medical devices in accordance with the requirements of Article 23 of the Code.
Chapter 3. Procedure for issuance of a temporary registration certificate to vaccines against Covid-19, produced outside the Republic of Kazakhstan
Footnote. The rules are supplemented by Chapter 3 in accordance with the resolution of the Government of the Republic of Kazakhstan dated 15.04.2021 No. 244.
16. The state body, taking into account the epidemiological situation in the Republic of Kazakhstan, sends a request to the state expert organization on the need to verify the availability of registration of the vaccine in the country of the manufacturer and the compliance of the manufacturer of the vaccine with the requirements of the GMP.
The state expert organization within 3 (three) working days from the date of registration of a request from a state body checks and analyzes the available information from open official, Internet resources and other sources about:
1) registration of the vaccine in the country of the applicant-manufacturer;
2) compliance of the manufacturer of the vaccine with the requirements of GMP.
According to the results of the work, the expert organization sends the opinion of the state expert organization to the state body on the presence/absence of registration of the vaccine in the country of the manufacturer and the compliance/non-compliance of the production site with the requirements of the GMP.
17. Temporary registration certificate of vaccines against Covid-19, produced outside the Republic of Kazakhstan, is issued provided that the relevant decision of the interdepartmental commission for prevention and non-spread of the coronavirus infection in the Republic of Kazakhstan is available (order of the Prime Minister of the Republic of Kazakhstan dated January 27, 2020 No. 10-p) and on the basis of the opinion of the state expert organization on the availability of registration of the vaccine in the country of the manufacturer and the compliance of the production site with the requirements of GMP.
18. A temporary registration certificate is issued for up to 8 (eight) months.
Chapter 4. Procedure for amending the registration dossier of vaccines with a temporary registration certificate
Footnote. The rules are supplemented by Chapter 4 in accordance with the resolution of the Government of the Republic of Kazakhstan dated 15.04.2021 No. 244.
19. During the validity period of temporary registration certificate, the applicant for amendments to the registration dossier submits to the state expert organization:
1) an application for amendments to the registration dossier of the vaccine in the form in accordance with Appendix 5 to these Rules;
2) documents in accordance with the list of changes made to the registration dossier of the vaccine, in accordance with Appendix 6 to these Rules.
The state expert organization registers the application on the day of receipt and submits the documents received to the expert commission for consideration.
20. The expert commission within 10 (ten) working days from the date of submission of documents for consideration assesses the completeness of the submitted documents and their consideration in compliance with the principles of independence, objectivity.
If there are questions or comments on the documents submitted, the expert commission sends to the applicant within no more than 1 (one) working day from the date of submission of documents for consideration, the official request (in any form) on the need to provide additional clarification and (or) eliminate the revealed comments in full at a time not exceeding 3 (three) working days.
21. According to the results of the consideration and discussion of the application and documents, the expert commission within 1 (one) working day forms a conclusion on amendments to the registration dossier of the vaccine in the form in accordance with Appendix 7 to these Rules.
In cases when the applicant submits an incomplete package of documents, as well as not full elimination of the comments revealed by the expert commission, a negative conclusion is issued by the expert commission.
In cases where the applicant submits an application and a package of documents that meet the requirements of these Rules, the expert commission issues a positive conclusion.
22. The state body on the basis of the conclusion submitted by the expert commission within 1 (one) working day decides to amend the registration dossier, with the issuance of an updated temporary registration certificate in accordance with Appendix 4 to these Rules, or refuses to amend the registration dossier of the vaccine.
Appendix 1 to the Rules of temporary state registration of vaccines against Covid-19 |
Footnote. The text in the upper right corner of Appendix 1 as amended by the resolution of the Government of the Republic of Kazakhstan dated 15.04.2021 No. 244.
Form |
Application for temporary state registration of a vaccine
1. | Type of procedure | Temporary registration | ||||||||||||||||
2. | Trade name | in Kazakh | ||||||||||||||||
in Russian | ||||||||||||||||||
in English | ||||||||||||||||||
3. | International Non-proprietary Name | in Kazakh | ||||||||||||||||
in Russian | ||||||||||||||||||
in English | ||||||||||||||||||
4. | Pharmaceutical form | in Kazakh | ||||||||||||||||
in Russian | ||||||||||||||||||
5. | Dosage (concentration) (filled if available, volume filled in the package) | The concentration is indicated for liquid, soft and gaseous dosage forms. | ||||||||||||||||
6. | Anatomical-therapeutic-chemical classification | Сode | ||||||||||||||||
Name in Kazakh | ||||||||||||||||||
Name in Russian | ||||||||||||||||||
7. | Type of medicinal product (to be filled in for the corresponding medicinal product, only one type of medicinal product is selected) | |||||||||||||||||
1) | ||||||||||||||||||
2) | ||||||||||||||||||
8. | Form of dispensing in the country of the applicant |
Prescribed by a doctor; | ||||||||||||||||
9. | Methods of administration | |||||||||||||||||
10. | Information about devices for administration | |||||||||||||||||
11. | Packing (complete the list of values) | |||||||||||||||||
№ | Type (primary or secondary) | Name | Size (if available) | Volume (if available) | Number of units in a package | Brief description | ||||||||||||
1) | Primary | |||||||||||||||||
2) | Intermediate (if available) | |||||||||||||||||
3) | Secondary | |||||||||||||||||
4) | Secondary Packaging Barcode (GTIN) (if available) | Indicate barcode for each dosage (concentration) | ||||||||||||||||
12. | Complete qualitative and quantitative composition (complete the list of values) | |||||||||||||||||
Item No. | Type of substance (active or auxiliary) | Name | Quantity per unit of a pharmaceutical form | Normative document regulating quality, or pharmacopoeia indicating the year of publication | Manufacturer, country and address of the production site (for active substances) | Controlled by the International Narcotics Control Board (marked if available) | The presence of toxic substances (marked if available) | Wild or cultivated (for medicinal plant materials) and place of growth | Marker of human or animal origin (marked if available) | |||||||||
1) | Active | II tab.III tab.IV tab. | 1 list 2 list | |||||||||||||||
2) | Auxiliary | |||||||||||||||||
13. | Name of active pharmaceutical substance | |||||||||||||||||
14. | Shelf life of a pharmaceutical product | suggested shelf life | ||||||||||||||||
suggested period of use (after the first opening of the container) | ||||||||||||||||||
suggested period of use (after dissolution or dilution) | ||||||||||||||||||
15. | Transportation conditions | |||||||||||||||||
16. | Storage conditions | Suggested storage conditions | ||||||||||||||||
Suggested storage conditions after the first opening of a package | ||||||||||||||||||
17. | Title of protection for the invention or a utility model, trade mark (if available) | |||||||||||||||||
Name of the title of protection | No. of the title of protection | Date of issue | Time limit for issuance | |||||||||||||||
18. | Production |
1) completely in the given production; | ||||||||||||||||
19. | Manufacturer (s) of the medicinal product and production site (s) (including the production areas of any component (including the solvent of the dosage form) that is part of the medicinal product) | |||||||||||||||||
Item No. | Type of manufacturer | Name, country (in Kazakh, Russian, English) | No., date and validity period of the authorization document | Legal address | Current address | Telephone, fax, e-mail | Surname, name, patronymic (if available), position of the head | Surname, name, patronymic (if available), position of the contact person | ||||||||||
1) | Manufacturer | |||||||||||||||||
2) | Packing company | |||||||||||||||||
3) | primary | |||||||||||||||||
4) | secondary | |||||||||||||||||
5) | Manufacturer exercising quality control | |||||||||||||||||
6) | Manufacturer responsible for batches release | |||||||||||||||||
7) | License holder | Data on the production license issued by the authorized body of the manufacturer's country | ||||||||||||||||
8) | Registration certificate holder | |||||||||||||||||
9) | Applicant or representative office | Data according to the power of attorney | ||||||||||||||||
10) | Authorized person for pharmacovigilance in the Republic of Kazakhstan | |||||||||||||||||
20. | Laboratory of the country of origin for quality control of blood products and vaccines, responsible for quality control (batch release) | |||||||||||||||||
1) | name of the laboratory | |||||||||||||||||
2) | address of the place of business | |||||||||||||||||
3) | Country | |||||||||||||||||
4) | Telephone/fax | |||||||||||||||||
5) | ||||||||||||||||||
22. | Data on the Agreement for the examination of medicines | |||||||||||||||||
1) | Agreement No. | |||||||||||||||||
2) | Date of conclusion | |||||||||||||||||
3) | Validity period | |||||||||||||||||
23. | Entity that performs payment for the examination | |||||||||||||||||
1) | Name | |||||||||||||||||
2) | Country | |||||||||||||||||
3) | Legal address | |||||||||||||||||
4) | Current address | |||||||||||||||||
5) | Surname, name, patronymic (if available), position of the head | |||||||||||||||||
6) | Telephone | |||||||||||||||||
7) | Fax | |||||||||||||||||
8) | ||||||||||||||||||
9) | Business identification number | |||||||||||||||||
10) | Individual identification number | |||||||||||||||||
11) | Bank | |||||||||||||||||
12) | Current account | |||||||||||||||||
13) | Foreign currency account | |||||||||||||||||
14) | Code | |||||||||||||||||
15) | Bank identification code | |||||||||||||||||
Applicant: __________________________________________________________________________ | ||||||||||||||||||
Date | ||||||||||||||||||
Surname, name, patronymic and position of the responsible person of the Applicant | ||||||||||||||||||
Signature |
Appendix 2 to the Rules of temporary state registration of vaccines against COVID-19 |
Footnote. The text in the upper right corner of Appendix 2 as amended by the resolution of the Government of the Republic of Kazakhstan dated 15.04.2021 No. 244.
The list of documents submitted for temporary state registration of vaccines for manufacturers of the Republic of Kazakhstan
Footnote. The list - as amended by the resolution of the Government of the Republic of Kazakhstan dated 23.09.2021 No. 668 (shall be enforced from the day of its first official publication.).
№ | Names of documents |
1 | 2 |
Part I General documentation* | |
IA1. | For production in the territory of the Republic of Kazakhstan - a notarized GMP certificate (if any). For production based on the transfer (transfer) of the full cycle or part of production and technological processes - a notarized GMP certificate. |
I А2. | A copy of the state license for pharmaceutical activities (notarized) |
I А3. | Appendix to the license |
I А4. | If several manufacturers are involved in the production process, the documents of paragraphs IA2, IA3, IA4 are submitted for all production participants |
I А5. | Licensed agreement (contract) for the right of production (before the expiration of the patent for the original drug) (if any) |
I А6. | A notarized copy of the security document for the invention or useful model of the original medicinal product (submitted by the patent holder of the security document), the security document for the trademark (if any) |
I А8. | A document confirming the quality of the finished product of three series (analysis certificate, analysis protocol), one series of which coincides with a series of a sample of the drug submitted for registration |
I А 9. | Prion security document for animal substances from the manufacturer |
1.В.3. | The text of the labeling for primary and secondary packages, stickers, labels in Kazakh and Russian |
Part II Chemical, pharmaceutical and biological documentation* | |
II | Content |
II А | Composition |
II А 1 | Qualitative and quantitative composition of the drug (active, excipients) |
II А 2 | A document confirming the quality of the packaging and sealing materials of the finished product |
II А 3 | Pharmaceutical development (description of APS, excipients, development of the drug, development of the production process, compatibility of components, surplus, stability, microbiological purity) |
II В | Information about production: |
II В 1 | Production formula |
II В 2 | Description of production technology |
II В 3 | Control in the production process (operational control) |
II С | Methods for monitoring the source materials |
II С 1 | Active substance |
II С 1.1 | A document confirming the quality of the active substance of three series (certificate of analysis of the substance from the manufacturer, analysis protocol, analytical passport) |
II С 2 | Excipients |
II С 2.1 | Quality certificates for excipients |
II С 3 | Packaging material (primary and secondary packaging) |
II С 3.1 | Certificates of the quality of packaging material with the application of documents governing their quality |
II D | The quality control methods of intermediate products (if necessary) |
II Е | Specification of the quality and methodology of controlling the finished product |
II E 1 | The regulatory document of the manufacturer for quality control and safety of the drug in electronic form in the "PDF" and (or) "DOC" format, an explanatory note to it |
II E 2 | Validation of testing methods for the drug* |
II F | Stability test results for a period of at least 3 (three) months** |
II Н | Animal control data |
II L. | Additional information confirming quality (if necessary) |
Part III. Pharmacological and toxicological documentation | |
III. | Content |
III А. | Data on toxicity (acute and chronic), (medical immunobiological drug - toxicity with a single introduction and introduction of repeated doses) |
III В. | Impact on reproductive function |
III С. | Data on embryotoxicity and teratogenicity |
III D. | Data on mutagenicity (if any) |
III Е. | Data on carcinogenicity (if any) |
III F. | Pharmacodynamics (for medical genetically biological preparations - the results of a study of reactogenicity) |
III G. | Pharmacokinetics (for medical immunobiological drugs - the results of specific activity) |
III H. | Data on local irritating effects (for medical immunobiological drugs - the results of the study of immunogenicity) |
III Q. | Additional information confirming security (if necessary) |
Part IV. Clinical documentation *** | |
IV. | Content |
IV А. | Clinical pharmacology data (pharmacodynamics, pharmacokinetics) |
IV В | Clinical, immunological efficiency |
IV С | Diagnostic efficiency |
IV D | The results of clinical studies (tests), including preclinical research reports, intermediate reports of the I - II phases of clinical studies |
IV D1 | Data of post-registration experience (if any) |
IV E | Additional information confirming the efficiency |
For production based on the transfer (transfer) of the full cycle or part of production and technological processes, the registration dossier is additionally attached with: |
Note:
* For pharmacopeic techniques, verification data are presented;
** In the event of emergency situations of a natural or technogenic nature and eliminating their consequences, organization and conduct of sanitary-anti-epidemic and sanitary-preventive measures and the related restrictive measures, including quarantine, a domestic producer of a vaccine against Covid-19 when making changes to the registration dossier provides the following:
the results of stability studies conducted in the manner prescribed by the Rules for the Medicine Stability, Storage and Re-Control of drugs, approved by the order of the Minister of Health of the Republic of Kazakhstan dated October 28, 2020 No. ҚР ДСМ 165/2020 (registered in the Register of state registration of regulatory legal acts under No. 21545), in 1 (one) month after the release of 3 (three) consecutive industrial series;
a guarantee obligation to provide the results of stability studies conducted after 3 (three) and 6 (six) months for 3 (three) consecutive industrial series after the completion of stability studies.
*** the approved research protocol, the approved study report, the permission of the state body to conduct a study (if any), the approval of the ethical commission, a copy of the sponsor liability agreement and (or) the research center, in the event of harm to the life and health of the subject of the study, a copy of individual registration maps of the subjects of the study (for international, multicenter clinical studies of 20%), chromatograms (when providing a study of bioequivalence), copies of contracts between the sponsor of clinical research and the research center (contract research organization) (if necessary after the removal of confidential information); the approved research protocol, the approved study report, the permission of the state body to conduct a study (if any), the approval of the ethical commission, a copy of the sponsor liability agreement and (or) the research center, in the event of harm to the life and health of the subject of the study, a copy of individual registration cards of the subjects of the study (for international, multicenter clinical studies - 20%), chromatograms (when providing a study of bioequivalence), copies of contracts between the sponsor of clinical research and the research center (contract research organization) (if necessary after the removal of confidential information);
**** a warranty obligation to submit a report on the validation of production processes conducted on 3 (three) consecutive industrial series within 7 (seven) days after the completion of validation.
Appendix 3 to the Rules of temporary state registration of vaccines against COVID-19 |
Footnote. Appendix 3 as amended by the resolution of the Government of the Republic of Kazakhstan dated 15.04.2021 No. 244.
Conclusion on the safety, quality and effectiveness of the vaccine
1. The expert commission reports the results of the examination for safety, quality and effectiveness of the vaccine for the purposes of temporary state registration in the Republic of Kazakhstan:
Number and date of application | |
The trade name of the vaccine (indicating the dosage form, dosage, concentration and volume of filling, the number of doses in the package for the drug) | |
Organization-manufacturer, country-manufacturer, holder of a temporary registration certificate | |
The conclusion of the expert commission (positive or negative) |
2. Conclusion (positive): materials and documents of the registration dossier to the vaccine presented for temporary state registration in the Republic of Kazakhstan, meet the requirements of the Rules of temporary state registration of vaccines against Covid-19 (hereinafter - the Rules).
The vaccine (the commercial name of the vaccine indicating the dosage form, dosage, concentration and volume of filling, the number of doses in the package) may be registered in the Republic of Kazakhstan for a period of 18 (eighteen) months.
Conclusion (negative): materials and documents of registration dossier to the vaccine presented for temporary state registration in the Republic of Kazakhstan do not meet the established requirements of the Rules.
The vaccine (the commercial name of the vaccine indicating the dosage form, dosage, concentration and volume of filling, the number of doses in the package) may not be registered in the Republic of Kazakhstan.
Head of the expert commission
____________ ________________________________________________
signature name, surname, patronymic (if any)
Members of the expert commission
____________ ________________________________________________
signature name, surname, patronymic (if any)
____________ ________________________________________________
signature name, surname, patronymic (if any)
____________ ________________________________________________
signature name, surname, patronymic (if any)
Appendix 4 to the Rules of temporary state registration of vaccines against COVID-19 |
Footnote. Appendix 4 as amended by the resolution of the Government of the Republic of Kazakhstan dated 15.04.2021 No. 244.
Form |
Coat of arms of the Republic of Kazakhstan
Ministry of Health of the Republic of Kazakhstan
Temporary registration certificate РК-БП - №_________
1. | Name of the holder of the registration certificate | |
2. | Country of the holder of the registration certificate | |
To certify that the drug is registered and allowed for use in medical practice in the territory of the Republic of Kazakhstan (information on a registered drug) | ||
3. | Trade name of the drug | |
4. | For manufacturers, the trade name for exports | |
5. | International nonproprietary name (if any) | |
6. | Dosage form | |
7. | Dosage | |
8. | Packing | |
9. | The code of anatomical and therapy-chemical classification | |
10. | The composition of active substances | |
11. | Shelf life | |
12. | The issue procedure (by prescription, no prescription) |
Information about the manufacturer of the drug
№ | Type of organization or production site | Name of organization | Country |
1. | Manufacturer | ||
2. | Packer |
The date of temporary state registration “___” ______ 20___ No. _____ of the decision.
Valid until ____ ______ 20___.
FULL NAME (if any) of the head of the state body (or authorized person)
Medical use of vaccines that received a temporary registration certificate on a voluntary basis is allowed, in the presence of reports on the I - II phases of clinical research and intermediate report of the III phase of research conducted with the inclusion of at least 50 (fifty) % of the research subjects provided for by the protocol of clinical research.
Appendix 5 to the Rules of temporary state registration of vaccines against COVID-19 |
Footnote. The Rules are supplemented by Appendix 5 in accordance with the resolution of the Government of the Republic of Kazakhstan dated 15.04.2021 No. 244.
Form |
Application for amendments to the registration dossier of the vaccine
1. | Trade name | in Kazakh | |||||||||||||||||
in Russian | |||||||||||||||||||
in English | |||||||||||||||||||
2. | International nonproprietary name | in Kazakh | |||||||||||||||||
in Russian | |||||||||||||||||||
in English | |||||||||||||||||||
3. | Dosage form | in Kazakh | |||||||||||||||||
in Russian | |||||||||||||||||||
4. | Dosage (concentration) (filled out if any, the volume is filled in the package) | The concentration is indicated for liquid, soft and gaseous dosage forms | |||||||||||||||||
5. | Anatomical and therapy-chemical classification | Code | |||||||||||||||||
Name in Kazakh | |||||||||||||||||||
Name in Russian | |||||||||||||||||||
6. | Methods of introduction | ||||||||||||||||||
7. | Packaging (fill out a list of values) | ||||||||||||||||||
№ | Form (primary or secondary) | Name | Size (if any) | Volume (if any) | Number of units in a package | Brief description | |||||||||||||
1) | Primary | ||||||||||||||||||
2) | Intermediate (if any) | ||||||||||||||||||
3) | Secondary | ||||||||||||||||||
4) | Barcode of secondary packaging (GTIN) (if any) | Indicate the barcode for each dosage (concentration) | |||||||||||||||||
8. | Full qualitative and quantitative composition (a list of values is filled out) | ||||||||||||||||||
№ | Type of substance (active or excipient) | Name | Number per unit of dosage form | Normative document regulating the quality, or pharmacopeia indicating the year of publication | Manufacturer, country and address of the production site (for active substances) | Controlled by the International Committee for Drug Control (noted if any) | The presence of toxic substances (noted if any) | Wild or cultivated (for medicinal plant material) and the place of growth | A sign of human or animal origin (noted if any) | ||||||||||
1) | Active |
II tab. |
1-list | ||||||||||||||||
2) | Excipient | ||||||||||||||||||
9. | Shelf live of the drug | The proposed shelf life | |||||||||||||||||
The proposed period of application (after the first opening of the container) | |||||||||||||||||||
The proposed period of application (after dissolution or dilution) | |||||||||||||||||||
10. | Transportation conditions | ||||||||||||||||||
11. | Storage conditions | The proposed storage conditions | |||||||||||||||||
The proposed storage conditions after the first opening of the packaging | |||||||||||||||||||
12. | Security document for an invention or useful model, trademark (if any) | ||||||||||||||||||
Name of security document | № of security document | Date of issue | Time period for issuing | ||||||||||||||||
13. | Production |
1) completely at this production; | |||||||||||||||||
14. | The manufacturer (s) of the drug and the site (s) of production (including areas of production of any component (including a solvent of the dosage form), which is part of the drug) | ||||||||||||||||||
№ | Type of manufacturer | Name, country (in Kazakh, Russian, English) | №, date and validity of the permits | Legal address | Actual address | Telephone, fax, e-mail | Name, surname, patronymic (if any), position of the head | Name, surname, patronymic (if any), position of the contact person | |||||||||||
1) | Manufacturer | ||||||||||||||||||
2) | Enterprise –packer | ||||||||||||||||||
3) | Primary | ||||||||||||||||||
4) | Secondary | ||||||||||||||||||
5) | Quality control manufacturer | ||||||||||||||||||
6) | Manufacturer responsible for the release of the series | ||||||||||||||||||
7) | License holder | Data on production license issued by the authorized body of the country of the manufacturer | |||||||||||||||||
8) | Holder of the registration certificate | ||||||||||||||||||
9) | Applicant or representative office | Data on power of attorney | |||||||||||||||||
10) | Authorized person for implementation of the pharmacological control in the Republic of Kazakhstan | ||||||||||||||||||
15. | Laboratory of the country-manufacturer for quality control of blood products and vaccines, responsible for quality control (release of series) | ||||||||||||||||||
1) | Name of laboratory | ||||||||||||||||||
2) | address of the place of activity | ||||||||||||||||||
3) | Country | ||||||||||||||||||
4) | tel/fax | ||||||||||||||||||
5) | e- mail | ||||||||||||||||||
16. | Changes made to the registration dossier of the drug (indicate the changes made) | ||||||||||||||||||
Type of changes | Before changes | The changes made | |||||||||||||||||
17. | Data on the contract for examination of drugs | ||||||||||||||||||
1) | № of contract | ||||||||||||||||||
2) | Date of conclusion | ||||||||||||||||||
3) | Period of validity | ||||||||||||||||||
18. | Subject that paid for the examination | ||||||||||||||||||
1) | Name | ||||||||||||||||||
2) | Country | ||||||||||||||||||
3) | Legal address | ||||||||||||||||||
4) | Actual address | ||||||||||||||||||
5) | FULL NAME. (if any), position of the head | ||||||||||||||||||
6) | Telephone | ||||||||||||||||||
7) | Fax | ||||||||||||||||||
8) | |||||||||||||||||||
9) | Business identification number | ||||||||||||||||||
10) | Individual identification number | ||||||||||||||||||
11) | Bank | ||||||||||||||||||
12) | Operating account | ||||||||||||||||||
13) | Foreign currency account | ||||||||||||||||||
14) | The code | ||||||||||||||||||
15) | Bank identification code | ||||||||||||||||||
Applicant: _____________________________________________________ | |||||||||||||||||||
Date | |||||||||||||||||||
Full name and position of the executive person and the applicant | |||||||||||||||||||
Signature |
Appendix 6 to the Rules of temporary state registration of vaccines against COVID-19 |
Footnote. The Rules are supplemented by Appendix 6 in accordance with the resolution of the Government of the Republic of Kazakhstan dated 15.04.2021 No. 244.
Form |
List of changes made to the registration dossier of the vaccine
А. Administrative changes
А.1 Changing the name and (or) address of the holder of the registration certificate | Conditions | Documents and data | Procedure | |
а) the holder of the registration certificate does not change | 1 | 1, 2 | IA | |
б) changing the holder of the registration certificate | 2, 3, 4 | IB | ||
Conditions | ||||
Documentation | ||||
А.2 Changing (trade) name of the drug | Conditions | Documents and data | Procedure | |
Drugs | 1 | 1, 2, 3, 4, 5 | IB | |
Conditions | ||||
Documentation | ||||
А.3 Changing the name of active pharmaceutical substance or excipient | Conditions | Documents and data | Procedure | |
1 | 1, 2 | IA | ||
Conditions | ||||
Documentation | ||||
А.4 Changing the name and (or) addresses: the manufacturer (including, if applicable, quality control sites) or the holder of the master file of an active pharmaceutical substance (hereinafter referred to as MFAPS), or the supplier of active pharmaceutical substance, source materials, reagents or intermediate products used in production of active pharmaceutical substance (if indicated in the technical dossier), if the registration dossier does not have certificates of conformity PH. Eur., or manufacturer of a new auxiliary substance (if indicated in the technical dossier) | Conditions | Documents and data | Procedure | |
1 | 1, 2, 3 | IA | ||
Conditions | ||||
Documentation | ||||
А.5 Changing the name and (or) address of the manufacturer of the drug, including production sites and quality control sites | Conditions | Documents and data | Procedure | |
а) the actions for which the manufacturer (importer) is responsible, include the release of the series | 1 | 1, 2, 3 | IA | |
b) the actions for which the manufacturer/importer is responsible, do not include the release of series | 1 | 1, 2, 3 | IA | |
Conditions | ||||
Documentation | ||||
А.6 | Change of the code of anatomical and therapy-chemical (hereinafter-ATC) classification | Conditions | Required documentation | Type of procedure |
1 | 1, 2 | IВ | ||
Conditions | ||||
Documentation | ||||
А.7 | Exclusion of the production site (including for active pharmaceutical substance, intermediate products, a drug, a packager, a manufacturer responsible for the release of a series, quality control of the series or supplier of the source material, reagent or excipient (if indicated in the dossier) | Conditions | Required documentation | Type of procedure |
1, 2 | 1, 2 | IA | ||
Conditions | ||||
Documentation | ||||
A.8 Changing the audit date for verification of the compliance of the manufacturer of active pharmaceutical substance to the Rules of proper production practice of the Republic of Kazakhstan | Conditions | Required documentation | Type of procedure | |
1 | IA | |||
Documentation |
Б. Change of the quality
Б.I Active pharmaceutical substance
Б.I. а) production
Б.I.а.1 A change in the manufacturer of the source material/reagent/intermediate product used in the process of production of active pharmaceutical substance (APS), or a change in the manufacturer of the APS (including, if applicable, quality control sites), if there is no certificate of compliance with the European pharmacopei in the registration dossier. | Conditions | Required documentation | Type of procedure |
а) the proposed manufacturer belongs to the same pharmaceutical group as the approved manufacturer | 1, 2, 3 | 1, 2, 3, 4, 5, 6, 7, 9 | IВ |
b) the introduction of a new manufacturer of an active pharmaceutical substance, justified by MFAPS | - | - | II |
c) the proposed manufacturer uses a sharply different method of synthesis or production conditions that change important indicators of the quality of active pharmaceutical substance, such as a qualitative and (or) quantitative profile of impurities that requires qualifications, or physico-chemical properties that affect bioavailability | - | - | II |
d) A new manufacturer of material requiring the assessment of viral safety and (or) risk of transmissive spongyform encephalopathy (hereinafter - TSE) | - | - | II |
e) The change affects the biological active pharmaceutical substance or source material/reagent/intermediate product used in the production of a biological/immunological drug | - | - | II |
f) a change in the procedure for quality control of active pharmaceutical substance: changing or adding the site on which the control/test of the series is carried out | 2, 4 | 1, 5 | IВ |
g) the introduction of a new manufacturer of an active pharmaceutical substance that does not have MFAPS and requires a significant update of the corresponding section of the dossier according to an active pharmaceutical substance | - | - | II |
h) the inclusion of an alternative platform for sterilization of an active pharmaceutical substance using the method of state pharmacopei of the Republic of Kazakhstan | - | 1, 2, 4, 5, 8 | IB |
i) introduction of a new site for micronization | 2, 5 | 1, 4, 5, 6 | IВ |
j) changes in the testing of quality control of biological active pharmaceutical substance: replacing or inclusion of the site on which the control/testing of the series is carried out, including the biological/immunological/immuno-chemical method | - | - | II |
k) a new site for storage of the main bank of cells and (or) working banks of cells | - | 1, 5 | IB |
Conditions | |||
Documentation | |||
Б.I.а.2 Changes in the production process of active pharmaceutical substance | Conditions | Required documentation | Type of procedure |
а) a non-essential change in the production process of active pharmaceutical substance | 1, 2, 3, 4, 5, 6, 7 | 1, 2, 3 | IВ |
b) a significant change in the process of production of active pharmaceutical substance, which can have a significant effect on the quality, safety or effectiveness of the drug | - | - | II |
c) the change affects the biological/ immunological substance or the use of another substance obtained by chemical synthesis in the production of a biological/ immunological drug, which can have a significant effect on the quality, safety or effectiveness of the drug and is not associated with the protocol | - | - | II |
d) the change affects the plant drug, namely: geographical source, method of production or preparation | - | - | II |
e) non-significant change in the closed part of the MFAPS | - | 1, 2, 3, 4 | IB |
Conditions | |||
Documentation | |||
Note | to Б.I.а.2.б) Significant changes in active pharmaceutical substances obtained by chemical synthesis include changes in the method of synthesis or production conditions, which are able to change important indicators of the quality of active pharmaceutical substance, such as qualitative and (or) quantitative profile of impurities that requires qualifications, or physical and chemical properties, affecting bioavailability. | ||
Б.I.а.3 Changes in the size of the series (including the range of the size of the series) of an active pharmaceutical substance or an intermediate product used in the production process of an active pharmaceutical substance | Conditions | Required documentation | Type of procedure |
а) an increase in the size of the series up to 10 times compared to the registered size | 1, 2, 3, 4, 5, 6, 7, 8 | 1, 2, 5 | IВ |
b) 10-fold fragmentation | 1, 2, 3, 4, 5 | 1, 2, 5 | IВ |
c) the change requires the analysis of the comparability of biological/immunological active pharmaceutical substance | - | - | II |
d) an increase in the size of the series more than 10 times compared to the registered size | - | 1, 2, 3, 4 | IB |
e) an increase/decrease in the scale of production of biological/immunological active pharmaceutical substance without changing the production process (for example, duplication of the line) | - | 1, 2, 3, 4 | IB |
Conditions | |||
Documentation | |||
Б.I.а.4 Changes in intra-production tests or acceptability criteria used in the production of active pharmaceutical substance | Conditions | Required documentation | Type of procedure |
а) tightening intra-production criteria for acceptability | 1, 2, 3, 4 | 1, 2 | IA |
б) adding new intra-production tests or acceptance criteria | 1, 2, 5, 6 | 1, 2, 3, 4, 6 | IA |
в) exclusion of an insignificant intra -production test | 1, 2, 7 | 1, 2, 5 | IA |
г) expansion of approved intra-production criteria for acceptability, which significantly affect the total quality of active pharmaceutical substance | II | ||
д) exclusion of an intra-production test, which can significantly affect the total quality of active pharmaceutical substance | II | ||
е) adding or replacing an intra-production test for security or quality reasons | 1, 2, 3, 4, 6 | IB | |
Conditions | |||
Documentation | |||
Б.I.а.5 Change in the active pharmaceutical substance of the seasonal, prepandemic or pandemic vaccine for influenza prevention | Conditions | Required documentation | Type of procedure |
а) replacing the strain (s) of the seasonal, prepandemic or pandemic vaccine for influenza prevention | II |
Б.I. б) Quality control of the active pharmaceutical substance
Б.I.б.1 Changing the specification parameters and (or) acceptance criteria of an active pharmaceutical substance, source material / intermediate product / reagent used in the production process of an active pharmaceutical substance | Conditions | Required documentation | Type of procedure |
а) tightening the acceptance criteria for the specification of drugs, subject to release of series by the official control body | 1, 2, 3, 4 | 1, 2 | IA |
б) tightening of specification acceptance criteria | 1, 2, 3, 4 | 1, 2 | IA |
в) adding a new parameter and the corresponding test method to the specification | 1, 2, 5, 6, 7 | 1, 2, 3, 4, 7 | IВ |
г) exclusion of a minor specification parameter (e.g. exclusion of an outdated parameter) | 1, 2, 8 | 1, 2, 6 | IA |
д) exclusion of a specification parameter that can significantly affect the overall quality of the active pharmaceutical substance and (or) drug | II | ||
е) a change that is beyond the approved range of acceptance criteria for specifications of the active pharmaceutical substance | II | ||
ж) extension of the approved specification acceptance criteria for source materials/intermediate products that significantly affect the total quality of the active pharmaceutical substance and (or) drug | II | ||
з) addition or replacement (excluding biological and immunological substance) of a specification parameter and its corresponding test method for reasons of safety or quality | 1, 2, 3, 4, 5, 7 | IB | |
и) if there is no article of the State Pharmacopoeia of the Republic of Kazakhstan for the active pharmaceutical substance, changing its own specification data to the data of an unofficial pharmacopoeia or a pharmacopoeia of a third country | 1, 2, 3, 4, 5, 7 | IB | |
Conditions | |||
Documentation | |||
Б.I.б.2 Changing the analytical method of the active pharmaceutical substance or source material, intermediate product, reagent used in the process of manufacturing the active pharmaceutical substance | Conditions | Required documentation | Type of procedure |
а) changes to an approved analytical method | 1, 2, 3, 4 | 1, 2 | IВ |
б) exclusion of the analytical method of the active pharmaceutical substance or source material, intermediate product, reagent, if an alternative analytical method has already been approved | 7 | 1 | IA |
в) other changes in the analytical methodology (including replacement or addition) of a reagent that does not significantly affect the total quality of the active pharmaceutical substance | 1, 2, 3, 5, 6 | 1, 2 | IВ |
г) a significant change or replacement of a biological, immunological, immunochemical test method or a method that uses a biological reagent for a biologically active pharmaceutical substance | II | ||
д) other changes in the analytical methodology (including the addition or replacement) of the active pharmaceutical substance or source material/intermediate product | 1, 2 | IB | |
Conditions | |||
Documentation |
Б.I. в) packaging and sealing system
Б.I.в.1 Change in the primary packaging of the active pharmaceutical substance | Conditions | Required documentation | Type of procedure |
а) qualitative and (or) quantitative composition | 1, 2, 3 | 1, 2, 3, 4, 6 | IA |
б) qualitative and (or) quantitative composition for sterile or non-frozen biological/immunological active pharmaceutical substances | II | ||
в) liquid active pharmaceutical substances (non-sterile) | 1, 2, 3, 5, 6 | IB | |
Conditions | |||
Documentation | |||
Б.I.в.2 Changing the parameters of the specification and (or) acceptance criteria for the primary packaging of the active pharmaceutical substance | Conditions | Required documentation | Type of procedure |
а) tightening specification acceptance criteria | 1, 2, 3, 4 | 1, 2 | IA |
б) adding a new parameter to the specification and the corresponding test method | 1, 2, 5 | 1, 2, 3, 4, 6 | IA |
в) exclusion of a non-essential specification parameter (for example, exclusion of an outdated parameter) | 1, 2 | 1, 2, 5 | IA |
г) adding or replacing a specification parameter for safety or quality reasons | 1, 2, 3, 4, 6 | IB | |
Conditions | |||
Documentation | |||
Б.I.в.3 Changing the analytical methodology for testing the primary packaging of the active pharmaceutical substance | Conditions | Required documentation | Type of procedure |
а) minor changes to the approved analytical method | 1, 2, 3 | 1, 2 | IA |
б) other changes to the analytical method (including additions or replacement) | 1, 3, 4 | 1, 2 | IA |
в) exclusion of an analytical method if an alternative method has already been approved | 5 | 1 | IA |
Conditions | |||
Documentation |
Б.I. г) stability
Б.I.г.1 Changing the retest period, storage period or storage conditions of the active pharmaceutical substance, if the registration dossier does not contain a certificate of conformity of the European Pharmacopoeia covering the retest period | Conditions | Required documentation | Type of procedure |
а) retest period/storage period | 1 | 1, 2, 3 | IA |
2. Increasing the retest period by extrapolating stability data that does not correspond to the documents of the Republic of Kazakhstan (*) | II | ||
3. An increase in the storage period of a biological/immunological active pharmaceutical substance that does not comply with an approved stability study program | II | ||
4. Increase or introduction of a retest period/storage period confirmed by natural storage data | 1, 2, 3 | IB | |
б) storage conditions | |||
1. Changing the storage conditions of the active pharmaceutical substance to more stringent ones | 1 | 1, 2, 3 | IA |
2. Changing the storage conditions of biological / immunological active pharmaceutical substances, if stability studies were not carried out in accordance with the current approved stability protocol | II | ||
3. Changing the storage conditions of the active pharmaceutical substance | 1, 2, 3 | IB | |
в) change of the approved stability study program | 1, 2 | 1, 4 | IA |
Conditions | |||
Documentation | |||
(*) Note | retest period not applicable to biological/immunological active pharmaceutical substances |
Б.I. д) design field and protocol of post-registration changes
Б.I.д.1 Introduction of a new design field or expansion of the approved design field of an active pharmaceutical substance, affecting | Conditions | Required documentation | Type of procedure |
а) one operational unit of the manufacturing process of an active pharmaceutical substance, including relevant intra-production controls and (or) analytical methods | 1, 2, 3 | II | |
б) analytical methods of source materials / intermediate products and (or) active pharmaceutical substance | 1, 2, 3 | II | |
Documentation | |||
Б.I.д.2 Introduction of a post-registration protocol for the management of changes affecting the active pharmaceutical substance | Conditions | Required documentation | Type of procedure |
1, 2, 3 | II | ||
Documentation | |||
Б.I.д.3 Exclusion of the post-registration protocol for the management of changes affecting the active pharmaceutical substance | Conditions | Required documentation | Type of procedure |
1 | 1, 2 | IA | |
Conditions | |||
Documentation | |||
Б.I.д.4 Changes to the approved change management protocol | Conditions | Required documentation | Type of procedure |
а) significant changes to the change management protocol | II | ||
б) minor changes to the change management protocol that do not change the strategy described in the protocol | 1 | IB | |
Documentation | |||
Б.I.д.5 Implementation of changes provided for by the approved change management protocol | Conditions | Required documentation | Type of procedure |
а) implementation of the change does not require additional auxiliary data | 1 | 1, 2, 4 | IA |
б) implementation of the change requires additional auxiliary data | 1, 2, 3, 4 | IB | |
в) implementation of the change in a biological/immunological medicinal product | 1, 2, 3, 4, 5 | IB | |
Conditions | |||
Documentation |
Б.II Medicinal product
Б.II. а) appearance and composition
Б.II.а.1 Changing or adding imprints, engravings or other marks, including replacing or adding ink used in the manufacture of a medicinal product | Conditions | Required documentation | Type of procedure |
а) changes in imprints, engravings or other marks | 1, 2, 3, 4 | 1, 2 | IB |
б) change in breaking lines / scored lines intended for division into equal doses | 1, 2, 3 | IB | |
Conditions | |||
Documentation | |||
Б.II.а.2 Changing the shape or size of the dosage form | Conditions | Required documentation | Type of procedure |
а) tablets, capsules, suppositories and pessaries with immediate release | 1, 2, 3, 4 | 1, 4 | IA |
б) dosage forms with a delayed, modified or prolonged release and tablets with a breaking line designed to divide into equal doses | 1, 2, 3, 4, 5 | IB | |
в) adding a new set for a radiopharmaceutical drug with a different volume of filling | II | ||
Conditions | |||
Documentation | |||
(*) Note | For Б.II.а.2 в), any change in the “dosage” of a medicinal product requires an application for an extension of registration | ||
Б.II.а.3 Changing the composition (excipients) of the medicinal product | Conditions | Required documentation | Type of procedure |
а) change in the composition of flavors (flavors) or dyes | |||
1. Addition, exclusion or replacement | 1, 2, 3, 4, 5, 6, 7, 9 | 1, 2, 4, 5, 6 | IВ |
2. Increase or decrease of content | 1, 2, 3, 4 | 1, 2, 4 | IВ |
б) other excipients | |||
1. Any minor correction of the quantitative composition of the excipients of the medicinal product | 1, 2, 4, 8, 9, 10 | 1, 2, 7 | IВ |
2. Qualitative or quantitative changes in one or more excipients that significantly affect the quality, safety or efficacy of the medicinal product | II | ||
3. Change affecting the biological/immunological product | II | ||
4. Any new excipient involving materials of human or animal origin requiring evaluation of viral safety data and/or TSE risk | II | ||
5. Change justified by the results of the bioequivalence study | II | ||
6. Replacement of one excipient with a similar excipient with the same functional characteristics in the same amount | 1, 3, 4, 5, 6, 7, 8, 9 | IB | |
Conditions | |||
Documentation | |||
Б.II.а.4 Change in the mass of the shell of oral dosage forms or change in the mass of the capsule shell | Conditions | Required documentation | Type of procedure |
а) solid dosage forms for oral administration | 1, 2, 3, 4 | 1, 2 | IB |
б) delayed, modified or extended release dosage forms in which the shell is a key release factor | II | ||
Conditions | |||
Documentation | |||
Б.II.а.5 Change in the concentration of a single-dose, fully administered parenteral medicinal product with the same content of active pharmaceutical substance per dose unit (i.e. dosage) | Conditions | Required documentation | Type of procedure |
II | |||
Б.II.а.6 Removing the solvent/diluent container from packaging | Conditions | Required documentation | Type of procedure |
1, 2 | IB | ||
Documentation |
Б.II. б) Production
Б.II.б.1 Replacement of the manufacturing site for part or all of the manufacturing processes of the medicinal product | Conditions | Required documentation | Type of procedure |
а) site for secondary packaging | 1, 2 | 1, 3, 8 | IA |
б) site for primary packaging | 1, 2, 3, 4, 5 | 1, 2, 3, 4, 8, 9 | IA |
в) a site where manufacturing operations are carried out for biological / immunological medicinal products or dosage forms produced using complex manufacturing processes, with the exception of series release, series quality control and secondary packaging | II | ||
г) site requiring primary or product of specific inspection | II | ||
д) a site where any manufacturing operations for non-sterile medicinal products are carried out, with the exception of series release, series control, primary and secondary packaging | 1, 2, 3, 4, 5, 6, 7, 8, 9 | IB | |
е) a site where any manufacturing operations are carried out with sterile medicinal products produced using aseptic methods (excluding biological / immunological medicinal products), with the exception of series release, sries quality control and secondary packaging | 1, 2, 3, 4, 5, 7, 8 | IB | |
Conditions | |||
Documentation | |||
Notes: |
When changing the production site in the country and outside the Republic of Kazakhstan, with which there is no GMP mutual recognition agreement, the holders are recommended to consult with the authorized body before submitting the notification and provide information on all previous inspections for the last 2-3 years and (or) all planned inspections, including dates of inspections, categories of products inspected, supervisory authority, and other details. Declarations of an authorized person concerning the active pharmaceutical substance. | ||
Б.II.б.2 Change of importer, series release agreements and drug quality control testing | Conditions | Required documentation | Type of procedure |
а) replacement or addition of a site for quality control/series testing | 1, 2, 3 | 1, 2 | IA |
б) replacement or addition of a manufacturer responsible for the release of series of a biological/immunological medicinal product and any test methods carried out on the site that are a biological/immunological method | II | ||
в) replacement or addition of a manufacturer responsible for the release of series | |||
1. Except for quality control/ series testing | 1 | 1, 2, 3, 4 | IA |
2. Including quality control/series testing | 1, 2, 3, | 1, 2, 3, 4 | IA |
3. Including quality control/biological/immunological medicinal product testing and one of the on-site testing methods is biological/immunological/immunochemical | II | ||
Conditions | |||
Documentation | |||
Б.II.б.3 Changing the manufacturing process of a medicinal product, including an intermediate product used in the manufacture of a medicinal product | Conditions | Required documentation | Type of procedure |
а) minor changes in the production process | 1, 2, 3, 4, 5, 6, 7 | 1, 3, 4, 5, 6, 7, 8 | IВ |
б) significant changes in the manufacturing process that have a significant impact on the quality, safety and efficacy of the medicinal product | II | ||
в) medicinal product is biological/immunological and the change requires an assessment of comparability | II | ||
г) introduction of a non-standard terminal sterilization method | II | ||
д) introduction or increase of the excess used in relation to the active pharmaceutical substance | II | ||
е) minor change in the production process of an aqueous suspension for oral administration | 1, 2, 4, 6, 7, 8 | IB | |
Conditions | |||
Documentation | |||
Б.II.б.4 Changing the series size (including series size ranges) of a medicinal product | Conditions | Required documentation | Type of procedure |
а) enlargement up to 10 times compared to the approved | 1, 2, 3, 4, 5, 7 | 1, 4 | IВ |
б) downscaling up to 10 times | 1, 2, 3, 4, 5, 6 | 1, 4 | IВ |
в) the change requires a comparability analysis of the biological/immunological medicinal product or a change in the series size requires a new bioequivalence study | II | ||
г) the change affects all other dosage forms produced using complex manufacturing processes | II | ||
д) enlargement more than 10 times compared to the approved size of the series of dosage forms with immediate release (for oral administration) | 1, 2, 3, 4, 5, 6 | IB | |
е) the scale of production of a biological / immunological medicinal product has increased / decreased without changing the production process (for example, duplication of the line) | 1, 2, 3, 4, 5, 6 | IB | |
Conditions | |||
Documentation | |||
Б.II.б.5 Changing intra-production tests or acceptance criteria used in the manufacture of a medicinal product | Conditions | Required documentation | Type of procedure |
а) tightening intra-production acceptance criteria | 1, 2, 3, 4 | 1, 2 | IA |
б) adding new tests or acceptance criteria | 1, 2, 5, 6 | 1, 2, 3, 4, 5, 7 | IВ |
в) exclusion of a non-essential intra-production test | 1, 2, 7 | 1, 2, 6 | IA |
г) exclusion of intra-production testing, which can significantly affect the overall quality of the medicinal product | II | ||
д) expansion of approved intra-production acceptance criteria that significantly affect the overall quality of the medicinal product | II | ||
е) addition or replacement of intra-production testing for safety or quality reasons | 1, 2, 3, 4, 5, 7 | IB | |
Conditions | |||
Documentation |
Б.II. в) quality control of excipients
Б.II.в.1 Changing specification parameters and (or) excipient acceptance criteria | Conditions | Required documentation | Type of procedure |
а) tightening specification acceptance criteria | 1, 2, 3, 4 | 1, 2 | IA |
б) adding a new specification parameter and corresponding test method to the specification | 1, 2, 5, 6, 7 | 1, 2, 3, 4, 6, 8 | IВ |
в) exclusion of a non-essential specification parameter (for example, exclusion of an outdated parameter) | 1, 2 | 1, 2, 7 | IA |
г) a change outside the approved specification acceptance criteria | II | ||
д) exclusion of a specification parameter that can significantly affect the overall quality of the medicinal product | II | ||
е) addition or substitution (excluding biological and immunological product) of a specification parameter and corresponding test method for reasons of safety or quality | 1, 2, 3, 4, 5, 6, 8 | IB | |
ж) if there is no article of the State Pharmacopoeia of the Republic of Kazakhstan for the excipient, a change in the own specification data for an unofficial pharmacopoeia or a pharmacopoeia of a third country | 1, 2, 3, 4, 5, 6, 8 | IB | |
Conditions | |||
Documentation | |||
Б.II.в.2 Changing of analytical procedure for excipient | Conditions | Required documentation | Type of procedure |
а) minor changes to an approved analytical method | 1, 2, 3, 4 | 1, 2 | IA |
б) exclusion of an analytical method if an alternative method has already been approved | 5 | 1 | IA |
в) replacement of a biological/immunological/immunochemical test method or a method that uses a biological reagent | II | ||
г) other changes to the analytical method (including additions or replacement) | 1, 2 | IB | |
Conditions | |||
Documentation | |||
Б.II.в.3 Changing the source of obtaining an excipient or reagent with a risk of TSE | Conditions | Required documentation | Type of procedure |
а) from a material with a TSE risk to a material of plant or synthetic origin | |||
1. For excipients or reagents not used in the production of a biological/immunological active pharmaceutical substance or a biological/immunological medicinal product | 1 | 1 | IA |
2. For excipients or reagents used in the manufacture of a biological/immunological active pharmaceutical substance or a biological/immunological medicinal product | 1, 2 | IB | |
б) a change or introduction of a material with a TSE risk or replacement of a material with a TSE risk with another material with a TSE risk that does not have a TSE certificate of conformity | II | ||
Conditions | |||
Documentation | |||
Б.II.в.4 Change in the synthesis or preparation of a non-pharmacopoeial excipient (if described in the registration dossier) or a new excipient | Conditions | Required documentation | Type of procedure |
а) minor change in the synthesis or preparation of a non-pharmacopoeial excipient or a new excipient | 1, 2 | 1, 2, 3, 4 | IВ |
б) specifications are changed or there is a change in the physicochemical properties of the excipient that affect the quality of the medicinal product | II | ||
в) excipient biological / immunological substance | II | ||
Conditions | |||
Documentation |
Б.II. г) drug quality control
Б.II.г. 1 Changing specification parameters and (or) acceptance criteria for a medicinal product | Conditions | Required documentation | Type of procedure |
а) tightening specification acceptance criteria | 1, 2, 3, 4 | 1, 2 | IB |
б) tightening of specification acceptance criteria of medicinal products subject to series release by an official control body | 1, 2, 3, 4 | 1, 2 | IB |
в) adding a new parameter and the corresponding test method to the specification | 1, 2, 5, 6, 7 | 1, 2, 3, 4, 5, 7 | IВ |
г) exclusion of a non-essential specification parameter (for example, exclusion of an outdated parameter) | 1, 2 | 1, 2, 6 | IA |
д) a change outside the approved specification acceptance criteria | II | ||
е) exclusion of a specification parameter that can significantly affect the total quality of the medicinal product | II | ||
ж) addition or substitution (excluding biological and immunological preparations) of a specification parameter and its corresponding test method for reasons of safety or quality | 1, 2, 3, 4, 5, 7 | IB | |
з) updating the dossier in order to comply with the provisions of the updated general article of the State Pharmacopoeia of the Republic of Kazakhstan for the medicinal product (*) | 1, 2, 3, 4, 7, 8 | 1, 2 | IA |
и) an article of the State Pharmacopoeia of the Republic of Kazakhstan "Uniformity of dosing" is introduced in order to replace the current registered method, or an article of the State Pharmacopoeia of the Republic of Kazakhstan "Uniformity of mass", or "Uniformity of contents" | 1, 2, 10 | 1, 2, 4 | IA |
Conditions | |||
Documentation | |||
(*) Note | if the “current edition” is mentioned in the dossier of the registered medicinal product, there is the need to notify the authorized bodies about the updated article of the State Pharmacopoeia of the Republic of Kazakhstan. In this regard, such a change is applied in the absence of a mention of the updated pharmacopoeial article in the technical dossier, and the change is made in order to include a mention of the updated version. | ||
Б.II.г.2 Changing the analytical method of the medicinal product | Conditions | Required documentation | Type of procedure |
а) minor changes to the approved analytical method | 1, 2, 3, 4 | 1, 2 | IВ |
б) exclusion of an analytical method if an alternative method has already been approved | 4 | 1 | IA |
в) change (replacement) of a biological/immunological/immunochemical test or method in which a biological reagent is used, or replacement of a biological reference product not covered by an approved protocol | II | ||
г) other changes to the analytical method (including additions or replacement) | 1, 2 | IB | |
д) updating the analytical methodology in order to comply with the updated general article of the State Pharmacopoeia of the Republic of Kazakhstan | 2, 3, 4, 5 | 1 | IA |
е) in order to reflect the compliance with the State Pharmacopoeia of the Republic of Kazakhstan and exclude the mention of an outdated own analytical method and its number (*) | 2, 3, 4, 5 | 1 | IA |
Conditions | |||
Documentation | |||
(*) Note | if the “current edition” is mentioned in the dossier of the registered medicinal product, there is no need to notify the authorized bodies about the updated article of the State Pharmacopoeia of the Republic of Kazakhstan. | ||
Б.II.г.3 A change affecting the introduction of real-time release or release by parameters in the manufacture of a medicinal product | Conditions | Required documentation | Type of procedure |
II |
Б.II. д) packaging and sealing system
Б.II.д.1 Change in the primary packaging of the medicinal product | Conditions | Required documentation | Type of procedure |
а) qualitative and quantitative composition | |||
1. Solid dosage forms | 1, 2, 3 | 1, 2, 3, 4, 6 | IВ |
2. Soft and non-sterile liquid dosage forms | 1, 2, 3, 5, 6 | IB | |
3. Sterile medicinal products and biological/immunological medicinal products | II | ||
4. The change affects packaging that has less protective properties while changing storage conditions and (or) reducing the shelf life | II | ||
б) changing the type of container or adding a new container | |||
1. Solid, soft and non-sterile liquid dosage forms | 1, 2, 3, 5, 6, 7 | IB | |
2. Sterile medicinal products and biological/immunological medicinal products | II | ||
3. Exclusion of the primary packaging container that does not lead to the complete elimination of the dosage or dosage form | 4 | 1, 8 | IA |
Conditions | |||
Documentation | |||
Note | For Б.II.Д.1.б) - if the change leads to the "formation of a new dosage form", then such a change requires an application for registration extension | ||
Б.II.д.2 Changing the parameters of the specification and (or) acceptance criteria for the primary packaging of the medicinal product | Conditions | Required documentation | Type of procedure |
а) tightening specification acceptance criteria | 1, 2, 3, 4 | 1, 2 | IA |
б) adding a new parameter and the corresponding analytical method to the specification | 1, 2, 5 | 1, 2, 3, 4, 6 | IВ |
в) exclusion of a non-essential specification parameter (for example, exclusion of an outdated parameter) | 1, 2 | 1, 2, 5 | IA |
г) adding or replacing a specification parameter for safety or quality reasons | 1, 2, 3, 4, 6 | IB | |
Conditions | |||
Documentation | |||
Б.II.д.3 Changing the analytical method for the primary packaging of the medicinal product | Conditions | Required documentation | Type of procedure |
а) minor changes to an approved analytical method | 1, 2, 3 | 1, 2 | IВ |
б) other changes to the analytical method (including replacement or addition) | 1, 3, 4 | 1, 2 | IВ |
в) exclusion of an analytical method if an alternative method has already been approved | 5 | 1 | IA |
Conditions | |||
Documentation | |||
Б.II.д.4 Changing the shape or dimensions of the primary packaging or sealing (primary packaging) | Conditions | Required documentation | Type of procedure |
а) non-sterile drugs | 1, 2, 3 | 1, 2, 4 | IВ |
б) a change in shape or size affects key indicators of the packaging material that significantly affect the delivery, use, safety or stability of the medicinal product | II | ||
в) sterile drugs | 1, 2, 3, 4 | IB | |
Conditions | |||
Documentation | |||
Б.II.д.5 Changing the size of the medicinal product package | Conditions | Required documentation | Type of procedure |
а) a change in the number of dosage form units (for example, tablets, ampoules, etc.) in the package | |||
1. The change is within the approved package size range | 1, 2 | 1, 3 | IA |
2. The change is not within the approved package size range | 1, 2, 3 | IB | |
б) change in the size (s) of the package (s) | 3 | 1, 2 | IA |
в) change in the nominal mass / nominal volume of sterile multi-dose (or single-dose with partial extraction) of parenteral medicinal products and biological / immunological multi-dose parenteral medicinal products | II | ||
г) change in nominal mass/nominal volume of non-parenteral multi-dose (or single-dose with partial extraction) medicinal products | 1, 2, 3 | IB | |
Conditions | |||
Documentation | |||
Note: | For Б.II.д.5.в) and г) - if the change leads to a change in the “dosage” of the medicinal product, then such a change requires an application for an extension. | ||
Б.II.д.6 Changing any component of the (primary) packaging that does not directly come into contact with the medicinal product (for example, the color of removable caps, colored code rings on ampoules, changing the cap that protects the needle (using a different plastic) | Conditions | Required documentation | Type of procedure |
а) a change affecting information about the medicinal product | 1 | 1 | IВ |
б) a change that does not affect information about the medicinal product | 1 | 1 | IA |
Conditions | |||
Documentation | |||
Conditions | Required documentation | Type of procedure | |
а) supplier exclusion | 1 | 1 | IA |
б) replacement or addition of a supplier | 1, 2, 3, 4 | 1, 2, 3 | IВ |
в) any change in spacer suppliers of metered dose inhaler | II | ||
Conditions | |||
Documentation | |||
Б.II.д.8 Changing the labeling design of primary and secondary packaging | Conditions | Required documentation | Type of procedure |
1 | 1,2 | IA | |
Conditions | |||
Documentation |
Б.II. е) stability
Б.II.е.1 Changing the shelf life or storage conditions of the medicinal product | Conditions | Required documentation | Type of procedure |
а) shortening the shelf life of the medicinal product | |||
1. Packed in commercial packaging | 1 | 1, 2, 3 | IA |
2. After the first opening | 1 | 1, 2, 3 | IA |
3. After dilution or recovery | 1 | 1, 2, 3 | IA |
б) increase of the shelf life of the medicinal product | |||
1. Packed in commercial packaging (confirmed by real-time data) | 1, 2, 3 | IB | |
2. After the first opening (confirmed by real-time data) | 1, 2, 3 | IB | |
3. After dilution or recovery (confirmed by real-time data) | 1, 2, 3 | IB | |
4. Increasing the shelf life by extrapolating data on stability that does not correspond to the documents of the Republic of Kazakhstan (*) | II | ||
5. Extending the shelf life of a biological/immunological medicinal product in accordance with an approved stability study program | 1, 2, 3 | IB | |
в) changing the storage conditions of biological / immunological medicinal products, if stability studies were carried out not in accordance with the current approved stability study program | II | ||
г) changing the storage conditions of the medicinal product or the medicinal product after dilution/recovery | 1, 2, 3 | IB | |
д) changing the approved stability protocol | 1, 2 | 1, 4 | IВ |
Conditions | |||
Documentation | |||
(*) Note: | For a biological/immunological medicinal product, extrapolation is not applicable | ||
(1) | If there is an obligation to check the expiration date on industrial series, experimental series are acceptable. |
Б.II. ж) project field and protocol of post-registration changes
Б.II.ж.1 Introduction of a new project field or expansion of the approved project field of the drug (with the exception of biological), affecting: | Conditions | Required documentation | Type of procedure |
а) one or more separate operations of the production of the drug, including the corresponding intra -production controls and (or) analytical methods | 1, 2, 3 | II | |
б) analytical methods for excipients/intermediate products and (or) drug | 1, 2, 3 | II | |
Documentation | |||
Б.II.ж.2 Introduction of the post–registration protocol of changes affecting the drug | Conditions | Required documentation | Type of procedure |
1, 2, 3 | II | ||
Documentation | |||
Б.II.ж. 3 Exclusion of the approved protocol of management of changes affecting the drug | Conditions | Required documentation | Type of procedure |
1 | 1 | IA | |
Conditions | |||
Documentation | |||
Б.II.ж.4 Changes in the approved change management protocol | Conditions | Required documentation | Type of procedure |
а) significant changes in the change management protocol | II | ||
б) insignificant changes in the change management protocol that do not change the strategy described in the protocol | 1 | IB | |
Documentation | |||
Б.II.ж. 5 Implementation of the changes provided for by the approved change management protocol | Conditions | Required documentation | Type of procedure |
а) implementation of the change does not require additional auxiliary data | 1 | 1, 2, 4 | IA |
б) implementation of the change requires additional auxiliary data | 1, 2, 3, 4 | IB | |
в) implementation of the change of the biological/ immunological drug | 1, 2, 3, 4, 5 | IB | |
Conditions | |||
Documentation |
Б.II. з Safety in relation to extraneous agents
Б.II.з.1 Update of the Information “Safety assessment related to extraneous agents” (section 3.2.A.2 of the registration dossier) | Conditions | Required documentation | Type of procedure |
а) research affecting the production stages, studied for the first time for one or more extraneous agents | II | ||
б) replacing outdated studies affecting production stages and extraneous agents previously included in the dossier | |||
1. With a change of the risk assessment | II | ||
2. Without a change of the risk assessment | 1, 2, 3 | IB | |
Documentation |
Б.III Certificate of conformity to European pharmacopoeia (CEP) (if any)/TSE/articles
Б.III.1 Submission of a new or updated certificate of conformity to the European Pharmacopoeia or the exclusion of a certificate of conformity to the European pharmacopoeia | Conditions | Required documentation | Type of procedure |
To the pharmaceutical substance, to the source material/reagent/intermediate product used in the process of production of pharmaceutical substance | |||
а) a certificate of conformity to the European Pharmacopoeia of the corresponding article of the European Pharmacopoeia | |||
1. New certificate from a previously approved manufacturer | 1, 2, 3, 4, 5, 6, 9 | 1, 2, 3, 4, 5 | IA |
2. Updated certificate from a previously approved manufacturer | 1, 2, 3, 4, 6 | 1, 2, 3, 4, 5 | IA |
3. A new certificate from a new manufacturer (replacement or addition) | 1, 2, 3, 4, 5, 6, 9 | 1, 2, 3, 4, 5 | IВ |
4. Exclusion of certificates (if several certificates were attached to the material) | 8 | 3 | IA |
5. A new certificate for a non-sterile active pharmaceutical substance to be used in a sterile drug, when using water at the last stage of the synthesis, and the absence of endotoxins in it is not declared in relation to the material | 1, 2, 3, 4, 5 | IB | |
б) a certificate of conformity to the European Pharmacopoeia for TSE for an active pharmaceutical substance/source material/reagent/intermediate product/excipient | |||
1. A new certificate for an active pharmaceutical substance from a new or previously approved manufacturer | 3, 5, 9 | 1, 2, 3, 4, 5 | IВ |
2. A new certificate for a pharmaceutical substance/source material/reagent/intermediate product/excipient from a new or previously approved manufacturer | 3, 6, 7 | 1, 2, 3, 4, 5 | IВ |
3. Updated certificate from a previously approved manufacturer | 7 | 1, 2, 3, 4, 5 | IВ |
4. Exclusion of certificates (if several certificates were attached to the material) | 8 | 3 | IA |
5. A new/updated certificate from a previously approved/new manufacturer using materials of human or animal origin, in relation to which an assessment of the risk of potential contamination by foreign agents is needed | II | ||
Conditions | |||
Documentation | |||
Б.III.2 Changes in order to comply with the State Pharmacopoeia of the Republic of Kazakhstan | Conditions | Required documentation | Type of procedure |
а) a change in the specification (s) of the earlier non - pharmacopoeial substance in order to comply with the State Pharmacopoeia of the Republic of Kazakhstan | |||
1. Active pharmaceutical substance | 1, 2, 3, 4, 5 | 1, 2, 3, 4 | IВ |
2. Excipient/source material of active pharmaceutical substance | 1, 2, 4 | 1, 2, 3, 4 | IВ |
б) changes in order to comply with the updated relevant article of the State Pharmacopoeia of the Republic of Kazakhstan | 1, 2, 4, 5 | 1, 2, 3, 4 | IВ |
в) a change in specifications from the State Pharmacopoeia of the Republic of Kazakhstan | 1, 4, 5 | 1, 2, 3, 4 | IВ |
Conditions | |||
Documentation | |||
Б. IV Changing the registration dossier due to other regulatory procedures
Б.V.a.2 The inclusion of a new, updated or corrected master file of the vaccine antigen (hereinafter-MFVA) in the registration dossier of the drug (MFVA procedure of the 2nd stage) | Conditions | Required documentation | Type of procedure |
а) the first inclusion of the new MFVA | II | ||
б) inclusion of updated/corrected MFVA: changes affect the properties of the drug | 1, 2, 3, 4 | IB | |
в) inclusion of updated/corrected MFVA: changes do not affect the properties of the drug | 1, 2, 3, 4 | IA | |
Conditions | |||
Documentation |
В. Changing safety, efficiency and pharmacological supervision
В.I Medical drugs for medical use
В.I.1 Change in the overall characteristics of the drug, labeling of the reproduced/hybrid/bioanalogical drug after evaluating the same change in the reference drug | Conditions | Required documentation | Type of procedure |
а) implementation of the change (s) in respect of which from the holder of the registration certificate it is not required to submit new additional data | 1, 2 | IB | |
б) the implementation of the change (s) requiring the presentation by the HRC of additional data substantiating such changes (for example, comparability) | II | ||
Documentation | |||
В.I.2 Change (s) of the general characteristics of the drug, labeling of the drug for medical use, aimed at the implementation of the result of the procedure affecting the PSAR or post-registration study of security | Conditions | Required documentation | Type of procedure |
а) the introduction of the wording agreed by the authorized body | 1 | 1 | IВ |
б) making changes requiring the presentation by the HRC of additional data substantiating such changes | 2 | 2, 3, 4 | II |
Conditions | |||
Documentation | |||
В.I.3 Changes, which are a significant change in the general characteristics of the drug due to new quality data, preclinical, clinical data or pharmacological control data | Conditions | Required documentation | Type of procedure |
II | |||
Note: | This change is not applied if new data is submitted in accordance with the change in B.I.13. In such cases, a change in the overall characteristics of the drug, labeling falls under the scope of the application of B.I.13. | ||
В.I.4 Changing the conditions of the release of the drug | Conditions | Required documentation | Type of procedure |
а) reproduced/hybrid/bioanalogical drugs after changing the conditions of the release of the reference drug | 1 | 1, 2 | IB |
б) other reasons for changing the conditions of the release | 1 | 2, 3, 4, 5 | II |
Conditions | |||
Documentation | |||
В.I.5 Change (s) of indication (s) for use | Conditions | Required documentation | Type of procedure |
а) inclusion of a new indication for the use or change of previously approved | 2 | 1, 2, 3 | II |
б) exclusion of indications for the use | 1 | 1,2 | IB |
Conditions | |||
Documentation | |||
Note | If the addition or change in the indication for use occurs due to the implementation of the conclusion of the expert committee or changes in information about the drug of the reproduced/ hybrid/ bioanalogical drug after examination of the same change in the reference drug, the changes in B.I.1 and B.I.2, are applied, respectively. | ||
В.I.6 Exclusion: | Conditions | Required documentation | Procedure |
а) dosage forms | 1, 2 | IB | |
б) dosage | 1, 2 | IB | |
Documentation | |||
Note | If the dosage form or dosage under consideration were registered in the form of a separate drug, then the exclusion of such a dosage form or dosage will be considered as not making changes, but removal from circulation. | ||
В.I.7 Introduction or change in the resume of the pharmacological control system of the drug for medical use (*) | Conditions | Required documentation | Type of procedure |
а) the introduction of the resume of the pharmacological control system, changes in the qualified person of pharmacological control (including contact information) and (or) a change in the location of the PSMF | 1, 2 | IВ | |
Documentation | |||
Note: |
This change covers the introduction of the PSMF, regardless of the presence in the technical part of the registration dossier of the detailed description of the pharmacological control system. | ||
В.I.8 Change in the existing system of pharmacological control according to a detailed description of the pharmacological control system (hereinafter - the DDPCS) | Conditions | Required documentation | Type of procedure |
а) a change in a qualified person for pharmacological control and (or) contact information, and (or) reservation procedures | 1 | 1 | IВ |
б) a change in the security database and (or) basic contract agreements in order to fulfill pharmacological control obligations and (or) a change in the venue | 1, 2, 3 | 1 | IВ |
в) other changes in the DDPCS that do not affect the functioning of the pharmacological control system (for example, a change in the location of the main storage/archive, administrative changes) | 1 | 1 | IВ |
г) making changes to the DDPCS based on the results of the DDPCS examination of another drug of the same HRC | 4 | 1, 2 | IВ |
Conditions | |||
Documentation | |||
В.I. 9 Changing the frequency and (or) date of submitting a periodic security report (DDPCS) of drugs for medical use | Conditions | Required documentation | Type of procedure |
1 | 1, 2 | IВ | |
Conditions | |||
Documentation | |||
Note | This change is applied only if the cycle of the DDPCS is indicated in the registration dossier in ways, different from indicating the link to the list of reporting dates, and if necessary, the submission of the DDPCS. | ||
В.I.10 Introduction or changes in obligations and registration conditions, including the risk management plan | Conditions | Required documentation | Type of procedure |
а) the implementation of the wording agreed with the authorized body | 1 | 1, 2 | IВ |
б) the implementation of changes requiring the submission by the HRC of additional data that needs an examination by an authorized body (*) | II | ||
Conditions | |||
Documentation | |||
Note | This change covers only the situation in which the introduced change affects the conditions and (or) registration obligations exclusively, including the risk management plan and (or) conditions and (or) registration obligations under exceptional circumstances and conditional registration | ||
(*) | the introduction of a risk management plan, requested by the authorized body, always requires a significant examination | ||
В.I. 11 The inclusion or exclusion of a black symbol or explanatory instructions regarding drugs included in the list of drugs subject to additional monitoring | Conditions | Required documentation | Type of procedure |
1 | 1, 2 | IВ | |
Conditions | |||
Documentation | |||
Note | This change covers a situation in which the inclusion or exclusion of a black symbol or explanatory instructions is not carried out within the framework of another regulatory procedure (for example, extension or change procedures that affect information about the drug) | ||
В.I.12 Other changes not described in other sections of this Addition, including the submission of studies to the authorized body (*) | Conditions | Required documentation | Type of procedure |
II | |||
Note | If the examination by the authorized body of the data presented leads to a change in the general characteristics of the drug, labeling, this change covers the corresponding changes to the general characteristic of the drug, and labeling. | ||
(*) | This change is not applied to changes that are adopted as changes of the IB type by default in accordance with any other section of this Addition. |
Note:
When making changes to the registration dossier of type II:
- by paragraphs Б.I, a list of documents of sections I, II of the list (updated sections I A7 - a document confirming the quality of the active substance (certificate of analysis of 3 series of active pharmaceutical substance from the manufacturer, certificate of analysis of the substance from the manufacturer, certificate of compliance with the monograph of European pharmacopeia, protocol of analysis, analytical passport, data on the study of the stability of the finished product under long-term and accelerated conditions for the study of stability using the declared substance for at least 6 months) and II C 1 - active substance in accordance with the changes made) is provided.
- by paragraphs Б.II, a list of documents of sections I (updated section I A8 - a document confirming the quality of the finished product of 3 industrial series (analysis certificate, protocol of analysis), one series of which coincides with the series of the sample of the drug submitted for registration in accordance with the changes made) and II list are provided.
Appendix 7 to the Rules of temporary state registration of vaccines against COVID-19 |
|
Form |
Footnote. The rules are supplemented by Appendix 7 in accordance with the resolution of the Government of the Republic of Kazakhstan dated 15.04.2021 No. 244.
Conclusion on changes to the registration dossier of the vaccine
1. The expert commission reports the results of the examination for safety, quality and effectiveness of the vaccine for the purposes of temporary state registration in the Republic of Kazakhstan:
Number and date of application | |
The trade name of the vaccine (indicating the dosage form, dosage, concentration and volume of filling, the number of doses in the package - for the drug) | |
Organization-manufacturer, country-manufacturer, holder of a temporary registration certificate | |
Type of changes made | |
The conclusion of the expert commission (positive or negative) |
2. Conclusion (positive): materials and documents of the registration dossier to the vaccine presented to make changes to the registration dossier meet the requirements of the Rules of temporary state registration of vaccines against Covid-19, (hereinafter-the Rules).
The changes made can be registered.
Conclusion (negative): materials and documents of the registration dossier to the vaccine, presented to make changes to the registration dossier, do not meet the established requirements of the Rules.
The changes made cannot be registered.
Head of the expert commission
____________ ___________________________________
signature name, surname, patronymic (if any)
Members of the expert commission
____________ ___________________________________
signature name, surname, patronymic (if any)
____________ ___________________________________
signature name, surname, patronymic (if any)
____________ ___________________________________
signature name, surname, patronymic (if any)