ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of August 25, 2025 No. 83

About modification and amendments in the order of the Minister of Health of the Republic of Kazakhstan of January 27, 2021 No. KR DSM-10 "About approval of rules of conducting examination of medicines and medical products"

I ORDER:

1. Bring in the order of the Minister of Health of the Republic of Kazakhstan of January 27, 2021 No. KR DSM-10 "About approval of rules of conducting examination of medicines and medical products" (it is registered in the Register of state registration of regulatory legal acts at No. 22144) the following changes and amendments:

state preamble in the following edition:

"According to items 4 and the 10th Articles 23, Item 3 of article 239 of the Code of the Republic of Kazakhstan "About health of the people and health care system", the subitem 1) of article 10 of the Law of the Republic of Kazakhstan "About the state services", part one of Item 1 of Rules of registration and examination of safety, quality and efficiency of the medical products approved by the Decision of Council of the Eurasian Economic Commission of February 12, 2016 No. 46, Item 3 of Rules of registration and examination of the medicines for medical application approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 78, and also the Decision of Council of the Eurasian economic commission of June 10, 2022 No. 96 "About temporary measures for establishment of features of drug circulation for medical application" I ORDER:";

in rules of conducting examination of the medicines approved by appendix 1 to the specified order:

state Item 1 in the following edition:

"1. These rules of conducting examination of medicines (further – Rules) also the 10th articles 23, Item 3 of article 239 of the Code of the Republic of Kazakhstan "About health of the people and health care system" (further – the Code), the subitem 1) of article 10 of the Law of the Republic of Kazakhstan "About the state services" are drafted according to Item 3 of Rules of registration and examination of the medicines for medical application approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 78, and also the Decision of Council of the Eurasian economic commission of June 10, 2022 No. 96 "About temporary measures for establishment of features of drug circulation for medical application" with items 4 (further – the Law) and determine procedure for conducting examination of medicines including strategically important medicines (further – medicines), and also procedure for rendering the state service "Issue of the Conclusion about Safety, Quality and Efficiency of Medicines and Medical Products".";

state Item 17 in the following edition:

"17. The state expert organization provides entering of data on stage of rendering the state service into information system of monitoring of rendering the state services according to the subitem 11) of Item 2 of article 5 of the Law and sends the relevant information to state body.";

state Item 23 in the following edition:

"23. In the presence of notes to documents of the registration file to the applicant through information system the inquiry (in any form), certified by the digital signature, with indication of the revealed notes and need of their elimination in full in time, not exceeding 45 (forty five) working days is sent to "personal account".";

state Items 30 and 31 in the following edition:

"30. The applicant within 45 (forty five) working days from the date of receipt of the summary request specified in Item 29 of these rules directs in full one summary response and materials to request of the state expert organization.

In case of the additional questions concerning the data provided by the applicant in the response to prior request, the applicant within 20 (twenty) working days from the moment of receipt of request directs one summary response and materials to additional request of the state expert organization.

31. By results of hearing within 15 (fifteen) working days materials go to Advisory council for decision making about refusal and the termination of examination of medicine, or about issue of the conclusion about safety, quality and efficiency of medicines in forms according to appendices 14, 15 to these rules.

The advisory council considers the arrived materials monthly, and results of the decision with indication of the reasons go to the applicant within 8 (eight) working days from the date of decision making.";

state Item 36 in the following edition:

"36. In case of detection of notes in case of laboratory testing the letter with indication of the revealed notes and need of their elimination in full in time, not exceeding 65 (sixty five) working days is sent the applicant to "personal account" through information system.";

state Item 41 in the following edition:

"41. On the end of examination (initial examination, specialized examination and laboratory researches) the applicant within 20 (twenty) working days which are not entering in time conducting examination approves with the state expert organization in electronic form through personal account the general (administrative) information about medicine, resulting documents (the regulating document on quality, the instruction on medical application and prototypes of marking of packaging, labels, stickers with marking), including correctness of the entered data and in case of detection of discrepancy of updating of resulting documents.

Approval is performed in electronic form through personal account.

In the absence of approval by the applicant after 20 (twenty) working days from end date of examination of data on medicine, the conclusion about safety, quality and efficiency of medicine is created without its approval.";

state Item 44 in the following edition:

"44. The conclusion about safety, quality and efficiency of medicine is valid 120 (hundred twenty) working days. In case of expiration of the conclusion, the applicant repeatedly submits the application, documents and materials for conducting examination of medicine, provided in Item 8 of these rules.";

state Items 54 and 55 in the following edition:

"54. The holder of the registration certificate of original medicine submits the application for modification of the instruction on medical application (leaf insert) within 60 (sixty) working days after updating of general characteristic of medicine in the country of the producer or holder of the registration certificate.

55. The state expert organization after modification of the instruction of original medicine or, in the absence of registration of original medicine in the Republic of Kazakhstan, in case of identification on the international sources and results of pharmakonadzor about changes in general characteristic of original medicine informs through information resources of all holders of registration certificates of generic medicines on need of entering of corresponding changes into the instruction on medical application (leaf insert) and general characteristic of medicine through the procedure of modification of the registration file within 60 (sixty) working days after modification of the instruction of original medicine of information on safety from the date of placement of information on the website of the expert organization.

The holder of the registration certificate of original medicine makes changes to the instruction on medical application (leaf insert) and general characteristic of medicine based on the state expert organization of information on the discrepancies revealed as a result of pharmakonadzor and on official international sources within 60 (sixty) working days from the date of placement of information on the website of the expert organization placed on information resource.

Holders of registration certificates submit the application for modification of the registration file within 60 (sixty) working days from the date of placement of the harmonized information on the website of the expert organization for the registered medicines in general characteristic of medicine and the instruction on medical application of medicine (leaf insert) (further – OHLP and the Instruction of HP) medicines with the same international unlicensed name or with the same active ingredient.";

third the subitem 4) of Item 58 to state the paragraph in the following edition:

"The statement for modification, the emergency restrictions concerning introduction (initiated by the holder of the registration certificate or state body), moves the holder of the registration certificate for consideration no later than within 40 (forty) working days from the moment of the notification.";

to state paragraph two of Item 59 in the following edition:

"The state expert organization within 20 (twenty) working days after receipt of request sends the answer to the applicant in electronic form.";

66, of 67, of 68, 68-1 and 69 to state Items in the following edition:

"66. Examination of medicine in case of state registration, including modification, requiring new registration, is carried out in time, not exceeding 140 (hundred forty) working days, including:

1) initial examination of medicine – 20 (twenty) working days;

2) specialized examination – 60 (sixty) working days (including, check of authenticity or transfer into Kazakh of general characteristic of medicine and the instruction on medical application (leaf insert), markings of prototypes of packaging, labels, stickers);

3) laboratory researches – 50 (fifty) working days;

4) forming of the conclusion about safety, efficiency and quality – 10 (ten) working days.

67. Examination of medicine with the existing registration certificate at the time of filing of application for examination and the acting minister of health care entering the List of strategically important medicines and medical products, approved by the order of March 3, 2023 No. 35 (it is registered in the Register of state registration of regulatory legal acts at No. 32025) (further – the List of strategically important medicines and medical products) and medicine in case of re-registration is carried out within 90 (ninety) working days, including:

1) initial examination of medicine – 15 (fifteen) working days;

2) specialized examination – 65 (sixty five) working days, (including, confirmation of authenticity or transfer into Kazakh of general characteristic of medicine and the instruction on medical application (leaf insert), prototypes of marking of packaging, labels, stickers);

3) forming of the conclusion about safety, efficiency and quality – 10 (ten) working days.

68. Examination of medicine in case of modification of the registration file like ІА, type ІБ and type II with laboratory testing is carried out in time, not exceeding 80 (eighty) working days, including:

1) initial examination of medicine – 10 (ten) working days;

2) specialized examination – 40 (forty) working days, (including, confirmation of authenticity or transfer into Kazakh of OHLP and the Instruction of HP, prototypes of marking of packaging, labels, stickers);

3) laboratory researches – 20 (twenty) working days;

4) forming of the conclusion about safety, efficiency and quality – 10 (ten) working days.

68-1. Examination of medicine in case of modification of the registration file like IA which are not requiring assessment of safety, quality and efficiency and ratio advantage risk of medicine (specialized examination) is carried out in time, not exceeding 20 (twenty) working days, including:

1) initial examination of medicine – 10 (ten) working days;

2) forming of the conclusion about safety, efficiency and quality and confirmation of authenticity or transfer into Kazakh of general characteristic of medicine and the instruction on medical application (leaf insert), prototypes of marking of packaging, labels, stickers – 10 (ten) working days.

69. Examination of medicine in case of modification of the registration file like ІА, type ІБ and type II without laboratory testing is carried out in time, not exceeding 45 (forty five) working days, including:

1) initial examination of medicine – 8 (eight) working days;

2) specialized examination – 30 (thirty) working days (including, confirmation of authenticity or transfer into Kazakh of general characteristic of medicine and the instruction on medical application (leaf insert), prototypes of marking of packaging, labels, stickers);

3) forming of the conclusion about safety, efficiency and quality – 7 (seven) working days.";

add with Item 69-1 of the following content:

"69-1. Expertize of medicine in case of modification of the registration file regarding approval of the place of drawing control (identification) sign in prototypes of marking of packagings of medicines is carried out in time, not exceeding 10 (ten) working days, including:

1) initial examination of medicine – 5 (five) working days;

2) forming of the conclusion about safety, efficiency and quality – 5 (five) working days.";

70, 71 and 72 to state Items in the following edition:

"70. The accelerated expertize of medicine is carried out in the terms which are not exceeding 60 (sixty) working days including:

1) initial examination – no more than 10 (ten) working days;

2) specialized examination – no more than 40 (forty) working days, including confirmation of authenticity of transfer of marking of prototypes of packaging, labels, stickers, general characteristic of medicine, the instruction on medical application (leaf insert);

3) forming of the conclusion about safety, efficiency and quality of medicine, drafts of resulting documents of examination of medicines – no more than 10 (ten) working days.

71. Examination of the medicines participating in the procedure of joint retraining of WHO is carried out to the terms which are not exceeding 65 (sixty five) working days including:

1) initial examination – no more than 10 (ten) working days;

2) specialized examination – no more than 45 (forty five) working days, including confirmation of authenticity of transfer of marking of prototypes of packaging, labels, stickers, general characteristic of medicine, the instruction on medical application (leaf insert);

3) forming of the conclusion about safety, efficiency and quality of medicine, drafts of resulting documents of examination of medicines – no more than 10 (ten) working days.

72. Does not enter terms of conducting examination of medicine:

1) time of completion of shortage of the registration file;

2) time of provision by the applicant of documents and materials on demand on any of examination stages;

3) time of the organization and conducting pharmaceutical inspection.

The applicant within 30 (thirty) working days from the date of receipt of the notification on need of conducting inspection provides the letter of consent and provides the statement for conducting pharmaceutical inspection in pharmaceutical inspectorate.

Duration of the organization and conducting pharmaceutical inspection does not exceed 90 (ninety) working days from the date of submission of the statement by the applicant on conducting pharmaceutical inspection.

4) terms of provision of the report of clinical trials in case of observance of the conditions determined by Item 11 of these rules. At the same time terms of provision of the report of clinical trial do not exceed 120 (hundred twenty) working days from start date of clinical trial;

The organization and carrying out Advisory council, duration of the organization and carrying out Advisory council does not exceed 5) 30 (thirty) calendar days from the date of the notification of the applicant on removal of materials at Advisory council;

6) approvals by the applicant of resulting documents;

7) the organization and laboratory testing in the presence of representatives of the expert organization in laboratory of quality control of the producer or in the contractual laboratory used by the producer including with use of means of remote interaction, including audio-or video conference.

Duration of laboratory researches in the presence of representatives of the expert organization in laboratory of quality control of the producer or in the contractual laboratory used by the producer including with use of means of remote interaction, including audio-or video conference does not exceed 85 (eighty five) working days from the date of receipt by the applicant of the notification on need of its carrying out.";

appendices 5, 14, 15, 17 and 18 to the specified Rules to be reworded as follows according to appendices 1, of 2, of 3, 4 and 5 to this order;

in rules of conducting examination of the medical products approved by appendix 2 to the specified order:

state Item 1 in the following edition:

"1. These rules of conducting examination of medical products (further – Rules) are developed in compliance by part one of Item 1 of Rules of registration and examination of safety, quality and efficiency of the medical products approved by the Decision of Council of the Eurasian Economic Commission of February 12, 2016 No. 46, with items 4 and the 10th Articles 23, Item 3 of article 239 of the Code of the Republic of Kazakhstan "About health of the people and health care system" the subitem 1) of article 10 of the Law of the Republic of Kazakhstan "About the state services" and determine procedure for conducting examination of medical products, including strategically important medical products (further – medical products), and also procedure for rendering the state service "Issue of the Conclusion about Safety, Quality and Efficiency of Medicines and Medical Products";

state Items 6 and 7 in the following edition:

"6. In these rules the following terms and determinations are used:

1) medical products for in vitro of diagnostics of open type – medical products for diagnostics of in vitro which operation according to their functional purpose is possible when using reagents (reactants) of wide range of producers;

2) the software is medical product on condition of compliance to its all following criteria:

represents the computer program or its modules regardless of the used platform equipment room, and also methods of placement of the software and provision of access to it;

is not component of other medical product;

it is intended by the producer for delivery of health care;

the result of action of the software consists in interpretation in the automatic mode, including with use of technologies of artificial intelligence, or in the parameters set by the health worker influencing adoption of the clinical decisions, data set received from the medical products allowed to the address in accordance with the established procedure or entered by health workers for the purpose of delivery of health care;

3) consumable materials to the medical product in vitro of diagnostics of the closed type – the consumable materials providing its full functioning according to the set purpose and included in its picking for use with this medical product;

4) medical products for in vitro of diagnostics of the closed type – medical products for diagnostics of in vitro which operation according to their appointment is possible only when using special reagents (reactants) provided by the producer for this medical product and its modifications included in its picking;

5) medical products for diagnostics out of live organism (in vitro) – any tools, devices, devices, the equipment, materials, reagents, calibrators, control materials and other products applied in the medical purposes separately or in combination among themselves and also together with the accessories necessary for application of the specified products to destination, including the special software, and information of rather physiological or pathological condition, inborn pathology, predisposition to certain clinical condition or disease, compatibility of fabrics with the potential recipient intended by the producer of medical product for application in case of researches out of live organism (in vitro) of samples of biological materials of the person for obtaining, forecasting of reactions to therapeutic impacts, the choice of therapeutic means and (or) control of treatment;

6) medical products – products of medical appointment and medical equipment;

7) products of medical appointment – the materials, products, solutions, reagents, sets, sets used for delivery of health care according to functional purpose and the instruction of the producer;

8) medical equipment – the devices, devices, the equipment, complexes, systems applied separately or in combination among themselves to delivery of health care according to the functional purpose and operational characteristics established by the producer;

9) the name of medical product – the verbal designation of medical product determining it functional purpose, model, version, modification, type;

10) the component part of medical product – the part of medical product which is not independent medical product including blocks, parts, the product elements, materials, spare parts provided by the producer for use according to functional purpose, operational characteristics, management of the producer on field service;

11) set (set) of medical products - the set of the medical products combined by general functional purpose and scope, having general marking with indication of the list of the medical products which are part of set (set) according to documentation of the producer;

12) belonging to medical products – the product which is not medical product, intended by the producer for combined use with one or several medical products for use according to their appointment;

13) safety of medical product – lack of unacceptable risk when using the medical product connected with damnification of life, to health of the person, and also the environment;

14) the conclusion about safety, quality and efficiency of medical product – the document containing results of examination of the medical products declared for examination;

15) consumable material to medical products – the products and materials spent when using medical products, providing carrying out manipulations according to functional purpose of medical product, operational characteristics, management on field service of the producer;

16) component of medical product – the main unit (part) of medical product, the component part, accessory, consumable material, reagent to medical product.

17) the main unit of medical equipment (devices, devices, the equipment) – the element (node) of medical equipment (in the presence) provided by the producer, which is integral part of medical equipment, providing its functioning according to appointment and the operation manual and to field service of the producer;

18) the producer of medical product – the subject in the field of drug circulation and medical products, responsible for development and production of medical product, making it available for use on its own behalf irrespective of, it is developed and made by this person or from his name other person (persons), and bearing responsibility for its safety, quality and efficiency;

19) quality of medical product – degree of compliance of set of properties and characteristics of medical product to the purposes of its intended use;

20) the document on quality of medical product (further – the document on quality) – documents (international, regional), the national standards, standards of the organization establishing complex of quality requirements, safety, to techniques of testing, and also transportation and storage of medical products;

21) efficiency of medical product – set of the properties and characteristics of medical product providing goal achievement of purpose, established by the producer of medical product and confirmed with practice of its use;

22) Advisory council of the state expert organization (further – Advisory council) – the collegiate organ created in the state expert organization for consideration of matters of argument in results of examination, the bases (reasons) of issue of the negative conclusions about safety, quality and efficiency of medicines of medical products and to acceptance of the final decision;

23) modification of medical product – the kind of medical product having general with the main medical product the constructive, technological signs developed based on the main product for the purpose of its enhancement, expansion of functional purpose, application or specialization of application in the medical purposes;

24) model – the independent unit of medical product identified by the producer of medical product certain alphabetic, digital or alphanumeric reference;

25) the production site – territorially isolated complex of the producer of medical products intended for accomplishment of all production process of medical products or its certain stages;

26) the authorized representative of producer – the legal entity or physical person registered as the individual entrepreneur, which is resident of the Republic of Kazakhstan, authorized by the power of attorney of the producer of medical product to represent its interests concerning the address of medical product in the territory of the Republic of Kazakhstan according to the current legislation of the Republic of Kazakhstan in the field of health care;

27) the applicant – the producer (manufacturer) or their representative, authorized to submit the application, documents and materials for conducting examination of medical product for registration, re-registrations, modification of the registration file;

28) strategically important medicines and medical products – the medicines and medical products intended for medical application in conditions:

military operations and liquidation of their effects;

origins, preventions and mitigations of consequences of emergency situations;

threats of origin, spread of new especially dangerous infectious diseases and liquidation of their effects;

prevention, diagnostics, treatment of the diseases and defeats received as a result of impact of adverse chemical, biological, radiation factors, and also liquidation of their effects;

absence or threat of lack of medicines or medical products in the markets of state members of the Eurasian Economic Union in the conditions of introduction of rationing economic arrangements concerning at least one of state members;

29) tiporazmerny row – number of the products made of homogeneous raw materials with general physical and chemical properties on general engineering procedure, the having single functional purpose and application differing only in the sizes and (or) amount and (or) color according to documentation of the producer;

30) the registration file – the set of documents and materials of the established content represented to the statement for examination of medical product;

31) modification of the registration file of medicine or medical product – the procedure performed based on examination of the changes made to the registration file during effective period of the registration certificate.

7. For conducting examination of medical product and receipt of the state service "Issue of the Conclusion about Safety, Quality and Efficiency of Medicines and Medical Products" (further – the state service) the applicant by means of the portal of "the electronic government" (www.egov.kz) and object of informatization "the information system of the state expert organization "www.ndda.kz"" (further – information system) provides the following documents:

1) the statement on conducting examination of medical product in electronic form in form according to appendix 1 to these rules;

2) the registration file in electronic form in format of the cross-platform electronic document according to appendix 2 to these rules;

3) the data confirming payment by the applicant of the amount for conducting examination on the settlement account of the state expert organization;

Samples of the medical product which is subject to laboratory researches according to Item 27 of these rules, standard samples of chemicals, test strains of microorganisms, cultures of the cages, specific reagents, consumable materials necessary for reproducibility of techniques of laboratory researches of medical product in the quantities sufficient for triple testing with residual expiration date at least six months with observance of storage conditions and transportations if other is not provided by documents on quality of the producer, according to appendix 3 to these rules the applicant provides 4) within 5 (five) working days from the moment of filing of application purposely under the delivery-acceptance certificate in Service center of applicants (further – TsOZ) to the state expert organization.

Samples of medical product, with storage duration less than six months, and also the medical product requiring special storage conditions (temperature condition, humidity) are provided by the applicant under the delivery-acceptance certificate directly in test laboratory of the state expert organization just before laboratory researches.";

add with Item 9-1 of the following content:

"9-1. Confirmation of adoption of documents through information system is display in "personal account" of the applicant of the status about acceptance of request for rendering the state service.

In cases of submission of documents by the applicant through the portal in "personal account" the status about acceptance of request for rendering the state service with indication of date and the place of receipt of result of the state service is displayed.";

state Item 17 in the following edition:

"17. In the presence of notes to documents of the registration file to the applicant through information system the inquiry (in any form) certified by the digital signature (further – the EDS), with indication of the revealed notes and need of their elimination once in full in time, not exceeding 50 (fifty) working days from signature date of request is sent to "personal account".";

state Item 22 in the following edition:

"22. During conducting specialized examination in the presence of notes to the applicant through information system the inquiry (in any form) certified by the EDS with indication of the revealed notes and need of their elimination in full in time, which is not exceeding 50 (fifty) working days is sent to "personal account".";

add with Item 22-1 of the following content:

"22-1. In case of question of reliability of the submitted documents and materials in case of examination of medical products, the expert organization is guided by information placed on official public sources, the official sites of state bodies in the field of the address of medical products, the manufacturing plants, the international notified bodies, the international national authorities on accreditation in the field of technical regulation or in the field of the address of medical products and also during conducting examination sends the corresponding inquiry to the declared producers of medical products.";

state Items 23 and 24 in the following edition:

"23. In case of the additional questions concerning the data provided by the applicant in the response to prior request, the applicant within 25 (twenty five) working days from the moment of receipt of request directs the response and required materials to additional request of the state expert organization.

24. By results of hearing materials go to Advisory council for decision making about refusal in rendering the state service, or about issue of the conclusion about safety, quality and efficiency of medical products in forms according to appendices 12, 13 to these rules.

The advisory council considers the arrived materials monthly, and results of the decision with indication of the reasons go to the applicant within 8 (eight) working days.";

2) of Item 28 to state the subitem in the following edition:

"2) availability of the document of notified body on compliance of production of medical product and quality control system of products to requirements of Directives of the European commission on medical products or the certificate of MDR (Medical Device Regulation – Regulations on medical products);";

state Item 32 in the following edition:

"32. In case of impossibility of laboratory testing of samples of medical products in test laboratory of the state expert organization for the separate indicators specified in the certificate (protocol) of the analysis of the producer, such testing are performed in other accredited laboratories based on the contract between the expert organization and accredited laboratory according to the legislation of the Republic of Kazakhstan on public procurements.

In the absence of other accredited laboratory, medical products which are carrying out testing, the expert organization recognizes results of laboratory researches on the separate indicators specified in the certificate (protocol) of the analysis of the producer.

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