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ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of June 7, 2023 No. 110

About approval of rules of the organization and carrying out purchase of medicines, medical products and specialized medical products within the guaranteed amount of free medical care, additional amount of medical care for persons containing in pre-trial detention centers and organizations of criminal and executive (penitentiary) system at the expense of budgetary funds and (or) in system of compulsory social medical insurance, pharmaceutical services

(In edition of Orders of the Minister of Health of the Republic of Kazakhstan of 27.12.2024 No. 112, 23.06.2025 No. 58 (see terms of entry into force), 25.12.2025 No. 172)

According to subitem 15-1) of article 7 of the Code of the Republic of Kazakhstan "About health of the people and health care system" I ORDER:

1. Approve rules of the organization and carrying out purchase of medicines, medical products and specialized medical products within the guaranteed amount of free medical care, additional amount of medical care for persons containing in pre-trial detention centers and organizations of criminal and executive (penitentiary) system at the expense of budgetary funds and (or) in system of compulsory social medical insurance, pharmaceutical services according to appendix to this order.

2. To provide to department of medicinal policy of the Ministry of Health of the Republic of Kazakhstan in the procedure established by the legislation of the Republic of Kazakhstan:

1) state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;

2) placement of this order on Internet resource of the Ministry of Health of the Republic of Kazakhstan after its official publication;

3) within ten working days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan submission to Legal department of the Ministry of Health of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1) and 2) of this Item.

3. To impose control of execution of this order on the supervising vice-Minister of Health of the Republic of Kazakhstan.

4. This order becomes effective after ten calendar days after day of its first official publication.

Minister of Health of the Republic of Kazakhstan

A. Giniyat

Appendix

to the Order of the Minister of Health of the Republic of Kazakhstan of June 7, 2023 No. 110

Rules of the organization and carrying out purchase of medicines, medical products and specialized medical products within the guaranteed amount of free medical care, additional amount of medical care for persons containing in pre-trial detention centers and organizations of criminal and executive (penitentiary) system at the expense of budgetary funds and (or) in system of compulsory social medical insurance, pharmaceutical services

Section 1. Basic provisions

Chapter 1. General provisions

1. These rules of the organization and carrying out purchase of medicines, medical products and specialized medical products within the guaranteed amount of free medical care, additional amount of medical care at the expense of budgetary funds and (or) in system of compulsory social medical insurance, pharmaceutical services (further – Rules) are developed for persons containing in pre-trial detention centers and organizations of criminal and executive (penitentiary) system according to subitem 15-1) of article 7 of the Code of the Republic of Kazakhstan "About health of the people and health care system" (further – the Code) and determine procedure for the organization and carrying out purchase of medicines and medical products, specialized medical products within the guaranteed amount of free medical care, additional amount of medical care for persons, containing in pre-trial detention centers and organizations of criminal and executive (penitentiary) system, at the expense of budgetary funds and (or) in system of compulsory social medical insurance, pharmaceutical services.

2. In these rules the following concepts are used:

1) information system of accounting of out-patient provision of medicines – the information system determined by authorized body in the field of health care for automation of accounting of the statement of recipes, leave of medicines and medical products by the supplier of pharmaceutical service within the guaranteed amount of free medical care and (or) medical care in system of compulsory social medical insurance at the out-patient level;

2) the passing remaining balance – remaining balance in warehouses of the single distributor of the medicines and medical products which were earlier purchased including within not reduced inventory;

3) the potential supplier – the physical person performing business activity, the legal entity (except for public institutions, if other is not established for them the laws of the Republic of Kazakhstan) applying for the conclusion of the agreement according to these rules;

4) the affiliate of the potential supplier – physical person or legal entity which has the right directly and (or) to indirectly determine decisions and (or) to exert impact on the decisions made by this potential supplier, including owing to the agreement or other transaction, and also physical person or legal entity concerning which this potential supplier has such right;

5) fund of social medical insurance (further – fund) – the non-profit organization making accumulation of assignments and fees, and also performing purchase and fee of the subjects of health care providing medical care in amounts and on conditions which are provided by the agreement of purchase of medical services, and other functions determined by the laws of the Republic of Kazakhstan;

6) fixed price – the price of medicine or medical product determined by results of purchase at which the supplier shall deliver medicine or medical product to the single distributor;

7) the collaborator – the subjects of health care involved as the supplier to joint agreement performance about rendering pharmaceutical services;

8) the single distributor – the legal entity performing activities within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance according to article 247 of the Code;

9) the list of the medicines and medical products which are purchased from the single distributor (further – the list of the single distributor), – the list of the medicines and medical products which are purchased from the single distributor developed and approved by authorized body in the field of health care, containing:

international non-proprietary names and short characteristic of medicines;

names (structure) and short characteristic of medical products;

10) information system of the single distributor – the information system determined by the single distributor automating activities of the single distributor and allowing message exchange of electronic documents with all concerned parties of process of distribution;

11) the price list of the single distributor – the price offer on medicines and medical products approved by the single distributor, containing list of the medicines which were purchased by the single distributor and medical products with indication of their characteristic, unit of measure, packing, the name of the producer, the country of the producer, the price which is not exceeding ceiling prices for the international non-proprietary name and ceiling prices for the trade name of medicines and medical products according to the order of the Minister of Health of the Republic of Kazakhstan of September 4, 2021 No. KR DSM-96 "About ceiling approval of prices for the international non-proprietary name of medicine or technical characteristic of medical product within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance" (it is registered in the Register of state registration of regulatory legal acts at No. 24253) (further – the Order 96) and the order of the Minister of Health of the Republic of Kazakhstan of August 5, 2021 No. KR DSM - 77 "About ceiling approval of prices for the trade name of medicines and medical products within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance" (it is registered in the Register of state registration of regulatory legal acts at No. 23886) (further – the Order 77), taking into account markup of the single distributor;

12) markup of the single distributor – the allowance approved by authorized body in the field of health care to the price of medicines, the medical products which are purchased by the single distributor specified in the delivery agreement;

13) medicine – the means representing or containing the substance or combination of substances coming into contact with human body, intended for treatment, prevention of diseases of the person or recovery, correction or change of its physiological functions by means of pharmacological, immunological or metabolic impact or for diagnosis of diseases and condition of the person;

14) the long-term agreement of supply of medicines and medical products – the civil contract signed by the single distributor for up to ten years with the prolongation right up to three years with the producer of medicines or medical products located in the territory of the Republic of Kazakhstan or with the customer of contract manufacturing of the original patented medicines and also with customers of contract manufacturing of medical products for supply of medicines or medical products or with the subject in the field of drug circulation and medical products having intention to create production or to modernize the operating production of medicines and medical products, located in the territory of the Republic of Kazakhstan, according to the procedure, established by the legislation of the Republic of Kazakhstan;

15) contract manufacturing of medicines and medical products (further – contract manufacturing) – production of medicines and medical products on contractual basis on production capacities of producers of the medicines and medical products located in the territory of the Republic of Kazakhstan which provide full compliance with requirements of proper production practice (GMP) for medicines and the international standard of quality management system (ISO 13485) for producers of medical products;

16) the web portal of purchase of medicines and medical products, services at subjects of health care (further – the web portal) – the information system providing single point of access to electronic services of purchase of medicines and medical products, services at subjects of health care within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance;

17) the single operator in the field of purchase of medicines and medical products, services at subjects of health care (further – the single operator) – the legal entity determined by authorized body in the field of health care in coordination with authorized body in the field of public procurements;

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

19) not reduced inventory of medicines and medical products - the inventory of the medicines and medical products necessary for uninterrupted provision of medicines established and which is systematically filled up by the single distributor at the expense of own means in amount to twenty five percent from the declared amount of medicines and (or) medical products subjects of health care according to the order of the Minister of Health of the Republic of Kazakhstan of August 20, 2021 No. KR DSM-88 "About determination of the list of the medicines and medical products which are purchased from the single distributor" (it is registered in the Register of state registration of regulatory legal acts at No. 24078) (further – the Order 88);

20) the international unlicensed name of medicine – the name of medicine recommended by the World Health Organization;

21) authorized body in the field of health care – the central executive body performing management and cross-industry coordination in the field of protection of public health of the Republic of Kazakhstan, medical and pharmaceutical science, medical and pharmaceutical education, sanitary and epidemiologic wellbeing of the population, drug circulation and medical products, qualities of rendering medical services (help);

22) the State register of medicines and medical products – the electronic information resource containing data about the medicines and medical products registered and allowed for medical application in the Republic of Kazakhstan;

23) subjects of health care – the organizations of health care, and also the physical persons practising private medicine and pharmaceutical activities;

24) portable medical complex – mobile clinics (offices) based on road transport equipped with the necessary medical equipment which are used for ensuring availability and extension of the list of the rendered medical services to the population of the rural zone and the remote settlements or for the benefit of defense and homeland security;

25) the investment project – complex of the actions providing investments on creation new and (or) upgrade of the operating productions of medicines according to standards of proper production practice (GMP) and medical products, with standards of quality management system of ISO;

26) the customer of contract manufacturing – the legal entity (except for public institutions, if other is not established for them the laws of the Republic of Kazakhstan) having contract manufacturing with the producer located in the territory of the Republic of Kazakhstan and the contract for the contract manufacturing of medicine and (or) medical product which signed with it;

27) kliniko-technical reasons – the document containing information on the need for required medical equipment and readiness of the organization of health care it to apply;

28) the clinical protocol – scientifically proved recommendations about prevention, diagnostics, treatment, medical rehabilitation and palliative medical care in case of certain disease or the patient's condition;

29) the list of the drugs, psychotropic substances and precursors which are subject to control in the Republic of Kazakhstan – the list of the drugs which are subject to control in the Republic of Kazakhstan, the psychotropic substances and precursors numbered and united in the corresponding tables and the list on the basis of international conventions;

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

31) 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;

32) 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;

33) medical task – the document created by the customer (applicant) with indication of necessary diagnostic testings and (or) medical manipulations according to level according to the state standard rate of network of the organizations of health care, profile of the medical organization and the clinical protocol for purchase of medical equipment on the terms of the expanded term of field service;

33-1) 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;

34) local authorities of public administration by health care of areas, cities of republican value and the capital – the state bodies realizing state policy in the field of health care, providing execution of the legislation of the Republic of Kazakhstan in the field of health care and other functions according to article 13 of the Code;

35) orphan (rare) medicine (further – orphan medicine) – the medicine intended for diagnostics, etiopatogenetichesky or pathogenetic treatment of orphan (rare) diseases which frequency does not exceed officially certain level in the Republic of Kazakhstan;

36) No. 172 is excluded according to the Order of the Minister of Health of the Republic of Kazakhstan of 25.12.2025

37) the production site – territorially isolated complex of the producer of medicines and (or) medical products intended for accomplishment of all and (or) part of production process of medicines and (or) medical products or its certain stages;

38) the supplier – the physical person performing business activity, the legal entity (except for public institutions if other is not established for them by the laws of the Republic of Kazakhstan), signed according to these rules with the organizer of purchase, the customer, the lessor or the single distributor the agreement (the long-term agreement, the agreement, the memorandum, the agreement of financial leasing according to legal acts of the Republic of Kazakhstan, other transaction) which subject are supply of medicines and (or) medical products, rendering pharmaceutical services;

39) the applicant – physical person or legal entity, competent to submit applications, documents and materials for issue of the conclusion for compliance of characteristics of the technical specification on purchase of medical equipment to at least two models of different producers, or local authorities of public administration by health care of areas, cities of republican value and the capital, military-medical (medical) divisions, departmental divisions (organizations) rendering medical services the directing requests for implementation of purchase of medical equipment through the single distributor;

40) the delivery agreement – the agreement (the long-term agreement, the agreement, the memorandum, other transaction) concluded between the single distributor, the organizer of purchase or the customer on the one hand and the supplier on the other hand on the purchase of medicines and (or) medical products according to these rules signed by the parties on the web portal or in information system of the single distributor and certified by digital signatures of the parties;

41) payment of cost of pharmaceutical service – compensation to subjects in the field of drug circulation and medical products of actual costs for the rendered pharmaceutical services within the guaranteed amount of free medical care and (or) medical care in system of compulsory social medical insurance;

42) the request – the offer on participation in purchase with the purpose to be acknowledged supplier in accordance with the terms of the announcement or the invitation about purchase and conditions of these rules;

43) expert evaluation – assessment performed by the state expert organization in the field of drug circulation and medical products according to the order of the Minister of Health of the Republic of Kazakhstan of January 5, 2021 No. KR DSM-1 "About approval of technique of implementation of expert evaluation of optimum technical characteristics and kliniko-technical reasons for medical products" (it is registered in the Register of state registration of regulatory legal acts at No. 22040);

44) the conclusion on compliance of characteristics of the technical specification on purchase of medical equipment to at least two models of different producers – the document, the issued expert organization according to these rules, for planning and the organization of purchase of medical equipment, used in case of delivery of health care within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance;

45) the expert – the physical person having special and (or) technical knowledge, experience at least five years and qualification on the corresponding profile, the confirmable relevant documents (diplomas, certificates, certificates and other documents), attracted by the customer, the organizer of purchases or the single distributor on a grant basis to making the expert opinion on compliance or discrepancy of the characteristic of the medicines and (or) products of medical appointment or the technical specification of medical equipment offered by the potential supplier, to the conditions of the announcement or invitation to purchase and conditions established by these rules;

46) purchase – acquisition by the customer, organizer of purchase, the lessor and the single distributor, medicines and (or) medical products, pharmaceutical services within the guaranteed amount of free medical care, additional amount of medical care for persons containing in pre-trial detention centers and organizations of criminal and executive (penitentiary) system at the expense of budgetary funds and (or) in system of compulsory social medical insurance, according to the procedure and the methods established by these rules;

47) the agreement of purchase – the agreement signed between the single distributor and the customer on the purchase of medicines and (or) medical products according to these rules signed by the parties or created in information system of the single distributor and certified by digital signatures of the parties;

48) the agreement of purchase – the agreement signed between the customer and the supplier on the purchase of medicines and (or) medical products according to these rules and other regulatory legal acts of the Republic of Kazakhstan signed by the parties or certified by digital signatures of the parties;

49) the organizer of purchase – person determined by the customer who organizes purchase by the methods provided by these rules and sends purchase results to the customer for the conclusion of the agreement of purchase or the contract for rendering pharmaceutical services;

50) the tripartite agreement of purchase – the agreement signed between the single distributor, the customer and the supplier within the long-term agreement of delivery of medical equipment;

51) the expanded term of field service – the complete cycle of works including delivery, installation, field service of medical equipment, including replacement of the components which fulfilled resource, replacement or recovery of separate parts of medical equipment, the setup and adjustment of medical equipment specific to this medical equipment of work, cleaning, lubricant and if necessary partition of the main mechanisms and nodes, removal of dust, dirt, traces of corrosion and oxidation from the outside and internal surfaces of the case of medical equipment of its components (with partial block and nodal disassembly) and other transactions specific to specific type of medical equipment specified in operational documentation;

52) the contract of delivery of medical equipment with the expanded term of field service – the agreement signed between the customer of medical equipment and the supplier on delivery, installation, field service of medical equipment for a period of up to 10 years;

53) expert group – the group of specialists in profile of required medical equipment determined by authorized body in the field of health care and annually approved by the single distributor;

54) customers – local authorities of public administration by health care of areas, cities of republican value and the capital, military-medical (medical) divisions, departmental divisions (organizations) rendering medical services, and also the subjects of health care rendering medical services within the guaranteed amount of free medical care, additional amount of medical care for persons containing in pre-trial detention centers and organizations of criminal and executive (penitentiary) system at the expense of budgetary funds and (or) in system of compulsory social medical insurance;

55) the affiliate of the customer, the organizer of purchase, the lessor or the single distributor – person (except for the state bodies performing regulation of its activities within the conferred powers) who has opportunity directly and (or) indirectly to determine decisions and (or) to exert impact on accepted by the customer, the organizer of purchase, the lessor or the single distributor of the decision, including owing to the agreement or the agreement of financial leasing, and also any person concerning whom the customer or the organizer of purchase or the lessor or the single distributor have such opportunity;

Marginal 56) the price for the trade name of medicine or medical product within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance (further – the ceiling price for the trade name) – the price of the trade name of the medicine or medical product registered in the Republic of Kazakhstan above which the purchase within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance cannot be made;

Marginal 57) the price for the international non-proprietary name of medicine or technical characteristic of medical product within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance (further – the ceiling price for the international non-proprietary name) – the price of the international non-proprietary name of medicine or technical characteristic of the medical product registered in the Republic of Kazakhstan above which the purchase within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance cannot be made;

58) the tender – the purchase method among potential suppliers directed to determination of the winner according to these rules;

59) pharmaceutical service – the activities of subjects in the field of drug circulation and medical products connected with out-patient provision of medicines of the population including purchase, transportation, storage, accounting and realization of medicines and medical products, within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance;

60) the supplier of pharmaceutical service – the subject of health care rendering services in providing the population in recipes with medicines and (or) medical products based on the contract with local state body health care of areas, cities of republican value and the capital or the single distributor according to the procedure and the methods determined by these rules;

61) pharmaceutical activities – the activities performed in the field of health care on production and (or) production, and (or) wholesale and (or) retail sale of medicines and medical products, connected with purchase (acquisition), storage, import, export, transportation, quality control, registration, distribution, use and destruction of medicines and medical products, and also ensuring their safety, quality and efficiency;

62) the agreement on rendering pharmaceutical services – the agreement signed between the customer and the supplier of pharmaceutical services according to these rules and other regulatory legal acts of the Republic of Kazakhstan, signed by the parties or certified by digital signatures of the parties;

63) foreign producer – the foreign legal entity created in the territory of foreign state and who is the nonresident of the Republic of Kazakhstan, performing production or conversion of medicines, ready to the use (application), and (or) medical products outside the Republic of Kazakhstan and confirming with their certificates of origin issued by competent authorities in the country of the exporter;

64) the electronic document – the document in which information is provided in electronic and digital form and is certified by means of the digital signature;

65) the digital signature – set of electronic digital symbols created by means of the digital signature and confirming reliability of the electronic document, its accessory and invariance of content;

66) DDP the INCOTERMS 2020 – the international trade term of standard agreement provisions of the international purchase and sale which are developed and determined by International Chamber of Commerce when the goods are delivered to the customer to the destination specified in the agreement cleared of all customs duties and risks;

67) the forecast price – the approximate price which is marked out for purchase of medicines and (or) medical products for the purpose of the prevention of origin and spread of infectious and parasitic diseases and also prevention and elimination of effects of emergency situations;

68) similar medical equipment – the medical equipment having similar characteristics and picking that allows it to perform the same functions and to be interchangeable;

69) the agreement of financial leasing - the tripartite agreement according to which the lessor shall acquire in property the leasing subject specified by the leasing recipient at the supplier according to these rules and provide to the leasing recipient this subject of leasing in temporary ownership and use for a fee according to the Civil code of the Republic of Kazakhstan;

70) the lessor - the legal entity, with absolute participation of the state in its authorized capital (the participant of the leasing transaction) who by the attracted and (or) own money acquires subject of leasing in property and gives him to the leasing recipient on terms of the contract of leasing. Within one leasing transaction the lessor has no right to act as other her participant at the same time;

71) the leasing recipient - the participant of the leasing transaction who accepts leasing subject on terms of the contract of leasing;

72) leasing payments - the periodical payments representing the total amount of payments under the agreement of leasing for all duration of the agreement of leasing which shall be calculated taking into account compensation of all or essential part of cost of subject of leasing at the price of the moment of the conclusion of the agreement of leasing and performed throughout the duration of the agreement of leasing which include:

1) compensation to the lessor of purchase costs of subject of leasing and any other expenses which are directly connected with acquisition, delivery of subject of leasing and its reduction in the working condition for proper use according to the agreement of leasing;

2) remuneration on leasing;

73) leasing term - the term for which the subject of leasing is provided to the leasing recipient in temporary ownership and use according to the agreement of financial leasing at the same time early agreement cancelation of financial leasing in case of reservation of ownership right regarding leasing for the lessor does not involve change of term of leasing.

3. The purchase is made with respect for the following principles:

1) provision to potential suppliers of equal opportunities for participation in the procedure of carrying out purchases;

2) fair competition among potential suppliers;

3) publicity and transparency of process of purchases;

4) support of the Kazakhstan producers.

4. For the purpose of optimum and effective expenditure of the budgetary funds allocated for purchase of medicines and medical products within the guaranteed amount of free medical care, and means of compulsory social medical insurance medicines and medical products are bought at the prices which are not exceeding No. KR DSM-94 established by the Order 96 and the Order 77, the order of the acting minister of health care of the Republic of Kazakhstan of August 27, 2021 "About ceiling approval of prices of the producer for the trade name of medicine, ceiling prices for the trade name of medicine for retail and wholesale" (it is registered in the Register of state registration of regulatory legal acts at No. 24229) (further – the Order 94) except for of the unregistered medicines and medical products, imported on the territory of the Republic of Kazakhstan based on the conclusion (the allowing document) issued by authorized body in the field of health care.

5. The purchase of medicines, medical products or pharmaceutical services is performed by the customer or the organizer of purchase by means of the web portal one of the following methods:

1) tender;

2) request of price offers;

3) from one source;

4) purchase at the single distributor according to its list;

5) through the single distributor in the cases provided by these rules.

6) special purchase;

Involvement of the collaborator by the potential supplier for rendering pharmaceutical services is allowed. Information on the collaborator's compliance to conditions, established by these rules, is provided by the potential supplier in the technical specification.

5-1. The lessor performs purchase of medical equipment, for further transfer to subjects of health care on the terms of financial leasing according to Chapter 1 of Section 3 of these rules.

The purchase provided by Chapter 12 of Section 3 of these rules is carried out on papers, till September 30, 2025.

5-2. Customers perform purchase of medicines and medical products of 4-1 Section 3 of these rules which is not included in the Order 88 according to Chapters 1, in 3, of 4,.

6. The purchase of specialized medical products is performed by the customer or the organizer of purchase according to the legislation of the Republic of Kazakhstan on public procurements.

7. The single distributor the purchase is performed by one of the following methods:

1) the tender by means of the web portal;

2) from one source by means of the web portal;

3) at the Kazakhstan and foreign producers or through structural divisions of the United Nations;

4) according to long-term agreements of delivery.

8. The potential supplier does not participate in purchase if:

1) close relatives, the spouse (spouse) or cousins-in-laws of the first heads of this potential supplier and (or) the authorized representative of this potential supplier have power of decision about the choice of the supplier or are customer representative, the organizer of purchase, the lessor or the single distributor in the carried-out purchase;

2) financial and economic activities of the potential supplier or supplier are suspended.

9. The potential supplier participating in purchase corresponds to the following conditions:

1) legal capacity (for legal entities), civil capacity to act (for the physical persons performing business activity);

2) legal capacity on implementation of the related pharmaceutical activity;

3) it is not affiliated with members and the secretary of the commission (commission), and also customer representatives, the organizer of purchase, the lessor or the single distributor who make decisions (directly and (or) indirectly) and (or) exert impact on the made decisions by the commission (commission);

4) absence of debt in the budget, including for the compulsory pension contributions compulsory for professional pension contributions, social assignments and assignments and (or) fees on compulsory social medical insurance;

5) is not subject to insolvency proceeding or liquidation;

6) is not participant of the tender for one lot with the affiliate.

Conditions of this Item are not applied when implementing purchase at foreign producers and through the international organizations founded by the United Nations.

10. The potential supplier within purchase on one lot represents one trade name of medicine or medical product, except for case when under the terms of the announcement or the invitation to purchase its completeness is required.

Local authorities of public administration by health care of areas, cities of republican value and the capital perform purchase of pharmaceutical services within the guaranteed amount of free medical care:

1) for medicines and the medical products entering the order of the Minister of Health of the Republic of Kazakhstan of August 5, 2021 No. KR DSM - 75 "About approval of the List of medicines and medical products for free and (or) preferential out-patient ensuring separate categories of citizens of the Republic of Kazakhstan with certain diseases (conditions)" (it is registered in the Register of state registration of regulatory legal acts at No. 23885), but not entering the list of the single distributor;

2) for the purpose of providing children, in medicine purchase cases in the instruction on which medical application there is specifying about contraindications to application for children;

3) in case of individual intolerance of the patient based on the conclusion of the medical and advisory commission and the decision of local representative bodies of areas, the cities of republican value and the capital.

11. To purchased and released, including in case of purchase of pharmaceutical services, the following conditions are shown to medicines and medical products:

1) availability of state registration in the Republic of Kazakhstan, except for the medicines made in the drugstores, component parts which are part of product of medical appointment, not used as independent product, the unregistered medicines, medical products imported on the territory of the Republic of Kazakhstan based on the conclusion (the allowing document).

In case of purchase of medical equipment in the special vehicle – availability of state registration in the Republic of Kazakhstan as single portable medical complex.

Lack of need of registration of the component part of medical equipment (from delivery set) is confirmed by the letter of the expert organization or authorized body in the field of health care;

At the same time exceeding of the offered functional, technical, quality and operational characteristics of medical equipment to requirements of the technical specification is allowed;

2) compliance of the characteristic or technical specification to conditions of the announcement or invitation to purchase.

At the same time exceeding of the offered functional, technical, quality and operational characteristics of medical equipment to requirements of the technical specification is allowed;

3) marginal not exceeding of the prices according to the international unlicensed name and the trade name (in the presence) approved by the Order 96 and the Order 77, taking into account markup of the single distributor (in case of purchase by the single distributor), the prices in the announcement or the invitation to purchase, except for the unregistered medicines and medical products imported on the territory of the Republic of Kazakhstan based on the conclusion (the allowing document) issued by authorized body in the field of health care;

4) storage and transportation in the conditions providing preserving their safety, efficiency and quality according to the order of the Minister of Health of the Republic of Kazakhstan of February 16, 2021 No. KR DSM-19 "About approval of storage precautions and transportations of medicines and medical products" (it is registered in the Register of state registration of regulatory legal acts at No. 22230);

5) compliance of marking, consumer packaging and the instruction for use of medicines and medical products to requirements of the legislation of the Republic of Kazakhstan, except as specified import to the Republic of Kazakhstan of the unregistered medicines and (or) medical products;

The expiration date of medicines and medical products on the delivery date the supplier to the customer constitutes 6):

at least fifty percent from the specified expiration date on packaging (in case of expiration date less than two years);

at least twelve months from the specified expiration date on packaging (in case of expiration date two years and more);

The expiration date of the medicines and medical products which are purchased on the delivery date by the supplier to the single distributor constitutes 7):

at least sixty percent from the specified expiration date on packaging (in case of expiration date less than two years) by supply of medicines and medical products to the period November, December of the year preceding year for which the purchase, January of the come financial year and at least fifty percent is made in case of subsequent deliveries within financial year;

at least fourteen months from the specified expiration date on packaging (in case of expiration date two years and more) by supply of medicines and medical products to the period November, December of the year preceding year for which the purchase, January of the come financial year and at least twelve months is made in case of subsequent deliveries within financial year;

8) the expiration date of medicines and medical products on the delivery date the single distributor to the customer constitutes:

at least thirty percent from the expiration date specified on packaging (in case of expiration date less than two years);

at least eight months from the specified expiration date on packaging (in case of expiration date two years and more);

The expiration date of vaccines on the delivery date the single distributor to the customer constitutes 9):

at least forty percent from the specified expiration date on packaging (in case of expiration date less than two years);

at least ten months from the specified expiration date on packaging (in case of expiration date two years and more);

10) less expiration dates specified in subitems 8) and 9) of this Item for the passing remaining balance of medicines and medical products of the single distributor which are delivered to the customer for proper use before the expiration of their validity;

11) novelty of medical equipment, its neispolzovannost and production during twenty four months preceding the delivery moment;

12) introduction of the medical equipment relating to gages into the register of the state system of unity of measurements of the Republic of Kazakhstan according to the legislation of the Republic of Kazakhstan on unity of measurements.

Lack of need of entering of medical equipment into the register of the state system of unity of measurements of the Republic of Kazakhstan proves to be true according to the legislation of the Republic of Kazakhstan on ensuring unity of measurements;

13) respect for quantity, quality and delivery dates or rendering pharmaceutical service under the terms of the agreement.

12. The conditions provided by subitems 4), 5), 6), 7), 8), 9), 10), 11), 12) and 13) of Item 11 of these rules are confirmed by the supplier in case of agreement performance of delivery, purchase or the agreement of financial leasing.

13. The customer, the organizer of purchase, the single distributor do not establish to medicines and medical products of condition, not provided by these rules.

The lessor does not establish to medical equipment of condition, not provided by these rules.

Chapter 2. Support of the Kazakhstan producers and (or) producers of state members of the Eurasian Economic Union

14. If one potential supplier who is the Kazakhstan producer and (or) the producer of state members of the Eurasian Economic Union (further – EEU), submitted the request corresponding to conditions of the announcement or invitation to purchase and conditions of these rules participates in purchase on lot, such potential supplier is recognized the winner, and requests of other potential suppliers automatically are rejected, except for purchase of medical equipment worth over 20 million tenges for unit, performed through the Single distributor.

In case of the purchase of medical equipment worth over 20 000 000 (twenty million) tenges for unit performed through the Single distributor one potential supplier who is the Kazakhstan producer and (or) the producer of state members of the Eurasian Economic Union (further – EEU), submitted the request corresponding to conditions of the announcement or invitation to purchase and conditions of these rules participates in case when in purchase on lot, the conditional discount in the amount of 20% at auction stage of the purchase price is provided to such potential supplier.

15. If two and more potential suppliers who are the Kazakhstan producers and (or) producers of state members of EEU whose requests correspond to conditions of the announcement or invitation to purchase and conditions of these rules then the winner among them participate in purchase on lot it is determined by the smallest price following the results of auction, and requests of other potential suppliers automatically are rejected.

16. The status of the Kazakhstan producer of the potential supplier when carrying out purchase is confirmed by the following documents:

1) the license for pharmaceutical activities for production of medicines and (or) medical products received according to the legislation of the Republic of Kazakhstan on permissions and notifications;

2) the registration certificate on medicine or medical product issued according to the order of the Minister of Health of the Republic of Kazakhstan of February 9, 2021 to No. KR DSM-16 "About approval of rules of state registration, re-registration of medicine or medical product, modification of the registration file of medicine or medical product" (it is registered in the Register of state registration of regulatory legal acts at No. 22175), with indication of the Kazakhstan producer as the producer.

Within the conclusion of the agreement or the supplementary agreement to the long-term agreement of delivery the customer, the organizer of purchase or the single distributor checks availability of the supplier in the register of the Kazakhstan producers.

17. The status of the potential manufacturing supplier of state members of EEU is confirmed by the following documents:

1) the license for pharmaceutical activities for production of medicines and (or) medical products received according to the legislation of the Republic of Kazakhstan on permissions and notifications;

2) the registration certificate, corresponding to the decision of Council of EEU of November 3, 2016 No. 78 "About Rules of registration and examination of medicines for medical application" and to the decision of Council of EEU of February 12, 2016 No. 46 "About Rules of registration and examination of safety, quality and efficiency of medical products";

3) the certificate of ISO 13485, (for medical products 2a (sterile) safety of class and 2b and 3 classes of safety).

Chapter 3. Support of entrepreneurial initiative

18. On the conclusion of agreements the potential suppliers who received according to requirements of the legislation in the field of health care of the Republic of Kazakhstan the certificate on object compliance to requirements have advantage:

1) proper production practice (GMP) in case of purchase of medicines and the conclusion of long-term agreements of supply of medicines;

2) proper distributor practice (GDP) in case of purchase of medicines and pharmaceutical services;

3) proper pharmaceutical practice (GPP) in case of purchase of pharmaceutical services.

19. For receipt of benefit on the conclusion of the agreement of purchase or the delivery agreement to the request:

1) the Kazakhstan producers in case of purchase of medicines and the conclusion of long-term agreements of supply of medicines put the certificate on compliance of object and production to requirements of proper production practice (GMP);

2) potential suppliers in case of purchase of medicines put the certificate on object compliance to requirements of proper distributor practice (GDP);

3) potential suppliers and (or) their collaborators in case of purchase of pharmaceutical services put the certificate on object compliance to requirements of proper pharmaceutical practice (GPP).

20. If only one potential supplier who submitted the request corresponding to conditions of the announcement or invitation to purchase and conditions of these rules and the certificate on object compliance to requirements of proper production practice (GMP) or proper distributor practice (GDP) participates in purchase on lot, such potential supplier is recognized the winner, and requests of other potential suppliers automatically are rejected.

21. If two and more potential suppliers who submitted the tenders corresponding to conditions of the announcement or invitation to purchase and conditions of these rules and certificates on compliance of objects to requirements of proper production practice (GMP) or proper distributor practice (GDP) participate in purchase on lot, then the winner among them is determined by the smallest price following the results of auction, and requests of other potential suppliers automatically are rejected.

If on lot two and more potential suppliers who provided the registration certificate, completely and in accuracy corresponding to data of the state register of medicines and (or) medical products or number of permission (conclusion) of authorized body in the field of health care on import of medicine and (or) medical product to the Republic of Kazakhstan participate in purchase, the benefit is provided to the potential suppliers who provided the registration certificate, at the same time the winner among them is determined by the smallest price following the results of auction, and requests of other potential suppliers automatically are rejected.

Chapter 4. Examination

21-1. The customer, the organizer of purchase or the single distributor attracts to purchase (in need of) the expert or experts of profile specialties in the questions requiring special knowledge and (or) technical knowledge.

The customer and (or) the organizer of purchase determines experts for financial year by profile specialties for examination of requests regarding compliance of pharmaceutical service, medicines and (or) medical products to the description, characteristics or technical specifications in the announcement or the invitation.

At the same time customers and (or) organizers of purchase bear responsibility for compliance of experts to the subitem 45) of Item 2 of these rules.

The authorized body in the field of health care determines lists of experts in profile specialties for separate financial year for the purchase which is carried out by the single distributor.

For examination of the offered medicines experts in the field of clinical pharmacology in addition are attracted.

For examination of tenders in case of purchase of medical equipment worth over 20000000 (twenty million) tenges the authorized body determines at least two experts for ensuring interchangeability within financial year.

21-2. Person cannot be the expert:

1) interested in results of procedures of purchase (representatives of the single distributor, the potential supplier);

2) being the close relative, the spouse (spouse) or the cousin-in-law of the first head of the single distributor, the customer or the organizer of purchase.

21-3. The expert has no right to vote in case of decision making about purchase.

The expert opinion has advisory nature and is considered in case of decision making about purchase.

21-4. In case of involvement of the expert for purchase on the web portal conducting examination is performed in the following procedure:

1) experts are registered on the web portal as its users;

2) the member of the commission by means of the web portal sends to the secretary the notification on need of receipt of the expert opinion on the corresponding lot not later than 2 (two) working days before the expiration of the publication of the protocol of vote;

3) the secretary of the commission after receipt of the notification on need of receipt of the expert opinion by means of the web portal without delay sends to the corresponding expert the notification on need of submission of the expert opinion on lot. In case of receipt on the same lot of the notification on need of the expert opinion from other member of the tender commission, the renewed notification to the expert does not go. In case of purchase of medicines and products of medical appointment the notification goes with specification of the questions which are subject to studying by the involved experts.

4) the web portal automatically distributes to members of the commission the expert opinion after its signing by the expert.

21-5. In case of involvement of the expert for the purchase which is carried out on paper the expert opinion it is drawn up in writing, signed by the expert and applied to the minutes of the commission.

The expert opinion is registered the secretary and is not subject to response and (or) replacement.

21-6. The member of the commission in case of disagreement with the expert opinion does not take it into account.

If the request of the potential supplier is rejected based on the expert opinion, it is published by the secretary along with the protocol of vote.

21-7. Use of the expert opinion during 12 (twelve) calendar months when carrying out the subsequent purchases is allowed.

Section 2. Procedure of purchase by the customer or organizer of purchase

Chapter 1.

It is excluded according to the Order of the Minister of Health of the Republic of Kazakhstan of 27.12.2024 No. 112

Chapter 2.

It is excluded according to the Order of the Minister of Health of the Republic of Kazakhstan of 27.12.2024 No. 112

Chapter 3.

It is excluded according to the Order of the Minister of Health of the Republic of Kazakhstan of 27.12.2024 No. 112

Chapter 4.

It is excluded according to the Order of the Minister of Health of the Republic of Kazakhstan of 27.12.2024 No. 112

Chapter 5. Planning and organization of purchase of medical equipment

Paragraph 1. Planning of purchase of medical equipment

91. Customers no later than January 15 send for review to authorized body in the field of health care the list of medical equipment with the following supporting documents:

1) kliniko-technical reasons according to the order of the Minister of Health of the Republic of Kazakhstan of January 5, 2021 No. KR DSM-1 "About approval of technique of implementation of expert evaluation of optimum technical characteristics and kliniko-technical reasons for medical products" (it is registered in the Register of state registration of regulatory legal acts at No. 22040).

2) at least three commercial the offer from different producers.

92. The authorized body in the field of health care no later than February 15 sends to customers, the single distributor and to the expert organization the approved list of medical equipment worth over 20 000 000 (twenty million) tenges.

93. Customers after obtaining from authorized body in the field of health care of the approved list of medical equipment worth over 20 000 000 (twenty million) no later than May 1 of the current year send to the expert organization, with approval of local authorities of public administration of health care of areas, cities of republican value and the capital:

1) the statement in form, according to appendix 7 to these rules taking into account specifying of the compared parameters of medical equipment from the technical specification and their values according to the standards of the technical specification of medical equipment approved by the order of the Minister of Health of the Republic of Kazakhstan No. KR DSM-167/2020 of October 29, 2020 "About approval of the minimum standards of equipment of the organizations of health care by medical products" (it is registered in the Register of state registration of regulatory legal acts at No. 21560) (in the presence of the approved standard);

2) the documents and materials containing data on technical characteristics of similar medical equipment in full accordance with data of the state register of medicines and medical products;

3) the copy of the recommended conclusion by results of carrying out expert evaluation of the kliniko-technical reasons for medical equipment issued according to the order No. KR DSM-1.

For issue of the conclusion on compliance of characteristics of the technical specification on purchase of medical equipment to at least two models of different producers comparative analysis of functional parameters of the technical specification with technical characteristics at least two models of different producers of the medical equipment provided by the applicant is carried out.

The applicant in case of the choice of the similar equipment considers technical characteristics, opportunities and picking of the compared models.

The conclusion is issued on the registered medical equipment for the organization of centralized purchase of medical equipment in case of delivery of health care within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance.

94. The expert organization performs issue of the conclusion on compliance of characteristics of the technical specification on purchase of medical equipment to at least two models of different producers following the results of comparative analysis within 10 (ten) working days from the date of registration of a statement in form, according to appendix 8 to these rules.

In case of issue of the conclusion on compliance of characteristics of the technical specification on purchase of medical equipment to at least two models of different producers materials of the state register of medicines and medical products and documents of the corresponding registration file are considered.

95. In the presence of notes to the submitted documents according to Item 93 of appendix 7 to these rules and (or) materials of the corresponding registration file, the expert organization sends to the applicant the answer (in any form) with indication of the revealed notes and need of their elimination in time which is not exceeding 7 (seven) working days from the moment of the direction of notes.

For the period of elimination of notes, terms of consideration of the application stop.

In case of not elimination by the applicant of notes the expert organization sends to the applicant the notification (in any form) about the termination of consideration of the application.

96. The expert organization performs issue of the conclusion on compliance of characteristics of the technical specification on purchase of medical equipment to at least two models of different producers, the health cares of areas, cities of republican value and the capital directed by local authorities of public administration.

97. The applicant provides reliability, completeness and contents of the submitted documents according to the current legislation of the Republic of Kazakhstan and these rules.

Provision by the applicant of doubtful data is the basis for refusal in issue of the conclusion.

Conclusion effective period on compliance of characteristics of the technical specification on purchase of medical equipment to at least two models of different producers constitutes no more than 12 months from the date of its issue.

98. Customers perform purchase of medical equipment which cost does not exceed 20 000 000 (twenty million) tenges, according to Section 3 of these rules in coordination with the administrator of the budget program.

At the same time the conclusion on compliance of characteristics of the technical specification on purchase of medical equipment is not required to at least two models of different producers on medical equipment worth below 20 000 000 (twenty million) tenges.

99. Medical equipment worth over 20000000 (twenty million) tenges is acquired by the customer through the single distributor.

99-1. Medical equipment, (five million) tenges worth from 5 000 000 to 200 000 000 (two hundred million) tenges is also acquired by the attracted and (or) own money of the lessor according to the submitted application by subjects of health care.

If repayment of leasing payments, and also the initial contribution is (in the presence) provided at the expense of means of the local budget or transfers from the republican budget upper limit of cost of the medical equipment which is purchased by the lessor according to the submitted application by subjects of health care it is allowed to exceed 200 000 000 (two hundred million) tenges.

100. Customers perform purchase of medical equipment worth over 20000000 (twenty million) tenges for unit by giving to the single distributor by means of information system of the single distributor annually no later than June 1 of the request in form, according to appendix 9 to these rules which contains:

1) the list of acquired medical equipment in form, according to appendix 9 to these rules;

2) the technical specification in form, according to appendix 9 to these rules (by preparation of the technical specification the customer includes in it the parameters influencing functional purpose of medical equipment which lack leads to impossibility of application to destination).

In the presence of the standard of the technical specification on the declared name of medical equipment, the Minister of Health of the Republic of Kazakhstan approved by the order No. KR DSM-167/2020 of October 29, 2020 "About approval of the minimum standards of equipment of the organizations of health care by medical products" the technical specification is created by the customer according to the approved standard of the technical specification" (it is registered in the Register of state registration of regulatory legal acts at No. 21560);

3) the conclusion on compliance of characteristics of the technical specification on purchase of medical equipment to at least two models of different producers (on medical equipment on which there is no standard of the technical specification approved by the order of the Minister of Health of the Republic of Kazakhstan No. KR DSM-167/2020 of October 29, 2020 "About approval of the minimum standards of equipment of the organizations of health care by medical products" (it is registered in the Register of state registration of regulatory legal acts at No. 21560) (further – the order No. KR DSM-167/2020).

At the same time, the customers who are under authority of local authorities of public administration by health care of areas, cities of republican value, the capital submit applications to local authorities of public administration by health care on the territoriality for approval and the further direction to the single distributor by means of information system of the single distributor.

Customers and (or) local authorities of public administration by health care, in the presence of requests for purchase of medical equipment, identical on technical characteristic, combine such requests in one line item (one lot).

In the presence of requests for purchase of medical equipment with identical technical characteristics, the single distributor combines them in one lot.

The price of lot is determined from the smallest price from the identical requests submitted by customers.

At the same time delivery date of medical equipment is established by the single distributor of 90 calendar days, no later than December 15. The amount of advance payment is established in the amount of 0%.

101. Reliability of the data containing in the request is assigned to customers (applicants).

102. The single distributor within 10 (ten) working days from the moment of receipt of the request by means of information system of the single distributor considers the request for completeness of the provided data.

The request of the customer returns to completion in case of discrepancy of the technical specification of the customer with parameter value of the technical specification of the medical equipment specified in the conclusion compliance of characteristics of the technical specification on purchase of medical equipment to at least two models of different producers (in the absence of the approved standard of the technical specification on the declared name of medical equipment).

The request of the customer returns to completion in case of discrepancy of the technical specification of the customer created according to the approved standard of the technical specification (in the presence of the approved standard) with the standard of the technical specification approved by the order No. KR DSM-167/2020.

The customer allows reduction of the request in compliance within 10 (ten) working days and to bring repeatedly to the single distributor by means of information system of the single distributor.

103. Repeatedly introduced technical specification of the customer is considered no more than 10 (ten) working days.

104. Not elimination or incomplete elimination of notes are the bases for variation of the request of the customer.

105. The organization of purchase of medical equipment is performed by the single distributor in compliance Chapter 1 of Section 3 of these rules.

106. Monthly till the 5th following for reporting customers (applicants) provide to the single distributor information on the conclusion of agreements and delivery of medical equipment worth over 20 000 000 (twenty million) tenges on form, according to appendix 9-1 to these rules, and also the supporting document upon introduction by suppliers of ensuring agreement performance.

The single distributor within 5 (five) working days after submission of information from customers (applicants) submits to authorized body in the field of health care the report on results of purchase on form, according to appendix 9-2 to these rules.

Chapter 6. Conclusion of the agreement of purchase or contract for rendering pharmaceutical services

107. The customer within 5 (five) calendar days from the date of summing up the tender or receipt of results of purchase from the organizer of purchase sends to the potential supplier the signed agreement of purchase or the contract for rendering pharmaceutical services constituted in form according to appendix 5 and (or) 6 of these rules.

108. Within 10 (ten) working days from the date of receipt of the agreement the winner of the tender signs it or in writing notifies the customer on disagreement with its conditions or refusal of signature.

109. Non-presentation in the specified time of the signed contract or notification on disagreement with conditions is considered refusal of its conclusion. The term of consideration of refusal does not exceed 2 (two) working days from the date of representation of refusal of the conclusion of the agreement.

110. The agreement of purchase or the contract for rendering pharmaceutical services become effective from the date of signing by his authorized representatives of the parties.

111. If the winner of the tender evaded from agreement signature of purchase or the contract for rendering pharmaceutical services at the scheduled time or did not notify the customer on disagreement with its conditions, then the customer signs the contract with the participant of the tender, to the corresponding conditions of these rules and which price offer is the second after the proposal of the winner.

112. Entering of any changes and (or) new conditions into the agreement (except for reduction of the price of medicines and (or) medical products, amount) which are changed by contents of the offer which was basis for the choice of the supplier including replacement of the trade name specified in the agreement, other trade name are not allowed.

113. Modification of the signed agreement on condition of the invariance of structure or the characteristic of medicine and (or) medical product which was basis for the choice of the supplier is allowed:

1) by mutual consent of the parties regarding reduction of the price of medicines and (or) medical products and, respectively, a price of the agreement;

2) by mutual consent of the parties regarding reduction of amount of medicines and (or) medical products, pharmaceutical services.

114. Negotiation by the customer or organizer of purchase with the potential supplier declared as the winner of the tender for the purpose of reduction of the price of medicines and (or) medical products or pharmaceutical service before agreement signature of purchase and the contract for rendering pharmaceutical services using audio-and video fixing is allowed. The potential supplier makes the decision at discretion on consent or disagreement to reduction of the price of medicines and (or) medical products or pharmaceutical service that is not the basis for refusal by the customer or the organizer of purchase in agreement signature with the potential supplier declared as the winner of the tender.

Chapter 7.

It is excluded according to the Order of the Minister of Health of the Republic of Kazakhstan of 23.06.2025 No. 58

Chapter 8. Purchase at the single distributor

Paragraph 1. List of the single distributor

120. Customers perform purchase of the medicines and medical products included in the Order 88, at the single distributor.

121. The single distributor within 5 (five) working days from the date of summing up purchase submits in authorized body in the field of health care the report on results of purchase.

Paragraph 2. Purchase of medicines and (or) medical products according to the list of the single distributor

122. For implementation of purchase according to the list of the single distributor the need for medicines and medical products is created according to the order of the Minister of Health of the Republic of Kazakhstan of August 20, 2021 No. KR DSM-89 "About approval of rules of providing with medicines and medical products within the guaranteed amount of free medical care, additional amount of medical care to persons containing in pre-trial detention centers and organizations of criminal and executive (penitentiary) system at the expense of budgetary funds and (or) in system of compulsory social medical insurance, and also rules and techniques of forming of need for medicines and medical products within the guaranteed amount of free medical care, additional amount of medical care to persons containing in pre-trial detention centers and organizations of criminal and executive (penitentiary) system at the expense of budgetary funds and (or) in system of compulsory social medical insurance" (it is registered in the Register of state registration of regulatory legal acts at No. 24069).

123. Requests are created for ceiling prices for the international non-proprietary name.

124. Requests of customers until the conclusion of the agreement of purchase are form of expression of their consent to perform purchase of medicines, medical products.

125. The budget request on out-patient provision of medicines goes local authorities of public administration by health care of areas, cities of republican value and the capital to the single distributor.

126. The single distributor annually no later than May 1 performs purchase of medicines and (or) medical products taking into account amount of not reduced inventory on the basis:

1) the requests created by customers for rendering the fast, stationary, hospital-replacing help and prevention of diseases;

2) the budget request created by local authorities of public administration by health care of areas, cities of republican value and the capital on out-patient provision of medicines.

127. Implementation by the single distributor of partial purchase is allowed in case of:

1) emergence of need of pro rata reduction of amount of the medicines declared by customers and (or) medical products when carrying out purchase of medicines and (or) medical products for the corresponding financial year in the same financial year;

2) lack of offers from potential suppliers on delivery of the amount declared by customers of medicines and (or) medical products.

128. After carrying out purchase the single distributor claims and sends to authorized body in the field of health care, to fund, customers the price list for the corresponding financial year.

129. Within out-patient provision of medicines between the single distributor and fund the agreement of payment of cost of pharmaceutical services according to the procedure, determined by authorized body in the field of health care, according to Item 3 of article 69 of the Code, within the amount allocated with authorized body in the field of health care is signed.

Paragraph 3. Purchase for rendering the fast, stationary and hospital-replacing help and prevention of diseases

130. Customers within 10 (ten) working days from the moment of receipt of the price list adjust the preliminary application for the corresponding financial year and send to the single distributor the corrected request.

131. In case of execution of the corrected request for medicines and (or) medical products customers round amount of the declared medicines and (or) medical products to quantity, multiple to the minimum packaging from total annual amount, for the purpose of preserving their quality.

The amount of medicines and (or) medical products in the corrected request can be changed by customers towards reduction to 10 (ten) percent from the quantity specified in preliminary applications.

Reduction of amount of medicines (or) medical products over 10 (ten) percent is allowed in coordination with local authorities of public administration by health care of areas, cities of republican value and the capital, authorized body in the field of health care or fund, in case of:

availability of contraindications to application for children according to the instruction on medical application of medicine,

individual intolerance of the patient based on the conclusion of the medical and advisory commission with participation of the first head of the customer,

reorganization, liquidations and reducings financing.

132. For the conclusion of the agreement customers in information system of the single distributor enter information:

number and document date, the customer's head confirming post (faces, it replacing);

number and the name of the budget program within which the purchase is performed;

payment details,

place of delivery (address) of medicines and (or) medical products.

And also represent the copy of constituent documents, the certificate of state registration, the copy of the order on the head, the copy of the contract with fund, the license in the field of drug trafficking, psychotropic substances and precursors as necessary.

133. The single distributor within 10 (ten) working days from the date of receipt of the corrected request from customers directs to signing to customers agreements for ceiling prices in form, according to appendix 11 to these rules.

134. Customers no later than 5 (five) working days from the date of receipt of the agreement from the single distributor sign it in information system of the single distributor, except for customers, created in form of business of public institution which sign the agreement in form, according to appendix 12 to these rules at the price list prices on paper, seal and transfer them to the single distributor under the delivery-acceptance certificate.

135. In case of origin at customers in the same financial year of additional requirement customers submit to the single distributor the additional requests for purchase created in information system of the single distributor.

Paragraph 4. Purchase for out-patient provision of medicines

136. The single distributor signs the contract with local authorities of public administration by health care of areas, cities of republican value and the capital within 10 (ten) working days from approval date of the price list of the single distributor within the allocated budgetary funds in form according to appendix 13 to these rules.

136-1. The request for shipment is adjusted monthly within the allocated budgetary funds towards increase.

136-2. The single distributor performs shipment taking into account the analysis of remaining balance with the subsequent adjustment of the request for shipment.

136-3. Ensuring requirement within adjustment is performed from not reduced inventory of medicines and medical products.

137. No. 112 is excluded according to the Order of the Minister of Health of the Republic of Kazakhstan of 27.12.2024

138. No. 112 is excluded according to the Order of the Minister of Health of the Republic of Kazakhstan of 27.12.2024

139. No. 112 is excluded according to the Order of the Minister of Health of the Republic of Kazakhstan of 27.12.2024

140. No. 112 is excluded according to the Order of the Minister of Health of the Republic of Kazakhstan of 27.12.2024

141. No. 112 is excluded according to the Order of the Minister of Health of the Republic of Kazakhstan of 27.12.2024

142. The single distributor sends monthly to authorized body in the field of health care information on execution of contractual commitments on rendering pharmaceutical services.

143. No. 58 is excluded according to the Order of the Minister of Health of the Republic of Kazakhstan of 23.06.2025

Chapter 9. Procedure for cost recovery to suppliers of pharmaceutical services

144. Local authorities of public administration by health care of areas, cities of republican value and the capital monthly compensate to suppliers of pharmaceutical services the cost of medicines, medical products established by the agreement on rendering pharmaceutical services, and the amount of remuneration for transportation services, to storage, accounting and realization of medicines, medical products expressed in percentage ratio, established by the agreement on rendering pharmaceutical services.

At the same time the cost of medicines, medical products does not exceed ceiling prices for the international non-proprietary name and ceiling prices for the trade name.

145. Local authorities of public administration by health care of areas, cities of republican value and the capital compensate costs to suppliers of pharmaceutical services for actually rendered services according to acts of the performed works based on reconciliation of the provided data on secure registers (the register of recipes) with data in information system of accounting of out-patient provision of medicines within allocated funds. The amount of the agreement is adjusted taking into account actually rendered amount of services.

Section 3. Purchase procedure

Chapter 1. The tender performed by means of the web portal by the single distributor, the customer, the organizer or the lessor of purchase

Paragraph 1. Tender procedure

146. The potential suppliers corresponding to Items 8 and 9 of these rules participate in the tender.

146-1. The single distributor performs purchase by tender method according to Chapter 1 of Section 3 of these rules in case of:

1) recognition of purchase at the Kazakhstan and foreign producers cancelled;

2) purchase of the medicines containing drugs, psychotropic substances and precursors.

146-2. At the request of authorized body in the field of health care implementation of purchase of medicines and (or) medical products in volume of three-year requirement is allowed.

147. The tender consists of the consecutive stages representing:

1) consideration of requests of potential suppliers by the tender commission regarding compliance to conditions of the announcement and to conditions of these rules and acceptance on the basis of quorum of decisions on variation of requests or determination of winners of the tender for non-competitive lots and the admission to auction – on competitive, and also automatic variation the web portal of the requests of potential suppliers which are not rejected by the commission if their competitors on lot are given support of the Kazakhstan producers and (or) producers of state members of EEU or entrepreneurial initiative;

2) auction among the potential suppliers allowed by the commission to auction, automatic detection by the web portal of winners of the tender and the suppliers who took the second place, and summing up, and in cases of variation of all requests or lack of the competition on lots, – automatic leading by the web portal of results.

148. The decision of the single distributor, customer or organizer of purchase of the commission his workers in odd quantity at least three people, including the head or faces fulfilling its duties are included.

The tender commission is effective from the date of entry into force of the decision on its creation and stops the activities after the publication of the protocol of results.

148-1. In case of the organization of purchase of medical equipment, for the lessor, the chairman of the tender commission determines the first head of the lessor or person fulfilling its duties. Employees of authorized body in the field of health care (under approval), its subordinated organizations (under approval) and the lessor are part of the commission.

149. The secretary of the tender commission determines the staff employee of the single distributor, the customer, the organizer or the lessor of purchase which timely provides:

1) the publication on the web portal of the announcement of carrying out the tender;

2) upon the demand of the member of the tender commission about submission of the expert opinion on any lot the direction to the corresponding expert of the notification on need of making the expert opinion;

3) forming following the results of vote of the tender commission of the draft of the protocol of vote for acquaintance, and upon the demand of any of members of the commission – renewal of vote on the web portal;

4) the publication on the web portal of the protocol of vote;

5) cancellation on the web portal of the tender in general or to any lot in decision making cases about its cancellation or recognition invalid with familiarizing of its copy;

6) informing on tender results for the conclusion of agreements.

150. The announcement of carrying out the tender is published in the Kazakh and Russian languages on the web portal within 3 (three) working days from the date of decision making by the single distributor, customer, organizer or lessor of purchase with mailing by the web portal of the notification to all registered potential suppliers and represents information containing:

1) name, number and time of placement of the announcement;

2) name, legal address, business identification code, bank account of the single distributor or lessor;

3) lots with indication of number, the name of medicine and (or) medical product, its characteristic with appendix of the technical specification of medical equipment, the unit of measure, quantity which is marked out the price and total amount;

4) place of delivery or rendering pharmaceutical service;

5) delivery dates or rendering pharmaceutical service;

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