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ORDER OF THE GOVERNMENT OF THE REPUBLIC OF KAZAKHSTAN

of June 4, 2021 No. 375

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 and (or) in system of compulsory social medical insurance, pharmaceutical services and recognition voided some decisions of the Government of the Republic of Kazakhstan

According to the subitem 3) of article 6 of the Code of the Republic of Kazakhstan "About health of the people and health care system" the Government of the Republic of Kazakhstan DECIDES:

1. Approve the enclosed Rules of the organization and carrying out purchase of medicines, medical products and specialized medical products within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance, pharmaceutical services.

2. Recognize invalid some decisions of the Government of the Republic of Kazakhstan according to appendix to this resolution.

3. This resolution becomes effective after ten calendar days from the date of its first official publication.

Prime Minister of the Republic of Kazakhstan

A. Mamin

Approved by the Order of the Government of the Republic of Kazakhstan of June 4, 2021 No. 375

Rules of the organization and carrying out purchase of medicines, medical products and specialized medical products within the guaranteed amount of free medical care 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 and (or) in system of compulsory social medical insurance, pharmaceutical services (further – Rules) are developed according to the subitem 3) of article 6 of the Code of the Republic of Kazakhstan of July 7, 2020 "About health of the people and health care system" (further – the Code) and determine procedure for the organization and carrying out purchase of medicines and medical products, specialized medical products, pharmaceutical services within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance.

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 – medicines and the products of medical appointment accepted last financial years from suppliers on warehouse of the single distributor including unrealized customers from 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 medicines and medical products developed and approved by authorized body in the field of health care which is purchased from the single distributor containing:

characteristics of medicines and medical products, possibilities of the conclusion of the long-term agreement of delivery with domestic producers;

specifying for medicines of the international non-proprietary name or structure, for medical product – the name or structure;

the name for medical equipment, the technical specification and picking, unit price and by picking, delivery dates according to each name;

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 the medicines and medical products determined according to the procedure, established by authorized body in the field of health care, 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 agreement signed by the single distributor for up to ten years with producer of medicines and (or) medical products of the Republic of Kazakhstan or the customer of contract manufacturing of medicines and medical products located in the territory of the Republic of Kazakhstan on supply of the medicines and (or) medical products made according to requirements of proper production practice (GMP) for medicines and requirements of the international standard of quality management system (ISO 13485) for medical products, except for medical products of class of safety of potential risk of application 1 and 2a (except sterile); or with the subject in the sphere of drug circulation and medical products having intention to create and modernize production of medicines and (or) medical products or contract manufacturing of medicinal circles of stvo and (or) medical products with the producer of medicines located in the territory of the Republic of Kazakhstan, according to requirements of proper production practice (GMP) for medicines, and for medical products – according to requirements of the international standard of quality management system (ISO 13485), except for medical products of class of safety of potential risk of application 1 and 2a (except sterile), 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 sphere 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 sphere of public procurements;

18) the state expert organization in the sphere 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 are the medicines and medical products necessary for uninterrupted provision of medicines established and which are systematically filled up by the single distributor at the expense of own means in amount to twenty five percent from the total amount of medicines and (or) medical products from predesigns of subjects of health care according to the list of the single distributor for the corresponding financial year;

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

23) 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;

24) 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 according to standards of quality management system of ISO according to the procedure, established by the Law of the Republic of Kazakhstan of November 9, 2004 "About technical regulation" (further – the Law "About Technical Regulation");

25) authorized body in the field of the industry and infrastructure development – the central executive body performing management in spheres of the industry and infrastructure development, development of local content, the pharmaceutical and medical industry;

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 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;

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

30) 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;

31) 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;

32) 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;

33) 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;

34) domestic producer – the physical person performing the business activity, or the legal entity which are resident of the Republic of Kazakhstan, corresponding to the following criteria:

pharmaceutical activities for production of medicines and (or) medical products in the territory of the Republic of Kazakhstan are performed based on the corresponding license for pharmaceutical activities obtained according to the Law of the Republic of Kazakhstan of May 16, 2014 "About permissions and notifications" (further – the Law "About Permissions and Notifications");

the medicines and (or) medical products ready to the use (application) are made according to their state registration in the Republic of Kazakhstan (registration certificate) on the production sites located in the Republic of Kazakhstan;

medicines and (or) medical products are made or subjected to sufficient conversion according to criteria of sufficient conversion in the territory of the Republic of Kazakhstan and intended for the further address in the territory of the Republic of Kazakhstan according to the Law "About Technical Regulation";

medicines and (or) medical products are subjected to sufficient conversion in the territory of special economic zones of the Republic of Kazakhstan according to criteria of sufficient conversion according to the Law "About Technical Regulation" and exported on other part of customs area of the Republic of Kazakhstan;

35) 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;

36) 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), the agreement (the long-term agreement, the agreement, the memorandum, other transaction) which concluded according to these rules with the organizer of purchase, the customer or the single distributor whose subject is supply of medicines and (or) medical products, rendering pharmaceutical services;

37) 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 and other regulatory legal acts of the Republic of Kazakhstan signed by the parties on the web portal or in information system of the single distributor and certified by digital signatures of the parties;

38) payment of cost of pharmaceutical service – compensation to subjects in the sphere 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;

39) 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 requirements of these rules;

40) expert evaluation – assessment performed by the state expert organization in the sphere of drug circulation and medical products according to technique of implementation of the expert evaluation of optimum technical characteristics and kliniko-technical reasons for medical products approved by authorized body in the field of health care;

41) the expert – the physical person having special and (or) technical knowledge, experience and qualification in the field of the carried-out purchases, 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 conditions of the announcement or invitation to purchase and the requirements established by these rules;

42) purchase – acquisition by the customer, organizer of purchase and the single distributor of medicines and (or) medical products, pharmaceutical services within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance, according to the procedure and the methods established by these rules;

43) 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 and other regulatory legal acts of the Republic of Kazakhstan signed by the parties or created in information system of the single distributor and certified by digital signatures of the parties;

44) 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;

45) 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;

46) 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;

47) 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 and (or) in system of compulsory social medical insurance;

48) the affiliate of the customer, the organizer of purchase 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 or the single distributor of the decision, including owing to the agreement, and also any person concerning whom the customer or the organizer of purchase or the single distributor have such right;

Marginal 49) 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 medicine or medical product 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 50) 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 medical product above which the purchase within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance cannot be made;

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

52) pharmaceutical service – the activities of subjects in the sphere 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;

53) 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;

54) 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;

55) 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;

56) the international pharmaceutical organizations – the organizations in the international pharmaceutical market performing at the expense of volume rebates of foreign producers regional (at the level of the states) the wholesale supplies of medicines and (or) medical products;

57) 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;

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

59) 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;

60) 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.

Chapter 2. The principles, methods and restrictions connected with purchase

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 domestic producers.

4. For the purpose of optimum and economical expenditure of the budgetary funds allocated for purchase of medicines and the medical products intended for rendering the guaranteed amount of free medical care and (or) medical care in system of compulsory social medical insurance, the purchase is made at the prices which are not exceeding ceiling prices for the international non-proprietary name, and also ceiling prices for the trade name established by authorized body in the field of health care, 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.

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

1) tender;

2) request of price offers;

3) from one source;

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

6. The purchase of specialized medical products within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance 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) tender;

2) from one source;

3) at foreign producers, the international pharmaceutical organizations and through the international organizations founded by the United Nations and also domestic producers of the medicines and medical products which do not have the registered analogs in the Republic of Kazakhstan according to the international non-proprietary name (structure) and (or) the characteristic.

8. In case of recognition of the tender cancelled, the single distributor makes the decision on purchase implementation by the methods provided by Chapters 13 or 14 of these rules.

9. Workers, and also affiliates of the customer, the organizer of purchase or the single distributor do not participate in quality of potential suppliers when implementing the purchase regulated by these rules.

10. The potential supplier and his affiliate do not act as the participant of the tender for one lot.

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

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

2) financial and economic activities of the potential supplier or supplier are suspended according to the legislation of the Republic of Kazakhstan or the legislation of the state of the potential nonresident supplier of the Republic of Kazakhstan.

12. The potential supplier does not participate in the purchase regulated by these rules, and its application for participation in purchase is subject to variation if the potential supplier is affiliated with:

1) customer representatives, the organizer of purchase or the single distributor who have the right directly and (or) to indirectly make decisions and (or) to exert impact on the made decisions by the tender commission (commission);

2) members of the tender commission (commission);

3) secretary of the tender commission (commission).

13. Involvement of the collaborator by the potential supplier for rendering pharmaceutical services is allowed. Information on the collaborator's compliance to qualification requirements is provided by the potential supplier in the technical specification.

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