ORDER OF THE GOVERNMENT OF THE REPUBLIC OF KAZAKHSTAN

of November 8, 2017 No. 719

About modification of the orders of the Government of the Republic of Kazakhstan of October 30, 2009 No. 1729 "About approval of Rules of the organization and carrying out purchase of medicines, preventive (immunobiological, diagnostic, disinfecting) medicines, products of medical appointment and medical equipment, pharmaceutical services in rendering the guaranteed amount of free medical care and medical care in system of compulsory social medical insurance" and of July 8, 2015 No. 515 "About approval of Rules of purchase of services in storage and transportation of medicines and products of medical appointment as the single distributor within the guaranteed amount of free medical care and system of compulsory social medical insurance and modification and amendments in some decisions of the Government of the Republic of Kazakhstan"

The government of the Republic of Kazakhstan DECIDES:

1. Bring the following changes in some decisions of the Government of the Republic of Kazakhstan:

1) in the order of the Government of the Republic of Kazakhstan of October 30, 2009 No. 1729 "About approval of Rules of the organization and carrying out purchase of medicines, preventive (immunobiological, diagnostic, disinfecting) medicines, products of medical appointment and medical equipment, pharmaceutical services in rendering the guaranteed amount of free medical care and medical care in system of compulsory social medical insurance" (SAPP of the Republic of Kazakhstan, 2009, Art. No. 47-48, 444):

Rules of the organization and carrying out purchase of medicines, preventive (immunobiological, diagnostic, disinfecting) medicines, products of medical appointment and medical equipment, pharmaceutical services in rendering the guaranteed amount of free medical care and medical care in system of compulsory social medical insurance, approved by the specified resolution to be reworded as follows according to appendix 1 to this resolution;

2) in the order of the Government of the Republic of Kazakhstan of July 8, 2015 No. 515 "About approval of Rules of purchase of services in storage and transportation of medicines and products of medical appointment as the single distributor within the guaranteed amount of free medical care and system of compulsory social medical insurance and modification and amendments in some decisions of the Government of the Republic of Kazakhstan" (SAPP of the Republic of Kazakhstan, 2015, Art. No. 37-38, 265):

state heading in the following edition:

"About approval of Rules of purchase of services in storage and transportation of medicines and products of medical appointment, services in accounting and realization of medicines and products of medical appointment as the single distributor within the guaranteed amount of free medical care and in system of compulsory social medical insurance and modification and amendments in some decisions of the Government of the Republic of Kazakhstan";

1) of Item 1 to state the subitem in the following edition:

"1) Rules of purchase of services in storage and transportation of medicines and products of medical appointment, services in accounting and realization of medicines and products of medical appointment as the single distributor within the guaranteed amount of free medical care and in system of compulsory social medical insurance;";

Rules of purchase of services in storage and transportation of medicines and products of medical appointment as the single distributor within the guaranteed amount of free medical care and in system of compulsory social medical insurance, approved by the specified resolution to be reworded as follows according to appendix 2 to this resolution.

2. This resolution becomes effective after ten calendar days after day of its first official publication.

Appendix 1

to the Order of the Government of the Republic of Kazakhstan of November 8, 2017 No. 719

Approved by the Order of the Government of the Republic of Kazakhstan of October 30, 2009 No. 1729

Rules of the organization and carrying out purchase of medicines, preventive (immunobiological, diagnostic, disinfecting) medicines, products of medical appointment and medical equipment, pharmaceutical services in rendering the guaranteed amount of free medical care and medical care in system of compulsory social medical insurance

Section 1. Basic provisions

Chapter 1. General provisions

1. These rules of the organization and carrying out purchase of medicines, preventive (immunobiological, diagnostic, disinfecting) medicines, products of medical appointment and medical equipment, pharmaceutical services in rendering the guaranteed amount of free medical care and medical care in system of compulsory social medical insurance (further - Rules), articles 6, the subitem 7) of article 10 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" (further - the Code), Item 2 of article 7 of the Law of the Republic of Kazakhstan of November 16, 2015 "About compulsory social medical insurance" are drafted according to the subitem 12) and determine procedure for the organization and carrying out purchase of medicines, products of medical appointment and medical equipment, pharmaceutical services in rendering the guaranteed amount of free medical care and medical care in system of compulsory social medical insurance.

2. In these rules the following concepts are used:

1) the affiliate of the customer or 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;

2) 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;

3) customers - local authorities of public administration by health care of areas, the cities of republican value and the capital, military-medical (medical) divisions, departmental divisions (organizations), and also the subjects of health care belonging to the state companies, legal entities, fifty and more percent of voting shares (shares) of which belongs to the state, the rendering medical services within the guaranteed amount of free medical care and in system of compulsory social medical insurance;

4) the single distributor - the legal entity performing within the guaranteed amount of free medical care and in system of compulsory social medical insurance activities according to article 77 of the Code;

5) purchase - acquisition by the customer, single distributor, lessor of medicines, preventive (immunobiological, diagnostic, disinfecting) medicines, products of medical appointment, medical equipment, pharmaceutical services in rendering the guaranteed amount of free medical care and in system of compulsory social medical insurance according to the procedure and the methods established by these rules including with use of the web portal of purchases;

6) expert evaluation - assessment performed by the lessor, individual entrepreneurs and legal entities according to technique of implementation of expert evaluation of optimum technical characteristics and kliniko-technical reasons for the medical equipment approved by authorized body in the field of health care;

7) medicine - the means representing or containing pharmacological the active agents coming into contact with human body or getting into its bodies and fabrics intended for prevention, diagnostics and treatment of diseases, and also change of condition and functions of organism: medicinal substance, medicinal raw materials, balk-products of medicines, medicines;

8) immunobiological medicines - medicines for specific prevention, diagnostics and treatment of infectious and immune diseases (including allergic) by means of immunological methods, other diseases and physiological conditions, means for indication of infectious agents and their antigens in objects of external environment, blood medicines (irrespective of obtaining method), and also the medicines rendering medical and preventive effects through immune system;

9) medical equipment - the devices, devices and the equipment used separately in complexes or systems in the medical purposes for prevention, diagnostics, treatment of diseases, rehabilitation, scientific research of medical nature;

10) products of medical appointment - the products, materials used for holding preventive, diagnostic and medical actions: the medical tools, dental, consumable, dressing and sutural materials fixing bandages and devices, products of medical optics;

11) homogeneous goods - goods which, without being identical, have similar characteristics and consist of similar components that allows them to perform the same functions and to be interchangeable;

12) the potential 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), applying for the conclusion of the agreement according to these rules;

13) 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 the agreement according to these rules, the agreement of financial leasing according to legal acts of the Republic of Kazakhstan;

14) the tender - the purchase method providing open competition between potential suppliers and directed to determination of the most advantageous conditions of the agreement on purchase;

15) the tender with use of two-stage procedures (further - the two-stage tender) - the purchase method providing open competition between potential suppliers and directed to determination of the most advantageous conditions of the agreement using the auction performed according to these rules;

16) the tender documentation - documentation submitted by the customer or the organizer of the tender to the potential supplier for preparation of the tender according to these rules;

17) the tender - the proposal of the potential supplier constituted according to the tender documentation or provisions of these rules;

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

19) domestic producer - the physical person performing business activity, or the legal entity, being residents of the Republic of Kazakhstan, corresponding to the following criteria:

pharmaceutical activities for production of medicines, products of medical appointment or medical equipment in the territory of the Republic of Kazakhstan are performed based on the corresponding permission (notification) received (directed) according to the Law of the Republic of Kazakhstan of May 16, 2014 "About permissions and notifications";

the goods 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;

goods are made or subjected to sufficient conversion according to criteria of sufficient conversion of goods 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 of the Republic of Kazakhstan of November 9, 2004 "About technical regulation";

goods are subjected to sufficient conversion in the territory of special economic zones of the Republic of Kazakhstan according to criteria of sufficient conversion of goods according to the Law of the Republic of Kazakhstan of November 9, 2004 "About technical regulation" and exported on other part of customs area of the Republic of Kazakhstan;

20) foreign producer (manufacturing plant) - the foreign legal entity created by the legislation of foreign state, who is the nonresident of the Republic of Kazakhstan, goods of which, ready to the use (application), are completely made or processed outside the Republic of Kazakhstan that is confirmed with the certificates of origin issued by competent authorities in the country of the exporter;

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

characteristics of medicines, products of medical appointment, their marginal prices, 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 products of medical appointment - the name or structure;

the name of medical equipment, the technical specification and picking, cost for unit and by picking, delivery dates on each description of goods;

22) authorized body in the field of the state support of industrial and innovative activities - the central executive body performing management in spheres of the industry and industrial and innovative development, development of the pharmaceutical and medical industry of the country, the state investment policy and policy of support of investments;

23) residents of the Republic of Kazakhstan are citizens of the Republic of Kazakhstan, including the foreigners and stateless persons having the document on the right of permanent residence in the Republic of Kazakhstan, all legal entities created according to the legislation of the Republic of Kazakhstan with the location in the territory of the Republic of Kazakhstan and also their branches and representations with the location in the Republic of Kazakhstan and beyond its limits;

24) nonresidents of the Republic of Kazakhstan - the physical persons, legal entities, their branches and representations which are not specified in the subitem 23) of this Item;

25) fixed price - the price of medicine, product of medical appointment determined by results of purchase at which the supplier shall deliver medicines, products of medical appointment to the single distributor;

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

27) cost recovery to the supplier of pharmaceutical service - compensation for the account of fund or means of local executive body of areas, the cities of republican value and the capital to the supplier of pharmaceutical service of costs at the cost established by results of purchase by the single distributor or local authorities of public administration by health care of areas, the cities of republican value and the capital, medicines, products of medical appointment including the cost of transportation services, to storage, accounting and realization of medicines, products of medical appointment;

28) the long-term agreement of supply of medicines, products of medical appointment - the civil agreement signed by the single distributor with the legal entity - the resident of the Republic of Kazakhstan on supply of medicines, the products of medical appointment made according to requirements of proper production practice (GMP) for medicines and requirements of the international standard for products of medical appointment having the certificate of origin for the internal address according to the legislation of the Republic of Kazakhstan or with the legal entity having intention on creation of production of medicines, products of medical appointment according to requirements of proper production practice (GMP) for medicines and requirements of the international standard for products of medical appointment;

29) guarantee field service - the range of services on maintenance of the delivered medical equipment in good repair including any kinds of maintenance, technical diagnostics and fault detection of the equipment, rescue and recovery operations, technical consultations which are rendered by the supplier (the manufacturer, the contractor), including remotely (online, with use of specialized programs and the equipment, the data transmission channel identified barkody or other method), on condition of its proper use and storage is free for the term defined by agreements of purchase, long-term agreements of delivery, tripartite agreements of purchase and financial leasing, except for recoveries of the consumable materials and the worn-out nodes established by the plant the producer;

30) 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;

31) the agreement of purchase - the agreement signed between the customer and the supplier on the purchase of goods according to these rules and other regulatory legal acts of the Republic of Kazakhstan fixed in writing, signed by the parties or certified by digital signatures of the parties with all appendices;

32) the delivery agreement - the agreement signed between the single distributor and the supplier on the purchase of medicines, products of medical appointment 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 with all appendices;

33) the agreement of purchase - the agreement signed between the single distributor and the customer on the purchase of medicines, products of medical appointment 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 with all appendices;

34) the agreement on rendering pharmaceutical services - the agreement signed between the customer or the single distributor and the supplier on the purchase of pharmaceutical services according to these rules and other regulatory legal acts of the Republic of Kazakhstan fixed in writing, signed by the parties or created in information system of the single distributor and certified by digital signatures of the parties with all appendices;

35) 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;

36) the lessor - the legal entity (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 financial leasing;

37) the leasing recipient - the organization of health care (the participant of the leasing transaction) which accepts leasing subject on terms of the contract of financial leasing;

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

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 financial leasing;

remuneration on leasing;

39) the medical equipment requiring unification - the medical equipment with uniform technical characteristics which is purchased by the organizations of health care for rendering homogeneous medical services at the expense of means of the republican budget including target current transfers to regional budgets, budgets of the cities of Astana and Almaty on material equipment of the medical organizations at the local level;

40) 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;

41) 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 products of medical appointment 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";

42) the long-term agreement of delivery of medical equipment - the civil agreement signed by the single distributor with the legal entity - the resident of the Republic of Kazakhstan on delivery of the medical equipment made according to requirements of international standards and having the certificate of origin for the internal address according to the legislation of the Republic of Kazakhstan;

43) the price list of the single distributor - the price offer on goods created according to the procedure, established by these rules, approved as the single distributor for customers and service providers on accounting and sales of goods, containing list of the goods which were purchased by the single distributor 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 marginal price according to the list of the single distributor taking into account markup of the single distributor for unit, and also for medicines trade and the international non-proprietary name or structure, for products of medical purpose of the trade name or structure;

44) orphan medicines - medicines for treatment and diagnosis of orphan (rare) diseases;

45) the state expert organization in the field of drug circulation, products of medical appointment and medical equipment - the organization determined by authorized body in the field of health care for conducting examination in case of state registration, re-registration and modification of the registration file of medicines, products of medical appointment and medical equipment (further - the expert organization);

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

47) 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;

48) 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;

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

50) 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 the conditions provided by the agreement of purchase of medical services and other functions determined by the laws of the Republic of Kazakhstan;

51) goods - medicines, preventive (immunobiological, diagnostic, disinfecting) medicines, products of medical appointment and (or) medical equipment;

52) the international unlicensed name of medicine - the name of medicine recommended by the World Health Organization;

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

54) the passing remaining balance - medicines and (or) the products of medical appointment accepted last financial years from suppliers on warehouse of the single distributor including unrealized customers from not reduced inventory;

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

56) DDP the INCOTERMS 2010 - 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;

57) 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;

58) 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 concerning compliance of the characteristic or the technical specification of the offered goods of potential suppliers to the list of the single distributor or the technical specification and requirements to the purchased goods established by these rules;

59) the web portal of purchases - the information system created at the expense of means of the single distributor determined by authorized body in the field of health care for provision of single point of access to the electronic procurement which are carried out by the single distributor, the customer or the organizer of purchase;

Marginal 60) the price for medicine, product of medical appointment and medical equipment within the guaranteed amount of free medical care and in system of compulsory social medical insurance (further - marginal price) - the price of medicine, product of medical appointment and above which medical equipment the purchase by the single distributor and the organizations of health care providing medical care within the guaranteed amount of free medical care and in system of compulsory social medical insurance cannot be made;

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

62) service in accounting and realization of medicines, products of medical appointment - the activities of subjects in the field of drug circulation, products of medical appointment connected with providing the population with medicines, products of medical appointment, providing accounting, storage, realization (prescription dispensing) to the population;

63) the service provision agreement on accounting and realization of medicines, products of medical appointment - the agreement signed between the single distributor and the service provider on accounting and realization of medicines, products of medical appointment according to these rules and other regulatory legal acts of the Republic of Kazakhstan, fixed in writing, signed by the parties with all appendices;

64) local authorities of public administration by health care of areas, the 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, performing management in the field of protection of public health, drug circulation, products of medical appointment and medical equipment, exercising monitoring and control of activities of subjects of health care;

65) service of the single distributor - set of the services rendered by the single distributor to fund connected with out-patient provision of medicines of the population medicines, products of medical appointment within the guaranteed amount of free medical care and medical care in system of compulsory social medical insurance;

66) 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, goods issue by the supplier of pharmaceutical service or service in accounting and realization within the guaranteed amount of free medical care and medical care in system of compulsory social medical insurance at the out-patient level;

67) cost recovery to the supplier of service in accounting and realization of goods - compensation by the single distributor of costs for storage, realization and accounting of goods to the supplier of service in accounting and realization of medicines, products of medical appointment by results of purchase of services by fund;

68) not reduced inventory of medicines and products of medical appointment - the list of medicines, products of medical appointment established and acquired by the single distributor in the current financial year at the expense of own means in amount to ten percent from the total amount of the medicines, products of medical appointment from the list of the single distributor which were actually purchased by customers in previous year;

69) the service provision agreement of the single distributor - the agreement signed between fund and the single distributor on the purchase of service of the single distributor according to these rules and other regulatory legal acts of the Republic of Kazakhstan fixed in writing, signed by the parties or created in information system of the single distributor and certified by digital signatures of the parties with all appendices;

70) the non-paid delivery agreement of medicines, products of medical appointment - the agreement signed between the single distributor and subjects of health care within out-patient provision of medicines for the purpose of out-patient provision of medicines of the attached population by fund, fixed in writing, signed by the parties with all appendices, signed in the form approved by authorized body in the field of health care according to these rules and other regulatory legal acts of the Republic of Kazakhstan;

71) portable complex - special motor transport on which medical equipment, products of medical appointment allowing to carry out autonomous medical and diagnostic actions is stationary fixed (not figurative and not portable).

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

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

1) optimum and effective expenditure of the money used for purchase;

2) provisions to potential suppliers of equal opportunities for participation in the procedure of carrying out purchase;

3) fair competition among potential suppliers;

4) publicity and transparency of process of purchase;

5) supports of domestic producers;

6) supports of entrepreneurial initiative;

7) patsiyentooriyentirovannost of the medicinal help;

8) uninterrupted providing population of the Republic of Kazakhstan with medicines, products of medical appointment, medical equipment.

4. For the purpose of optimum and effective expenditure of the budgetary funds allocated for purchase of medicines, the products of medical appointment, medical equipment intended for rendering the guaranteed amount of free medical care, medical care in system of compulsory social medical insurance, medicines products of medical appointment and medical equipment are bought at the prices which are not exceeding the marginal prices established by authorized body in the field of health care.

5. Annually till June first of the corresponding financial year the authorized body in the field of health care approves ceiling prices for medicines, products of medical appointment according to the list of the single distributor to the following financial year.

6. The purchase 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) at the single distributor according to its list;

5) through the single distributor on acquisition of medical equipment;

6) acquisitions of medical equipment on the terms of financial leasing according to the procedure, the established legal acts of the Republic of Kazakhstan for financial leasing of health care by the organizations, except for public institutions.

The purchase provided by subitems 1) - 3) this Item, customers or organizers of purchase can conduct procurements on the web portal.

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

1) two-stage tender;

2) from one source;

3) special procedure of purchase of medicines, products of medical appointment for the prevention of origin and spread of infectious and parasitic diseases, prevention and elimination of effects of emergency situations;

4) special procedure of purchase according to long-term agreements of delivery at the potential suppliers having intention on creation and (or) upgrade of production of medicines, products of medical appointment;

5) special procedure of purchase according to long-term agreements of delivery at the potential suppliers having production of medicines, products of medical appointment;

6) special procedure of purchase according to long-term agreements of delivery at the potential suppliers having production on medical equipment.

The purchase provided by subitems 1) and 2) of this Item the single distributor can conduct procurements on the web portal.

In cases of simultaneous carrying out in one financial year according to subitems 1) or 2) of this Item and purchase methods according to subitems 4), 5) of this Item in which the same potential supplier in whose requests medicines and (or) products of medical appointment with one characteristic and (or) technical characteristic are specified (lots) takes part requests with such lots which procedure of opening is begun earlier are considered by the single distributor of procedures of purchase tender or tender committee. At the same time such lots in the purchase begun later are not considered by tender or tender committee before summing up the purchase begun earlier.

In case of the conclusion tender or tender committee in the purchase begun later such lots deviate by the single distributor of the long-term agreement by results of the purchase begun earlier without consideration.

8. The lessor performs purchase of medical equipment for further transfer of health care to the organizations on the terms of financial leasing through the single distributor.

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

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

The potential supplier does not participate in purchase if:

1) close relatives, the spouse (spouse) or cousins-in-laws 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, the single distributor or the lessor in the carried-out purchase;

2) the head of the potential supplier applying for participation in procurement is connected with management, organization, participation in the authorized capital of the legal entities who are in the list of unfair potential suppliers or suppliers;

3) the head of the potential supplier applying for participation in purchase is the physical person performing business activity which is included in the list of unfair potential suppliers or suppliers;

4) the potential supplier who is the physical person performing business activity, applying for participation in purchase is the head of the potential supplier included in the list of unfair potential suppliers (suppliers);

5) the potential supplier consists in the list of unfair potential suppliers (suppliers);

6) 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 supplier - the nonresident of the Republic of Kazakhstan.

10. The list of unfair potential suppliers or suppliers is created by the customer, the organizer of purchase, the single distributor or the lessor based on the decisions of the courts which took legal effect and goes to authorized body in the field of health care for placement on its Internet resource according to the procedure and the terms provided by authorized body in the field of health care.

11. The bases for inclusion in the list of unfair potential suppliers or suppliers are:

1) representation by potential suppliers of unreliable information on qualification requirements or requirements to the goods and services acquired within rendering the guaranteed amount of free medical care and medical care in system of compulsory social medical insurance;

2) evasion of the potential suppliers determined by winners from the conclusion of the agreement according to these rules;

3) evasion of the potential suppliers who took the second place from the conclusion of the agreement according to these rules;

4) non-execution or improper execution by suppliers of obligations under the agreements signed with them that led to agreement cancelation by the customer, organizer of purchase or the single distributor unilaterally.

12. Involvement of the collaborator by the potential supplier for rendering pharmaceutical services is allowed, at the same time the collaborator of the potential supplier conforms to the qualification requirements imposed to the potential supplier of pharmaceutical services, established in subitems 1), 3), 10) of Item 14 of these rules.

Chapter 3. The qualification requirements imposed to the potential supplier

13. The following qualification requirements are imposed to potential suppliers of goods:

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

2) work experience in the pharmaceutical market of the Republic of Kazakhstan at least one year (this requirement does not extend to producers);

3) solvency - not to have tax debt, debt on the compulsory pension contributions compulsory for professional pension contributions, social assignments and assignments and (or) fees on compulsory social medical insurance;

4) not to be subject to insolvency proceeding or liquidation, financial and economic activities shall not be suspended according to legal acts of the Republic of Kazakhstan at the time of carrying out purchases;

5) not to consist in the list of unfair potential suppliers (suppliers);

6) legal capacity of the potential supplier performing types of activity on occupation which receipt of permission, the direction of the notification is necessary proves to be true by means of information systems of state bodies according to the Law of the Republic of Kazakhstan of November 24, 2015 "About informatization". In case of lack of data in information systems of state bodies, the potential supplier represents notarially certified copy of the corresponding permission (notification) got (directed) according to the Law of the Republic of Kazakhstan of May 16, 2014 "About permissions and notifications".

14. The following qualification requirements are imposed to potential suppliers of pharmaceutical services:

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

2) residence of the Republic of Kazakhstan;

3) legal capacity of the potential supplier performing types of activity on occupation which receipt of permission, the direction of the notification is necessary proves to be true by means of information systems of state bodies according to the Law of the Republic of Kazakhstan of November 24, 2015 "About informatization". In case of lack of data in information systems of state bodies, the potential supplier represents notarially certified copy of the corresponding permission (notification) got (directed) according to the Law of the Republic of Kazakhstan of May 16, 2014 "About permissions and notifications";

4) solvency - not to have tax debt, debt on the compulsory pension contributions compulsory for professional pension contributions, social assignments and assignments and (or) fees on compulsory social medical insurance;

5) not to be subject to insolvency proceeding or liquidation, financial and economic activities shall not be suspended according to legal acts of the Republic of Kazakhstan at the time of carrying out purchases;

6) not to consist in the list of unfair potential suppliers and (or) suppliers;

7) to have work experience in the pharmaceutical market of the Republic of Kazakhstan at least a year;

8) availability of information and communication infrastructure for maintaining information system of accounting of out-patient provision of medicines;

9) not to be made responsible for non-execution or improper execution of obligations by it according to the purchase agreements of pharmaceutical services signed within the last two years based on the judgment which took legal effect;

10) lack of restrictions, stipulated in Item 9 these rules;

11) lack of the relations with the single distributor prohibited by these rules.

15. Qualification requirements are applied taking into account the features of method of purchase established by these rules.

16. The customer, the organizer of purchase or the single distributor do not impose the qualification requirements which are not provided by these rules to the potential supplier.

The potential supplier in confirmation of its compliance to qualification requirements represents to the customer, the organizer of purchase, the single distributor documents and/or copies of documents provided by these rules on paper or by means of the web portal of purchases.

17. The potential supplier on one lot of the tender, the two-stage tender represents one trade name with indication of producer of medicine; products of medical appointment; medical equipment, except for the case specified in Item 18 of these rules.

In case of purchase of pharmaceutical services the potential supplier on one name of medicine, products of medical appointment, and also when carrying out purchase from one source or method of request of price offers represents one trade name with indication of producer of medicine; products of medical appointment; medical equipment, except for the case specified in Item 19 of these rules.

18. The potential supplier of medical equipment on one lot of the tender in cases when for use with the purchased main medical equipment in addition are required medical equipment and (or) products of medical appointment for joint use in picking, can provide two and more producers.

19. Local authorities of public administration by health care of areas, the 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 products of medical appointment which are entering the list of medicines and products of medical appointment for free providing the population within the guaranteed amount of free medical care at the out-patient level with certain diseases (conditions) approved by authorized body in the field of health care, but not entering the list of the single distributor;

2) for the purpose of providing children, in cases of purchase by the single distributor of medicine, in the instruction (approved by authorized body in the field of drug circulation) 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 city of republican value and the capital.

Chapter 4. Requirements to the goods acquired within rendering the guaranteed amount of free medical care and medical care in system of compulsory social medical insurance

20. To purchased and released (in case of purchase of pharmaceutical services) to medicines, products of medical appointment, preventive (immunobiological, diagnostic, disinfecting) the following requirements are imposed on the medicines intended for rendering the guaranteed amount of free medical care and medical care in system of compulsory social medical insurance:

1) availability of registration of medicines, products of medical appointment, preventive (immunobiological, diagnostic, disinfecting) medicines in the Republic of Kazakhstan according to provisions of the Code and the procedure determined by authorized body in the field of health care (except for the medicines made in drugstores, the orphan medicines included in the list of orphan medicines approved by authorized body in the field of health care, the unregistered medicines, products of medical appointment, the component parts which are part of product of medical appointment and medical equipment and not used as the independent product or the device 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);

2) medicines, preventive (immunobiological, diagnostic, disinfecting) medicines, products of medical appointment are stored and transported in the conditions providing preserving their safety, efficiency and quality according to the Storage precautions and transportations of medicines, products of medical appointment and medical equipment approved by authorized body in the field of health care;

3) marking, consumer packaging and the instruction for use of medicines, preventive (immunobiological, diagnostic, disinfecting) medicines, products of medical appointment conform to requirements of the legislation of the Republic of Kazakhstan and to the procedure established by authorized body in the field of health care;

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