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The document ceased to be valid since February 26, 2021 according to Item 2 of the Order of the Government of the Republic of Kazakhstan of February 9, 2021 No. 47

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 medical products by the single distributor within the guaranteed amount of free medical care and system of compulsory social medical insurance

(as amended on 09-02-2021)

The government of the Republic of Kazakhstan DECIDES:

1. Approve the enclosed Rules of purchase of services in storage and transportation of medicines and medical products as the single distributor within the guaranteed amount of free medical care and system of compulsory social medical insurance.

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

Prime Minister of the Republic of Kazakhstan

K. Masimov

Approved by the Order of the Government of the Republic of Kazakhstan of July 8, 2015 No. 515

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

Chapter 1. General provisions

1. These rules of purchase of services in storage and transportation of medicines and medical products, services in accounting and realization of medicines and medical products by the single distributor within the guaranteed amount of free medical care and in system of compulsory social medical insurance (further - Rules) are developed according to subitem 12-2) of article 6 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" (further - the Code) and determine procedure for the choice by the single distributor of service providers by storage and transportation, and also service providers on accounting and realization of medicines, medical products within the guaranteed amount of free medical care and in system of compulsory social medical insurance.

2. In these rules the following concepts are used:

1) 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;

2) 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;

3) medical products - any tools, devices, devices, the equipment, materials and other products which are applied in the medical purposes separately or in combination among themselves, and also with the accessories necessary for application of the specified products to destination, including the special software are intended by the producer of medical product for prevention, diagnostics, treatment of diseases, medical rehabilitation and monitoring of condition of human body, carrying out medical researches, recovery, replacement, change of anatomical structure or physiological functions of organism, prevention or termination of pregnancy and which functional purpose is not implemented by pharmacological, immunological, genetic or metabolic impact on human body and can be supported by use of medicines;

4) tender with use of two-stage procedures (further - tender) - the method of the choice of the potential supplier of services using auction according to these rules providing open competition between potential suppliers of services and directed to determination of the smallest price of purchase of services in storage and transportation of medicines, medical products, and also services in accounting and realization of medicines, medical products;

5) the bid - the proposal of the potential supplier constituted according to the technical specification and provisions of these rules;

6) the long-term agreement on storage and transportation of medicines and medical products - the civil agreement of rendering services signed by the single distributor with the subject in the sphere of drug circulation and medical products - resident of the Republic of Kazakhstan, to relevant requirements of proper distributor practice (GDP);

7) 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;

8) 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;

9) 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;

10) auction - comparison of the prices of potential suppliers for the purpose of determination of the smallest price;

11) 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 any physical person or legal entity concerning which this potential supplier has such right;

12) the technical specification - the requirement description which there shall correspond the purchased services;

13) service in storage and transportation of medicines, medical products - the service rendered to the single distributor by subjects in the sphere of drug circulation, medical products, connected with acceptance, storage, accounting and transportation of goods within the service provision agreement to customers, suppliers of service in accounting and sales of goods, operational warehouses (or) between distribution centers;

14) the cost of service in accounting and realization of medicines, medical products - the service cost established by results of service purchase according to the procedure, determined by these rules, in the amount of no more than twelve percent from the goods price on the price list of the single distributor;

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

16) the collaborator - the subjects of health care involved as the supplier to joint agreement performance of rendering service in accounting and sales of goods;

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

18) the affiliate of 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 the decisions made by the single distributor, including owing to the agreement, and also any person concerning whom the single distributor have such right;

19) proper distributor practice (GDP) - the part of system of quality assurance guaranteeing quality of medicines throughout all stages of supply chain including storage and transportation, from the producer to the subjects enabling retail sale or leave to the population of medicines including the organizations performing medical activities;

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

21) purchase - acquisition by the single distributor of services in storage and transportation, and also services in accounting and realization of medicines, medical products within 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;

22) 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 of rendering service according to these rules;

23) 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 of rendering service according to these rules;

24) 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;

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

26) goods - medicines, medical products;

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

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

29) the price list of the single distributor - the price offer on goods approved by 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 medical products of the trade name or structure;

30) fund of social medical insurance - 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;

31) 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;

32) the actual price of service in storage and transportation of goods (further - the service price) - the monetary value of cost of service in storage and transportation of goods calculated by formulas:

on custodial service (W) = Wj * (S1+S 2), where Wj - the cost of 1 pallet which developed by results of tender depending on the region (j), S1 - quantity of pallets with special temperature condition; S2 - quantity of pallets without special temperature condition;

on transportation service (T) = Cij * K1 * K 2, where Cij - the freight charge which developed by results of tender for 1 km depending on load-carrying capacity of motor transport (i) and the region (j), K1 - corrective coefficient (rise in price) in need of use of the temperature-controlled equipment for transportation of goods, K2 - corrective coefficient (rise in price) during winter season when using winter diesel fuel;

on handling works (L) = Lj * Lki, where Lj - the cost of 1 normo-hour of handling works which developed by results of tender depending on the region (j); Lki - the number of the normo-hours spent for unloading/loading of the car depending on the tonnage (i);

33) the cost of service in storage and transportation of goods - the service cost established by results of service purchase according to the procedure, determined by these rules, calculated using the service price, at the expense of markup of the single distributor;

34) draft cost of service in storage and transportation of goods - the amount allocated for purchase of service for the corresponding financial year which is created by the single distributor taking into account at least three price lists (price or commercial offers) on custodial service (tenge/pallet) to transportation (tenge/kilometer) and handling works (tenge / normo-chas) (in case of determination of market service offerings the amounts received in case of the collection of primary requests of the customers and summary predesigns of requirement provided to the single distributor for the corresponding financial year according to the procedure, determined by the Government of the Republic of Kazakhstan are applied);

35) distribution center (pharmaceutical hub) - pharmaceutical warehouse of the single distributor (the warehouse belonging to the single distributor on the property right or other corporeal right including based on the agreement of rendering service in storage and transportation of medicines, medical products, the long-term agreement of rendering service in storage and transportation of medicines, medical products) or the pharmaceutical warehouse of subjects of health care performing within service in storage and transportation goods acceptance from suppliers of goods, accounting, storage including not reduced inventory and the passing remaining balance, leave and transportation of goods to the operational warehouses and (or) customers and service providers of accounting and sales of goods located in the region of servicing, export and (or) goods issue to other distribution centers;

36) the region of servicing - the part of the territory of the Republic of Kazakhstan including several administrative and territorial units (the area, the city of republican value, the capital) in one of which is located distribution center;

37) operational warehouse - the pharmaceutical warehouse of subjects of health care located in administrative and territorial unit (the area, the city of republican value, the capital) performing goods acceptance from distribution center and (or) from the supplier of goods, accounting, storage, leave and transportation of goods to the customers and service providers of accounting and sales of goods located in the territory of administrative and territorial unit (the area, the city of republican value, the capital);

38) the agreement of rendering service in storage and transportation of medicines, medical products - the civil agreement of rendering service signed by the single distributor with the physical person performing business activity or the legal entity - the resident of the Republic of Kazakhstan for the corresponding financial year;

39) 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;

40) need of customers - the amount of primary requests of the customers and summary predesigns of requirement provided by local authorities of public administration by health care of areas, the cities of republican value and the capital, and also the central executive bodies and other central state bodies having military-medical (medical) divisions, departmental divisions (organizations), including amounts of the declared goods, to the single distributor according to the procedure, determined by the Government of the Republic of Kazakhstan;

41) pallet - unit of account for custodial services of one pallet, where pallet - the transport container taking the tough platform and place sufficient for creation of the integrated unit load, used as the basis for collection, warehousing, overload and transportation of goods;

42) normo-hour - unit of time of performance of works, unit of account for the handling works made by the supplier of service: unloading of the vehicle, placement of goods on storage, picking (assembly) for shipment/movement of goods, palletizing (placement on pallet and wrapping packaging material), loading on transport, unloading in delivery location.

3. The purchase of services 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) uninterrupted providing population of the Republic of Kazakhstan with safe, effective and high-quality medicines, medical products.

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

1) two-stage tender;

2) from one source.

5. The purchase of services in storage and transportation of goods, and also services in accounting and sales of goods is performed by the single distributor. The single distributor will organize and also the purchase by method from one source carries out competition c by use of two-stage procedures.

6. The single distributor based on need of customers, no later than September first starts procedures of purchase:

services in storage and transportation of goods through distribution centers and (or) through operational warehouses. The service in storage and transportation of goods through distribution centers, taking into account availability of transport communications of the Republic of Kazakhstan is bought in the cities of Astana, Aktobe, Almaty, Shymkent. The service in storage and transportation of goods through operational warehouses is bought in administrative and territorial unit (area), except for administrative and territorial units (area) in which distribution centers are located;

services in accounting and sales of goods.

7. The list of unfair potential suppliers (suppliers) is created by the single distributor based on the judgment 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.

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 services;

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

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

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

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