of June 7, 2023 No. 110
About approval of rules of the organization and carrying out purchase of medicines, medical products and specialized medical products within the guaranteed amount of free medical care, additional amount of medical care for persons containing in pre-trial detention centers and organizations of criminal and executive (penitentiary) system at the expense of budgetary funds and (or) in system of compulsory social medical insurance, pharmaceutical services
According to subitem 15-1) of article 7 of the Code of the Republic of Kazakhstan "About health of the people and health care system" PRIKAZYVAYU:
2. To provide to department of medicinal policy of the Ministry of Health of the Republic of Kazakhstan in the procedure established by the legislation of the Republic of Kazakhstan:
1) state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;
2) placement of this order on Internet resource of the Ministry of Health of the Republic of Kazakhstan after its official publication;
3) within ten working days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan submission to Legal department of the Ministry of Health of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1) and 2) of this Item.
3. To impose control of execution of this order on the supervising vice-Minister of Health of the Republic of Kazakhstan.
4. This order becomes effective after ten calendar days after day of its first official publication.
Minister of Health of the Republic of Kazakhstan
A. Giniyat
Appendix
to the Order of the Minister of Health of the Republic of Kazakhstan of June 7, 2023 No. 110
1. These rules of the organization and carrying out purchase of medicines, medical products and specialized medical products within the guaranteed amount of free medical care, additional amount of medical care at the expense of budgetary funds and (or) in system of compulsory social medical insurance, pharmaceutical services (further – Rules) are developed for persons containing in pre-trial detention centers and organizations of criminal and executive (penitentiary) system according to subitem 15-1) of article 7 of the Code of the Republic of Kazakhstan "About health of the people and health care system" (further – the Code) and determine procedure for the organization and carrying out purchase of medicines and medical products, specialized medical products within the guaranteed amount of free medical care, additional amount of medical care for persons, containing in pre-trial detention centers and organizations of criminal and executive (penitentiary) system, at the expense of budgetary funds and (or) in system of compulsory social medical insurance, pharmaceutical services.
2. In these rules the following concepts are used:
1) information system of accounting of out-patient provision of medicines – the information system determined by authorized body in the field of health care for automation of accounting of the statement of recipes, leave of medicines and medical products by the supplier of pharmaceutical service within the guaranteed amount of free medical care and (or) medical care in system of compulsory social medical insurance at the out-patient level;
2) the passing remaining balance – remaining balance in warehouses of the single distributor of the medicines and medical products which were earlier purchased including within not reduced inventory;
3) the potential supplier – the physical person performing business activity, the legal entity (except for public institutions, if other is not established for them the laws of the Republic of Kazakhstan) applying for the conclusion of the agreement according to these rules;
4) the affiliate of the potential supplier – physical person or legal entity which has the right directly and (or) to indirectly determine decisions and (or) to exert impact on the decisions made by this potential supplier, including owing to the agreement or other transaction, and also physical person or legal entity concerning which this potential supplier has such right;
5) fund of social medical insurance (further – fund) – the non-profit organization making accumulation of assignments and fees, and also performing purchase and fee of the subjects of health care providing medical care in amounts and on conditions which are provided by the agreement of purchase of medical services, and other functions determined by the laws of the Republic of Kazakhstan;
6) fixed price – the price of medicine or medical product determined by results of purchase at which the supplier shall deliver medicine or medical product to the single distributor;
7) the collaborator – the subjects of health care involved as the supplier to joint agreement performance about rendering pharmaceutical services;
8) the single distributor – the legal entity performing activities within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance according to article 247 of the Code;
9) the list of the medicines and medical products which are purchased from the single distributor (further – the list of the single distributor), – the list of the medicines and medical products which are purchased from the single distributor developed and approved by authorized body in the field of health care, containing:
international non-proprietary names and short characteristic of medicines;
names (structure) and short characteristic of medical products;
10) information system of the single distributor – the information system determined by the single distributor automating activities of the single distributor and allowing message exchange of electronic documents with all concerned parties of process of distribution;
11) the price list of the single distributor – the price offer on medicines and medical products approved by the single distributor, containing list of the medicines which were purchased by the single distributor and medical products with indication of their characteristic, unit of measure, packing, the name of the producer, the country of the producer, the price which is not exceeding ceiling prices for the international non-proprietary name and ceiling prices for the trade name of medicines and medical products according to the order of the Minister of Health of the Republic of Kazakhstan of September 4, 2021 No. KR DSM-96 "About ceiling approval of prices for the international non-proprietary name of medicine or technical characteristic of medical product within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance" (it is registered in the Register of state registration of regulatory legal acts at No. 24253) (further – the Order 96) and the order of the Minister of Health of the Republic of Kazakhstan of August 5, 2021 No. KR DSM - 77 "About ceiling approval of prices for the trade name of medicines and medical products within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance" (it is registered in the Register of state registration of regulatory legal acts at No. 23886) (further – the Order 77), taking into account markup of the single distributor;
12) markup of the single distributor – the allowance approved by authorized body in the field of health care to the price of medicines, the medical products which are purchased by the single distributor specified in the delivery agreement;
13) medicine – the means representing or containing the substance or combination of substances coming into contact with human body, intended for treatment, prevention of diseases of the person or recovery, correction or change of its physiological functions by means of pharmacological, immunological or metabolic impact or for diagnosis of diseases and condition of the person;
14) the long-term agreement of supply of medicines and medical products – the civil contract signed by the single distributor for up to ten years with the prolongation right up to three years with the producer of medicines or medical products located in the territory of the Republic of Kazakhstan or with the customer of contract manufacturing of the original patented medicines and also with customers of contract manufacturing of medical products for supply of medicines or medical products or with the subject in the sphere of drug circulation and medical products having intention to create production or to modernize the operating production of medicines and medical products, located in the territory of the Republic of Kazakhstan, according to the procedure, established by the legislation of the Republic of Kazakhstan;
15) contract manufacturing of medicines and medical products (further – contract manufacturing) – production of medicines and medical products on contractual basis on production capacities of producers of the medicines and medical products located in the territory of the Republic of Kazakhstan which provide full compliance with requirements of proper production practice (GMP) for medicines and the international standard of quality management system (ISO 13485) for producers of medical products;
16) the web portal of purchase of medicines and medical products, services at subjects of health care (further – the web portal) – the information system providing single point of access to electronic services of purchase of medicines and medical products, services at subjects of health care within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance;
17) the single operator in the 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 – the inventory of the medicines and medical products necessary for uninterrupted provision of medicines established and which is systematically filled up by the single distributor at the expense of own means in amount to twenty five percent from the total amount of medicines and (or) medical products from predesigns of subjects of health care according to the order of the Minister of Health of the Republic of Kazakhstan of August 20, 2021 No. KR DSM-88 "About determination of the list of the medicines and medical products which are purchased from the single distributor" (it is registered in the Register of state registration of regulatory legal acts at No. 24078) (further – the Order 88) 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) the State register of medicines and medical products – the electronic information resource containing data about the medicines and medical products registered and allowed for medical application in the Republic of Kazakhstan;
23) subjects of health care – the organizations of health care, and also the physical persons practising private medicine and pharmaceutical activities;
24) portable medical complex – mobile clinics (offices) based on road transport equipped with the necessary medical equipment which are used for ensuring availability and extension of the list of the rendered medical services to the population of the rural zone and the remote settlements or for the benefit of defense and homeland security;
25) the investment project – complex of the actions providing investments on creation new and (or) upgrade of the operating productions of medicines according to standards of proper production practice (GMP) and medical products, with standards of quality management system of ISO;
26) the customer of contract manufacturing – the legal entity (except for public institutions, if other is not established for them the laws of the Republic of Kazakhstan) having contract manufacturing with the producer located in the territory of the Republic of Kazakhstan and the contract for the contract manufacturing of medicine and (or) medical product which signed with it;
27) kliniko-technical reasons – the document containing information on the need for required medical equipment and readiness of the organization of health care it to apply;
28) the clinical protocol – scientifically proved recommendations about prevention, diagnostics, treatment, medical rehabilitation and palliative medical care in case of certain disease or the patient's condition;
29) the list of the drugs, psychotropic substances and precursors which are subject to control in the Republic of Kazakhstan – the list of the drugs which are subject to control in the Republic of Kazakhstan, the psychotropic substances and precursors numbered and united in the corresponding tables and the list on the basis of international conventions;
30) medical products – products of medical appointment and medical equipment;
31) products of medical appointment – the materials, products, solutions, reagents, sets, sets used for delivery of health care according to functional purpose and the instruction of the producer;
32) medical equipment – the devices, devices, the equipment, complexes, systems applied separately or in combination among themselves to delivery of health care according to the functional purpose and operational characteristics established by the producer;
33) medical task – the document created by the customer (applicant) with indication of necessary diagnostic testings and (or) medical manipulations according to level according to the state standard rate of network of the organizations of health care, profile of the medical organization and the clinical protocol for purchase of medical equipment on the terms of the expanded term of field service;
34) local authorities of public administration by health care of areas, cities of republican value and the capital – the state bodies realizing state policy in the field of health care, providing execution of the legislation of the Republic of Kazakhstan in the field of health care and other functions according to article 13 of the Code;
35) orphan (rare) medicine (further – orphan medicine) – the medicine intended for diagnostics, etiopatogenetichesky or pathogenetic treatment of orphan (rare) diseases which frequency does not exceed officially certain level in the Republic of Kazakhstan;
36) domestic producer – the physical person performing the business activity, or the legal entity who is 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 "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 of the Republic of Kazakhstan "On regulation of trading activity" (further – the Law "On Regulation of Trading Activity");
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 "On Regulation of Trading Activity" are exported on other part of customs area of the Republic of Kazakhstan;
37) the production site – territorially isolated complex of the producer of medicines and (or) medical products intended for accomplishment of all and (or) part of production process of medicines and (or) medical products or its certain stages;
38) the supplier – the physical person performing business activity, the legal entity (except for public institutions if other is not established for them by the laws of the Republic of Kazakhstan), 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 are supply of medicines and (or) medical products, rendering pharmaceutical services;
39) the applicant – physical person or legal entity, competent to submit applications, documents and materials for issue of the conclusion for compliance of characteristics of the technical specification on purchase of medical equipment to at least two models of different producers, or local authorities of public administration by health care of areas, cities of republican value and the capital, military-medical (medical) divisions, departmental divisions (organizations) rendering medical services the directing requests for implementation of purchase of medical equipment through the single distributor;
40) the delivery agreement – the agreement (the long-term agreement, the agreement, the memorandum, other transaction) concluded between the single distributor, the organizer of purchase or the customer on the one hand and the supplier on the other hand on the purchase of medicines and (or) medical products according to these rules signed by the parties on the web portal or in information system of the single distributor and certified by digital signatures of the parties;
41) payment of cost of pharmaceutical service – compensation to subjects in the 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;
42) the request – the offer on participation in purchase with the purpose to be acknowledged supplier in accordance with the terms of the announcement or the invitation about purchase and conditions of these rules;
43) expert evaluation – assessment performed by the state expert organization in the sphere of drug circulation and medical products according to the order of the Minister of Health of the Republic of Kazakhstan of January 5, 2021 No. KR DSM-1 "About approval of technique of implementation of expert evaluation of optimum technical characteristics and kliniko-technical reasons for medical products" (it is registered in the Register of state registration of regulatory legal acts at No. 22040);
44) the conclusion on compliance of characteristics of the technical specification on purchase of medical equipment to at least two models of different producers – the document, the issued expert organization according to these rules, for planning and the organization of purchase of medical equipment, used in case of delivery of health care within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance;
45) the expert – the physical person having special and (or) technical knowledge, experience 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 the conditions of the announcement or invitation to purchase and conditions established by these rules;
46) 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, additional amount of medical care for persons containing in pre-trial detention centers and organizations of criminal executive (penitentiary) system at the expense of budgetary funds and (or) in system of compulsory social medical insurance according to the procedure and the methods established by these rules;
47) the agreement of purchase – the agreement signed between the single distributor and the customer on the purchase of medicines and (or) medical products according to these rules signed by the parties or created in information system of the single distributor and certified by digital signatures of the parties;
48) the agreement of purchase – the agreement signed between the customer and the supplier on the purchase of medicines and (or) medical products according to these rules and other regulatory legal acts of the Republic of Kazakhstan signed by the parties or certified by digital signatures of the parties;
49) the organizer of purchase – person determined by the customer who organizes purchase by the methods provided by these rules and sends purchase results to the customer for the conclusion of the agreement of purchase or the contract for rendering pharmaceutical services;
50) the tripartite agreement of purchase – the agreement signed between the single distributor, the customer and the supplier within the long-term agreement of delivery of medical equipment;
51) the expanded term of field service – the complete cycle of works including delivery, installation, field service of medical equipment, including replacement of the components which fulfilled resource, replacement or recovery of separate parts of medical equipment, the setup and adjustment of medical equipment specific to this medical equipment of work, cleaning, lubricant and if necessary partition of the main mechanisms and nodes, removal of dust, dirt, traces of corrosion and oxidation from the external and internal surfaces of the case of medical equipment of its components (with partial block and nodal dismantling) and other transactions specific to specific type of medical equipment specified in operational documentation;
52) the contract of delivery of medical equipment with the expanded term of field service – the agreement signed between the customer of medical equipment and the supplier on delivery, installation, field service of medical equipment for a period of up to 10 years;
53) expert group – the group of specialists in profile of required medical equipment determined by authorized body in the field of health care and annually approved by the single distributor;
54) customers – local authorities of public administration by health care of areas, cities of republican value and the capital, military-medical (medical) divisions, departmental divisions (organizations) rendering medical services, and also the subjects of health care rendering medical services within the guaranteed amount of free medical care, additional amount of medical care for persons containing in pre-trial detention centers and organizations of criminal and executive (penitentiary) system at the expense of budgetary funds and (or) in system of compulsory social medical insurance;
55) the affiliate of the customer, the organizer of purchase 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 opportunity;
Marginal 56) the price for the trade name of medicine or medical product within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance (further – the ceiling price for the trade name) – the price of the trade name of the medicine or medical product registered in the Republic of Kazakhstan above which the purchase within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance cannot be made;
Marginal 57) the price for the international non-proprietary name of medicine or technical characteristic of medical product within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance (further – the ceiling price for the international non-proprietary name) – the price of the international non-proprietary name of medicine or technical characteristic of the medical product registered in the Republic of Kazakhstan above which the purchase within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance cannot be made;
58) the tender – the purchase method among potential suppliers directed to determination of the winner according to these rules;
59) pharmaceutical service – the activities of subjects in the 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;
60) the supplier of pharmaceutical service – the subject of health care rendering services in providing the population in recipes with medicines and (or) medical products based on the contract with local state body health care of areas, cities of republican value and the capital or the single distributor according to the procedure and the methods determined by these rules;
61) pharmaceutical activities – the activities performed in the field of health care on production and (or) production, and (or) wholesale and (or) retail sale of medicines and medical products, connected with purchase (acquisition), storage, import, export, transportation, quality control, registration, distribution, use and destruction of medicines and medical products, and also ensuring their safety, quality and efficiency;
62) the agreement on rendering pharmaceutical services – the agreement signed between the customer and the supplier of pharmaceutical services according to these rules and other regulatory legal acts of the Republic of Kazakhstan, signed by the parties or certified by digital signatures of the parties;
63) foreign producer – the foreign legal entity created in the territory of foreign state and who is the nonresident of the Republic of Kazakhstan, performing production or conversion of medicines, ready to the use (application), and (or) medical products outside the Republic of Kazakhstan and confirming with their certificates of origin issued by competent authorities in the country of the exporter;
64) the electronic document – the document in which information is provided in electronic and digital form and is certified by means of the digital signature;
65) the digital signature – set of electronic digital symbols created by means of the digital signature and confirming reliability of the electronic document, its accessory and invariance of content;
66) DDP the INCOTERMS 2020 – the international trade term of standard agreement provisions of the international purchase and sale which are developed and determined by International Chamber of Commerce when the goods are delivered to the customer to the destination specified in the agreement cleared of all customs duties and risks;
67) the forecast price – the approximate price which is marked out for purchase of medicines and (or) medical products for the purpose of the prevention of origin and spread of infectious and parasitic diseases and also prevention and elimination of consequences of emergency situations;
68) similar medical equipment – the medical equipment having similar characteristics and picking that allows it to perform the same functions and to be interchangeable.
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 effective expenditure of the budgetary funds allocated for purchase of medicines and medical products within the guaranteed amount of free medical care, and means of compulsory social medical insurance medicines and medical products are bought at the prices which are not exceeding 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 established by the Order 96 and the Order 77, except for.
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) purchase at the single distributor according to its list;
5) through the single distributor in the cases provided by these rules.
Involvement of the collaborator by the potential supplier for rendering pharmaceutical services is allowed. Information on the collaborator's compliance to conditions, established by these rules, is provided by the potential supplier in the technical specification.
The purchase provided by the subitem 1) 2), 3) of this Item is carried out according to Chapters 2, of 3, 4 Sections 2 of these rules.
6. The purchase of specialized medical products is performed by the customer or the organizer of purchase according to the legislation of the Republic of Kazakhstan on public procurements.
7. The single distributor the purchase is performed by one of the following methods:
1) the tender by means of the web portal;
2) from one source by means of the web portal;
3) from one source;
4) according to long-term agreements of delivery.
In the absence of possibility of carrying out the purchase provided by subitems 2) and 4) of this Item by means of the web portal, the purchase is carried out on papers.
8. 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.
9. The potential supplier participating in purchase corresponds to the following conditions:
1) legal capacity (for legal entities), civil capacity to act (for the physical persons performing business activity);
2) legal capacity on implementation of the related pharmaceutical activity;
3) it is not affiliated with members and the secretary of the commission (commission), and also customer representatives, the organizer of purchase or the single distributor who have opportunity directly and (or) to indirectly make decisions and (or) to exert impact on the made decisions by the commission (commission);
4) absence of debt in the budget, including for the compulsory pension contributions compulsory for professional pension contributions, social assignments and assignments and (or) fees on compulsory social medical insurance;
5) is not subject to insolvency proceeding or liquidation;
6) is not participant of the tender for one lot with the affiliate.
Conditions of this Item are not applied when implementing purchase at foreign producers and through the international organizations founded by the United Nations.
10. The potential supplier within purchase on one lot represents one trade name of medicine or medical product, except for case when under the terms of the announcement or the invitation to purchase its completeness is required.
Local authorities of public administration by health care of areas, cities of republican value and the capital perform purchase of pharmaceutical services within the guaranteed amount of free medical care:
1) for medicines and the medical products entering the order of the Minister of Health of the Republic of Kazakhstan of August 5, 2021 No. KR DSM - 75 "About approval of the List of medicines and medical products for free and (or) preferential out-patient ensuring separate categories of citizens of the Republic of Kazakhstan with certain diseases (conditions)" (it is registered in the Register of state registration of regulatory legal acts at No. 23885), but not entering the list of the single distributor;
2) for the purpose of providing children, in medicine purchase cases in the instruction on which medical application there is specifying about contraindications to application for children;
3) in case of individual intolerance of the patient based on the conclusion of the medical and advisory commission and the decision of local representative bodies of areas, the cities of republican value and the capital.
11. To purchased and released, including in case of purchase of pharmaceutical services, the following conditions are shown to medicines and medical products:
1) availability of state registration in the Republic of Kazakhstan, except for the medicines made in drugstores, the orphan medicines included in the order of the Minister of Health of the Republic of Kazakhstan of October 20, 2020 in No. KR DSM - 142/2020 "About approval of the list of orphan diseases and medicines for their treatment (orphan)" (it is registered in the Register of state registration of regulatory legal acts at No. 21479), the unregistered medicines, the medical products imported on the territory of the Republic of Kazakhstan based on the conclusion (the allowing document), accessories which are part of product of medical appointment and not used as independent product or the device; in case of purchase of medical equipment in the special vehicle – availability of state registration in the Republic of Kazakhstan as single portable medical complex.
Lack of need of registration of the accessory of medical equipment (delivery set) is confirmed by the letter of the expert organization or authorized body in the field of health care;
2) compliance of the characteristic or technical specification to conditions of the announcement or invitation to purchase.
At the same time excess of the offered functional, technical, quality and operational characteristics of medical equipment to requirements of the technical specification is allowed;
3) marginal not excess of the prices according to the international unlicensed name and the trade name (in the presence) approved by the Order 96 and the Order 77, taking into account markup of the single distributor (in case of purchase by the single distributor), the prices in the announcement or the invitation to purchase, except for the unregistered medicines and medical products imported on the territory of the Republic of Kazakhstan based on the conclusion (the allowing document) issued by authorized body in the field of health care;
4) storage and transportation in the conditions providing preserving their safety, efficiency and quality according to the order of the Minister of Health of the Republic of Kazakhstan of February 16, 2021 No. KR DSM-19 "About approval of storage precautions and transportations of medicines and medical products" (it is registered in the Register of state registration of regulatory legal acts at No. 22230);
5) compliance of marking, consumer packaging and the instruction for use of medicines and medical products to requirements of the legislation of the Republic of Kazakhstan, except as specified import to the Republic of Kazakhstan of the unregistered medicines and (or) medical products;
The expiration date of medicines and medical products on the delivery date the supplier to the customer constitutes 6):
at least fifty percent from the specified expiration date on packaging (in case of expiration date less than two years);
at least twelve months from the specified expiration date on packaging (in case of expiration date two years and more);
The expiration date of the medicines and medical products which are purchased on the delivery date by the supplier to the single distributor constitutes 7):
at least sixty percent from the specified expiration date on packaging (in case of expiration date less than two years) by supply of medicines and medical products to the period November, December of the year preceding year for which the purchase, January of the come financial year and at least fifty percent is made in case of subsequent deliveries within financial year;
at least fourteen months from the specified expiration date on packaging (in case of expiration date two years and more) by supply of medicines and medical products to the period November, December of the year preceding year for which the purchase, January of the come financial year and at least twelve months is made in case of subsequent deliveries within financial year;
8) the expiration date of medicines and medical products on the delivery date the single distributor to the customer constitutes:
at least thirty percent from the expiration date specified on packaging (in case of expiration date less than two years);
at least eight months from the specified expiration date on packaging (in case of expiration date two years and more);
The expiration date of vaccines on the delivery date the single distributor to the customer constitutes 9):
at least forty percent from the specified expiration date on packaging (in case of expiration date less than two years);
at least ten months from the specified expiration date on packaging (in case of expiration date two years and more);
10) less expiration dates specified in subitems 8) and 9) of this Item for the passing remaining balance of medicines and medical products of the single distributor which are delivered to the customer for proper use before the expiration of their validity;
11) novelty of medical equipment, its neispolzovannost and production during twenty four months preceding the delivery moment;
12) introduction of the medical equipment relating to gages into the register of the state system of unity of measurements of the Republic of Kazakhstan according to the legislation of the Republic of Kazakhstan on unity of measurements.
Lack of need of entering of medical equipment into the register of the state system of unity of measurements of the Republic of Kazakhstan proves to be true according to the legislation of the Republic of Kazakhstan on ensuring unity of measurements;
13) respect for quantity, quality and delivery dates or rendering pharmaceutical service under the terms of the agreement.
12. The conditions provided by subitems 4), 5), 6), 7), 8), 9), 10), 11), 12) and 13) of Item 11 of these rules are confirmed by the supplier in case of agreement performance of delivery or purchase.
13. The customer, the organizer of purchase, the single distributor do not establish to medicines and medical products of condition, not provided by these rules.
14. If one potential supplier who is domestic producer and (or) the producer of state members of the Eurasian Economic Union (further – EEU), submitted the request corresponding to conditions of the announcement or invitation to purchase and conditions of these rules participates in purchase on lot, such potential supplier is recognized the winner, and requests of other potential suppliers automatically are rejected.
15. If two and more potential suppliers who are domestic producers and (or) producers of state members of EEU whose requests correspond to conditions of the announcement or invitation to purchase and conditions of these rules then the winner among them participate in purchase on lot it is determined by the smallest price following the results of auction, and requests of other potential suppliers automatically are rejected.
16. The status of domestic producer of the potential supplier when carrying out purchase is confirmed by the following documents:
1) the license for pharmaceutical activities for production of medicines and (or) medical products received according to the legislation of the Republic of Kazakhstan on permissions and notifications;
2) the registration certificate on medicine or medical product issued according to the order of the Minister of Health of the Republic of Kazakhstan of February 9, 2021 to No. KR DSM-16 "About approval of rules of state registration, re-registration of medicine or medical product, modification of the registration file of medicine or medical product" (it is registered in the Register of state registration of regulatory legal acts at No. 22175), with indication of domestic producer as the producer.
In case of the conclusion of the agreement or the supplementary agreement to the long-term agreement of delivery the domestic producer on the delivered medicines and medical products provides the certificate of origin of medicines, medical products for the internal address of "CT-KZ".
17. The status of the potential manufacturing supplier of state members of EEU is confirmed by the following documents:
1) license for pharmaceutical activities for production of medicines and (or) medical products;
2) the registration certificate, corresponding to the decision of Council of EEU of November 3, 2016 No. 78 "About Rules of registration and examination of medicines for medical application" and to the decision of Council of EEU of February 12, 2016 No. 46 "About Rules of registration and examination of safety, quality and efficiency of medical products".
18. On the conclusion of agreements the potential suppliers who received according to requirements of the legislation in the field of health care of the Republic of Kazakhstan the certificate on object compliance to requirements have advantage:
1) proper production practice (GMP) in case of purchase of medicines and the conclusion of long-term agreements of supply of medicines;
2) proper distributor practice (GDP) in case of purchase of medicines and pharmaceutical services;
3) proper pharmaceutical practice (GPP) in case of purchase of pharmaceutical services.
19. For receipt of benefit on the conclusion of the agreement of purchase or the delivery agreement to the request:
1) domestic producers in case of purchase of medicines and the conclusion of long-term agreements of supply of medicines put the certificate on compliance of object and production to requirements of proper production practice (GMP);
2) potential suppliers in case of purchase of medicines put the certificate on object compliance to requirements of proper distributor practice (GDP);
3) potential suppliers and (or) their collaborators in case of purchase of pharmaceutical services put the certificate on object compliance to requirements of proper pharmaceutical practice (GPP).
20. If only one potential supplier who submitted the request corresponding to conditions of the announcement or invitation to purchase and conditions of these rules and the certificate on object compliance to requirements of proper production practice (GMP) or proper distributor practice (GDP) participates in purchase on lot, such potential supplier is recognized the winner, and requests of other potential suppliers automatically are rejected.
21. If two and more potential suppliers who submitted the tenders corresponding to conditions of the announcement or invitation to purchase and conditions of these rules and certificates on compliance of objects to requirements of proper production practice (GMP) or proper distributor practice (GDP) participate in purchase on lot, then the winner among them is determined by the smallest price following the results of auction, and requests of other potential suppliers automatically are rejected.
If on lot two and more potential suppliers who provided the registration certificate, completely and in accuracy corresponding to data of the state register of medicines and (or) medical products or number of permission (conclusion) of authorized body in the field of health care on import of medicine and (or) medical product to the Republic of Kazakhstan participate in purchase, the benefit is provided to the potential suppliers who provided the registration certificate, at the same time the winner among them is determined by the smallest price following the results of auction, and requests of other potential suppliers automatically are rejected.
22. For performing procedures of the organization and carrying out purchase of medicines, medical products or pharmaceutical services the customer decision path determines the organizer of purchase, and also the official of the customer representing the interests of the last in the forthcoming purchase, except as specified, when the organizer of purchase and the customer act in one person.
23. The legal entity, fifty and more percent of voting shares (shares in the authorized capital) which belong to the state, and also the state company can act as the organizer of purchase for persons affiliated with it.
24. Customers or organizers of purchase hold tenders according to regulations of this Chapter of these rules.
The customer or the organizer of purchase inform potential suppliers on purchase of medicines, medical products or pharmaceutical services by method of carrying out the tender at least in 20 (twenty) calendar days, in case of the repeated tender – at least in 15 (fifteen) calendar days prior to day of the end of acceptance of tenders by placement of the announcement on Internet resource of the customer or organizer of purchase.
25. The announcement of carrying out purchase of medicines, medical products or pharmaceutical services by method of carrying out the tender, is placed on Internet resource of the customer or organizer of purchase and includes the following information:
1) name and address of the customer or organizer;
2) the name of the purchased pharmaceutical services, international non-proprietary names of the purchased medicines and (or) medical products, trade names – in case of individual intolerance of the patient, about purchase amount, the place of deliveries, the amounts allocated for purchase on each lot;
3) terms and delivery conditions;
4) procedure and source of transfer of the tender documentation;
5) place of representation (acceptance) of documents and final submission due date of tenders;
6) date, time and the place of opening of envelopes with tenders.
26. For carrying out the tender by the customer or organizer of purchase the tender commission is formed. On each tender the separate structure of the commission affirms.
27. The tender commission workers of the customer or the organizer of purchase in odd quantity at least three people are included.
28. The tender commission is effective from the date of entry into force of the decision on its creation and stops the activities in day of the conclusion of the agreement of purchase or recognition of the tender cancelled, or cancellations of results in cases of identification of violations when carrying out purchase to the conclusion of the agreement of purchase.
29. The tender commission the first heads of the customer or the organizer of purchase or their deputies, and also heads of operating structural units and specialists are included.
30. The chairman of the tender commission determines the first head or the deputy manager of the customer or the organizer of purchase who direct activities of the commission, plan work and exercise general control of implementation of its decisions. During absence of the chairman of its function the vice-chairman of the commission performs.
31. The order of the head of the customer or organizer of purchase from number of persons employed of the customer or the organizer of purchase appoints the secretary of the tender commission who is not part of the commission and has no right to vote.
32. The secretary of the tender commission submits to potential suppliers the tender documentation, accepts from them envelopes with tenders, prepares offers and other required materials on the agenda of meeting of the tender commission, constitutes the minutes of the tender commission, keeps the magazine of registration of tenders in which date and time of their representation, surname, name and middle name (are specified in case of its availability) person which provided envelope with the tender. The magazine is stitched, pages are numbered, the last page is certified by the authorized signature of the customer or organizer of purchase.
33. The customer or the organizer of purchase involve the expert or experts of profile specialties in the questions requiring special knowledge and (or) technical knowledge.
For separate financial year the customer or the organizer of purchase determine experts in profile specialties for examination of requests regarding compliance of medicines and (or) medical products to characteristics or technical specifications in the announcement.
34. The expert draws the expert opinion according to the technical specification (characteristic) of medicines and (or) medical products on compliance of the medicines offered by potential suppliers and (or) medical products and pharmaceutical services to conditions to the purchased medicines and (or) medical products and pharmaceutical services, provisions of the tender documentation before decision making by the commission.
35. The expert does not participate in vote in case of adoption of the decision by the tender commission.
The expert opinion is drawn up in writing, signed by the expert and attached to the minutes of the commission.
36. The expert opinion is considered by the commission in case of assessment and comparison of tenders, determination of the winner.
37. The meeting of the tender commission is held on condition of participation at least two thirds of total number. The decision of the tender commission is made by open voting and deemed accepted if the simple majority of votes from the total number of the participating members of the commission is given for it.
In case of equality of votes, accepted is considered the decision for which also the chairman of the tender commission voted, and in case of its absence – the vice-chairman of the tender commission.
38. In the absence of any of members of the tender commission, in the minutes the reason of its absence and the reference to the document confirming this fact are specified.
39. If in the appointed day and time the meeting of the tender commission on opening of envelopes with tenders did not take place on quorum absence reason, the secretary of the tender commission ensures safety of the envelopes provided on the tender with tenders and announces new date and time of opening of envelopes which are established no later than one working day after day of cancelled meeting of the tender commission in time.
At the same time again given envelopes with tenders are not accepted.
40. If in due time the necessary number of members of the tender commission is not provided, then the customer or the organizer of purchase make changes to structure of the tender commission within 3 (three) working days after day of cancelled meeting of the tender commission.
41. The minutes of the tender commission are signed and are polistno initialed by all her members, the chairman of the tender commission, his deputy and the secretary of the commission.
42. The customer or the organizer of purchase approve the tender documentation on purchase of medicines, medical products or pharmaceutical services according to these rules which is placed on their Internet resource and contains (depending on purchase subject):
1) structure of the tender documentation, the list of the documents which are subject to representation by the potential supplier in confirmation of its compliance to the conditions provided by Items 8 and 9 of these rules and the purchased medicines and (or) medical products – Item 11 of these rules;
2) technical and quality characteristics of the purchased medicines and (or) medical products, pharmaceutical services, including technical specifications;
3) amount of the purchased medicines, medical products or pharmaceutical services and the amounts allocated for their purchase on each lot;
4) place, terms and other delivery conditions of medicines, medical products or rendering pharmaceutical services;
5) conditions of payments and draft agreement of purchase of medicines and (or) medical products or contract for rendering pharmaceutical services;
6) requirements to languages of the tender, agreement of purchase or contract for rendering pharmaceutical services;
7) requirements to execution of the tender;
8) procedure, form and terms of introduction of warranty providing tender;
9) specifying on opportunity and procedure for withdrawal of the tender;
10) place and final term of acceptance of tenders and term of their action;
11) forms of the request of potential suppliers for explanations on contents of the tender documentation in need of procedure for meeting with them;
12) the place, date, time and the procedure of opening of envelopes with tenders;
13) procedure of consideration of tenders;
14) provision conditions to potential suppliers - domestic producers of support, determined by these rules;
15) introduction conditions, form, amount and method of warranty providing agreement of purchase or contract for rendering pharmaceutical services;
16) the list and amount of medicines, the medical products released on free and (or) preferential basis with indication of the international non-proprietary name or composition of medicines, and also technical characteristic and ceiling prices for the international non-proprietary name and (or) ceiling prices for the trade name on each lot (in case of purchase of pharmaceutical services).
In case of individual intolerance of the patient, based on the conclusion of the medical and advisory commission of the customer the list and amount of medicines, the medical products released on free and (or) preferential basis with indication of the trade name, and also technical characteristic and ceiling prices for the international non-proprietary name and (or) ceiling prices for the trade name on each lot (in case of purchase of pharmaceutical services);
17) list and number of medical equipment;
18) the list of settlements in which it is necessary to render pharmaceutical service, determined by local authorities of public administration by health care of areas, cities of republican value and the capital by each lot (in case of purchase of pharmaceutical services);
19) the conditions shown to potential suppliers of the pharmaceutical services, and also their collaborators provided by Items 8 and 9 of these rules (in case of purchase of pharmaceutical services).
43. The customer or the organizer of purchase allow separation of uniform medicines and (or) medical products into lots in the place of their delivery, and when implementing purchase of several types of uniform medicines and (or) medical products – on lots by their uniform types and (or) the place of delivery.
The purchase is divided by the customer or the organizer of purchase in case of purchase of pharmaceutical services into lots in the place of their rendering.
44. Not later than 10 (ten) calendar days before the expiration of final term of acceptance of tenders if necessary the potential supplier addresses the customer, the organizer of purchase for explanations according to the tender documentation on which the customer or the organizer of purchase no later than 3 (three) working days from the date of receipt of request make the explanation directed to all potential suppliers who received the tender documentation to receipt date of request without specifying of the author of request.
45. No later than 7 (seven) calendar days before the expiration of final term of acceptance of tenders the customer or the organizer of purchase if necessary on own initiative or in response to requests of potential suppliers make changes to the tender documentation about what it is without delay reported to all potential suppliers who submitted tenders or received the tender documentation.
At the same time the final term of acceptance of tenders is prolonged for term at least 5 (five) calendar days.
46. The customer or the organizer of purchase if necessary holds meeting with potential suppliers for explanation of conditions of the tender in the place and time, determined by the tender documentation about what the protocol including data on the course and content of meeting which goes to all potential suppliers who submitted tenders or received the tender documentation is constituted.
47. The potential supplier who showed willingness to participate in the tender before the expiration of final term of acceptance of tenders presents to the customer or the organizer of purchase in the sealed form the tender constituted according to provisions of the tender documentation.
48. The tender which arrived after the final term of acceptance of tenders is not opened and returns to the potential supplier.
49. The tender consists of the main part, technical part and warranty providing.
In case of involvement of the collaborator, the potential supplier also attaches to the tender the documents specified in subitems 2), 3), 4) and 5) of Item 50 of these rules.
50. The main part of the tender contains:
1) the application for participation in the tender for form, according to appendix 1 to these rules, (on the electronic medium the inventory of the documents attached to the request is submitted);
2) the copy of the charter for the legal entity (if in the charter the list of founders, participants or shareholders is not specified, the statement about the list of founders, participants or the copy of the foundation agreement, or the statement from the register of the acting shareholders after date of the announcement is also submitted);
3) the copy of the document granting the right to implementation of business activity without formation of legal entity issued by the relevant state body;
4) copies of the corresponding licenses for pharmaceutical activities and (or) on implementation of activities in the sphere of drug trafficking, psychotropic substances and precursors, notifications on the beginning or the termination of activities for wholesale and (or) retail sale of medical products or in the form of the electronic document, received according to the Law "About Permissions and Notifications", data on which prove to be true in information systems of state bodies. In the absence of data in information systems of state bodies, the potential supplier represents notarially certified copy of the corresponding license for pharmaceutical activities and (or) on implementation of activities in the sphere of drug trafficking, psychotropic substances and precursors, notifications on the beginning or the termination of activities for wholesale and (or) retail sale of the medical products received according to the Law "About Permissions and Notifications";
5) copies of certificates (in the presence):
about compliance of object and production to requirements of proper production practice (GMP);
about object compliance to requirements of proper distributor practice (GDP);
about object compliance to requirements of proper pharmaceutical practice (GPP);
6) the price offer on form, according to appendix 2 to these rules;
7) the original document, the warranty providing the tender confirming introduction.
51. Technical part of the tender contains:
1) technical specifications with indication of exact technical characteristics of the declared medicines and (or) medical products, pharmaceutical service on paper (in case of the statement of medical equipment, also on the electronic medium in the docx format);
2) the copy of the document on state registration of medicine and (or) medical product or permission (conclusion) of authorized body in the field of health care on import of medicine and (or) medical product to the Republic of Kazakhstan.
On the medicines and (or) medical products imported and made in the territory of the Republic of Kazakhstan before expiration of the registration certificate are represented: copies of the document confirming their import through frontier of the Republic of Kazakhstan, their receipt by the potential supplier; production by domestic producer, the conclusion about safety issued according to the order of the Minister of Health of the Republic of Kazakhstan of December 8, 2020 to No. KR DSM-237/2020 "About approval of Rules of import to the territory of the Republic of Kazakhstan and export from the territory of the Republic of Kazakhstan of medicines and medical products and rendering the state service "Issue of Coordination and (or) the Conclusion (the Allowing Document) for Import (Export) of the Medicines Registered and Not Registered in the Republic of Kazakhstan and Medical Products" (it is registered in the Register of state registration of regulatory legal acts at No. 21749).
52. Together with the tender the potential supplier brings warranty providing in the amount of one percent from the amount allocated for purchase of medicines, medical products or pharmaceutical services.
53. Warranty providing the tender (further – warranty providing) is presented in the form:
1) guarantee money contribution which is brought on the bank account of the customer or organizer of purchase or for the account provided by the Budget code of the Republic of Kazakhstan for organizers of purchase being state bodies and public institutions;
2) the bank guarantee in form, according to appendix 3 to these rules.
54. Warranty providing returns to the potential supplier within 5 (five) working days in cases:
1) withdrawal of the tender the potential supplier before the expiration of final term of its acceptance;
2) tender variations on the basis of discrepancy to provisions of the tender documentation;
3) recognitions by the winner of the tender of other potential supplier;
4) the terminations of procedures of purchase without determination of the winner of the tender;
5) entries into force of the agreement of purchase and introduction by the winner of the tender of warranty ensuring agreement performance of purchase.
55. Warranty providing does not return to the potential supplier if:
It withdrew 1) or changed the tender after the expiration of final term of acceptance of tenders;
2) the winner evaded from the conclusion of the agreement of purchase or the contract for rendering pharmaceutical services after recognition by the winner of the tender;
3) he is recognized as the winner and did not bring or out of time brought warranty providing the agreement of purchase or the contract for rendering pharmaceutical services.
56. The potential supplier if necessary withdraws the letter request before the expiration of final term of its acceptance.
57. Modification of tenders after the expiration of submission of tenders is not allowed.
58. The tender is printed or written with indelible ink, presented in the stitched and numbered form, the last page is fastened with the signature of the representative of the potential supplier.
Entering into the text of the tender of inserts between lines, podtirok or additions, except as specified need of correction of grammatical or arithmetic mistakes is not allowed.
The technical specification is presented in the stitched and numbered form, the last page is fastened with the signature of the representative of the potential supplier.
The technical specification of the tender and the original of warranty ensuring purchase are put to the tender separately and sealed with the tender in one envelope.
The envelope contains the name and legal address of the potential supplier, is subject to addressing to the customer or the organizer of purchase to the address specified in the tender documentation and contains the words "The Tender for Purchase ________ (the Name of the Tender Is Specified)" and "Not Open to _______ (the Date and Time of Opening of Envelopes Specified in the Tender Documentation Are Specified)".
59. Time duration between completion of acceptance of tenders and the beginning of opening of envelopes with tenders does not exceed 2 (two) hours.
60. Envelopes with tenders are opened with the tender commission on time and in the place, determined by the tender documentation, using audio-and video fixing.
At the procedure of opening of envelopes with tenders there can be potential suppliers or their authorized representatives.
Opening envelopes, the secretary of the tender commission announces the name and the address of potential suppliers from which tenders arrived, the posted prices on each lot, delivery conditions and payments, procedure for withdrawal of tenders, information on the documents constituting the tender and enters these data in minutes of opening of envelopes.
61. The tender commission performs assessment and comparison of tenders.
For the purpose of refining of compliance of potential suppliers to conditions of these rules regarding their non-participation in insolvency proceeding or liquidation the tender commission considers information placed on Internet resource of the authorized body exercising control of carrying out insolvency proceedings or liquidation.
62. The tender commission rejects the tender in general or on lot in cases:
1) non-presentations of warranty providing the tender in accordance with the terms of these rules;
2) non-presentations of the copy of the charter or the statement about the list of founders, participants or statements from the register of shareholders, or copies of the foundation agreement in the cases provided by these rules;
3) non-presentations of the copy of the document granting the right to implementation of business activity without formation of legal entity issued by the relevant state body (for the physical person performing business activity);
4) non-presentations of copies of the corresponding license for pharmaceutical activities and (or) on implementation of activities in the sphere of drug trafficking, psychotropic substances and precursors, notifications on the beginning or the termination of activities for wholesale and (or) retail sale of medical products or in the form of the electronic document, received according to the Law "About Permissions and Notifications", data on which prove to be true in information systems of state bodies, or non-presentations of notarially certified copies of the corresponding license for pharmaceutical activities and (or) on implementation of activities in the sphere of drug trafficking, psychotropic substances and precursors, notifications on the beginning or the termination of activities for wholesale and (or) retail sale of the medical products received according to the Law "About Permissions and Notifications", in the absence of data in information systems of state bodies;
5) availability in data of relevant organ of state revenues of information on debt in the budget, debt on the compulsory pension contributions compulsory for professional pension contributions, social assignments, assignments and (or) fees on compulsory social medical insurance (except for the amounts on which payment due dates are changed, not reflected in the total amount of debt);
6) non-presentations of the technical specification in accordance with the terms, the provided these rules;
7) representations by the potential supplier of the technical specification which is not corresponding to conditions of the tender documentation and these rules;
8) factual determinations of representation of unreliable information under the terms, provided by these rules to the medicines and (or) medical products and services acquired within these rules;
9) participation in insolvency proceeding or liquidation;
10) non-presentations of the documents confirming compliance of the offered medicines and (or) medical products, pharmaceutical services to Item 11 of these rules;
11) if the technical characteristic of the declared medical equipment does not correspond to the technical characteristic and (or) picking determined by the registration certificate and (or) the registration file;
12) discrepancies to conditions of Item 10 of these rules;
13) 21 these rules established by Items 15,;
14) if the tender has shorter effective period, than is specified in the conditions of the tender documentation;
15) non-presentations of the price offer or submission of the price offer not in form, according to appendix 2 to these rules;
16) representations by the potential supplier of the price of medicine and (or) medical product exceeding the price allocated for purchase on the corresponding lot and (or) ceiling price for the international non-proprietary name and ceiling price for the trade name;
17) submissions of the tender in not stitched type with not numbered pages, not ratified, without specifying on envelope of the name or legal address of the potential supplier, customer or organizer of purchase;
18) discrepancies of the potential supplier and (or) the collaborator to the conditions provided by Items 8 and 9 of these rules;
19) factual determinations of affiliation in defiance of conditions of these rules.
63. If the tender in general or its any lot are acknowledged cancelled, the customer or the organizer of purchase change content and conditions of the tender and hold the repeated tender according to Chapter 1 of Section 2 of these rules.
64. If the tender in general or any lot are acknowledged cancelled on the basis of submission only of one request corresponding to conditions of the tender documentation, then the customer or the organizer of purchase perform purchase by method from one source at the potential supplier who submitted this application.
65. Purchase by method of the tender or its any lot are recognized cancelled on one of the following bases:
1) lack of tenders;
2) variation of all tenders of potential suppliers.
66. The winner of the tender is determined among potential suppliers whose tenders are acknowledged as the tender commission corresponding to conditions of the announcement and conditions of these rules, on the basis of the smallest price offer.
For lack of the competition on lot or in case of variation of tenders of competitors on lot the winner of the tender the potential supplier whose tender is acknowledged as the tender commission single corresponding to conditions of the announcement and conditions of these rules is recognized.
67. The results of the tender are summed up within 10 (ten) calendar days from the date of opening of envelopes with tenders about what the protocol in which join is constituted:
1) names and short description of medicines, medical products or pharmaceutical services;
2) purchase amount;
3) names, the location and qualification data of the potential suppliers who submitted tenders;
4) the price and conditions of each tender according to the tender documentation;
5) statement of assessment and comparison of tenders;
6) bases of variation of tenders;
7) names and the location of the winner(s) on each lot of the tender and condition by which the winner, with indication of the trade name is determined;
8) names and the location of the participant of each lot of the tender which offer is the second after the proposal of the winner, with indication of the trade name;
9) the bases if the winner of the tender is not determined;
10) the term during which it is necessary to sign the agreement of purchase;
11) information on involvement of commission of experts.
68. Within 3 (three) calendar days from the date of summing up the tender the customer or the organizer of purchase notify the potential suppliers who took part in the tender on results of the tender by placement of the protocol of results on Internet resource of the customer or organizer of purchase.
69. The protocol on results of the tender is placed on Internet resource of the customer or organizer of purchase. The organizer of purchase within 3 (three) calendar days from the date of summing up sends to the customer verified copies of the protocol of results of purchase and the technical specification of medicines and (or) medical products of the winner.
70. Purchase application by method of request of price offers (further – price purchase) is allowed if the annual amount of purchase of uniform medicines and (or) medical products or pharmaceutical service in value term does not exceed the two-thousandfold size of the monthly settlement indicator established by the legislation for the corresponding financial year and also in cases, stipulated in Item 72 these rules.
71. For the purpose of application of price purchase crushing within financial year of annual amount of purchase of uniform medicines and (or) medical products, except for case of lack of medicines and (or) medical products at the single distributor is not allowed.
72. The purchase to sixty-day requirement (except for the subitem 2) of this Item) medicines and medical products at the prices which are not exceeding established by the Order 96 and the Order 77, and also to ninety-day requirement of pharmaceutical services is allowed in case of:
1) absence at customers or subjects of health care (within out-patient provision of medicines) remaining balance of medicines and medical products for timely rendering the guaranteed amount of free medical care and (or) medical care in system of compulsory social medical insurance based on the notification received from the single distributor in connection with:
violation by the single distributor of delivery dates under the contract of purchase signed between the single distributor and the customer;
the cancelled purchases of medicines, medical products or pharmaceutical service which are carried out by the single distributor by the methods determined by these rules;
2) purchase by the single distributor of medicine in the instruction on which medical application there is specifying about contraindications to application for children;
3) the needs for implementation of purchase of pharmaceutical services within the guaranteed amount of free medical care and (or) system of compulsory social medical insurance based on the conclusion of the medical and advisory commission and the decision of local representative bodies of areas, the cities of republican value and the capital;
4) recognition of the tender cancelled also have need for implementation of purchase of medicines and (or) medical products, pharmaceutical services for out-patient provision of medicines of the population within the guaranteed amount of free medical care and (or) system of compulsory social medical insurance.
73. The customer or the organizer of purchase perform request of price offers at least at two not affiliated potential suppliers with indication of amount, the place and the delivery schedule.
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