Decree 102 list 1. A list of certain types of medical devices originating from foreign countries is approved, in respect of which a restriction of admission is established for the purposes of procurement for the provision of state and municipal

In accordance with paragraph 3 of Article 14 federal law"On the contract system in the field of procurement of goods, works, services to ensure public and municipal needs"Government of the Russian Federation decides:

1. Approve the attached list certain types medical devices, originating from foreign countries, in respect of which a restriction of admission is established for the purposes of making purchases to meet state and municipal needs (hereinafter referred to as the list).

2. Establish that for the purposes of procurement of certain types of medical devices included in the list, the customer rejects all applications containing proposals for the supply of medical devices originating from foreign countries, with the exception of the Republic of Armenia, the Republic of Belarus and the Republic of Kazakhstan, provided that for participation in the determination of the supplier, at least 2 bids satisfying the requirements of the procurement documentation have been submitted, which at the same time:

3. Confirmation of the country of origin of medical devices included in the list is a certificate of origin issued by authorized body(organization) of the Russian Federation, the Republic of Armenia, the Republic of Belarus or the Republic of Kazakhstan in the form, established by the Rules determining the country of origin of goods, which are an integral part of the Agreement on the Rules for determining the country of origin of goods in the Commonwealth of Independent States dated November 20, 2009, and in accordance with the criteria for determining the country of origin of goods provided for by these Rules.

4. The restrictions on the admission of certain types of medical devices included in the list established by this resolution do not apply in the following cases:

Placement of notices on the procurement of certain types of medical devices included in the list in the unified information system in the field of procurement and (or) sending invitations to participate in determining the supplier in a closed way, carried out before the entry into force of this resolution;

Procurement of certain types of medical devices included in the list, diplomatic missions and consular offices Russian Federation, trade missions of the Russian Federation and official representative offices of the Russian Federation with international organizations to ensure its activities in the territory of a foreign state.

Prime Minister
Russian Federation
D. Medvedev

Article 9 dated December 19, 2018 N 1590)

b) for applications (final offers) containing proposals for the supply of medical devices for single use (use) made of polyvinyl chloride plastics included in List No. 2: (as amended by Decree of the Government of the Russian Federation of December 19, 2018 N 1590)

do not contain proposals for the supply of the same type of medical device from one manufacturer or manufacturers belonging to the same group of persons, corresponding to the criteria provided for in Article 9 of the Federal Law "On Protection of Competition", when comparing these applications (final offers); (as amended by Decree of the Government of the Russian Federation of December 19, 2018 N 1590)

contain proposals for the supply of these medical devices, the percentage of the cost of used materials (raw materials) of foreign origin in the price of the final product corresponds to that specified in the annex to the Decree of the Government of the Russian Federation of August 14, 2017 N 967 "On the specifics of the procurement of disposable medical devices ( use) from polyvinyl chloride plastics for state and municipal needs"; (as amended by Decree of the Government of the Russian Federation of December 19, 2018 N 1590)

contain proposals for the supply of these medical devices, for the production of which there is a document confirming the compliance of their own production with the requirements of GOST ISO 13485-2017 "Interstate standard. Medical devices. Quality management systems. Requirements for regulatory purposes". (as amended by Decree of the Government of the Russian Federation of December 19, 2018 N 1590)

2(1). In the event that an application (final offer), which contains a proposal for the supply of medical devices included in List No. 1 or List No. 2 and originating from foreign countries (with the exception of member states of the Eurasian economic union), is not rejected in accordance with the restrictions established by this Decree, the conditions for admission for the purpose of procurement of goods originating from a foreign state or a group of foreign states established by federal agency executive power that performs the functions of developing public policy and legal regulation in the field of procurement of goods, works, services to meet state and municipal needs. dated 04/22/2016 N 337, dated 05/30/2017 N 663, dated 08/14/2017 N 968, dated 12/19/2018 N 1590)

2(1.1). The clause has expired. (as amended by Decree of the Government of the Russian Federation of December 19, 2018 N 1590)

2(2). Install that: (as amended by Decree of the Government of the Russian Federation of 14.08.2017 N 968)

for the purposes of limiting the admission of certain types of medical devices originating from foreign countries, medical devices included in List No. 1 and not included in it cannot be the subject of one contract (one lot); (as amended by Decree of the Government of the Russian Federation of 14.08.2017 N 968)

for the purposes of procurement of medical devices for single use (use) made of polyvinyl chloride plastics included in List No. 2, medical devices included in List No. 2 and not included in it cannot be the subject of one contract (one lot). (as amended by Decree of the Government of the Russian Federation of 14.08.2017 N 968)

2(3). Establish that for the purposes of procurement of disposable medical devices (use) made of polyvinyl chloride plastics included in List No. 2, the procurement documentation must contain initial (maximum) prices calculated in accordance with the methodology approved by the Ministry of Health of the Russian Federation jointly with the Ministry of Industry and trade of the Russian Federation. (as amended by Decree of the Government of the Russian Federation of 14.08.2017 N 968)

3. Confirmation of the country of origin of medical devices included in List No. 1 and List No. 2 is a certificate of origin of goods issued by an authorized body (organization) of the Member States of the Eurasian Economic Union in the form established by the Rules for determining the country of origin of goods, which are an integral part of the Agreement on the Rules for determining the country of origin of goods in the Commonwealth of Independent States dated November 20, 2009 (hereinafter referred to as the Rules), and in accordance with the criteria for determining the country of origin of goods provided for by the Rules. (as amended by Decree of the Government of the Russian Federation of December 19, 2018 N 1590)

Confirmation of the percentage share of the cost of used materials (raw materials) of foreign origin in the price of the final product is an examination certificate issued by the Chamber of Commerce and Industry of the Russian Federation containing information on the share of the cost of foreign materials (raw materials) used to manufacture one unit of a medical product, calculated in accordance with subparagraph "c" of paragraph 2.4 of the Rules, or a similar document issued by the authorized body (organization) of the state - a member of the Eurasian Economic Union. (as amended by Decree of the Government of the Russian Federation of December 19, 2018 N 1590)

3(1). When executing a contract, at the conclusion of which the applications were rejected in accordance with the restrictions established by this resolution ( final proposals), which contain proposals for the supply of certain types of medical devices included in List No. 1 and originating from foreign countries (with the exception of the member states of the Eurasian Economic Union), the replacement of a medical device with a medical device whose country of origin is not a member state of the Eurasian Economic union, and replacement of the manufacturer of the medical device is not allowed. (as amended by Decrees of the Government of the Russian Federation of 04.22.2016 N 337, of 08.14.2017 N 968)

3(2) When executing a contract, during the conclusion of which, in accordance with the restrictions established by this Decree, applications (final offers) containing proposals for the supply of disposable medical devices (use) made of polyvinyl chloride plastics included in List No. 2 and originating from foreign states (with the exception of the member states of the Eurasian Economic Union), replacement of a medical device with a medical device whose country of origin is not a member state of the Eurasian Economic Union or the percentage of the cost of used materials (raw materials) of foreign origin in the price of the final product of which is more than indicated in the annex to the Decree of the Government of the Russian Federation of August 14, 2017 N 967 "On the peculiarities of the procurement of medical devices for single use (use) from polyvinyl chloride plastics to provide state and municipal needs" for the corresponding year, and replacement of the manufacturer of the medical device is not allowed. (as amended by Decree of the Government of the Russian Federation of December 19, 2018 N 1590)

4. The restrictions on the admission of certain types of medical devices included in List No. 1 established by this Resolution shall not apply in the following cases: (as amended by Decree of the Government of the Russian Federation of 14.08.2017 N 968)

placement of notices on the procurement of certain types of medical devices included in List No. 1 in a single information system in the field of procurement and (or) sending invitations to participate in determining the supplier in a closed way, carried out before the entry into force of this resolution; (as amended by Decree of the Government of the Russian Federation of 14.08.2017 N 968)

procurement of certain types of medical devices included in List No. 1 by customers specified in Part 1 of Article 75 of the Federal Law "On the contract system in the field of procurement of goods, works, services to meet state and municipal needs", on the territory of a foreign state to ensure its activities in this area. (as amended by Decrees of the Government of the Russian Federation of 04.22.2016 N 337, of 08.14.2017 N 968)

5. Establish that the provisions of this resolution do not apply in the case of the purchase of goods included in List No. 1 and List No. 2 as part of the implementation of: (as amended by Decree of the Government of the Russian Federation of May 15, 2019 N 602)

the Karelia cross-border cooperation program, the implementation procedure of which is provided for by the Agreement on Financing and Implementation of the Karelia Cross-Border Cooperation Program for the period 2014-2020, signed in Moscow on December 29, 2016; (as amended by Decree of the Government of the Russian Federation of May 15, 2019 N 602)

the Kolarctic cross-border cooperation program, the implementation procedure of which is provided for by the Agreement on Financing and Implementation of the Kolarctic Cross-Border Cooperation Program for the period 2014-2020, signed in Moscow on December 29, 2016; (as amended by Decree of the Government of the Russian Federation of May 15, 2019 N 602)

cross-border cooperation program "Russia - South-East Finland", the implementation procedure of which is provided for by the Agreement on financing and implementation of the cross-border cooperation program "Russia - South-East Finland" for the period 2014-2020, signed in Moscow on December 29, 2016; (as amended by Decree of the Government of the Russian Federation of May 15, 2019 N 602)

cross-border cooperation program "Russia-Latvia", the implementation procedure of which is stipulated by the Agreement on financing and implementation of the cross-border cooperation program "Russia-Latvia" for the period 2014-2020, signed in Moscow on December 29, 2016; (as amended by Decree of the Government of the Russian Federation of May 15, 2019 N 602)

cross-border cooperation program "Russia-Lithuania", the implementation procedure of which is stipulated by the Agreement on financing and implementation of the cross-border cooperation program "Russia-Lithuania" for the period 2014-2020, signed in Moscow on December 29, 2017; (as amended by Decree of the Government of the Russian Federation of May 15, 2019 N 602)

cross-border cooperation program "Russia - Poland", the procedure for the implementation of which is provided for by the Agreement on Financing and Implementation of the Cross-Border Cooperation Program "Russia - Poland" for the period 2014-2020, signed in Warsaw on December 29, 2017; (as amended by Decree of the Government of the Russian Federation of May 15, 2019 N 602)

cross-border cooperation program "Russia - Estonia", the implementation procedure of which is provided for by the Agreement on Financing and Implementation of the Cross-Border Cooperation Program "Russia - Estonia" for the period 2014-2020, signed in Moscow on December 29, 2016; (as amended by Decree of the Government of the Russian Federation of May 15, 2019 N 602)

the cross-border cooperation program "Interreg. Baltic Sea Region", the implementation procedure of which is provided for by the Agreement between the Government of the Russian Federation, the European Commission and the Government of the Federal Republic of Germany on financial contributions from the Russian Federation and European Union in order to ensure the implementation of the cross-border cooperation program "Interreg. Baltic Sea Region" for the period 2014 - 2020 on the territory of the Russian Federation (financial agreement), signed in Brussels on January 30, 2018. (as amended by Decree of the Government of the Russian Federation of May 15, 2019 N 602)

Confirmation of the purchase of goods within the framework of the programs specified in paragraphs two to nine of this paragraph is the conclusion of the Ministry of Industry and Trade of the Russian Federation, issued in the manner established by the Ministry of Industry and Trade of the Russian Federation in agreement with the Ministry of Economic Development of the Russian Federation. (as amended by Decree of the Government of the Russian Federation of May 15, 2019 N 602)

Prime Minister
Russian Federation
D. MEDVEDEV

APPROVED
Government Decree
Russian Federation
February 5, 2015 No. 102

LIST OF CERTAIN TYPES OF MEDICAL DEVICES ORIGINING FROM FOREIGN COUNTRIES FOR WHICH LIMITATIONS OF ADMISSION ARE ESTABLISHED FOR THE PURPOSE OF PROCUREMENT FOR STATE AND MUNICIPAL NEEDS

(as amended by Decree of the Government of the Russian Federation of 06/26/2019 N 813)

Code in accordance with the All-Russian classifier of products by type economic activity(OKPD2) OK 034-2014	Name of the type of medical devices<*>
13.20.44.120	Gauze medical bleached cotton
14.12.11 14.12.21 14.12.30.131 14.12.30.132 14.12.30.160	Medical clothes
14.12.30.170	Clothing for keeping fit
14.19.32.120	Special surgical disposable sterile non-woven products for the protection of the patient and medical personnel
17.22.12.130	Sanitary-hygienic products - absorbent underwear (diapers (except for size XS (extra small), diapers)
20.13.13.110	Microsources with iodine-125
20.20.14.000	Medical products containing antiseptic and disinfectant preparations
20.59.52.140	Culture media selective and non-selective
20.59.52.199 21.10.60.196	Reagent kits for neonatal screening in dried blood spots
20.59.52.199 21.20.10.139	Sets (sets) of reagents for hematological analyzers
20.59.52.199 21.20.23.111	Sets of biochemical reagents for the determination of enzymes
21.10.60.196	Reagent kits for the detection of infectious agents by polymerase chain reaction; kits of reagents for quantitative and qualitative determination of immunoglobulins or antigens of infectious agents by enzyme immunoassay; reagent kits for the quantitative determination of hormones by enzyme immunoassay
21.10.60.196 21.20.23.111	Sets of biochemical reagents for the determination of blood coagulation factors
21.20.23.111	Sets of biochemical reagents for the determination of substrates; sets of reagents for determining blood groups and Rh factor; kits of reagents for phenotyping of human blood by group systems Rh, Kell and Kidd
21.20.24.110	Adhesive dressing materials, including those impregnated or coated with drugs
21.20.24.131	Sterile and non-sterile gauze bandages
21.20.24.150	Medical gauze masks sterile and non-sterile; gauze cuts medical sterile and non-sterile; sterile medical dressing packages; tampons, setons, turundas, sterile and non-sterile gauze balls
21.20.24.160	Dressings and dressings, wound, impregnated or coated with drugs; antiseptic alcohol wipes; gauze wipes medical sterile and non-sterile
22.19.71.190	Anti-decubitus orthopedic mattresses with shape memory effect; anti-decubitus mattresses with gel elements; anti-decubitus orthopedic pillows with shape memory effect
22.22.14.000	Polymer containers for bioassays
26.20.13.000 26.20.14.000	Radiological Information Systems for acquisition, processing, transmission and archiving of digital medical images
26.51.53.140	Serum protein electrophoresis devices on cellulose acetate films
26.51.53.190	Detecting amplifiers for real-time polymerase chain reaction studies; urine protein analyzers; bilirubin analyzers; semi-automatic biochemical analyzers; blood coagulation analyzers; hemoglobinometers; individual glucometers
26.51.70.110	Dry air thermostats
26.60.11.111	Computer tomographs with the number of slices from 1 to 64
26.60.11.112 26.60.11.113	Mammographs; x-ray machines, mobile, ward; x-ray diagnostic complexes for 2 workplaces; x-ray diagnostic complexes for 3 workplaces; x-ray diagnostic complexes based on a remote-controlled table-support; fluorographs
26.60.11.113	Mobile surgical X-ray machines (C-arm)
26.60.11.113 26.60.12.110 26.60.12.129 32.50.1 32.50.21.112	Endoscopic complexes
26.60.11.120	Single photon emission computed tomography systems (gamma cameras)
26.60.11.120 26.60.11.129	Devices, devices and complexes for gamma-therapeutic contact radiation therapy of medium and high dose rate
26.60.12.111	Electrocardiographs
26.60.12.119 26.60.12.129 27.40.39.110 32.50.13.190	Otorhinoscopes
26.60.12.119 26.60.12.129 32.50.13	Tonometers for measuring intraocular pressure
26.60.12.123	Devices for the study of sound vibrations in human organs
26.60.12.129	Glucose analyzers; bedside heart monitors; complexes of daily electrocardiographic monitoring
26.60.12.132	Ultrasonic scanning devices
26.60.13	Neonatal phototherapy irradiators
26.60.13.190 32.50.13.190	Defibrillators; neonatal baby heaters; neonatal tables with automatic temperature control for heating newborns
26.60.14.120	Hearing aids non-implantable
27.40.39.110	Operating and examination medical lamps
28.25.13.111 28.25.13.115 28.25.13.119	Medical freezers; refrigerators combined laboratory; pharmaceutical refrigerators
28.25.14.110	Complex of equipment for clean rooms; equipment and devices for filtering, disinfecting and (or) air purification
30.92.2	Wheelchairs
32.50.1 32.50.13.190	Electrosurgical devices
32.50.11.000	Root needles
32.50.12.000	Air sterilizers; steam sterilizers
32.50.13.110	Surgical needles; piercing tools; syringes-injectors medical reusable and disposable with and without injection needles
32.50.13.120	Slit lamps; intraocular lenses; microsurgical instruments for ophthalmology; ophthalmic trial lens set
32.50.13.190	Apparatus for nasal respiratory support of breathing for newborns; hard-alloy dental burs; dental diamond heads, including shaped ones; containers for taking, storing and transporting biological samples for clinical laboratory research, including vacuum tubes for taking venous blood, tubes for taking capillary blood, containers for urine, feces and sputum; gynecological polymeric mirrors according to Cuzco; urogenital probes; microsurgical needle holders; neonatal intensive care incubators; auxiliary tools; instruments probing, bougienage; multi-surface exposure tools; pushing tools; cutting and impact tools with a sharp (cutting) edge; channel fillers; colposcopes; pneumatic micromotors for dental handpieces; air-conditioned medical modules (clean room); gynecological examination disposable sterile sets; tips for micromotors; dental turbine handpieces; microsurgical scissors; microsurgical forceps; pulp extractors; dental cutters
32.50.21.112	Therapeutic equipment (baths and hydromassage shower cabins)
32.50.21.121	Devices for inhalation anesthesia
32.50.21.121 32.50.21.122 32.50.21.129	Apparatus artificial ventilation lungs
32.50.22.110 32.50.22.190	Endoprostheses of limb joints
32.50.22.120	Handrails for bathroom and toilet (straight, angled, right, left)
32.50.22.127	Devices for external fixation; implants for osteosynthesis
32.50.22.128	crutches
32.50.22.129	Armchairs-chairs with sanitary equipment; supports (supports-walkers walking, supports-walkers on wheels); handrails (handrails) for self-lifting are angular, straight (linear) and folding; walkers on wheels; folding walkers, adjustable in height
32.50.22.152	Orthopedic children's shoes
32.50.22.190	Exoprostheses of the mammary (mammary) glands based on silicone gel
32.50.23.000	Cosmetic shells for active upper limb prostheses; artificial polyurethane foam feet; cover for the stump of the lower extremities
32.50.30.110	Beds medical functional
32.99.21.120	Support canes
32.99.59.000	Consoles for the supply of medical gases and electrical power

<*>When applying this list, one should be guided by both the code in accordance with the All-Russian Classifier of Products by Type of Economic Activity (OKPD2) and the name of the type of medical device.

APPROVED
Government Decree
Russian Federation
dated August 14, 2017 N 968

SCROLL
OF POLYVINYL CHLORIDE PLASTIC MEDICAL DEVICES OF DISPOSABLE USE (USE) ORIGINING FROM FOREIGN COUNTRIES, FOR WHICH LIMITATIONS OF ADMISSION ARE ESTABLISHED FOR THE PURPOSES OF PROCUREMENT FOR PROVISION OF STATE AND NATIONAL

(as amended by Decree of the Government of the Russian Federation of 14.08.2017 N 968)

Name of the medical device	Code according to All-Russian classifier products by type of economic activity (OKPD 2) OK 034-2014	Medical product type code<*>	Name of the type of medical product<*>	Classification features of the type of medical device<*>
1. Devices for transfusion of blood, blood substitutes and infusion solutions	32.50.13.110 32.50.13.190	114090 131660 131850 131880 136330 145530 145570 167580		devices (systems) for transfusion of blood, blood substitutes and infusion solutions, including those with a microfilter, for the safe transfusion of blood and its components, blood substitutes and infusion solutions from polymer and glass containers to a patient
		136330	basic set for intravenous injections
devices for transfusion of infusion solutions and blood substitutes (PR)		131850	filter for intravenous infusion system
devices for transfusion of infusion solutions and blood substitutes (PR)		131660	IV line extension kit
devices for transfusion of infusion solutions and blood substitutes (PR)		131880	clamp for intravenous infusion set, with calibrated dial
devices for transfusion of infusion solutions and blood substitutes (PR)		114090	non-absorbent intravenous infusion set
devices for transfusion of infusion solutions and blood substitutes (PR)		167580	heated IV set
devices for transfusion of blood, blood components and blood substitutes (PC)		145570	blood transfusion kit
		145570	blood transfusion kit
devices for transfusion of blood, blood components and blood substitutes with microfilter (PC with microfilter)		145530	blood transfusion filter
2. Containers for procurement, storage and transportation donated blood and its components	32.50.13.190 32.50.50.000	144260 144270 144290 144300 144310 144320 145490 169870 178820 322610		containers for harvesting, storing and transporting donated blood and its components, including those with a leukofilter, for obtaining whole blood from a donor and obtaining donor blood components: red blood cells, plasma, platelet concentrate and thrombocytopenia, including for obtaining depleted blood components leukocytes
containers for collection, storage and transportation of donated blood and its components without hemo-preservatives (dry), single-chamber (1000 ml)
containers for collection, storage and transportation of donated blood and its components without hemo-preservatives (dry), single-chamber (300 - 450 ml)
containers for collection, storage and transportation of donated blood and its components without hemo-preservatives (dry), two-chamber
containers for harvesting, storing and transporting donated blood and its components with hemoconservative, single-chamber		144260	blood donation kit, single chamber
containers for procurement, storage and transportation of donated blood and its components with hemoconservative, two-chamber		144270	blood donation kit, double chamber
containers for procurement, storage and transportation of donated blood and its components with hemoconservative, three-chamber		144320
containers for procurement, storage and transportation of donated blood and its components with hemoconservative, four-chamber		144300
containers for procurement, storage and transportation of donated blood and its components with hemoconservative		178820
		144320	blood donation kit, three-chamber
containers for collection, storage and transportation of donated blood and its components with an integrated leukocyte filter		178820	blood donation kit pediatric
containers for collection, storage and transportation of donated blood and its components with an integrated leukocyte filter		144300	blood donation kit, four-chamber
containers for collection, storage and transportation of donated blood and its components with an integrated leukocyte filter		144310	blood donation kit, five-chamber
containers for collection, storage and transportation of donated blood and its components with an integrated leukocyte filter		144290	blood donation kit, multi-chamber
polymer containers for deep freezing (cryopreservation) of donor blood components		145490	blood/tissue storage or culture container
polymer containers for deep freezing (cryopreservation) of donor blood components devices for removing leukocytes from donor blood and its components		169870	container for cryostorage of IVD samples, sterile
devices for removing leukocytes from donor blood plasma		322610
devices for removing leukocytes from donor blood plasma (bedside)		322610	apheresis system filter, for plasma
3. Consumables for ventilators	32.50.13.190 32.50.50.000	110230 151440 165230 173070 185610 185620 185630 185640 218750 275820 318730 324650 322250 327610 327640		consumables for ventilators - disposable, sterile medical products for use in conjunction with a ventilator, for the supply and removal of a controlled gas mixture
		275820	anesthetic breathing circuit, disposable
breathing circuit for artificial lung ventilation apparatus		185610	ventilator circuit, disposable
		218750	heat/moisture exchanger/bacterial filter, non-sterile
respiratory filter for ventilator		324650	heat/moisture exchanger/bacterial filter, sterile
respiratory filter for ventilator		318730	bacterial filter for medical gases, non-sterile, disposable
respiratory filter for ventilator		322250	bacterial filter for medical gases, sterile, disposable
ventilator humidifier		173070	humidifier of respiratory mixtures without heating
		185640	adapter for ventilator
connector/connector/adapter for ventilator		327640	breathing circuit tube/mask connector, sterile
connector/connector/adapter for ventilator		165140	breathing circuit connector, disposable
connector/connector/adapter for ventilator		151450	breathing circuit Y-connector, single use
connector/connector/adapter for ventilator		327610	breathing circuit tubing/mask connector, non-sterile, single use
moisture trap for ventilator		185620	ventilator water trap, disposable
4. Consumables for donor plasmapheresis/plateletpheresis devices	32.50.13.190 32.50.50.000			consumables for donor plasmapheresis / platelet-pheresis devices - disposable, sterile medical products for use in conjunction with apheresis devices for the preparation of donor plasma, platelet pools, and stem cells
set/set of consumables for plasma collection by high-speed centrifugation using HS technology
set/set of consumables for plasma collection by cross-filtration on a rotating membrane filter
bell for donor plasmapheresis machine
container with anticoagulant ACD-A for donor plasmapheresis machine		145450
container with anticoagulant sodium citrate 4% for donor plasmapheresis machine		145450	blood preservation solution containing an anticoagulant
			set of containers for the donor plasmapheresis machine, single-chamber
set of containers for the donor plasmapheresis apparatus			set of containers for the donor plasmapheresis apparatus, two-chamber
set of containers for the donor plasmapheresis apparatus			set of containers for the donor plasmapheresis apparatus, three-chamber
set of lines for the device of donor plasmapheresis		262870	apheresis tube set
set/set of consumables for the device of donor plateletpheresis
container with anticoagulant for donor plateletpheresis machine		145450	blood preservation solution containing an anticoagulant
5. Consumables for artificial (extracorporeal) blood circulation devices	32.50.13.190 32.50.50.000	111480 115570 115610 131520 191470 191560 191600 191610 191680 191770 191800 228290 228320 235170 331910 332960		consumables for the heart-lung machine (AIC) - disposable, sterile medical products for use in conjunction with heart-lung machines for temporary, complete or partial replacement of the pumping function of the heart if it is impossible to perform it by the body
set/set of consumables for the heart-lung machine
set (oxygenator + lines) for heart-lung machine
		115610	extracorporeal membrane oxygenator
heart-lung machine oxygenator		115570	bubble extracorporeal oxygenator
heart-lung machine oxygenator		131520	intravascular membrane oxygenator
reinforced arterial cannula for heart-lung machine		191600	cannula for cardiopulmonary bypass, arterial
reinforced pediatric arterial cannula for heart-lung machine		331910	artificial circulation cannula pediatric
		191610
femoral arterial cannula, for heart-lung machine		111480	aortic cannula
		191470	cannula for cardioplegic solution
arterial cannula, for heart-lung machine		228290	coronary cannula
arterial cannula, for heart-lung machine		228320	coronary sinus cannula
femoral venous cannula, for heart-lung machine		191610	artificial circulation cannula, femoral
venous cannula femoral bicaval for heart-lung machine		191680	cardiopulmonary bypass cannula, venous
venous cannula for heart-lung machine		298290	transseptal cannula for cardiopulmonary bypass systems
variable angle venous cannula for heart-lung machine
hemoconcentrator for heart-lung machine		235170	hemoconcentrator
drainage/suction for heart-lung machine
		191560	set of tubes for cardiopulmonary bypass
set of lines for heart-lung machine		191800	set of tubes for primary filling of the artificial circulation system
set of lines for heart-lung machine		332960	cardiopulmonary bypass tubing connector
pump/pump head for heart-lung machine		191770	centrifugal pump for cardiopulmonary bypass
6. Urine bags and colostomy bags		152440 152450 152460 152470 156370 156410 156420 200040 221840 221850 255030
		152450	colostomy bag closed, one-component	colostomy bags for the rehabilitation of patients with dysfunctions
one-component colostomy bag		156410	colostomy for intestinal stoma open type, one-piece	excretion of feces, with certain diagnoses, after operations, for
		156420	colostomy for intestinal stoma of open type, multi-component	use in the presence of a colostomy. Rehabilitation urinals for
two-component colostomy bag (assembly)		152460	colostomy bag, closed, multi-component	violations of the natural outflow of urine, after surgery, for use in the presence of a cytostoma
	32.50.13.190 32.50.13.110
two-component colostomy bag (assembly)
bag for colostomy bag
plate for colostomy bag		221840	colostomy plate, convex
plate for colostomy bag		221850	colostomy plate, flat
one-component urinal		255030	single-component urostomy bag
two-component urinal		200040	multicomponent urostomy bag
urinal bag		152470	urinal, closed, non-carryable, sterile
urinal bag		152440	urinal, closed, wearable, non-sterile
urinal bag		156370	urinal with drain cock without attachment to the patient, sterile

<*>The code, name of the type of medical device and its classification features are indicated in accordance with the nomenclature classification of medical devices approved by the order of the Ministry of Health of Russia.

Note. When applying this list, one should be guided by the code in accordance with the All-Russian Classifier of Products by Type of Economic Activity (OKPD 2), and (or) the code of the type of medical device in accordance with the nomenclature classification of medical devices approved by the order of the Ministry of Health of Russia, and (or) the name of the type of medical product, and (or) classification features of the type of medical product (if any).

There were no sanctions. By that time, Russia was a member of the World trade organization, which implies an equal legal regime for goods, works, services of all WTO member states. Accordingly, 44-FZ contains Article 14, which states that in relation to goods, works and services of foreign origin, a national regime is established: that is, they are equated to Russian ones.

However, under the WTO General Agreement on Tariffs and Trade of 1994 (GATT), there are exceptions to this agreement: such exceptions, in accordance with subparagraph "a" of paragraph 8 of Article III of the GATT, may be cases of procurement by government agencies of goods purchased for government purposes, which makes it possible establish an advantage for certain Russian goods when purchasing under Law No. 44-FZ.

Russia began to actively exercise this right in 2015. On the this moment there are twelve such restrictions and prohibitions. In order to understand the legislation on prohibitions on the purchase of foreign goods, one should remember those areas in which import substitution is applied (exemptions from national treatment).

Areas of exemption from the national regime (Art. 14 FZ-44)

1. Defense of the country and security of the state.
2. Engineering.
3. Medical products, including PVC products and coronary stents and catheters.
4. Medicines included in the list of vital and essential medicines(VED).
5. Certain types of goods light industry.
6. Software.
7. Radioelectronic industry.
8. Individual food items.
9. Furniture and woodworking industry.
10. Preferences for the goods of the states - members of the Eurasian Economic Union (EAEU), in which the Russian Federation.

Order of the Ministry of Economic Development of Russia dated March 25, 2014 No. 155 “On the conditions for the admission of goods originating from foreign countries for the purpose of procurement of goods, works, services to meet state and municipal needs”).

Naturally, it is impossible to replace all goods of foreign origin with Russian ones, therefore in each of these areas there are separate lists of products named by the Government of the Russian Federation, in respect of which exemptions from the national regime are applied.

Consequences of non-compliance with the rules of import substitution within the framework of 44-FZ

Responsibility for non-application of exemptions from the national regime in the notice and procurement documentation is defined in Part 4.2 of Article 7.30 of the Code of Administrative Offenses of the Russian Federation.

Part 4.2 of Article 7.30 of the Code of Administrative Offenses of the Russian Federation

Approval of tender documentation, auction documentation, documentation on the request for proposals, determination of the content of the notice on the request for quotations in violation of the requirements provided for by the legislation of the Russian Federation on the contract system in the field of procurement, except for cases, provided for in parts 4 and 4.1 this article, implies the imposition administrative fine on officials in the amount three thousand rubles.

The manager is responsible, or otherwise executive customer who approved the procurement documentation.

At the moment, this violation is one of the most common compounds detected control bodies, since it can be quite problematic for a procurement specialist to prevent violations of import substitution requirements. Why - consider below.

Mechanisms for exceptions to national treatment under the contract system

In order to understand how all these exemptions work, it is necessary to know what principles and mechanisms apply. legal regulation when establishing restrictions and prohibitions on the admission of foreign goods to purchases under 44-FZ.

I. Direct prohibitions on the admission of goods originating from foreign countries, works, services, respectively, performed, rendered foreign persons.

Everything is clear here: the Government of the Russian Federation, by its decree, prohibits the purchase of specific foreign goods according to the list under 44-FZ. As a rule, there are no problems with understanding these prohibitions.

Examples of prohibitions established by the Government of the Russian Federation:

1. Decree of the Government of the Russian Federation of July 14, 2014 No. 656 "On establishing a ban on the admission of certain types of engineering goods originating from foreign countries for the purposes of procurement for state and municipal needs." At the same time, cars of foreign brands that are assembled on the territory of the Russian Federation are considered Russian.
2. Decree of the Government of the Russian Federation of August 11, 2014 No. 791 "On the establishment of a ban on the admission of light industry goods originating from foreign states, and (or) services for the rental of such goods in order to make purchases to meet federal needs, the needs of the constituent entities of the Russian Federation and municipal needs." This decree contains two annexes - in relation to federal customers and in relation to regional and municipal customers with the corresponding lists.
3. Decree of the Government of the Russian Federation of January 14, 2017 No. 9 "On the establishment of a ban on the admission of goods originating from foreign countries, works (services) performed (rendered) by foreign persons for the purpose of purchasing goods, works (from servants) for defense needs country and state security.
4. Decree of the Government of the Russian Federation of November 16, 2015 No. 1236 "On establishing a ban on the admission of software originating from foreign countries for the purposes of procurement for state and municipal needs." Russia maintains a software registry.
5. Decree of the Government of the Russian Federation of September 5, 2017 No. 1072 (ban on goods for the furniture and woodworking industries). From December 1, 2017, a ban on the purchase of foreign furniture was introduced for two years.

II. Establishment of price preferences for Russian goods, or conditions for the admission of goods originating from foreign countries, works, services, respectively, performed, rendered by foreign persons.

Here we are talking on the Order of the Ministry of Economic Development of the Russian Federation of March 25, 2014 No. 155 "On the conditions for the admission of goods originating from foreign countries for the purposes of procurement of goods, works, services to meet state and municipal needs." This order uses two mechanisms of admission conditions.

The order contains a special list of goods to which it applies (for example, computer technology, food, a number of medical devices, etc.). When conducting an electronic auction under 44-FZ, procurement participants offering foreign goods, subject to the conditions established by Order No. 155, including the presence of applications with goods originating from the member states of the Eurasian Economic Union (Russia, Belarus, Kazakhstan, Armenia , Kyrgyzstan), conclude a contract at a price reduced by 15% in relation to the price of a foreign product offered during the auction.

For example, two participants took part in the purchase. Participant-1 offers Russian goods for 120 rubles, and Participant-2 offers foreign goods, but for 100 rubles. In this situation, Participant-2 wins, but since he offers foreign goods, the contract with him will be concluded, taking into account the requirements of Order No. 155, not for 100 rubles, but for 85 rubles.

The essence of the restrictions is to provide price preferences to manufacturers from the EAEU member states, which makes it unprofitable for procurement participants to offer foreign goods under 44-FZ. The admission conditions are established by the Ministry of Economic Development of Russia.

When purchasing goods, works and services in other ways (by holding a tender, request for proposals, request for quotations) evaluation and comparison of bids for participation in the procurement, which contain proposals for the supply of goods of Russian origin, for the purposes of evaluating bids, 15% of the price offered in them is deducted from the bid with the goods of the EAEU by 15 percent). That is, if a participant offers a Russian product for 100 rubles, then when calculating points according to the “contract price” criterion, it will be considered that he offered a price of 85 rubles, but the contract with such a participant will be concluded at a price of 100 rubles. However, other evaluation criteria are also taken into account.

III. Restrictions on the admission of goods originating from foreign countries, works, services, respectively, performed, provided by foreign persons

First, it is currently impossible to replace all foreign goods with Russian ones on the Russian market.

Secondly, there is no guarantee that within the framework of a specific purchase, a participant will definitely come out with Russian goods. Therefore, you can be left without the necessary goods, works and services. Therefore, the state has introduced another mechanism, which now prevails in the resolutions issued by the Government of the Russian Federation. In essence, this is the implementation of the “Third Man” principle, according to which a ban is imposed on the participation of foreign manufacturers in purchases not completely, but only if there are two Russian manufacturers and the EAEU (in some cases, only Russian ones). That is, in the absence of applications with goods from Russian manufacturers, foreign goods can be offered. Restrictions are established by the Government of the Russian Federation.

In order for the “Third Man” principle to be applied, the purchase must contain at least two bids with Russian goods, and these goods must be from different manufacturers. And only if these conditions are met, the application with foreign goods should be rejected. If two applications with Russian goods of the same manufacturer and an application with goods of foreign origin are submitted, then such an application is subject to admission to participation in the procurement. Therefore, in most cases, manufacturers from the EAEU member states are equated to Russian manufacturers.

The method is mainly used in medicine.

Examples of the implementation of the “third wheel” principle by the Government of the Russian Federation:

1. Decree of the Government of the Russian Federation of November 30, 2015 No. 1289 "On restrictions and conditions for the admission of drugs originating from foreign countries included in the list of vital and essential drugs for the purposes of procurement for state and municipal needs."
2. Decree of the Government of the Russian Federation of February 5, 2015 No. 102 "On restrictions and conditions for the admission of certain types of medical devices originating from foreign countries for the purposes of procurement for state and municipal needs."
4. Decree of the Government of the Russian Federation of September 26, 2016 No. 968 "On restrictions and conditions for the admission of certain types of radio-electronic products originating from foreign states for the purposes of procurement for state and municipal needs."
5. Decree of the Government of the Russian Federation of August 22, 2016 No. 832 "On restrictions on the admission of certain types of food products originating from foreign countries for the purposes of procurement to meet state and municipal needs".

Please note that in addition to the “Third man” principle, since 2017 the principle of "Second extra". This principle does not apply everywhere, but only when purchasing:

1. products made of PVC compounds, defined by the Government of the Russian Federation. If there is at least one application from a supplier included in the special register of suppliers, all applications of procurement participants not included in the register are rejected;
2. stents for coronary arteries and catheters. If there is at least one application with Russian goods, applications with foreign products are rejected.

Examples of the implementation of the “second man” principle by the Government of the Russian Federation:

1. Decree of the Government of the Russian Federation of August 14, 2017 N 967 "On the specifics of the procurement of disposable medical devices (use) from polyvinyl chloride plastics to meet state and municipal needs."
2. Decree of the Government of the Russian Federation of 04.12.2017 No. 1469 "On the restrictions and conditions for the admission of bare metal stents for the coronary arteries, stents for the coronary arteries that release medicine(including those with a non-absorbable polymer coating and with an absorbable polymer coating), standard balloon catheters for coronary angioplasty, aspiration catheters for embolectomy (thrombectomy), originating from foreign countries, for the purpose of procurement for state and municipal needs.

Ban on foreign software (Decree of the Government of the Russian Federation of November 16, 2015 No. 1236)

As part of Decree of the Government of the Russian Federation of November 16, 2015 No. 1236, there is a ban on the admission of foreign software to purchases under 44-FZ. The essence of this decision is as follows.

Ministry of Telecom and Mass Communications formed single register Russian programs for electronic computers and databases. If you want to buy foreign software if there is a similar Russian one, you are obliged to write a justification for the impossibility of complying with the ban on the admission of software originating from foreign countries for the purposes of procurement for state and municipal needs.

Example

In the presence of such a document in the procurement documentation, customers under 44-FZ can purchase foreign software.

However, from January 1, 2018, amendments to RF PP 1236 came into force, according to which the ban on the admission of programs for electronic computers and databases originating from foreign countries does not apply to software included in the unified register of programs for electronic computers and databases from the member states of the Eurasian Economic Union, with the exception of the Russian Federation.

That is, in addition to the register of Russian software, the Ministry of Telecom and Mass Communications will maintain register of Eurasian software. Accordingly, in order to justify the impossibility of complying with the ban on the purchase of foreign software, it will be necessary to indicate the absence of similar programs not only in Russia, but also in the EAEU countries.

Prohibition against goods of the furniture and woodworking industry (Decree of the Government of the Russian Federation of September 5, 2017 No. 1072)

Since December 1, 2017, there has been a two-year ban on the purchase of foreign furniture and woodworking products. A special list of such products has been established. The bottom line is a ban on the purchase of foreign products, except for goods produced in the EAEU countries, as during the competitive procedures, and when purchasing from sole supplier.

In addition, customers are obliged to establish an additional requirement for procurement participants to use domestic materials (EAEU) from items 1 and 2 of the list (Fibreboard and DSP) in the production of goods from items 3 - 29 of the list (part 2 of article 31 of FZ-44 ).

The list of certain types of goods of the furniture and woodworking industry originating from foreign countries, in respect of which a ban on admission is established for the purposes of procurement for state and municipal needs

No. p / p	Name of product	Code in accordance with the All-Russian Classifier of Products by Type of Economic Activity OK 034-2014 (KPES 2008)
1	Particleboard and similar boards of wood or other lignified materials	16.21.13
2	Fibreboards of wood or other lignified materials	16.21.14
3	Metal furniture for offices	31.01.11
4	Wooden furniture for offices	31.01.12
5	Wooden furniture for trade enterprises	31.01.13.000
6	Kitchen furniture	31.02.10
7	Wooden frame mattress bases	31.03.11.110
8	Mattress bases from a metal frame	31.03.11.120
9	Other mattress bases	31.03.11.190
10	Mattresses other than mattress bases	31.03.12
11	Metal furniture, n.e.c.	31.09.11
12	Wooden furniture for the bedroom, dining room and living room	31.09.12
13	Sofas, sofas, couches with a wooden frame, convertible into beds	31.09.12.110
14	Sofas, sofas, couches for children and teenagers with a wooden frame, transformable into beds	31.09.12.111
15	Sofas, sofas, couches with a wooden frame, convertible into beds, other	31.09.12.119
16	Wooden furniture for the bedroom	31.09.12.120
17	Wooden beds for adults	31.09.12.121
18	Wooden cabinets for the bedroom	31.09.12.123
19	Wooden cabinets for the bedroom	31.09.12.124
20	Wooden sets, sets of complete furniture for the bedroom	31.09.12.125
21	Other wooden bedroom furniture	31.09.12.129
22	Wooden furniture for the dining room and living room	31.09.12.130
23	Wooden dining tables for the dining room and living room	31.09.12.131
24	Wooden coffee tables	31.09.12.132
25	Wooden cabinets for the dining room and living room	31.09.12.133
26	Sets and sets of complete furniture	31.09.12.134
27	Other wooden furniture for dining and living rooms	31.09.12.139
28	Wooden furniture, n.e.c.	31.09.13
29	Furniture made of plastic materials	31.09.14.110

In connection with the prohibitions, the question arises: how is all this confirmed?

In the procurement documentation, the customer must require, as part of the application for participation in the procurement, the documents specified in paragraphs 2 - 4 of the criteria for confirming the production of industrial products in the Russian Federation, approved by the Government of the Russian Federation dated May 10, 2017 No. 550:

• a copy of the special investment contract + conclusion of the Ministry of Industry and Trade on the fulfillment / non-fulfillment of obligations;
• an examination certificate issued by the Chamber of Commerce and Industry;
• or ST-1 certificate issued by the CCI.

Ban on coronary arteries and catheters (Decree of the Government of the Russian Federation of December 4, 2017 No. 1469)

The ban on coronary arteries and catheters is in effect from December 14, 2017 to July 1, 2018. Here the “Second Extra” rule applies: that is, if there is at least one application with Russian products, applications with foreign goods are rejected. If none of the participants who offered foreign goods is rejected, then the order of the Ministry of Economic Development No. 155 is applied.

This prohibition only applies to electronic auctions and requests for proposals, when in addition to an application with a foreign product, at least one application with Russian products has been submitted.

The application must include one of the following documents:

• certificate ST-1;
• confirmation of production in the territory of the Russian Federation, issued by the Ministry of Industry and Trade of Russia until November 30, 2017 inclusive;
• conclusion on confirmation of production on the territory of the Russian Federation, issued by the Ministry of Industry and Trade of Russia from 01.12.2017.

Attention!

It is forbidden to combine in one purchase stents for coronary arteries and catheters and other types of medical devices, as well as two or more types of products specified in clause 1 of RF PP 1469

Preferences for goods from the EAEU member states (Order of the Ministry of Economic Development of Russia dated March 25, 2014 No. 155)

According to the order, there is a list of goods (food, computers, paper, furniture, etc.) in respect of which benefits are provided - price preferences. The order is valid only if there is at least one application with foreign goods and one application with goods from the EAEU states.

Implementation mechanism

1. on the indication (declaration) by the participant of the tender, auction, request for proposals or request for quotations in the application for participation of the country of origin of the goods;
2. on the provision of a document confirming the country of origin of the goods (details (if the document is available) are included in the contract).

Prohibition on engineering goods (Decree of the Government of the Russian Federation of July 14, 2014 No. 656)

A ban on the purchase of foreign cars according to the list specified in RF PP 656, the purchase of municipal equipment and certain types of special equipment, certain types equipment (eg generators). Accordingly, the customer does not have the right to purchase such products under 44-FZ.

List of certain types of engineering goods originating from foreign countries, in respect of which a ban on admission is established for the purposes of procurement for state and municipal needs

No. p / p	Code in accordance with the All-Russian classifier of products by type of economic activity OK 034-2014 (KPES 2008)	Name
1.	28.22.14.159	Other self-propelled machines and trolleys equipped with a crane, not included in other groups
2.	28.92.21.110	Bulldozers on caterpillar tractors
3.	28.92.50.000	Crawler tractors
4.	28.92.28.110	Dumps of bulldozers fixed
5.	28.92.28.120	Rotary dozer blades
6.	28.92.21.120	Bulldozers on wheeled tractors and tractors
7.	28.92.22.110	Self-propelled graders
8.	28.92.24.120	Self-propelled road rollers
9.	28.92.25.000	Self-propelled frontal loaders
10.	28.22.15.110	Fork lift trucks
11.	28.92.26.110	Self-propelled single-bucket excavators
12.	28.92.26.120	Full-revolving bucket loaders, except front-end shovel loaders
13.	28.92.27.110	Self-propelled bucket excavators
14.	29.10.21.000	Vehicles with a spark ignition engine, with a cylinder capacity not exceeding 1500 cm3, new
15.	29.10.22.000	Vehicles with a spark ignition engine, with a cylinder capacity of more than 1500 cm3, new
16.	29.10.23.000	Vehicles with compression-ignition internal combustion piston engine (diesel or semi-diesel), new
17.	29.10.24.000	Other means of transport for transporting people
18.	29.10.30.110	Buses
19.	29.10.30.120	Trolleybuses
20.	29.10.30.190	Passenger motor vehicles with a number of seats for at least 10 other
21.	29.10.41.110	Trucks with a diesel engine
22.	29.10.41.120	Dump trucks with diesel engine
23.	29.10.42.111	Trucks with a gasoline engine, having a technically permissible mass of not more than 3.5 tons
24.	29.10.42.112	Trucks with a gasoline engine, having a technically permissible mass of more than 3.5 tons, but not more than 12 tons
25.	29.10.42.120	Tipper trucks with gasoline engine
26.	29.10.43.000	Truck tractors for semi-trailers
27.	29.10.51.000	Truck cranes
28.	29.10.59.110	Vehicles for transporting building materials
29.	29.10.59.120	Timber trucks
30.	29.10.59.130	Means of transport for public utilities and road maintenance
31.	29.10.59.140	Fire trucks
32.	29.10.59.150	Means of transport for emergency rescue services and police
33.	29.10.59.160	Ambulances medical care
34.	29.10.59.170	Medical complexes on the chassis of vehicles
35.	29.10.59.180	Vehicles for maintenance of oil and gas wells
36.	29.10.59.210	Means of transport for the transportation of cash proceeds and valuable goods
37.	29.10.59.220	Means of transport for the carriage of goods using a trailer-dissolution
38.	29.10.59.230	Vehicles for the transportation of petroleum products
39.	29.10.59.240	Means of transport for the transport of food liquids
40.	29.10.59.250	Means of transport for the transportation of liquefied hydrocarbon gases at a pressure of up to 1.8 MPa
41.	29.10.59.260	Means of transport operational and service for the transportation of persons in custody
42.	29.10.59.270	Means of transport equipped with lifts with working platforms
43.	29.10.59.280	Means of transport - vans for the transport of foodstuffs
44.	29.10.59.310	Means of transport equipped with cranes-manipulators
45.	29.10.59.320	snow plows
46.	29.10.59.390	Vehicles special purpose other, not included in other groups
47.	29.20.21.110	Containers general purpose(universal)
48.	29.20.21.120	Containers specialized
49.	29.20.21.122	Tank containers
50.	29.20.23.110	Trailers (semi-trailers) for cars and trucks, motorcycles, scooters and quads
51.	29.20.23.120	Tank trailers and tank semi-trailers for transportation of oil products, water and other liquids
52.	29.20.23.130	Tractor trailers and semi-trailers
53.	29.20.23.190	Other trailers and semi-trailers, not included in other groups
53.1.	from 27.11.31.000	Generator sets with compression ignition internal combustion engines from 60 kW to 315 kW
54.	30.20.20.120	Passenger tram cars, self-propelled (motor)
55.	30.20.32.120	Tram cars, passenger, non-motorized

The list contains three groups of goods:

1. Goods specified in paragraphs 1-13, 17, 19, 27-32 and 34-55 of the list: for example, bulldozers, trolleybuses, truck cranes, etc.
2. Goods specified in items 14-16 and 33 of the list: for example, cars and ambulances.
3. Goods specified in items 18 and 20-26 of the list: for example, buses, diesel engine dump trucks, gasoline engine dump trucks, etc.

Purchase of engineering goods from the first group

These goods can only be purchased if their country of origin is the Russian Federation, the Republic of Belarus, the Republic of Armenia or the Republic of Kazakhstan.

In the notice and procurement documentation, the customer must indicate that:

1. in accordance with Part. 3 Article. 14 of Law No. 44-FZ and on the basis of Decree of the Government of the Russian Federation of 14.07.2014 No. 656, a ban on the admission of goods whose country of origin is not the Russian Federation, the Republic of Belarus, the Republic of Armenia or the Republic of Kazakhstan is established;
2. the procurement participant in the application can only offer goods whose country of origin is the Russian Federation, the Republic of Belarus, the Republic of Armenia or the Republic of Kazakhstan;
3. to confirm the country of origin of the goods, the application of the procurement participant must contain a certificate of origin of the goods (clause "h" clause 1 part 2 article 51; clause 6 part 5 article 66; clause 6 part 3 article 73 of the Law No. 44-FZ). Certificate ST-1 on the origin of goods from Russia is issued by the Chamber of Commerce and Industry of Russia.

Purchase of engineering goods from the second group

Such goods can be purchased if they meet the requirements provided for in the note to the list and one of the following conditions:

1. produced by business entities, for example:
   • JV CJSC "UNISON", Obchak village, Minsk region
   • JSC "Asia Auto" (car assembly plant), Ust-Kamenogorsk, st. Bazhova, 101/1
   • JSC "IzhAvto", Izhevsk, Republic of Udmurtia, etc.
2. produced by Russian legal entities that import auto components for the industrial assembly of motor vehicles on the basis of agreements on the import of goods intended for the industrial assembly of motor vehicles of headings 8701-8705 of the TN VED CU, their components and assemblies, concluded with the Ministry of Economic Development of Russia, subject to proper execution of these agreements;
3. or in the mode provided for in paragraph 6, paragraph 2, Art. 10 Agreements on issues of free (special, special) economic zones in the customs territory Customs Union and the customs procedure of the free customs zone of June 18, 2010

To confirm the compliance of the goods with the specified requirements, the application of the procurement participant must contain an examination certificate issued by the Chamber of Commerce and Industry of Russia (clause “h”, clause 1, part 2, article 51; clause 6, part 5, article 66; clause 6, part 3, article 73 of Law No. 44-FZ).

Purchase of engineering goods from the third group

It is possible to purchase such goods if they meet the requirements stipulated by the note to the list (i.e. a certain number of assembly operations have been carried out on the territory of Russia, Belarus, Kazakhstan, Armenia).

The notice and documentation states that:

1. in accordance with Part. 3 Article. 14 of Law No. 44-FZ and on the basis of Decree of the Government of the Russian Federation of July 14, 2014 No. 656, a ban on the admission of goods that do not meet the requirements provided for in the note to the list is established;
2. the procurement participant in the application can only offer goods that meet the requirements specified in the note to the list;
3. to confirm the conformity of the goods specified requirement the application of the procurement participant must contain an examination certificate issued by the Chamber of Commerce and Industry of Russia (subparagraphs “h”, paragraph 1, part 2, article 51; paragraph 6, part 5, article 66; paragraph 6, part 3, article 73 of Law No. 44- FZ).

Documents confirming the Russian (or EAEU) origin of engineering goods:

• A copy of the special investment contract;
• An examination certificate issued by the Chamber of Commerce and Industry (Order of the Chamber of Commerce and Industry dated August 25, 2014 No. 64);
• One-time certificate SCh-1 (Order of the Chamber of Commerce and Industry of August 25, 2014 No. 64).

Issues that arise when applying RF PP 656:

1. Let's say we buy a Lada car. The car "Lada" is Russian. But from the point of view of the application of RF PP 656, if the participant did not provide a document confirming the Russian origin of the goods as part of the application, then the customer must reject such an application. It turns out that the Russian manufacturer must confirm that it is domestic and pay money for the provision of the relevant document, or the supplier must do this. As a result, the ban is established in support of the Russian manufacturer, but blocks its entry into the market under 44-FZ. Which exit? 44-FZ contains one mistake that allows legally circumventing prohibitions and restrictions on the admission of foreign products. In Article 83 (on the request for proposals), they forgot to write that prohibitions and restrictions on the admission of foreign goods under Article 14 are established in the notice and procurement documentation on the request for proposals. Therefore, if the auction did not take place, the customer now has the right to conduct a request for proposals and not establish these prohibitions and restrictions.
2. Does leasing of equipment fall under RF PP 656?
3. If the customer attributed the purchased products to the wrong OKPD2 code?
4. How to apply one-time ST-1 certificates and examination certificates of the Chamber of Commerce and Industry of the Russian Federation, for which the supplier must pay every time he participates in public procurement?
5. Is it possible to mix lots (for example, include in one purchase engineering goods that fall and do not fall under RF PP 656)?

Prohibition on light industry goods (Decree of the Government of the Russian Federation of August 11, 2014 No. 791)

Here, too, we are not talking about all light industry goods, but only about those specified in the annexes to RF PP 791:

Appendix No. 1 to establishes a list for federal customers (with the exception of the state defense order);

Appendix No. 2 contains a list for customers at the regional and municipal levels.

The principle of RF PP 791: the purchase of foreign-made light industry goods or services for their rental is allowed only if there are no analogues produced in the territory of the Eurasian Economic Union.

In addition, as with the purchase of furniture, special additional requirements are established for procurement participants under Part 2 of Article 31 of the law on the contract system that materials and semi-finished products, the country of origin of which is a member state of the EAEU, must be used in the manufacture of light industry goods.

The main question that arises when applying RF PP 791 is how is this confirmed? The fact is that the resolution does not contain a list of documents that can confirm the compliance of light industry goods with its requirements. Whether to reject the application of participants who have not confirmed the country of origin of the goods. Some regulatory authorities believe that if the documents that the supplier must provide are not indicated in the resolution, then the application without the attached documents cannot be rejected. Others refer, for example, to Article 66 of Law No. 44-FZ, which establishes that the application must contain documents confirming compliance with the prohibitions and restrictions under Article 14, so you can demand a document, but such a document is provided in any form. The speaker is inclined to the second point of view: that is, the customer indicates in the documentation that such a document is provided in any form (for example, the participant declares the country of origin of the goods, materials and semi-finished products that were used in the manufacture of this product).

The second question: Whether to reject the application of the procurement participant who offered goods from EAEU countries, but did not specify the country of origin of the materials and semi-finished products that were used in their manufacture?

The question also arises of the possibility of using “mixed lots” in relation to goods included and not included in the lists of RF PP 791. Here, the law does not prohibit mixing lots, but one should be prepared to justify the need for such actions (technological interconnection of purchased goods).

Food ban (Decree of the Government of the Russian Federation of August 22, 2016 No. 832)

RF PP 832 is effective from September 3, 2016; it applies only to competitive procurement methods, it does not apply to purchases from a single supplier. The Decree provides for a list of food products originating from foreign countries, for which access restrictions are established for the purposes of procurement for state and municipal needs.

A list of certain types of food products originating from foreign countries, for which access restrictions are established for the purposes of procurement for state and municipal needs.

Code in accordance with the All-Russian Classifier of Products by Type of Economic Activity OK 034-2014	Name of the type of food
10.20.1	Fresh, chilled or frozen fish products
10.20.2	Fish prepared or otherwise preserved; caviar and caviar substitutes
10.20.3	Crustaceans, mollusks and other aquatic invertebrates, frozen, processed or preserved
10.84.30.120	Evaporated edible salt
10.84.30.130	Food table salt iodized
10.11.11.110	Steam beef, cooled or chilled
10.11.11.120	Steam veal, cooled or chilled
10.11.12	Pork steam, cooled or chilled, including for baby food
10.11.20.110	Edible offal of cattle, fresh, cooled or chilled
10.11.31	Meat of cattle (beef and veal), frozen, including for baby food
10.11.32	Frozen pork, including for baby food
10.12.1	Chilled poultry meat, including for baby food
10.12.40.120	Frozen edible offal of poultry
10.51.2	Dried milk and cream, sublimated
10.51.30.100	Butter
10.51.30.110	Butter
10.51.30.200	Oil pastes
10.51.30.210	Oil pastes
10.51.4 except 10.51.40.120	Cheeses, cheese products and cottage cheese
10.51.51	Milk and cream, condensed or containing added sugar or other sweetening matter, not dried
10.61.11.000	Rice, shelled
10.81.12	White beet or cane sugar and chemically pure sucrose in the solid state without flavoring or coloring additives
10.81.13	Refined beet or cane sugar with flavoring or coloring additives; maple sugar and maple syrup

If there is a product on this list, the customer must apply the prohibition under RF PP 832.

The mechanism of action of RF PP 832

The “Third Man” principle applies. If the customer has proposals for the supply of products included in the resolution from at least two Russian manufacturers, which is confirmed by documents in accordance with the specified resolutions, then applications for the supply of products from a foreign manufacturer are rejected by the procurement commission.

Confirmation of the country of origin of goods is the indication (declaration) by the procurement participant in the application in accordance with the law on the contract system of the name of the country of origin and the manufacturer of food products included in the list. The name of the country of origin of goods (food products) is indicated in accordance with the All-Russian Classification of the Countries of the World. The declaration is submitted in any form.

The controversial issue of the application of RF PP 832

Because the Russian legislation not allowed to register legal entity with the same name, how to determine from the information submitted by participants whether manufacturers are different organizations with the same name or is it the same legal entity?

Options for making decisions on admission / rejection of applications

Situation	Actions with requests for the supply of "foreign" goods
there are no applications for goods from Russia, all applications for "foreign" goods	admit
1 application for goods from Russia + applications for "foreign" goods	allow
2 or more applications for goods from Russia of the same manufacturer + applications for "foreign" goods	allow
2 or more applications for goods from Russia, goods from different manufacturers + applications for "foreign" goods	reject
2 applications for goods from Russia of various manufacturers (1 application - there are supporting documents, 2 applications - no supporting documents) (the application does not match the documentation) + requests for "foreign" goods	allow

Prohibition against radio-electronic products (Decree of the Government of the Russian Federation of September 26, 2016 No. 968)

RF PP 968 also includes a list of products for which a ban has been established. It includes almost all computer equipment, communication equipment, communications equipment, as well as video cameras, microphones, projectors and even plug sockets, chandeliers, lamps, fixtures, etc.

LIST OF CERTAIN TYPES OF RADIO-ELECTRONIC PRODUCTS ORIGINING FROM FOREIGN STATES IN RELATION TO WHICH LIMITATIONS AND CONDITIONS OF ADMISSION ARE ESTABLISHED FOR THE PURPOSE OF PURCHASING FOR STATE AND MUNICIPAL NEEDS

27.40.12.000

Code OKPD2	Name of the type of goods
26.11.22.110	Photoresistors
26.11.22.120	Photovoltaic cells
26.11.22.130	Laser diodes (semiconductor lasers)
26.11.22.190	Other semiconductor devices
26.11.22.210	LEDs
26.11.22.220	LED modules
26.11.22.230	Organic LEDs
26.11.22.290	Parts of LEDs and LED Modules
26.11.22.300	Piezoelectric devices and parts thereof
26.11.30.000	Integrated electronic circuits
26.20.11.110	Portable computers weighing not more than 10 kg, such as laptops, tablet computers, pocket computers, including those that combine the functions of a mobile telephone
26.20.11.120	Notebooks and similar computer equipment
26.20.12.110	POS terminals connected to a computer or data transmission network
26.20.12.120	ATMs and similar equipment connected to a computer or data network
26.20.13.000	Computers electronic digital, containing in one housing a central processing unit and an input and output device, whether or not combined for automatic data processing
26.20.14.000	Computers electronic digital supplied in the form of systems for automatic data processing
26.20.15.000	Other electronic digital computing machines, whether or not containing in one housing one or two of the following devices for automatic data processing: storage devices, input devices, output devices
26.20.16.110	Keyboards
26.20.16.120	Printers
26.20.16.130	Plotters
26.20.16.140	Data input/output terminals
26.20.16.150	Scanners
26.20.16.160	Touch input devices
26.20.16.170	Manipulators
26.20.16.190	Other input/output devices
26.20.17.110	Monitors connected to a computer
26.20.17.120	Projectors connected to a computer
26.20.18.000	Peripheral devices with two or more functions: data printing, copying, scanning, receiving and transmitting fax messages
26.20.21.110	Internal storage devices
26.20.21.120	External storage devices
26.20.22.000	Semiconductor storage devices that retain information when the power is turned off
26.20.30.000	Other automatic data processing devices
26.20.40.110	Devices and power supplies for computers
26.20.40.120	Replacement elements typical input and output devices
26.20.40.130	Computer tools and accessories
26.20.40.190	Other components and spare parts for computers, not included in other groups
26.30.11.110	Communication means performing the function of switching systems
26.30.11.120	Communication means performing the function of digital transport systems
26.30.11.130	Communication means performing the function of control and monitoring systems
26.30.11.140	Equipment used to record the volume of rendered communication services
26.30.11.150	Electronic communication means
26.30.11.160	Communication means, including software that ensures the implementation of established actions during the conduct of operational-search activities
26.30.11.190	Other communication transmitting equipment with receiving devices, not included in other groups
26.30.12.000	Communication transmitting equipment without receiving devices
26.30.13.000	TV cameras
26.30.21.000	Wired telephone sets with a cordless handset
26.30.22.000	Telephone sets for cellular networks or for other wireless networks
26.30.23.000	Other telephone sets, devices and equipment for the transmission and reception of speech, images or other data, including communication equipment for operation in wired or wireless communication networks (for example, local and wide area networks)
26.30.30.000	Parts and accessories of communication equipment
26.30.40.110	Antennas and antenna reflectors of all types and their parts
26.30.40.120	Parts and accessories of radio and television transmission equipment and television cameras
26.40.11.000	Broadcast radio receivers, except for automobiles, operating without an external power source
26.40.12.000	Broadcast radio receivers that do not work without an external power source
26.40.20.110	Television receivers (TVs) of color image with devices for recording and reproducing sound and images
26.40.20.120	Television receivers (television sets) of a color image without devices for recording and reproducing sound and images
26.40.20.130	Television receivers (TV sets) of black and white image
26.40.31.110	Electrical devices
26.40.31.120	Record players
26.40.31.130	Cassette players
26.40.31.190	Other sound reproduction apparatus
26.40.32.110	Tape recorders
26.40.32.120	Dictaphones
26.40.32.190	Other sound recording equipment
26.40.33.110	Camcorders
26.40.33.190	Other image recording and reproducing equipment
26.40.34.110	Monitors not specifically designed for use as peripheral equipment
26.40.34.120	Projectors without receivers not specifically designed for use as peripheral equipment
26.40.41.000	Microphones and stands for them
26.40.42.110	Loudspeakers
26.40.42.120	Headphones, headphones and combined devices consisting of a microphone and loudspeaker
26.40.43.110	Electric audio frequency amplifiers
26.40.43.120	Electrical Amplifier Installations
26.40.44.000	Receiving equipment for radiotelephony or radiotelegraphy, n.e.c.
26.40.51.000	Parts and accessories of audio and video equipment
26.40.52.000	Parts of radio receiving and transmitting equipment
26.40.60.000	Game consoles used with a television receiver or equipped with an integral screen and other commercial and gambling with electronic display
27.11.50.120	Electrical static converters
27.33.13.110	Connectors and sockets
27.33.13.120	Electrical connectors, contact clamps, clamp sets
27.33.13.130	Cable fittings
27.33.13.140	Electromagnetic contactors
27.33.13.150	Electromagnetic starters
27.33.13.160	Electrical apparatus for controlling electrical installations, except for electromagnetic contactors and starters, control and protection relays
27.33.13.190	Other switching and/or safety devices for electrical circuits, not included in other groups
27.40.11.000	Lamps sealed narrow beam
Tungsten halogen filament lamps, other than ultraviolet or infrared lamps
27.40.13.000	Incandescent lamps 100 - 200 W, n.e.c.
27.40.14.000	Other incandescent lamps, not included in other groups
27.40.15.110	Discharge lamps
27.40.15.120	Lamps ultraviolet
27.40.15.130	Infrared lamps
27.40.15.140	arc lamps
27.40.15.150	LED lamps
27.40.21.120	Electric portable lamps powered by dry cell batteries, accumulators, magnetos
27.40.22.110	Electric table, bedside or floor lamps intended for use with incandescent lamps
27.40.22.120	Electric table, bedside or floor lamps intended for use with fluorescent discharge lamps
27.40.22.130	Electric table, bedside or floor lamps designed for use with LED lamps and other LED light sources
27.40.22.190	Electric table, bedside or floor lamps intended for use with other types of lamps
27.40.24.110	Glowing pointers
27.40.24.120	Display boards and similar devices
27.40.25.110	Chandeliers
27.40.25.120	Suspended, ceiling, built-in and wall-mounted electrical lighting devices
27.40.33.110	Searchlights and similar spotlights intended for use with incandescent lamps
27.40.33.120	Spotlights and similar spotlights intended for use with fluorescent discharge lamps
27.40.33.130	Floodlights and similar spotlights intended for use with LED lamps and other LED light sources
27.40.33.190	Searchlights and similar spotlights with other types of lamps
27.40.39.110	Other lamps and lighting devices, not included in other groups
27.40.39.190	Other lighting fittings, not included in other groups
27.90.20.110	Display panels with liquid crystal or LED devices
27.90.20.120	Electric light and sound signaling devices
28.23.25.000	Parts and accessories of other office machines
28.23.26.000	Parts and accessories of photocopiers
29.31.23.110	Electrical lighting and signaling devices for vehicles and motorcycles

The “Third Man” principle also applies here, but there is one peculiarity: the national regime for the EAEU countries will be applied only from September 1, 2018. Prior to this, manufacturers from the EAEU are considered foreign.

The Russian origin of the goods is confirmed:

• Special investment contract.
• Conclusion of the Ministry of Industry and Trade.
• Notification of the assignment of the status of telecommunications equipment of Russian origin, issued by the Ministry of Industry and Trade of the Russian Federation.
• ST-1 certificate.

Ban on medical devices (Decrees of the Government of the Russian Federation No. 102 dated February 5, 2015, No. 967 dated August 14, 2017)

PP RF 102 contains two lists. The “Third Man” principle is applied to the first list (an application with a foreign product is rejected if there are two applications with goods from the EAEU).

According to the second list, taking into account the requirements of RF PP 967 (PVC products), the “Second Extra” principle applies (if there is at least one application from a supplier included in the special register of suppliers, all applications of participants not included in the register are rejected). This principle applies to procurement budget institutions providing medical care within the framework of state program free medical care. At the same time, such customers are obliged to request from the ETP all the second parts of the applications, regardless of the serial number.

Ban on medicines included in the Vital and Essential Drugs List (Decree of the Government of the Russian Federation dated November 30, 2015 No. 1289)

This prohibition only applies to medicines on the Essential and Essential Medicines List. medical use for 2018. It is used only in monolots, that is, when only one international name (INN) is purchased. Here, too, the principle of the "third wheel" applies. An application with a foreign VED is rejected if there are two applications with a domestic product. If no one was rejected, the order of the Ministry of Economic Development No. 155 (preferences) is applied.

Monolot Formation Rule established by the RF PP dated 10/17/2013 No. 929.

The origin of the goods is also confirmed by the ST-1 certificate.

As for mixed lots. Based on the practice of the FAS Russia, it is not recommended to mix goods included and not included in RF PP 1289 in one purchase.

All customers working under Law No. 44-FZ must apply Decree No. 102 (Decree of the Government of the Russian Federation dated 05.02.2015 No. 102 “On establishing restrictions on the admission of certain medical devices originating from foreign countries for the purposes of procurement for state and municipal needs”) only in procurement by competitive means. What does it mean?

If medical devices are included in the list approved by Decree No. 102, the customer is obliged to establish an appropriate restriction in the procurement documentation. Products in the list are classified according to OKPD classifier codes.

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At the same time, the list contains a special clause stating that when applying the list, one should be guided by both the code in accordance with OKPD and the name of the type of medical device indicated in the list. specified code. The reservation means that the restrictions do not apply to all medical devices related to the OKPD codes specified in the list, but only to the types of medical devices directly named in it.

According to paragraph 2 of Decree No. 102, the customer rejects all applications containing proposals for the supply of medical devices originating from foreign countries, with the exception of the Republic of Armenia, the Republic of Belarus and the Republic of Kazakhstan, provided that at least two satisfying requirements are submitted for participation in the determination of the supplier documentation on the procurement of bids, which at the same time:

• contain proposals for the supply of one or more types of medical devices included in the list, the country of origin of which is the Russian Federation, the Republic of Armenia, the Republic of Belarus or the Republic of Kazakhstan;
• do not contain proposals for the supply of the same type of medical device from one manufacturer.

That is, Decree No. 102 will only be applied under the combination of the two above conditions.

If only one application is submitted for the purchase, in which a foreign product is offered, such an application cannot be rejected. Or two applications, in one of which a foreign product is offered, and in the other a product from Russia, - in this case an application with a foreign product cannot be rejected either.

According to clause 3 of Decree No. 102, the country of origin of medical devices included in the list is confirmed by a certificate of origin issued by the Chamber of Commerce and Industry of the Russian Federation - ST-1. It is this certificate that the participant must submit as part of the application, and it is on the basis of this document that the country of origin of medical devices is determined. At the same time, the absence of the certificate -ST-1 in the application as such is not a basis for rejecting the application.

The decision to reject the application can only be made if at least two applications were submitted for the purchase, corresponding to clause 2 of Resolution No. 102. In this case, the customer is obliged to reject not only applications containing an offer to supply foreign products, but also those applications, in which CT-1 is not present.