18 May 2025

Public Procurement of Medicinal Products: Legal Regulation in Russia

May 18, 2025

A significant number of amendments have recently been made to public procurement legislation regarding medicinal products. While the positive impact of these amendments on the development of pharmaceutical procurement is undeniable, they have also given rise to a number of serious issues. This article analyzes the specifics of public procurement of medicinal products and the problems arising in law enforcement practice.

Procurement Methods

Federal Law No. 44-FZ of April 5, 2013, “On the Contract System in the Sphere of Procurement of Goods, Works, and Services for Meeting State and Municipal Needs” (hereinafter – “Law No. 44-FZ”, “The Contract System Law”) provides for the following methods of procuring medicinal products for state and municipal needs:

auction (open electronic auction, closed auction, closed electronic auction);
electronic Request for Quotations (RFQ);
single-source procurement.

Since medicinal products are included in the List of goods, works, and services for which the Customer is obliged to conduct an auction^[1], holding contests is not permitted (Part 7, Article 24 of Law No. 44-FZ).

An auction may be conducted starting from 0 rubles and is not restricted by price caps. Closed auctions are conducted in a limited number of cases explicitly provided for by Part 11, Article 24 of Law No. 44-FZ. Mostly, these are procurements related to state secrets, national defense, procurements by law enforcement agencies, etc.

Procurement of medicinal products via an electronic RFQ may be conducted in the following cases:

1) if the Initial Maximum Contract Price (IMCP) does not exceed 10 million rubles. In this case, the annual volume of all procurements conducted via electronic RFQ must not exceed 20% of the Customer’s total annual procurement volume or 100 million rubles for a Customer whose total annual procurement volume in the preceding calendar year was less than 500 million rubles;

2) regardless of the contract price, if:

the procurement results in a contract for the supply of goods necessary for the normal life support of citizens; In accordance with Clause 8.3, Part 1, Article 3 of Law No. 44-FZ, a contract for the supply of goods necessary for the normal life support of citizens includes, inter alia, a contract for the supply of medicinal products, the absence of which would lead to a disruption of the normal life support of citizens.
the Customer decided to unilaterally refuse to perform a previously concluded contract. In this case, the quantity of goods must be reduced by the quantity of goods delivered under the terminated contract;
medicinal products are necessary for assignment to a patient based on medical indications (individual intolerance, life-saving indications) by decision of a medical commission, which is recorded in the patient’s medical records and the register of medical commission decisions. In this case, the quantity of purchased medicinal products must not exceed the quantity necessary for the patient during the treatment period.

Current legislation also permits the procurement of medicinal products from a single source. Cases for such procurements are provided in Article 93 of Law No. 44-FZ:

procurement of medicinal products for an amount not exceeding 600,000 rubles. The annual volume of all procurements on this basis must not exceed 2 million rubles or 10% of the Customer’s total annual procurement volume and exceed 50 million rubles (Clause 4, Part 1, Article 93 of Law No. 44-FZ);
procurement from a state unitary enterprise of the relevant constituent entity of the Russian Federation or from a joint-stock company, 100% of the shares of which belong to the relevant constituent entity of the Russian Federation (Clause 6.1, Part 1, Article 93 of Law No. 44-FZ);
when necessary to provide emergency or urgent medical assistance, or due to an accident, force majeure, for prevention (upon introduction of a high-alert regime for management bodies and forces of the unified state system for prevention and liquidation of emergencies) or liquidation of emergencies, for humanitarian aid, if the use of competitive methods requiring time is inexpedient (Clause 9, Part 1, Article 93 of Law No. 44-FZ);
if medicinal products are intended for assignment to a patient based on medical indications (individual intolerance, life-saving indications) by decision of a medical commission, provided the contract amount does not exceed 1.5 million rubles.

The volume of purchased medicinal products must not exceed the quantity necessary prior to conducting an RFQ. Furthermore, the subject matter of a single contract cannot be medicinal products intended for assignment to two or more patients (Clause 28, Part 1, Article 93 of Law No. 44-FZ);

It should be noted that when conducting procurement under Clauses 6.1 and 9, Part 1, Article 93 of Law No. 44-FZ, the Customer is obliged to send a notification of such procurement to the authorized control body no later than one business day from the date of concluding the contract. A copy of the contract with justification for its conclusion is attached to the notification. For procurements from a State Unitary Enterprise (SUE) or Joint-Stock Company (JSC) of a constituent entity, it is also necessary to draft and include in the contract a justification of the contract price.

Since April 1, 2021, Article 93 of the Contract System Law has included a new type of single-source procurement: electronic procurement for an amount not exceeding 5 million rubles, referred to by specialists as “off-the-shelf procurement”. The peculiarity of its implementation is that it is conducted on special electronic platforms, and the name and characteristics of the purchased goods must be indicated using the Catalog of Goods, Works, and Services (KTRU) for meeting state and municipal needs located in the EIS. However, at present, the technical capability to procure medicinal products via this method has not been implemented. It is assumed that this will become possible starting July 1, 2025.

Pursuant to Part 4, Article 7.30.1 of the Code of Administrative Offenses of the Russian Federation (CAO RF), selecting a supplier determination method in violation of requirements established by contract system legislation entails the imposition of an administrative fine on officials in the amount of 30,000 to 50,000 rubles. Thus, when choosing a method for procuring medicinal products, one must be guided by criteria clearly established by legislation.

Description of the Procurement Object

One of the key issues in public procurement of medicinal products, causing a large number of disputes, is the description of the procurement object. Rules for describing the procurement object regarding medicinal products are provided by Article 33 of the Contract System Law, as well as by Decree of the Government of the Russian Federation No. 1380 of November 15, 2017, “On the specifics of describing medicinal products for medical use that are the object of procurement for meeting state and municipal needs” (hereinafter – “Rules for Description of Medicinal Products”, “Decree No. 1380”).

As a general rule, when describing the procurement object, functional, technical, and qualitative characteristics, as well as operational characteristics of the procurement object (if necessary), are indicated. At the same time, the description of the procurement object must not include:

requirements or indications regarding trademarks, service marks, trade names, patents, utility models, industrial designs, or the country of origin of the goods;
requirements for goods, information, works, or services, provided that such requirements or indications entail a limitation on the number of procurement participants.

The description of the procurement object regarding medicinal products must contain an indication of the INN (International Nonproprietary Names) of the medicinal products or, in the absence of such names, chemical or grouping names. The law permits competitive procurements by trade names only:

for medicinal products assigned to a patient based on medical indications by decision of a medical commission, via RFQ;
if the medicinal products are included in a special list of medicinal products approved by a Decree of the Government of the Russian Federation.

However, to date, this list has not been approved. In practice, procurement of insulin by trade names is particularly relevant. FAS Russia, in letter No. AЦ/89653/18 dated November 6, 2018, emphasized that the procurement of medicinal products by trade names is permitted strictly in cases established by law.

However, territorial offices of FAS (OFAS) may express a different position. For instance, in Case No. 073/06/106-473/2024^[2], a participant filed a complaint regarding an auction notice for the supply of insulin of a specific trade name. The Customer argued that various trade names of insulin are incompatible with each other and are not interchangeable. According to a letter from the Russian Association of Endocrinologists, a chaotic change of preparations has a negative impact on patients’ quality of life. The OFAS Commission concluded that the absence of a list of medicinal products approved by the Government of the Russian Federation does not exclude the possibility of the Customer purchasing medical preparations by trade name, provided there is justification for the necessity of such procurement and an objective need for the corresponding preparations. The complaint was dismissed. However, there is contrary practice^[3] where control bodies point out the Customer’s lack of legal grounds for indicating trade names instead of International Nonproprietary Names in the notice. In such cases, to defend one’s position, it will be necessary to appeal to judicial bodies, whose opinions on this issue also vary.

Decree No. 1380 establishes additional requirements for the description of medicinal products. Let us examine them in more detail.

1. When describing the procurement object, Customers must indicate:

the dosage form of the preparation, including equivalent ones, excluding the description of the dosage form and its characteristics pointing to a specific manufacturer (e.g., description of color, shape, taste, etc.);
the dosage of the medicinal product with the possibility of supplying the medicinal product in a multiple dosage and double quantity (e.g., 1 tablet with a dosage of 300 mg or 2 tablets with a dosage of 150 mg), as well as with the possibility of supplying the preparation in non-multiple equivalent dosages allowing the same therapeutic effect to be achieved (e.g., vials of 2.5 mg, or 3 mg, or 3.5 mg). Indication of the medicinal product’s concentration without establishing multiplicity is also permitted;
the remaining shelf life of the medicinal product, expressed in units of time (e.g., “no earlier than January 1, 2020” or “at least 12 months from the date of contract conclusion”, etc.).

2. Specific features are established for describing certain medicinal products:

regarding medicinal products in cartridges or other forms of release compatible with delivery (application) devices – there must be an indication of the possibility of supplying medicinal products with the condition of gratuitous transfer to patients of compatible delivery devices in the necessary quantity;
for multi-component (combined) medicinal products, as well as kits of registered medicinal products – there must be an indication of the possibility of supplying single-component medicinal products;
regarding medicinal products for which requirements for a kit with a solvent or device for dilution and administration of the medicinal product, as well as for the presence of tools for opening ampoules (e.g., files), may be established – there must be an indication of the possibility of supplying individual components of such a kit;
for medicinal products in release forms: “syringe”, “pre-filled syringe”, “syringe-tube”, “syringe-pen” – there must be an indication of the possibility of supplying the medicinal product with a delivery device corresponding to the volume of the administered medicinal product.
regarding medicinal products intended for parenteral use – indication of the route of administration of the medicinal product (for injection or for infusion) is permitted;
regarding medicinal products intended exclusively for use in pediatric practice – indication of the child’s age (from 0, from 3 months, from 12 months, etc.) is permitted.

3. As a general rule, when describing the object of drug procurement, it is not permitted to indicate:

equivalent dosages of the medicinal product envisaging the necessity of dividing a solid dosage form of the preparation;
the dosage of the medicinal product in certain units of measurement if conversion into other units of measurement is possible (e.g., “IU” (International Unit) can be converted into “mg” or “percent”, etc.);
the filling volume of the primary packaging of the medicinal product, with the exception of solutions for infusion;
the presence (absence) of excipients;
a fixed temperature storage regime for preparations if an alternative exists;
the form of release (primary packaging) of the medicinal product;
the number of units (tablets, ampoules) of the medicinal product in secondary packaging, as well as a requirement for the supply of a specific number of packages instead of the quantity of the medicinal product;
requirements for pharmacodynamic and/or pharmacokinetic parameters of the medicinal product (e.g., onset of action, manifestation of maximum effect, duration of action of the medicinal product);
other characteristics of medicinal products contained in instructions for use of medicinal products pointing to a specific manufacturer of the medicinal product.

Indicating these characteristics, with the exception of the possibility of dividing the dosage form and converting units, is permitted if there is no other possibility to describe the medicinal products, with a justification of the necessity of indicating such characteristics.

These requirements for the description of medicinal products are aimed at preventing the restriction of competition; however, in practice, they continue to cause numerous disputes. Furthermore, different positions form on the part of FAS Russia, the Ministry of Health of the Russian Federation, and the courts.

Thus, FAS Russia^[4] indicates the following as the most typical examples of restricting the number of participants in the procurement of medicinal products:

indicating specific dosage forms of preparations without equivalent forms (e.g., prolonged-action tablets without the possibility of supplying analogous preparations in a dosage form such as extended-release tablets);
indicating dosages of medicinal products expressed in international units (e.g., 1,000 IU) without the possibility of supplying an equivalent in an analogous dosage expressed in mass units (e.g., 1 mg);
a requirement for the supply of a certain dosage of a medicinal product without the possibility of supplying an analogous preparation in a multiple dosage and double quantity;
procurement of multi-component (combined) medicinal products without the possibility of supplying a set of single-component preparations in an analogous combination of active substances;
establishing requirements for the filling volume of primary packaging instead of requirements for dosage;
indicating the form of release (primary packaging) of the medicinal product (e.g., ampoule, vial, blister) without the possibility of supplying analogous preparations in a different form of release (packaging);
an unjustified requirement for the number of units (tablets, ampoules) of the medicinal product in secondary packaging, as well as a requirement for the supply of a specific number of packages instead of the quantity of the medicinal product;
indication of the supply of a medicinal product in a kit with a solvent (i.e., a preparation registered together with a solvent) without the possibility of supplying an equivalent preparation (registered without a solvent) jointly with any suitable solvent;
description of the color, shape, taste of tablets (capsules), color, shape, and material of primary and secondary packaging, etc.;
procurement of medicinal products jointly with medical devices and other goods.

At the same time, judicial practice, as well as the practice of control bodies in resolving disputes, differs significantly. For example, in Case No. A46-9521/2023^[5], the Customer purchased a medicinal product with the INN “Calcium folinate” in a dosage of 10 mg/ml. One of the procurement participants proposed a preparation with an equivalent dosage, in their opinion, of 5 mg/ml. This served as the reason for rejecting the bid. The antimonopoly authority concluded that the Customer’s actions violated the Rules for Description of Medicinal Products. The Customer appealed to the court demanding that the decision and order of the control body be declared illegal.

The court examined the instructions for the preparation, according to which, with a multiple dosage, the amount of active substance in one ml is less. Thus, to administer 10.8 mg of calcium folinate at a dosage of 10 mg/ml, the patient would need 1 ml of solution, while at a dosage of 5 mg/ml, 2 ml would be needed, which would also double the amount of administered excipients. The court concluded that the description of the procurement object was drafted taking into account the Customer’s individual needs and did not contradict current legislation.

In another case^[6], the court declared illegal an order from FAS Russia issued in connection with the Customer’s indication of the necessity to supply a medicinal product in a vial. This was due to the specifics of the prescription and method of its administration: an opened ampoule did not allow the preparation to be kept in a hermetic state for the necessary administration time, which led to the necessity of its destruction and unjustified waste of medicinal products. The court noted that a possible narrowing of the circle of procurement participants with a simultaneous increase in the efficiency of using funds cannot in itself be considered a violation of legislation.

Also, clarifications from the Ministry of Health of Russia^[7] indicate that single-component medicinal products in the form of aerosols or sprays, which are part of combined medicinal products, cannot ensure the achievement of the therapeutic effect obtained from the use of the combined medicinal product. In connection with this, procurement may be carried out without applying the rule on the supply of single-component medicinal products separately.

Decisions vary regarding whether the justification for the necessity of establishing additional characteristics is proper and sufficient. Thus, for example, FAS Russia in letter No. ME/50805/19 dated June 18, 2019, indicated that requirements for the packaging of a medicinal product due to the necessity of “ensuring the stability of packaging on a plane” “presence of free volume of packaging”, etc. do not influence the properties of the medicinal product, in connection with which the establishment of such characteristics limits the number of procurement participants and is unlawful. At the same time, for certain medicinal products, territorial OFAS have come to the conclusion that requirements in the description of the procurement object are justified. For example, in Case No. 074/06/105-23/2020^[8], the control body deemed justified the requirement for the medicinal product “Enoxaparin sodium” regarding the presence of a pre-filled syringe with a needle protection system or needle protection device, as this was conditioned by the Customer’s needs to protect medical personnel and the patient from injury and infection.

Furthermore, starting in 2025, Customers have faced difficulties in procuring foreign medicinal products. On January 1 of this year, the norm of Part 1.1, Article 33 of the Contract System Law entered into force, obliging Customers, when carrying out procurement, to indicate in the description of the procurement object the characteristics of goods of Russian origin. However, in practice, such medicinal products may not exist, or due to the specifics of providing medical assistance, the Russian preparation does not satisfy the Customer’s needs. As researchers of this issue believe^[9], since the Rules for Description of Medicinal Products permit the indication of additional characteristics of a medicinal product if justification is present, the provisions of Part 1.1, Article 33 of Law No. 44-FZ cannot oblige the Customer to purchase goods that they cannot use.

However, practice on this issue is not uniform. Thus, in Case No. 077/06/106-3190/2025^[10], a complaint was filed with the antimonopoly authority regarding a notice for the procurement of a medicinal product with the INN “Human normal immunoglobulin”. The applicant indicated that the requirement for a filling volume of 100 ml excludes the possibility of proposing preparations of Russian origin for supply. The Customer explained that the preparation required for procurement is used in pediatric practice. Doses are calculated individually depending on the severity of the disease and the child’s body weight. The required filling volume allows avoiding the occurrence of adverse events, including cerebral edema, pulmonary edema, and high blood pressure. In the State Register of Medicinal Products (GRLS), interchangeable medicinal products with the characteristics required by the Customer of Russian origin are absent. The antimonopoly authority recognized the complaint as unfounded.

At the same time, in another case No. 055/06/106-293/2025^[11], a complaint was filed regarding the procurement of a solution for infusion “Human normal immunoglobulin” with a filling volume of 100 ml. In justification of the complaint, it was also indicated that Russian goods with such a filling volume are absent. The Customer cited that Decree No. 1380 does not prohibit indicating the filling volume for this dosage form. In the event of procuring a medicinal product in a smaller volume, the patient would need to be administered the medicinal product repeatedly during a one-time medical manipulation, which increases the risk of contamination. The antimonopoly authority decided that the Customer did not prove the advantage of a filling volume of 100 ml over a medicinal product with a filling volume of 50 ml. The complaint was recognized as founded.

Thus, both courts and the control body subject the assessment of the validity of requirements for the procurement object (medicinal product) to individual evaluation. Often, regional offices of FAS Russia may adopt opposing decisions regarding the validity of the description of a medicinal product. We believe that when considering disputes between Customers and procurement participants, it is important to be guided by the necessity of maintaining a balance of interests of both the Customer and the potential supplier, as well as the interests of the patients themselves, who are the end consumers of the purchased drugs.

Interchangeability of Medicinal Products

Determining the interchangeability of medicinal products is of paramount importance for forming the procurement object and ensuring competition in the pharmaceutical market. For a long time, the interchangeability of medicinal products for the purpose of establishing violations of antimonopoly requirements for tenders was determined by FAS Russia by issuing letters and clarifications that were recommendatory in nature. Finally, in 2019, amendments were made to Federal Law No. 61-FZ of April 12, 2010, “On the Circulation of Medicinal Products» (hereinafter – “Law on Circulation of Medicinal Products”), establishing rules for determining the interchangeability of medicinal products.

According to Article 27.1 of the Law on Medicinal Products, the criteria for interchangeability of medicinal products are:

equivalence (for biosimilars – comparability) of qualitative and quantitative characteristics of pharmaceutical substances;
equivalence of dosage form;
equivalence or comparability of the composition of excipients;
identity of the method of administration and application;
compliance of the manufacturer with the rules of Good Manufacturing Practice (GMP).

Now, the interchangeability of medicinal products within one INN (chemical, grouping name) is determined by the Ministry of Health of the Russian Federation based on the conclusion of a commission of experts from the FSBI “Scientific Center for Expert Evaluation of Medicinal Products” The list of interchangeable medicinal products is posted by the Ministry of Health of Russia on its official website on the Internet and must be updated at least once a month. Note that in practice, information is not updated with the indicated frequency.

According to Clause 7 of Decree No. 1380, when procuring medicinal products, information on the interchangeability of medicinal products for medical use contained in the List of Interchangeable Medicinal Products posted on the official website of the Ministry of Health of Russia is used in the description of the procurement object. However, if information on interchangeability is contained in the specified list, it is not permitted to establish other requirements for criteria of interchangeability of medicinal products if they entail non-compliance with the description of the procurement object of one or several medicinal products.

At the same time, in practice, numerous questions continue to arise regarding the determination of the interchangeability of preparations. Thus, the Ministry of Health of Russia^[12] has issued clarifications that if dosage forms have the same method of administration and method of application but differ in the level of pharmacokinetic characteristics, as a result of which the clinical effect is also different, they cannot be recognized as equivalent.

A typical mistake when establishing the equivalence of dosages of medicinal products can be examined using the example of procuring a medicinal product under the INN “Sildenafil” where, in the description of the procurement object, the Customer recognized non-multiple dosages of 20 mg and 25 mg as equivalent. However, according to the medicinal product’s instruction data, the 20 mg dosage is indicated for use in pulmonary hypertension, while the 25 mg dosage is for the treatment of erectile dysfunction disorders.

According to explanations from the Treasury and the Ministry of Health of Russia^[13], when determining equivalent dosage forms and dosages, Customers may also use the Unified Structured Handbook-Catalog of Medicinal Products for Medical Use (hereinafter – “ESKLP”). Information on equivalent dosage forms and multiple dosages of medicinal products is located in the section “Groups of Interchangeability of MPs”. At the same time, the Ministry of Health of Russia clarified that information on groups of medicinal products in the ESKLP is of a reference nature^[14]. In the opinion of the Ministry of Health of Russia, the Customer, at their discretion when forming the procurement object, may use the recommended composition of medicinal products of each such group from the ESKLP, or independently select all necessary supply options. Note that information on interchangeability from the List of the Ministry of Health of Russia and the ESKLP may differ.

Furthermore, control bodies take different positions regarding the mandatory nature of using the ESKLP when determining interchangeability. A number of OFAS^[15] believe that the Customer, when determining equivalent dosage forms and dosages, has the right to establish only those equivalent dosage forms and dosages, information on which is indicated in the ESKLP. Other control bodies support the position of the Ministry of Health of Russia^[16] that the ESKLP is of a reference nature and may be applied by Customers when carrying out procurements of medicinal products for medical use.

Another source of interchangeability, in our view, may serve the List of Vital and Essential Drugs (hereinafter – “VED List”). There are situations where several dosage forms of one INN are included in the List of Interchangeable Medicinal Products, while only one is included in the VED List. Formally, Decree No. 1380 obliges the Customer to include all dosage forms in the description of the procurement object. However, this would deprive the Customer of the opportunity to use such a medicinal product in medical activity due to the provisions of legislation on protecting the health of citizens. Antimonopoly bodies recognize as lawful the refusal to recognize medicinal products included and not included in the VED List as equivalent^[17].

Thus, changes to current legislation are aimed at unifying methods for determining the interchangeability of medicinal products. However, when determining the interchangeability of medicinal products for the purpose of state procurement, it is desirable to analyze all indicated sources of information.

Requirements for Lot Formation

In accordance with Part 1, Article 33 of Law No. 44-FZ, if the object of procurement is medicinal products, the subject matter of one contract (one lot) cannot be:

medicinal products with INNs (in the absence of such names, with chemical, grouping names) and trade names;
medicinal products with different INNs or, in their absence, with chemical, grouping names, provided that the initial (maximum) contract price (lot price) exceeds the threshold value established by the Government of the Russian Federation.

Decree of the Government of the Russian Federation No. 929 of October 17, 2013^[18], established the following IMCP threshold values:

1 million rubles – for Customers whose volume of funds directed towards the purchase of drugs in the preceding year was less than 500 million rubles;
5 million rubles – for Customers whose volume of funds directed towards the purchase of drugs in the preceding year was from 500 million rubles to 5 billion rubles;
5 million rubles – for Customers whose volume of funds directed towards the purchase of drugs in the preceding year was more than 5 billion rubles.

If the subject matter of one contract is narcotic, psychotropic, radiopharmaceutical medicinal products, or a medicinal product with an INN within which there are no registered medicinal products analogous in dosage form and dosage, then the IMCP threshold value is established in the amount of 1,000 rubles. Moreover, in the case of conducting joint auctions, the IMCP threshold value will be the sum of all initial (maximum) prices of contracts concluded by the Customers^[19].

Also, limitations on lot formation are established by national regime rules effective from January 1, 2025; namely, combining medicinal products included and not included in the VED List into one lot is not permitted. The same ban will apply from September 1, 2025, to combining Strategically Significant Medicinal Products included in the List with any others, including those from the VED List^[20]. Thus, when forming a lot, Customers must observe the indicated limitations. Otherwise, the antimonopoly authority will recognize the Customer’s actions as posting information and documents in violation of requirements provided by contract system legislation.

Requirements for the Shelf Life of Medicinal Products when Forming the Procurement Object

According to Clause 2, Article 472 of the Civil Code of the Russian Federation, a supplier is obliged to transfer goods for which a shelf life is established to the buyer calculated so that they can be used for their intended purpose before the expiration of the shelf life.

Back in 2014, FAS Russia issued clarifications^[21] that the remaining shelf life of medicinal products established in the procurement notice must be justified and defined by a specific period (e.g., in years, months, days) during which the medicinal products retain their suitability, or by a specific date until which the medicinal products retain their suitability for use for their intended purpose. Consequently, Customers’ requirements regarding the remaining shelf life of a medicinal product expressed in percentages are illegal.

In October 2017, FAS Russia additionally confirmed the previously outlined position that Customers’ requirements regarding the remaining shelf life of a medicinal product expressed in percentages may entail the establishment of unequal conditions for manufacturers of medicinal products, restriction of competition, and the number of procurement participants^[22]. Furthermore, in the specified clarification, the antimonopoly authority indicated that in the absence of competition restriction, the Customer has the right to establish a requirement for a remaining shelf life of medicinal products exceeding the period for which the medicinal products are purchased (e.g., to form a reserve at the end of the calendar year and other reasons of an objective nature).

However, a requirement for a remaining shelf life significantly exceeding the planned consumption period (e.g., when planning procurement for a calendar year, the Customer requires the supply of a medicinal product with a remaining shelf life of 18 months) may have signs of violating the Contract System Law and antimonopoly legislation.

Note that in the period of 2014-2017, courts held the opposite position and supported Customers in disputes with antimonopoly bodies. However, in recent years, judicial practice on this issue is practically absent, which indicates that market participants have accepted this position. Based on the foregoing, to avoid complaints to the control body, it is recommended that Customers establish a remaining shelf life for purchased drugs tied to specific time periods, without expressing it in percentages, and also taking into account real requirements for the consumption period of the purchased medicinal products.

Requirement for a License when Carrying Out Public Procurement of Medicinal Products

As a general rule of Article 52 of the Law on Circulation of Medicinal Products, pharmaceutical activity is carried out by organizations for the wholesale trade of medicinal products, pharmacy organizations, individual entrepreneurs holding a license for pharmaceutical activity, medical organizations holding a license for pharmaceutical activity, and their separate subdivisions located in rural settlements where pharmacy organizations are absent.

In practice, when conducting procurements for the supply of medicinal products, questions arise as to exactly which organizations may be procurement participants. In particular, if such a participant has a license only for retail trade in medicinal products.

In the opinion of FAS Russia^[23], if the object of procurement is the supply of medicinal products, the Customer needs to establish a requirement for the participant to have a license for pharmaceutical activity specifying “wholesale trade of medicinal products” and if the procurement participant is a manufacturer of medicinal products – a license for the production of medicinal products.

As for a license for pharmaceutical activity with the right to perform works of “retail trade in medicinal products” in this case, the control body proposes to be guided by the literal interpretation of Civil Code norms, according to which supply implies the transfer of goods to a buyer for use in entrepreneurial activity, whereas retail sales imply the acquisition of goods by a buyer for personal and family needs not related to entrepreneurship. Accordingly, a retailer, not having a license for the right of wholesale trade in medicinal products, cannot be a procurement participant and supplier of medicinal products under a state contract.

Similar conclusions were made by Roszdravnadzor in clarifications issued in January 2020^[24]. Due to the transition to the registry model of licensing starting in 2021, requirements for documents confirming the existence of a license have changed. Currently, as part of the bid, in cases where this is provided for by the procurement procedure, the procurement participant provides an extract from the register of licenses as a document confirming the existence of a license (Clause 8, Part 2, Article 21 of Federal Law No. 99-FZ of May 4, 2011, “On Licensing Certain Types of Activities”).

Admission of Foreign Products in Public Procurement of Medicinal Products

By Article 14 of Law No. 44-FZ, when carrying out state procurements, goods originating from a foreign state are granted a national regime: equal conditions of access with goods of Russian origin. As an exception to this rule, the Russian Government is empowered to establish:

a ban on the procurement of goods originating from foreign states, works, and services performed or rendered by foreign persons (hereinafter – “admission bans”);
a restriction on the procurement of goods originating from foreign states, works, and services performed or rendered by foreign persons (hereinafter – “admission restrictions”);
a preference regarding goods of Russian origin, works, and services performed or rendered by Russian persons (hereinafter – “preferences”).

Since January 1, 2025, the rules for granting the national regime have undergone significant changes, and medicinal products are no exception. The procedure for granting the national regime is regulated in Decree of the Government of the Russian Federation No. 1875 of December 23, 2024, “On measures for granting the national regime when carrying out procurements of goods, works, and services for meeting state and municipal needs, procurements of goods, works, and services by certain types of legal entities» (hereinafter – “Decree No. 1875”).

Regarding medicinal products included in the VED List, admission restrictions and preferences are established. They are applied when conducting competitive procurements, as well as “off-the-shelf procurements» under Part 12, Article 93 of Law No. 44-FZ.

The mechanism for restricting the admission of foreign goods consists of rejecting bids with goods of foreign origin if at least one bid with proposals of goods from Russia or EAEU countries is filed for participation in the procurement. If all stages of production of the medicinal product, including the synthesis of the active substance molecule, are carried out in Russia or EAEU countries, preferences are additionally granted over medicinal products that do not have a full production cycle in the indicated countries. In such a case, when assigning a serial number to a bid containing a proposal for the supply of a preparation, all production stages of which are carried out in the Russian Federation or EAEU countries, the price proposal of such a participant is reduced by 15% from the price proposed by them. If, based on the results of the reduction, such a participant is recognized as the winner, the contract is concluded at the price actually proposed by them.

Information and documents confirming the country of origin of the good are:

the registry entry number from the Russian or Eurasian register of industrial goods;
the ST-1 certificate of the product – for drugs from the RF. It can be submitted if the procurement began before August 31, 2025, inclusive;
the ST-1 certificate of the product – for drugs from the EAEU, except the RF. This is possible until amendments are made to EAEU law regarding confirmation of the country of origin of goods by a registry entry number from the Eurasian register of industrial goods.

To confirm production stages, a document containing information on the stages of the technological process of medicinal product production issued by the Ministry of Industry and Trade of Russia is provided in addition. Note that the GMP document, which was previously also necessary for confirming production stages, is now not required.

During contract performance, replacement of the good with one originating from a foreign state, if the contract provides for the supply of a good of Russian origin, is not permitted (Part 4, Article 14 of Law No. 44-FZ).

From September 1, 2025, similar rules should become operational regarding medicinal products included in the List of Strategically Significant Medicinal Products, the production of which must be ensured in the territory of the Russian Federation (Sub-clause “ph”, Clause 4 of Decree No. 1875)^[25]. The exception is strategic medicinal products (INN) which are included in the list after January 1, 2025. For them, such rules will have to be applied only from September 1 of the second year after the year of inclusion in the list. For preparations not included in the VED List, neither restrictions nor preferences apply.

Thus, when evaluating bids for the supply of medicinal products included in the VED List, it is important to take into account the imposed restrictions on the supply of goods of foreign origin. In this regard, both unlawful rejection and unlawful admission of bids in violation of the specified rules will lead to administrative liability under Part 7, Article 7.30.1 of the CAO RF, and entails a warning or imposition of an administrative fine on commission members in the amount of 1 percent of the initial (maximum) contract price, but not less than 5,000 and not more than 30,000 rubles.

Procedure for Determining the IMCP in Public Procurement

By virtue of Part 22, Article 22 of Law No. 44-FZ, the Ministry of Health of the Russian Federation is empowered to establish the procedure for determining the initial (maximum) contract price, the price of a contract concluded with a single supplier (contractor, executor), and the initial unit price of a good, work, or service when carrying out procurements of medicinal products for medical use.

The procedure for determining the IMCP when conducting procurements for the supply of medicinal products was approved by Order of the Ministry of Health of the Russian Federation No. 1064n dated December 19, 2019 (hereinafter – “IMCP Determination Procedure”). The Procedure does not apply in the case of procuring drugs manufactured by pharmacy organizations.

As a general rule, the initial unit price of a medicinal product is established by one name (INN, in absence thereof - by grouping or chemical name, as well as the composition of a combined medicinal product) taking into account equivalent dosage forms and dosages. For calculation, the following methods are used simultaneously:

method of comparable market prices (market analysis);
tariff method;
calculation of the weighted average price;
reference prices.

Next, the Customer must choose the minimum of the price values calculated by the above methods. Let us consider the calculation procedure for each method in more detail.

When applying the method of comparable market prices, the Customer considers information on the price of medicinal products obtained by collecting and analyzing publicly available price information, including based on responses to requests for price information. The price excluding VAT is used for calculation.

The tariff method is used when procuring medicinal products included in the VED List. To determine the unit price by this method, data from the State Register of Maximum Selling Prices is used. Calculation is performed by dividing the registered maximum price per package of the medicinal product by the number of units in the package.

The weighted average price is calculated if the Customer had executed contracts (agreements) for the procurement of the same medicinal product, taking into account equivalent dosage forms and dosages, in the 12 months preceding the calculation month. When determining it, contracts under which medicinal products necessary for assignment to a patient based on medical indications (individual intolerance, life indications) by decision of a medical commission were purchased should not be taken into account. Also, the Customer has the right not to take into account prices:

of previously supplied medicinal products with a remaining shelf life of less than 20%;
of preparations whose circulation has been suspended;
if penalties were applied to suppliers under concluded contracts.

Calculation of the unit price of the preparation is performed based on acceptance documents. When calculating the unit price, VAT and the wholesale markup, if applied, are not taken into account. The size of the markup can be found in the price agreement protocol attached during the drug supply.

The reference price is calculated automatically in the Unified State Health Information System (EGISZ) twice a year (as of May 1 and November 1 of the current year), within one INN of the medicinal product taking into account equivalent dosage forms and dosages. The reference price is not yet applied, as the corresponding data on the necessity of its use are not posted in the EIS (Clause 6 of the IMCP Determination Procedure).

When calculating the unit price, information on the unit price of a medicinal product absent from civil circulation in the RF, based on information posted by Roszdravnadzor on its official website, is not used. Also, according to clarifications from FAS and the Ministry of Health of Russia^[26], prices of a preparation should not be taken into account if, according to data from the State Register of Medicinal Products and the Roszdravnadzor service, the shelf life of the medicinal product has expired since the date of its last entry into civil circulation in the Russian Federation.

From the unit prices of the preparation obtained by all methods, the lowest value is chosen, and VAT and wholesale markup (if admissible) are applied to it. A wholesale markup when procuring preparations for federal needs can be applied if:

the IMCP including the wholesale markup does not exceed 10 million rubles;
the IMCP is greater than 10 million rubles, but the unit price of the purchased preparation does not exceed its price from the State Register of Maximum Selling Prices.

When procuring for the needs of a constituent entity of the RF (municipal needs), similar rules apply. The wholesale markup is applied in cases where:

the IMCP including the wholesale markup does not exceed the size established by the highest executive body of the constituent entity of the RF, and does not exceed 10 million rubles;
the IMCP is greater than the size established by the highest executive body of the constituent entity of the RF and/or greater than 10 million rubles, but the unit price of the purchased preparation does not exceed its price from the State Register of Maximum Selling Prices.

To calculate the IMCP, the obtained unit price is then multiplied by the number of necessary units. If, with such a calculation, not a single bid is filed for participation in the procurement, when conducting subsequent procurements, the next minimum unit price value is used for calculation. If a contract is not concluded based on the results of conducting procurements using all IMCP variants, the maximum price value of the medicinal product from the State Register of Maximum Selling Prices is used.

Despite the long existence of this procedure, control bodies continue to identify a significant number of its violations. Thus, the Ministry of Finance of Russia^[27] has established that the most common violations are:

establishing the IMCP without applying the calculation of the weighted average unit price of the medicinal product, or the weighted average price is determined based on contracts concluded by the Customer earlier than 12 months preceding the calculation month.
applying a wholesale markup in unauthorized cases;
IMCP calculated without taking VAT into account;
non-application of the procedure when calculating the price for single-source procurements.

It is important for procurement organizers to avoid the above and other violations when calculating the IMCP, since under Part 3, Article 7.30.3 of the CAO RF, non-compliance with the procedure or form of justification of the initial (maximum) contract price entails a fine in the amount of 1 percent of the IMCP, but not less than 10,000 and not more than 50,000 rubles. Thus, when determining the IMCP in the process of organizing state or municipal procurement of medicinal products, it is important to strictly follow the requirements of the current IMCP Determination Procedure using all methods subject to application when calculating the IMCP.

Model Contracts for the Supply of Medicinal Products

According to Clause 11, Article 34 of Law No. 44-FZ, in the version effective until January 1, 2022, federal executive bodies carrying out regulatory and legal regulation in the relevant sphere of activity were empowered to develop and approve model contracts and model conditions, which are posted in the unified information system. The procedure for developing model contracts was approved by Decree of the Government of Russia No. 606 of July 2, 2014^[28], according to which model contracts consist of a constant part (conditions not subject to change) and a variable part (which implies variability of conditions depending on the specific procurement).

Order of the Ministry of Health of Russia No. 15n dated January 18, 2021^[29], approved the form of a model contract for the supply of medicinal products for medical use and the form of the information card of such a model contract. The main conditions of the contract include the delivery procedure (with unloading of goods/without unloading/by pickup, etc.), the contract price and procedure for changing it, rights and obligations of the parties, conditions for packaging and labeling of goods, acceptance-transfer, and measures of liability of the parties. In addition to defining contract conditions, the approved document lists such annexes to the contract as specifications, technical characteristics, calendar plan, shipping schedule, and acceptance certificate.

The approval of the specified model contract causes many questions in practice for pharmaceutical manufacturers and pharmacy organizations. Thus, according to clarifications from FAS Russia^[30], when procuring extemporaneous medicinal products, it is recommended to conclude a contract not for supply but for the manufacture of extemporaneous medicinal products, and thus, when concluding the corresponding contract, the model contract does not apply. At the same time, by virtue of a direct indication in the information card, the model contract is subject to application in cases of single-source procurement as well.

Furthermore, despite the existing variability of contract conditions, they may not always satisfy the Customer’s needs or keep pace with changes in current legislation. For example, the contract stipulates that upon delivery of goods, the supplier presents to the Customer a copy(ies) of the registration certificate of the medicinal product issued by the authorized body. However, due to the application of sanctions against the Russian Federation, currently, documents confirming the authorization to use a medicinal product in medical activity, along with the registration certificate, are: a permit for the temporary circulation of a series (batch) of a medicinal product, or a conclusion of an interdepartmental commission on the possibility of circulation in the Russian Federation of a series (batch) of a medicinal product in packaging intended for circulation in the territory of foreign states, issued in cases established by Decrees of the Government of the Russian Federation.

Also, making amendments to the Contract System Law often required adjusting the conditions of the model contract. However, the necessary changes were delayed. In practice, this created a situation where, on the one hand, the Customer was forbidden to make changes to the constant part of the contract, and on the other hand, signing the contract on the indicated conditions contradicted the current version of the Contract System Law. Due to the situation created, the antimonopoly authority formed a position^[31] that in case of a possible inconsistency of model contracts with the provisions of the Contract System Law, Customers must be guided by the requirements of the Contract System Law when drafting contracts. Thus, the duty to track changes and timely edit draft contracts was imposed on Customers instead of authorized bodies.

From January 1, 2022, amendments to the Contract System Law entered into force^[32], whereby the development of model contracts ceased, and powers to develop model conditions were transferred to the Government of the Russian Federation. However, according to clarifications from the Ministry of Finance of Russia^[33], conditions of model contracts approved prior to the day of entry into force of the specified amendments apply until the approval of model conditions by the Government of the Russian Federation. Thus, Customers should apply the model contract when carrying out state procurement of medicinal products until model conditions are approved. When preparing a draft contract, one should check it for relevance to the current version of the Contract System Law and timely make changes in case of identifying contradictions with the norms of the law.

Antimonopoly Requirements when Carrying Out Public Procurement

Article 17 of Federal Law No. 135-FZ of July 26, 2006, “On Protection of Competition” (hereinafter – “Law on Protection of Competition”) establishes a ban on actions that lead or may lead to the prevention, restriction, or elimination of competition, including:

prohibition of coordination by tender organizers of the activities of their participants;
conclusion of agreements between tender organizers and/or Customers with participants of these tenders if such agreements have as their goal or lead or may lead to restriction of competition and/or creation of preferential conditions for any participants;
creation of preferential participation conditions for a tender participant, including by means of access to information;
violation of the procedure for determining the winner or winners of tenders, request for quotations, request for proposals;
participation of tender organizers or Customers and/or employees of organizers or employees of Customers in the conducted tenders.

For example, the participation of a legal entity in a procurement was recognized as a violation due to the close relationship of the deputy head of the Customer’s contract service with one of the members of the board of directors of the organization participating in the procurement. The court concluded there was a conflict of interest because the powers of the head of the Customer’s contract service and his deputy are identical in functional duties, allowing influence on the procurement procedure and its result^[34].

In addition to directly established antimonopoly requirements for tenders, participants and Customers should also observe other antimonopoly prohibitions. In particular, cartel conspiracies have become quite common in recent years in the procurement of medicinal products. In accordance with Part 1, Article 11 of the Law on Protection of Competition, cartels are agreements between economic entities selling goods on the same commodity market (competitors) or acquiring goods on the same commodity market, if such agreements lead or may lead to:

establishment or maintenance of prices (tariffs), discounts, markups (surcharges), and/or margins;
raising, lowering, or maintaining prices at tenders;
division of the commodity market by territorial principle, volume of sale or purchase of goods, assortment of sold goods, or composition of sellers or buyers (Customers);
reduction or cessation of production of goods;
refusal to conclude contracts with certain sellers or buyers.

Quite common are cases of coordinated participation of several companies in procurements for the purpose of controlling the process of their conduct and maintaining necessary price proposals. Sometimes a number of organizations resort to digital technologies, namely using automated systems and software to maintain price ranges for IMCP reduction that are profitable for participants.

Thus, in Case No. A55-30553/2017^[35], FAS Russia recognized the existence of a cartel conspiracy between Company F. and Joint-Stock Company N. at tenders for the supply of medicinal products aimed at maintaining prices for them during the conduct of more than 400 auctions totaling more than 400 million rubles. The fact of conspiracy was established based on the aggregate of the following evidence:

coincidence of the user account that created bids on behalf of both firms;
use of identical IP addresses for submitting bids, price proposals, and signing contracts;
proposal in bids of goods with identical trade names;
use of each other’s funds to pay security;
purchase of goods for supply to Customers within the framework of contract execution from each other.

It is important to note that a quite large number of disputes are related to whether the participation of companies belonging to one holding in procurements can be considered a conspiracy. By virtue of Part 7 of the aforementioned Article 11 of the Law on Protection of Competition, provisions on cartel conspiracies do not apply to agreements between economic entities belonging to one group of persons if control is established by one such economic entity in relation to the other economic entity or if such economic entities are under the control of one person. However, proving the existence of grounds for the non-application of legal norms on the inadmissibility of cartel conspiracies to tender participants can be difficult. In these situations, organizations are forced to defend their rights in court.

At the same time, there is a practice of parties (FAS Russia and procurement participants) concluding settlement agreements^[36]. In such cases, the actions of tender participants may be qualified as an act of unfair competition, also prohibited by antimonopoly legislation.

Thus, within the framework of considering a case, the OFAS established that one person disposes of shares in the amount of 100% constituting the authorized capital of three companies, as well as a share in the amount of 96% in the authorized capital of a fourth company on the basis of ownership, which indicates that the specified companies are in a group of persons controlled by one person. Thus, the intentional submission by the specified companies of bids not corresponding to documentation requirements, as well as dumping reduction of the IMCP, could not be qualified as a cartel. The court, having established the identity of the defendants’ behavior during participation in the auction, as well as the dumping reduction of the initial maximum contract price by 95.5% with the aim of eliminating competition, agreed with the control body’s conclusions that the specified actions are an act of unfair competition aimed at obtaining advantages over competitors when carrying out entrepreneurial activity^[37].

It is important to pay attention to the fact that upon recognizing the validity of the control body’s position on a cartel conspiracy, participants in such a conspiracy are subject to being held liable for both administrative and criminal responsibility.

Administrative liability arises under Part 2, Article 14.32 of the CAO RF. for the conclusion by an economic entity of an inadmissible agreement if it leads or may lead to raising, lowering, or maintaining prices at tenders, or the conclusion of an inadmissible agreement by Customers with tender participants if it leads or may lead to restriction of competition and/or creation of preferential conditions for any participants.

Punishment for officials is an administrative fine in the amount of 20,000 to 50,000 rubles or disqualification for a term of up to 3 years; for legal entities, a fine in the amount of 1/10 to 1/2 of the initial cost of the tender subject matter, but not more than one twenty-fifth of the aggregate amount of the offender’s revenue from the sale of all goods (works, services) and not less than one hundred thousand rubles.

If income in a large amount was extracted or damage in a large amount was caused as a result of a cartel conspiracy, this act is qualified as a crime under Article 178 of the Criminal Code of the Russian Federation (CC RF) “Restriction of Competition” Punishment: a fine in the amount of 300,000 to 500,000 rubles or in the amount of wages or other income of the convicted person for a period of 1 to 2 years, or forced labor for a term of up to 3 years, or imprisonment for a term of up to 3 years. Additional punishment in the form of deprivation of the right to hold certain positions or engage in certain activities for up to 1 year may also be applied.

Let us recall that income in a large amount in this article is recognized as income the sum of which exceeds 80 million rubles, and income in an especially large amount – 395 million rubles. Large damage is recognized as damage the sum of which exceeds 16 million rubles, and especially large damage – 47.5 million rubles.

Summarizing, we note that in recent years, rules for public procurement of medicinal products have been actively improved to ensure a competitive environment and optimize procurement activity. However, the downside is the complexity of their application in practice due to the specifics of the procurement object. Therefore, it is extremely important for both participants and Customers to provide an objective assessment of their actions with a detailed analysis of all possible legal risks.

_________________________

^[1] Approved by Order of the Government of Russia No. 471-r dated March 21, 2016.

^[2] Decision of the Ulyanovsk OFAS Russia dated July 30, 2024, in Case No. 073/06/106-473/2024.

^[3] Decision of the Kirov OFAS Russia dated June 26, 2024, in Case No. 043/06/106-555/2024.

^[4] Letter of FAS Russia No. AK/28644/15 dated June 9, 2015, “On Consideration of the Appeal”.

^[5] Resolution of the Arbitration Court of the West Siberian District No. F04-1262/2024 dated May 6, 2024, in Case No. A46-9521/2023.

^[6] Review of Judicial Practice on the Application of Legislation of the Russian Federation on the Contract System in the Sphere of Procurement of Goods, Works, and Services for Meeting State and Municipal Needs, approved by the Presidium of the Supreme Court of the RF on June 28, 2017.

^[7] Letter of the Ministry of Health of Russia No. 418/25-5 dated February 14, 2018, “On Sending Responses to Frequently Asked Questions about Medicinal Products for Medical Use That Are the Object of Procurement for Meeting State and Municipal Needs”.

^[8] Decision of the Chelyabinsk OFAS Russia No. 074/06/105-23/2020 dated January 17, 2020.

^[9] Grigoryev A. Application of Part 1.1, Art. 33 of Law No. 44-FZ when Preparing the Description of the Procurement Object for Medical Devices and Medicinal Products // Progoszakaz, 2025, No. 5.

^[10] Decision of the Moscow Region OFAS Russia dated March 18, 2025, in Case No. 077/06/106-3190/2025.

^[11] Decision of the Omsk OFAS Russia No. 055/06/106-293/2025 dated March 24, 2025.

^[12] Letter of the Ministry of Health of Russia No. 3175/25-2 dated December 17, 2019, “On Issues of the Specifics of Carrying Out Procurements of Medicinal Products”.

^[13] Letter of the Treasury of Russia No. 14-00-05/7248, Ministry of Health of Russia No. 18-2/I/2-4135 dated April 7, 2020, “On the Application of the Unified Structured Handbook-Catalog of Medicinal Products for Medical Use”.

^[14] Letter of the Ministry of Health of Russia No. 18-2/I/2-8895 dated June 25, 2020.

^[15] Decision of the Moscow OFAS Russia dated June 20, 2024, in Case No. 077/06/106-8496/2024; Decision of the Samara OFAS Russia dated June 26, 2023, in Case No. 297-14243-23/4.

^[16] Decision of the Omsk OFAS Russia No. 055/06/106-98/2023 dated February 7, 2023.

^[17] Decision of the Penza OFAS Russia dated September 13, 2021, in Case No. 058/06/106-820/2021.

^[18] Decree of the Government of the RF No. 929 dated October 17, 2013, “On Establishing the Limit Value of the Initial (Maximum) Contract Price (Lot Price), Upon Exceeding Which Medicinal Products with Different International Nonproprietary Names or, in the Absence of Such Names, with Chemical, Grouping Names Cannot Be the Subject of One Contract (One Lot)”.

^[19] Letter of the Ministry of Economic Development of Russia No. D28i-685 dated February 20, 2017.

^[20] Resolution of the Arbitration Court of the West Siberian District No. F04-1262/2024 dated May 6, 2024, in Case No. A46-9521/2023.

^[21] Letter of FAS Russia No. AK/34487/14 dated August 26, 2014, “On Clarification of Issues of Establishment by State and Municipal Customers in Procurement Documentation of the Remaining Shelf Life of Medicinal Products”.

^[22] Letter of FAS Russia No. IA/71717/17 dated October 18, 2017, “On Clarification of Issues of Establishment by State and Municipal Customers in Procurement Documentation of the Remaining Shelf Life of Medicinal Products”.

^[23] Letter of FAS Russia No. IA/64899/17 dated September 19, 2017, “On the Necessity for Procurement Participants of Medicinal Products to Have a License for Wholesale Trade of Medicinal Products”.

^[24] Letter of the Federal Service for Surveillance in Healthcare (Roszdravnadzor) No. 01i-71/20 dated January 16, 2020, “On Retail and Wholesale Trade of Medicinal Products”.

^[25] Order of the Government of the RF No. 1141-r dated July 6, 2010, “On Approval of the List of Strategically Significant Medicinal Products”.

^[26] Letter of FAS Russia No. TN/95899/24, Ministry of Health of Russia No. 25-7/I/2-21105 dated October 23, 2024.

^[27] Letter of the Treasury of Russia No. 07-04-05/21-23295 dated October 30, 2019, “On Sending Generalized Information on the Results of Control Activities» (together with the Review of Deficiencies and Violations Identified by the Federal Treasury During Control Activities in the Financial and Budgetary Sphere Regarding Chief Managers of Federal Budget Funds, Managers, Recipients of Federal Budget Funds, and Management Bodies of State Extra-Budgetary Funds in the 1st Half of 2019).

^[28] Decree of the Government of the RF No. 606 dated July 2, 2014, “On the Procedure for Developing Model Contracts, Model Contract Conditions, as well as Cases and Conditions for Their Application» (became invalid as of January 1, 2022).

^[29] Order of the Ministry of Health of Russia No. 15n dated January 18, 2021, “On Approval of the Model Contract for the Supply of Medicinal Products for Medical Use and the Information Card of the Model Contract for the Supply of Medicinal Products for Medical Use”.

^[30] Letter of FAS Russia No. AD/49278/18 dated June 29, 2018, “On Consideration of the Appeal”.

^[31] Review of Judicial Practice in the Sphere of Placing Orders for State and Municipal Needs (October 2020) (Department for Control of Placing State Orders of FAS Russia).

^[32] Federal Law No. 360-FZ of July 2, 2021, “On Amendments to Certain Legislative Acts of the Russian Federation”.

^[33] Letter of the Ministry of Finance of Russia No. 24-06-06/82500 dated October 12, 2021.

^[34] Review of Judicial Practice in Cases Related to the Resolution of Disputes on the Application of Clause 9, Part 1, Article 31 of Federal Law No. 44-FZ of April 5, 2013, “On the Contract System in the Sphere of Procurement of Goods, Works, and Services for Meeting State and Municipal Needs” approved by the Presidium of the Supreme Court of the RF on September 28, 2016.

^[35] Ruling of the Supreme Court of the RF No. 306-AD18-25765 dated February 14, 2019, in Case No. A55-30553/2017.

^[36] Ruling of the Arbitration Court of the City of Moscow dated May 27, 2020, in Case No. A40-328775/19-139-2719.

^[37] Review of Practice of Application of Antimonopoly Legislation by Collegiate Bodies of FAS Russia (for the period from July 1, 2018, to July 1, 2019), approved by the minutes of the Presidium of FAS Russia.