Changes to the labeling of medicines have been prepared
July 31, 2025
The Ministry of Industry and Trade has developed amendments to the Russian Federation Government Resolution regulating the operation of the drug tracking system (MDLP) and the national product labeling system.
In particular, the following amendments are made to Resolution No. 1556 of the Government of the Russian Federation dated December 14, 2018, “On Approval of the Regulations on the System for Monitoring the Movement of Medicinal Products for Medical Use”: The Regulations on the MDLP will be supplemented with a new mechanism for exchanging data with the state system for monitoring the circulation of marked goods. Information from the MDLP will be transferred to this system, including:
– the number and date of labeling of drug packages;
– the volume of drugs put into circulation, as well as the date and details of the corresponding entries in the Roszdravnadzor information system.
At the same time, the MDLP will receive data from the labeling system on the serial numbers of medicines produced in EAEU countries throughout the entire production cycle.
Amendments to Resolution No. 515 of the Government of the Russian Federation dated April 26, 2019, “On the System for Labeling Goods with Means of Identification and Tracking the Movement of Goods”:
– It is proposed to include a new clause in the document providing for integration with the Roszdravnadzor information system to control the circulation of medicines.
The concept of “other participants” is also introduced: legal entities, individual entrepreneurs, branches and representative offices of foreign legal entities (tax residents of EAEU member states) in the Russian Federation, which submit information to the monitoring system to confirm the country of origin of goods subject to labeling. These participants will be required to provide the monitoring system with information confirming the country of origin of the goods being labeled.
Once approved, this document will come into force on September 1, 2025.
Changes to legislation on state regulation of alcohol and alcoholic products approved
July 25, 2025
The State Duma of the Russian Federation has adopted a bill “On Amendments to the Federal Law ”On State Regulation of the Production and Circulation of Ethyl Alcohol, Alcoholic and Alcohol-Containing Products and on Restricting the Consumption (Drinking) of Alcoholic Products,” which requires a license for the retail sale of alcohol and its sale in catering establishments for each facility separately. The amendments also apply to the licensing of alcohol production for pharmaceutical substances.
The authors of the bill propose amendments to:
– Federal Law No. 171-FZ of November 22, 1995, “On State Regulation of the Production and Circulation of Ethyl Alcohol, Alcoholic and Alcohol-Containing Products, and on Restricting the Consumption (Drinking) of Alcoholic Products”;
– Federal Law No. 108-FZ of April 3, 2023, “On Amendments to the Federal Law ‘On State Regulation of the Production and Circulation of Ethyl Alcohol, Alcoholic and Alcohol-Containing Products, and on Restrictions on the Consumption (Drinking) of Alcoholic Products.’”
The issuance of new licenses for the production, storage, and supply of ethyl alcohol has been postponed until April 1, 2027. If applications are submitted during the moratorium period, they will be returned without consideration.
The transition to mandatory electronic documentation in the circulation of alcohol and spirits has also been postponed from September 1, 2025, to March 1, 2026.
Link to the draft: https://sozd.duma.gov.ru/bill/506793-8
Draft law on procurement of medicines for patients with rare diseases approved
July 19, 2025
The State Duma has passed a bill on the procurement of medicines for patients with rare diseases listed in Government Decree No. 403 of April 26, 2012.
The draft law introduces amendments to Part 9 of Article 83 of the Federal Law “On the Fundamentals of Health Protection of Citizens in the Russian Federation,” which, taking into account Part 3 of Article 44 of the aforementioned federal law, adjusts the name of the list establishes the powers of the Government of the Russian Federation to approve the procedure and criteria for confirming the inability of a constituent entity of the Russian Federation to fulfill its powers to provide medicines to citizens suffering from diseases included in the list, as well as the procedure for providing interbudgetary transfers from the federal budget to co-finance the expenditure obligations of the constituent entities of the Russian Federation to provide citizens with registered medicines for the treatment of diseases included in the list.
The list includes 17 diseases, such as imperfect osteogenesis, acute hepatic porphyria, copper metabolism disorder, etc.
The law introduces a reserve fund to finance the treatment of orphan diseases. If it is not possible to provide the necessary medical supplies at the expense of the constituent entity of the Russian Federation, the necessary funds will be allocated from the federal budget.
In order to implement the bill, a resolution of the Government of the Russian Federation will be prepared, regulating the procedure and criteria for confirming the fact that a constituent entity of the Russian Federation is unable to fulfill its powers to provide medicines to citizens suffering from diseases included in the list, as well as the objectives, conditions, and procedure for providing financial support from the federal budget to provide medicines to the aforementioned persons in need of them, based on constitutional principles and taking into account the positions of the Constitutional Court of the Russian Federation formulated in Resolution No. 41-P of September 26, 2024.
The criteria for assessing the fulfillment by a constituent entity of the Russian Federation of its obligation to provide medicines to persons suffering from diseases included in the list, as provided for in the act of the Government of the Russian Federation, will make it possible to assess whether the situation that has arisen was caused by the improper fulfillment of the specified obligation by the constituent entity of the Russian Federation or whether it was caused by objective factors.
The document shall enter into force on January 1, 2026.
Reference: https://sozd.duma.gov.ru/bill/864824-8
Federal law on strategically important medicines adopted
July 14, 2025
The State Duma of the Russian Federation has adopted a law that establishes the definition of a list of strategically important medicines and grants the Government of the Russian Federation the authority to approve the list of strategically important medicines, as well as the procedure and criteria for its formation. The document amends Article 4 of Federal Law No. 61-FZ of April 12, 2010, “On the Circulation of Medicines.” According to the amendments, these include drugs that meet priority healthcare needs in the prevention and treatment of diseases, including those that are prevalent in the Russian Federation, the production of which must be organized in Russia.
Manufacturers of such drugs will receive state support measures, including preferences based on the “second surplus” principle (priority for Russian drugs in public procurement). The Russian government will approve the list, procedure, and criteria for its formation. The Ministry of Industry and Trade, the Ministry of Health, and the Federal Antimonopoly Service are still working together on the criteria. The law is expected to come into force on September 1, 2025.
The draft federal law “On Amending Article 4 of the Federal Law ”On the Circulation of Medicines” was prepared as part of the implementation of the action plan for the Strategy for the Development of the Pharmaceutical Industry of the Russian Federation for the period up to 2030, approved by the order of the Government of the Russian Federation dated March 30, 2024. No. 753-r (clause 1), with the aim of improving the development of healthcare in terms of providing the population with the necessary medicines for medical use.
Link: https://sozd.duma.gov.ru/bill/811556-8
A law regulating the sale of medicines, dietary supplements, and medical devices on marketplaces has been drafted
July 8, 2025
Draft law No. 959244-8 “On Certain Issues of Regulating the Platform Economy in the Russian Federation” has been developed, aimed at regulating digital platforms and marketplaces, which will affect, among other things, medicines and dietary supplements.
According to the document, a unified register of intermediary digital platforms (IDPs) will be created, which collectively ensure interaction between the operator, partners, and users for the purpose of concluding civil law contracts, as well as providing the technical capability to place orders and/or product cards, conduct transactions between partners and users, and make payments for goods (work, services) by the user to the partner, and included in the register of intermediary digital platforms, are defined as intermediary digital platforms.
It is proposed that the PCC register be maintained by a federal executive authority authorized by the Government of the Russian Federation. It is established that interaction between the operator and partners shall be based on an agreement between them after verification of information about the person intending to become a partner through the Unified State Register of Legal Entities, the Unified State Register of Individual Entrepreneurs, or identification and authentication using a unified system. Such an agreement may be concluded in electronic form on the PTS.
The bill establishes requirements for the placement of product cards by partners on the PPC. Thus, the operator is obliged to provide the partner with the technical capability to place information about the partner, product, work, service, including the availability of permits, licenses, or other documents necessary for the performance of work, provision of services, as well as information on the fulfillment of product labeling requirements in the card. In addition, the operator must include information in the card that the product offered for sale is subject to labeling if such a requirement is established by law.
One of the key responsibilities of the operator, reflecting the essence of the platform economy, is to include in the product card information that it is not the seller of the product offered, the performer of the work or services offered, and does not conclude a contract of sale of goods, a contract for services, or a contract for the provision of paid services (except in cases where the operator sells goods, performs work, or provides services on its own behalf).
In addition, the bill expressly prohibits the placement on the PPC of product cards containing, among other things, offers to sell goods that have been withdrawn from circulation, as well as goods that have not been registered with the state or included in the State Catalog of Pesticides and Agrochemicals, biologically active additives approved for use in the Russian Federation, medicines, and medical devices that have not been registered in accordance with the legislation of the Russian Federation.
A procedure for amending the agreement between the operator and the partner is established. As a general rule, in the event of a unilateral amendment by the operator to the agreement between the operator and the partner, such person is obliged to send a notification at least 15 days before such amendment comes into force.
The operator has the right to restrict access to the personal account (set a “block”) and/or restrict or terminate the placement of a product card if such measures are provided for in the agreement between the operator and the partner, in cases of violation by the partner of the legislation of the Russian Federation, as well as the detection of signs and/or facts of unauthorized access by third parties to the personal account. At the same time, a mandatory pre-trial appeal procedure is established for the actions (inaction) of the operator related to the application of liability measures, “blocking,” lowering the partner’s rating, and worsening the position of the product card in search results.
The bill introduces specific features of interaction between operators and partner-executors. Requirements for the operator’s logistics infrastructure and specific features of interaction with order delivery points are established.
In order to ensure state control functions, mandatory information exchange between PPC operators and tax authorities and state control (supervision) over compliance with legislation in the field of the platform economy in the Russian Federation are provided for.
Agreements between operators and sellers may be concluded in electronic form directly on the platform. Changes to the terms of the contract are permitted only after notifying the counterparty no later than 15 days before the amendments come into force.
The bill also establishes rules for the preparation of product cards. Operators must provide sellers with the opportunity to provide complete information about their products, including data on licenses, labeling, and permits. At the same time, platforms are required to post information about their intermediary status (if they do not act as agents) and warnings about the need for labeling when required by law.
Violations of the new rules will be punishable by fines of up to RUB 500,000, which will be established by additional articles of the Code of Administrative Offenses of the Russian Federation (14.68 and 14.69). The amendments will also affect legislation on trade and consumer protection, strengthening the responsibility of platforms to buyers.
Once the law is passed, its provisions will come into force on March 1, 2027.
Link: https://sozd.duma.gov.ru/bill/959244-8.
New national standard for medical and healthcare professionals
August 5, 2025
The head of the Federal Agency for Technical Regulation and Metrology signed Rosstandart Order No. 787-st dated July 24, 2025, approving GOST R 72213-2025 “Medical devices. Continuous monitoring of glucose concentration in interstitial fluid.”
The standard was developed by the Federal State Budgetary Institution “VNIIIMT” of Roszdravnadzor in conjunction with the Federation of Laboratory Medicine. It establishes requirements for medical devices for continuous monitoring of glucose concentration in interstitial fluid and for evaluating their effectiveness in clinical studies and trials. The standard will help to unify approaches to assessing the quality of medical devices; ensure patient safety; improve the effectiveness of diabetes diagnosis and treatment. It is intended for clinical studies of medical devices for continuous monitoring of glucose concentration in adults and children, with the exception of pregnant women, but may be used to develop a clinical trial program for pregnant women, provided that their safety is ensured. The standard is intended for use by medical device manufacturers, regulatory authorities, and healthcare professionals. The standard is not intended for use by patients and does not apply to medical devices that do not meet the definitions of continuous interstitial glucose monitoring.
Information about GOST R 72213-2025 is available on the Rosstandart portal. This national standard will come into effect in the Russian Federation on January 1, 2026.
Link: https://www.gost.ru/home/standarts/
Extension of the traceability system for pharmaceutical substances
July 1, 2025
On July 30, 2025, Resolution No. 976 of the Government of the Russian Federation dated June 28, 2025, “On Amendments to Resolution No. 2261 of the Government of the Russian Federation dated December 22, 2023,” was published and entered into force. No. 2261,” extending the term of the experiment on tracking pharmaceutical substances, which began on December 29, 2023, was supposed to end on December 31, 2024, but was extended until June 30, 2025.
According to the new resolution, the term of the experiment has been extended again, this time until August 31, 2025.
Link: http://publication.pravo.gov.ru/document/0001202506300022
Author
Dmitriy Kovalev
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