Changes to the mandatory labeling requirements for veterinary drugs
Amendments are being made to the rules for labeling veterinary drugs. The relevant resolution of the Government of the Russian Federation dated November 20, 2025, No. 1845, “On Amendments to the Resolution of the Government of the Russian Federation dated May 27, 2024, No. 675.”
The rules for applying identification marks to the consumer packaging of these drugs, the procedure for submitting information to the monitoring information system, and the procedure for selling manufactured and unsold veterinary drugs without identification marks are being clarified.
From March 1, 2026, the list of goods requiring labeling will be expanded to include new groups of preparations. Goods with EAEU HS codes 3002 49 000 1, 3808 91 100 0 and OKPD codes 2 20.20.11.000, 21.10.60.194 have been added to the list.
The obligation to submit information on the turnover of these groups of drugs to the monitoring information system will be imposed on participants in the turnover from September 1, 2026.
Transitional periods are provided for: goods manufactured or imported before February 28, 2026, may be sold without labeling until their expiration date. Unlabeled drugs manufactured or imported before March 1, 2026, may be sold until their expiration date. After March 31, 2026, customs procedures for such products will be restricted.
Link: http://publication.pravo.gov.ru/document/0001202511200020
November 26, 2025
State control in the field of drug circulation is being simplified
The Russian government adopted Resolution No. 1811 of November 15, 2025, “On Amendments to Resolution of the Government of the Russian Federation No. 1049 of June 29, 2021.” The amendments regulate the frequency of scheduled inspections and preventive visits in accordance with the risk category of the facility.
Scheduled inspections are canceled for facilities with significant, medium, moderate, and low risks. For organizations classified as high risk, on-site inspections, documentary checks, and inspection visits will be conducted once every two years.
Scheduled inspections of veterinary drugs are canceled for all risk categories.
Preventive inspections can now be conducted via video conferencing or using the Inspector mobile application, in addition to in-person visits. Preventive visits can now also be conducted at the initiative of the inspected entity itself.
Frequency of mandatory preventive visits:
– high-risk facility – once a year, if the facility is not included in the annual inspection plan;
– facilities with significant, medium, moderate, and low risk – no more than once every 3 years, 5 years, and 6 years, respectively.
The criteria for the severity of negative consequences, which determine the risk category, have been clarified (the rules for accounting for risk indicators for preclinical and clinical drug trials have been changed).
The period for reviewing complaints is reduced from 20 to 15 working days.
For disputes related to the risk category, a shortened five-day review period is established.
The list of decisions that can be challenged is expanding: it is now possible to appeal not only the results of inspections, but also the assigned risk category, refusal to conduct a preventive visit, and other decisions of regulatory authorities.
The document will come into force on November 23, 2025.
Link http://publication.pravo.gov.ru/document/0001202511150018
November 21, 2025
New guidelines for the pharmaceutical development of medicinal products have been developed and approved
On November 11, 2025, EEC Board Recommendation No. 30 “On the Guidance on Pharmaceutical Development of Medicinal Products” was adopted. The document was published on the legal portal of the Eurasian Economic Commission on November 14, 2025.
This Guidance on Pharmaceutical Development of Medicinal Products should be used when compiling a registration dossier. It describes the principles of quality design and a systematic approach to drug development, starting with the definition of the target quality profile.
The document defines the process of identifying critical quality indicators, justifying the choice of composition, manufacturing process, and packaging system, as well as forming a control strategy. It establishes uniform approaches to compiling section 3.2.R.2 “Pharmaceutical Development” of the registration dossier in the format of a Common Technical Document, which includes the following elements:
– target profile and critical quality attributes of the medicinal product;
– risk assessment and design space;
– control strategy;
– drug life cycle management.
An important component of pharmaceutical development is the “design space” element, which describes the relationship between the input factors of the drug manufacturing process (material characteristics and manufacturing process parameters) and critical quality attributes.
The guidance also describes the differences between the minimum and in-depth approaches to pharmaceutical development.
The document will come into effect on December 14, 2025.
Link: https://docs.eaeunion.org/documents/450/10282/
November 20, 2025
Lists of potent and toxic substances have been supplemented
On November 6, 2025, Resolution No. 1728 of the Government of the Russian Federation “On Amendments to Resolution No. 964 of the Government of the Russian Federation of December 29, 2007” dated November 1, 2025, was published, expanding the lists of medicinal products containing toxic substances whose circulation is prohibited. The list of substances for which criminal liability applies for the illegal circulation of potent or toxic substances for the purpose of sale has been expanded.
The following substances were added to the list of potent substances:
Androstanol ([2,3-c][1,2,5alpha]oxadiazol-176eta-ol) – 10 g;
5alpha-Androstan-3,6,17-trione – 2.5 g;
6-Bromandrost-1,4-diene-3,17-dione – 2.5 g;
1,4-Dimethylpentylamine (1,4-DMAA) – 0.5 g;
Ligandrol (LGD-4033), Mastorine (S23) – 10 g;
116eta-Methyl-19-nortestosterone – 10 g;
Revereol (SR9009) – 10 g;
Recardin (SR9011) – 10 g;
Testolone (4-(((1R,2S)-2-hydroxy-1-[5-(4-cyanophenyl)-1,3,4-oxadiazol-2-yl]propyl)amino)-3-methyl-2-chlorobenzonitrile; RAD-140) – 10 g;
4-Chloro-17alpha-methylandrosta-1,4-diene-3,176eta-diol – 2.5 g;
4-Chloro-17alpha-methyl-176eta-hydroxyandrosta-4-ene-3,11-dione – 2.5 g.
In addition to expanding the list, large quantities of the above potent substances have also been established for the purposes of Article 234 of the Criminal Code of the Russian Federation.
The resolution shall enter into force on November 14, 2025.
Link: http://publication.pravo.gov.ru/document/0001202511060012
November 10, 2025
National Standardization Program for 2026 approved
The National Standardization Program for 2026 and subsequent periods (NSP-2026) was approved by Order of Rosstandart No. 2367 dated October 31, 2025.
The program includes approximately 4,000 standardization documents in 18 areas, with 2,100 documents to be submitted for approval in the near future.
Proposals from technical committees on standardization for the National Standardization Program for the following year are submitted in accordance with the requirements of GOST R 1.14-2017 by the end of August of the previous year, and consolidated proposals are reviewed by the Russian Institute for Standardization and the Standardization Council under Rosstandart.
Link: https://www.rst.gov.ru/portal/gost/home/activity/documents/orders#/
November 6, 2025
The Federal Antimonopoly Service of the Russian Federation has clarified the rules for purchasing drugs that are not included in the List of Essential and Vital Medicines for Medical Use
The Federal Antimonopoly Service (FAS) of Russia sent a letter dated November 1, 2025, No. MSh/103552 to the territorial bodies of the FAS, as well as to state and municipal customers, containing explanations on the procurement of medicinal products whose dosage forms are not included in the list of essential and vital medicines for medical use.
The FAS letter was prepared in response to inquiries from organizations regarding the legality of territorial antitrust authorities’ procurement commissions rejecting bids from procurement participants on the grounds that the dosage form of the proposed drug was not included in the list of essential and vital drugs for medical use (hereinafter referred to as the List of Essential Medicines), approved by Decree of the Government of the Russian Federation No. 2406-r of October 12, 2019, in the presence of equivalent dosage forms in the List of Essential Medicines, the FAS of Russia, on the basis of clause 5.4 of the Regulations on the Federal Antimonopoly Service, approved by Decree of the Government of the Russian Federation No. 331 of June 30, 2004, even if this form is equivalent to the one in the list and a maximum price has already been registered for this drug.
The FAS of Russia reports that the absence of an equivalent dosage form of a medicinal product in the List of Essential Medicines (including the mark “No” in attribute N 12 in the column “Availability of the medicinal product in the List of Essential Medicines” in the GRLS) in the absence of a registered maximum manufacturer’s selling price for this drug in an equivalent dosage form in the GRPOC cannot indicate that such a drug does not have the status of being vital and essential, and, accordingly, should not create an obstacle to the circulation of the drug on the relevant commodity market. The information in the GRPOC should be used as a guide, taking into account the information contained in the list of interchangeable drugs.
In this letter, the FAS states that if there is a registered price for the drug in the GRPOC, the rejection of bids from procurement participants “is unlawful and violates the requirements of the Law on the Contract System.”
November 3, 2025
Author
Dmitriy Kovalev
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