How Rosselkhoznadzor Licenses Veterinary Warehouses in Russia Under Order 426 and the 2025 Checklist
A Rosselkhoznadzor inspector arrives at a veterinary warehouse with a tablet, not a notebook for freeform notes. Since October 10, 2025, inspections have been conducted according to a closed list of questions from a checklist approved by Order No. 937. The inspector has no right to ask a question that is not on the form. However, the flip side of this coin has not been canceled either: a distance of 50 centimeters from a rack to a wall instead of the required 60 is recorded in the report as a violation, rather than as a ground for a verbal warning.
For a warehouse owner, this changes the very logic of preparing for an inspection. Previously, one could rely on a general impression and good relations with the inspector. Now, the checklist is what works, and the warehouse must comply with it on every single point, rather than overall. Below, we discuss how the licensing of veterinary warehouses is structured today and what exactly is inspected.
How the Market Entry Model Has Changed
Until 2021, a license existed as a physical document. An organization submitted an application, waited for a decision, received a stamped form, and stored it in a safe alongside its corporate charter documents.
Since January 1, 2021, the licensing of 52 types of activities, including pharmaceutical activity, transitioned to a registry-based model under Federal Law No. 478-FZ. The paper blank ceased to exist. The entry in the register of licenses holds the legal force. An organization receives an extract from the register as an information document, while the right to operate is confirmed by the entry itself in the licensing authority’s database.
The next step occurred in 2022. Decree of the Government of the Russian Federation No. 547 dated March 31, 2022, «On Approval of the Regulation on the Licensing of Pharmaceutical Activities» (hereinafter referred to as Government Decree No. 547) replaced the previous regulation from 2011 and established the current procedure for all market participants, including veterinary pharmaceuticals. The document is valid until September 1, 2028.
The licensing authority for veterinary medicines is the Federal Service for Veterinary and Phytosanitary Supervision (Rosselkhoznadzor). The Service maintains a separate register of licenses for the circulation of medicines for veterinary use and publishes data from it on its official website in real time.
| Parameter | Before (until 2021) | Now (since 2021) |
|---|---|---|
| Form of confirming the right | Paper license form | Entry in the electronic register of licenses |
| Compliance verification | Planned or unplanned inspection without a unified form | On-site assessment with an obligatory checklist |
| Period for decision on issuance | Up to 45 business days | 10 business days (for ZATOs — 20) |
| Submission of application | In-person visit or mail | Unified Portal of State Services, UKEP |
Three Groups of Requirements for a License Applicant
A license applicant submits an application through the Unified Portal of State and Municipal Services. A legal entity signs it with an enhanced qualified electronic signature (UKEP). Rosselkhoznadzor evaluates the applicant’s compliance with licensing requirements within 10 business days, and for facilities located within closed administrative-territorial formations (ZATOs), this period is extended to 20 business days.
The assessment itself is conducted in the form of an on-site inspection, using video conferencing if necessary. The requirements verified by the inspector are divided into three groups.
Premises and equipment. The organization must own the production facility by right of ownership or on another legal basis that provides the right of possession and use. The premises must comply with the requirements of Article 54 of Federal Law No. 61-FZ «On the Circulation of Medicines,» the EAEU Good Distribution Practice (GDP) rules (Decision of the EEC Council No. 80 dated November 3, 2016), and the rules for storing medicines for veterinary use (Order of the Ministry of Agriculture No. 426).
Personnel. An employee whose activities are related to the wholesale trade, storage, transportation, or manufacture of veterinary medicines must have a higher or secondary pharmaceutical education along with a specialist certificate or completed accreditation, or a higher or secondary veterinary education along with a specialist certificate. If an individual entrepreneur applies for a license, the same requirement regarding education and certification applies to them personally, and not just to hired employees.
Government Decree No. 547 does not establish a separate requirement for work experience. The key condition is a combination of education, confirmed qualifications, and an executed employment contract with the organization. This distinguishes veterinary pharmaceuticals from related licensed fields, where work experience is explicitly prescribed in the licensing regulations: here, it is absent, and one can fully justify demanding that the inspector provide references to a non-existent standard regarding a three-year experience requirement for a warehouse director.
Quality system. EAEU GDP rules require a person responsible for the implementation and updating of standard operating procedures (SOPs), as well as for compliance with storage and transportation conditions. In practice, this function is assigned by order to the warehouse manager or a separate employee of the quality department.
The inspector verifies the existence of a quality system through the staff’s ability to explain their actions. Interviewing a warehouse employee about the procedure for handling defective products or temperature deviations is a standard part of an on-site assessment, on par with checking the documents themselves. The minimum set of procedures that covers the main questions of the checklist is as follows:
| Procedure | What it covers |
|---|---|
| Receiving control | Inspection of labeling, verification of batch numbers, control of container integrity |
| Temperature management | Reading records, sensor calibration, actions in case of an emergency |
| Stock rotation | Shipment of batches with the nearest expiration date first |
| Management of defective products and recalls | Batch isolation, notification of Rosselkhoznadzor, destruction timelines |
| Storage of potent and toxic substances | Access control, sealing, subject-quantitative accounting |
| Cleaning and disinfection | Wet cleaning schedule, choice of disinfectants |
Each procedure must correspond to what actually happens at the warehouse. If an SOP describes sensor calibration once a year, but there is no verification certificate in the file, this discrepancy is recorded as a violation, regardless of how neatly the document itself is prepared.
Rosselkhoznadzor verifies the existence of these three groups of requirements not only at entry. The Pension Fund confirms employment contracts with employees, while Rosobrnadzor and Rosreestr verify diplomas, certificates, and rights to the facility. Inquiries are made through interdepartmental cooperation channels, and the organization does not need to submit these documents in person if the information is already available in government systems.
What Happens When Changing Address or Types of Work
The registry-based model does not exempt a licensee from re-applying to the licensing authority in the event of any change in the actual circumstances of their activity. If a warehouse moves to a new address or adds a new type of work, for example, transitioning from simple storage to transportation, the licensee submits an application to amend the register of licenses.
The timeframe for such a decision is shorter than for an initial license: 5 business days instead of 10, and for facilities in closed administrative-territorial formations, this period is 20 business days. Formally, video communication during an on-site assessment is primarily used for the retail trade of medicines; for wholesale veterinary warehouses, the assessment is conducted in person. The application can be withdrawn at any time prior to the decision by the licensing authority.
What Order 426 Requires of Warehouse Premises
Order of the Ministry of Agriculture of the Russian Federation No. 426 dated July 29, 2020, «On Approval of the Rules for the Storage of Medicines for Veterinary Use» has been in effect since January 1, 2021, and applies to manufacturers, wholesale trade organizations, veterinary pharmacy organizations, individual entrepreneurs, and veterinary organizations.
Walls, partitions, and floors must allow for wet cleaning. Unpainted wooden floors, holes, and surface defects are not permitted. Heating with gas appliances with open flames or electric heaters with open coils is prohibited.
Storage on the floor without a pallet is prohibited. Pallets are arranged on the floor in a single row, or on racks in several tiers depending on the height of the rack. Stacking pallets in several rows in height without racks is not allowed.
For premises with an area of more than 10 square meters, the order specifies the exact geometry of rack placement.
| Placement parameter | Required distance |
|---|---|
| To external walls | At least 0.6 m |
| To the ceiling | At least 0.5 m |
| From the floor | At least 0.25 m |
| Aisles between racks | At least 0.75 m |
The purpose of these figures is access. Racks must be positioned so that personnel and, if necessary, loading devices can freely reach the goods, while walls, floors, and the racks themselves remain accessible for cleaning. Order 426 nowhere explains the distances in terms of heat loss or condensation: the wording of paragraph 8 speaks specifically about access and cleaning.
A separate requirement concerns systematization. Racks, cabinets, and shelves must be numbered and labeled; pallets must be labeled or numbered. Rack cards containing the name of the drug, batch number, expiration date, and quantity of storage units must be attached to racks and cabinets; for veterinary organizations, it is permitted to specify only the pharmacological group.
If the warehouse maintains records through an information system, paper rack cards do not need to be prepared. Systematization is carried out by pharmacological groups, route of administration, alphabetically, or by destination addresses. The organization chooses the approach independently and establishes it in its internal documents.
Instruments for measuring temperature and humidity must be placed at a distance of at least 3 meters from doors, windows, and heating appliances, provided the room area is larger than 10 square meters. Readings are recorded twice a day in a logbook, which is opened for each calendar year and stored for an additional four years after its conclusion.
Certain groups of drugs require specific conditions. Thermolabile vaccines and sera are stored in refrigeration equipment equipped with thermometers, ensuring that containers are not placed close to evaporators and that biological products are not kept on the inside of the refrigerator door. Products containing water of crystallization are stored at a temperature not exceeding +15°C and a humidity level of 50–65%. Products derived from blood or tissues are stored in a dark, dry place at a temperature from 0 to +15°C.
Flammable liquids are stored in airtight glass or metal containers. Containers with a volume of over 5 liters are placed on shelves in a single row in height; stacking with packing materials is prohibited. The filling of containers must not exceed 90% of the volume, and for alcohols in metal containers of over 5 liters, a stricter limit of 75% applies. Ether for anesthesia is stored at a temperature not exceeding +15°C, away from light and not closer than one meter to heating appliances; containers with diethyl ether must not be shaken, struck, or rubbed.
Toxic medicines are stored in a separate, isolated room. Potent substances are allowed to be kept in the general hall, but strictly in lockable metal cabinets or safes with an inscription on the outer side of the door; a list of contents must be attached to the inner side. After the end of the working day, such cabinets are locked and sealed by the responsible person. Narcotic and psychotropic drugs are stored separately from other groups in isolated rooms equipped with engineered security systems, according to the rules of Decree of the Government of the Russian Federation No. 1148 dated December 31, 2009.
Rosselkhoznadzor Inspections and the Cost of Error
The frequency of planned inspections depends on the risk category assigned to the facility under the federal law on state control. A facility with a high risk category, such as a large wholesale warehouse with a high turnover of thermolabile drugs, faces planned inspections more frequently than a small veterinary pharmacy with a low risk category. Unplanned inspections are initiated based on complaints, results of monitoring in the agency’s information systems, or upon the detection of a violation at a counterparty of the warehouse.
Since October 10, 2025, the inspector has been working with checklist forms from Rosselkhoznadzor Order No. 937 dated August 1, 2025. The document replaced Order No. 164 dated February 3, 2022, and contains closed lists of questions on pharmaceutical activities, storage, manufacturing, dispensing, and destruction of veterinary medicines. The inspector answers «yes,» «no,» or «not applicable» to each question, and cannot go beyond the approved list.
For a warehouse, this means the possibility of a self-audit. The checklist form can be downloaded to conduct an internal inspection before the inspector’s arrival, correcting non-compliances in advance.
Liability for violations is divided into two categories. Violation of license conditions without signs of a gross violation is qualified under Part 3 of Article 14.1 of the Administrative Code of the Russian Federation (KoAP RF) and entails a fine for legal entities of 30,000 to 40,000 ₽. A gross violation of licensing requirements (Part 4 of the same article) entails a fine of 100,000 to 200,000 ₽ or administrative suspension of activities for a period of up to 90 days; an official risks a fine of 5,000 to 10,000 ₽. The list of gross violations for pharmaceutical activities is approved by a separate annex to Government Decree No. 547.
In practice, gross violations include storage with deviations from the temperature regime specified by the manufacturer, lack of required education or certification among staff, sale without quality documents, and the mixing of high-quality products with defective ones due to violation of warehouse zoning.
The digital infrastructure surrounding the warehouse is also becoming more complex. Electronic certification of goods subject to state veterinary supervision is carried out through the «Mercury» component of the FGIS «VetIS»: each batch of drugs upon arrival at the warehouse and upon shipment from the warehouse must be accompanied by an electronic veterinary certificate. Since March 1, 2025, a second loop has been added. The prescription dispensing of drugs is processed through the «Galen» component of the same system according to the requirements of Ministry of Agriculture Order No. 776 dated November 2, 2022: a veterinary specialist issues a prescription in electronic form, and the organization dispensing the drug marks it as fulfilled in the system.
A paper prescription remains a backup option in case the specialist is not registered in «Galen». A warehouse combining wholesale trade with a retail veterinary pharmacy should keep both components in sight: an inspector can spot a mismatch in data between «Mercury» and «Galen» just as easily as a discrepancy in a paper logbook.
The third layer of digital control concerns the packaging itself. Decree of the Government of the Russian Federation No. 675 dated May 27, 2024, introduces mandatory labeling of medicines for veterinary use with identification markings, similar to the labeling system for medicines for medical use. For a warehouse, this means an additional point of verification upon receipt: the batch number and the labeling code on the packaging must match what is reflected in the information monitoring system.
What to Do
Conduct an audit of warehouse geometry. Measure the distances from racks to walls, ceiling, floor, and between rows. Eliminate any deviation from 0.6 / 0.5 / 0.25 / 0.75 meters before a planned inspection.
Check personnel documents. Collect copies of diplomas, specialist certificates, or accreditation certificates for all employees whose work involves the receipt, storage, and dispensing of medicines. Ensure that the data matches the records of Rosobrnadzor.
Download the current checklist under Order No. 937. Walk through the warehouse using it independently and record in writing every point with a «no» answer.
Verify logbooks and SOPs. Compare the actual procedures for receipt, storage of potent substances, and handling of defective products with the text of the standard operating procedures. The discrepancy between the document and practice has become the most common reason for a fine under Part 4 of Article 14.1 of the Administrative Code (KoAP), so it’s worth checking the actual actions of personnel against the text of each procedure during preparation.
Appoint a quality manager by order. Assign the function of implementing and updating SOPs, as well as monitoring storage conditions, to a specific employee, specifying their powers and area of responsibility.
In 2026, a veterinary warehouse operates with a specific list of questions that must be answered with a «yes» in advance, rather than an abstract slogan about good storage practice. Discipline in rack geometry, personnel documents, and temperature logbooks decides the outcome of an inspection before the inspector even enters the premises.
Regulatory framework:
1. Order of the Ministry of Agriculture of the Russian Federation No. 776 dated November 2, 2022 (procedure for prescribing veterinary medicines, «Galen» component)
2. Federal Law No. 61-FZ dated April 12, 2010, «On the Circulation of Medicines»
3. Federal Law No. 99-FZ dated May 4, 2011, «On the Licensing of Certain Types of Activities»
4. Decree of the Government of the Russian Federation No. 547 dated March 31, 2022, «On Approval of the Regulation on the Licensing of Pharmaceutical Activities»
5. Order of the Ministry of Agriculture of the Russian Federation No. 426 dated July 29, 2020, «On Approval of the Rules for the Storage of Medicines for Veterinary Use»
6. Order of the Ministry of Agriculture of the Russian Federation No. 555 dated September 21, 2020, «On Approval of the Rules of Good Pharmacy Practice of Medicines for Veterinary Use»
7. Order of Rosselkhoznadzor No. 937 dated August 1, 2025, «On Approval of Checklist Forms… in the Field of Circulation of Medicines for Veterinary Use»
8. Decision of the Council of the Eurasian Economic Commission No. 80 dated November 3, 2016, «On Approval of the Rules of Good Distribution Practice within the Eurasian Economic Union»
10. Decree of the Government of the Russian Federation No. 1148 dated December 31, 2009, «On the Procedure for Storage of Narcotic Drugs, Psychotropic Substances, and Their Precursors»
11. Decree of the Government of the Russian Federation No. 964 dated December 29, 2007 (lists of potent and toxic substances)