Storing Imported Medicines at Russian Customs. What the Dual Licensing Trap Means for Your Supply Chain
A container of insulin has arrived at the port of St. Petersburg. The temperature regime has been maintained, the paperwork is in order, and the customs broker is ready to file the declaration. There is nowhere to unload the cargo. The temporary storage warehouse (SVKh) at this port does not hold a pharmaceutical license, while the licensed pharmaceutical warehouse in the city is located outside the customs control zone (ZTC).
Such scenarios have long ceased to be rare exceptions. At the intersection of customs and pharmaceutical regulations, a regulatory trap has emerged that market participants refer to as the «ZTC trap.» Understanding its nature and finding a way out matters for every importer of medicinal products.
How the Situation Evolved
When medicines cross the EAEU border, they fall under the scrutiny of two independent oversight systems. Customs requires the goods to be placed in an SVKh within the customs control zone until clearance is complete. Roszdravnadzor mandates that medicine storage take place exclusively at facilities holding a valid pharmaceutical license.
For a long time, these systems developed in parallel, paying little attention to one another. The Federal Customs Service (FCS) structured its SVKh requirements around fiscal security: perimeter fencing, video surveillance, inspection equipment, and communication channels with the customs post. Roszdravnadzor shaped its standards around product quality: climate control, equipment validation, and staff with pharmaceutical education.
For years, the problem was bypassed through a tacit compromise. Medicines were placed in ordinary SVKhs, cleared, and moved to licensed warehouses within a matter of days. Regulators overlooked this formal discrepancy as long as cargo volumes remained moderate and no one required documentation of temporary storage conditions.
What Regulates Customs Warehouses
The operational procedure for SVKhs is governed by FCS Order No. 444 dated March 18, 2019 «On Approval of the Procedure for Performing Customs Operations when Placing Goods in a Temporary Storage Warehouse» (hereinafter — Order No. 444). The document outlines acceptance, placement, release of goods, and the DO-1 and DO-2 reporting forms in detail, but contains no mention of temperature regimes, humidity levels, or personnel qualifications required for handling medicines. The reporting system records the physical presence of goods at the facility; the condition parameters of the cargo remain entirely outside the scope of customs control.
What Regulates Medicine Storage
The storage of medicinal products is a licensed activity. Government Decree No. 547 dated March 31, 2022 «On Approval of the Regulations on Licensing Pharmaceutical Activities» (as amended on November 6, 2024; hereinafter — Decree No. 547) explicitly includes storage in the list of works and services constituting pharmaceutical activity. Licenses are issued by Roszdravnadzor for human medicines and by Rosselkhoznadzor for veterinary products.
Ministry of Health Order No. 260n dated April 29, 2025 «On Approval of Rules for the Storage of Medicinal Products for Medical Use» (entered into force on September 1, 2025; hereinafter — Order No. 260n) establishes requirements for premises and equipment, quality management systems, personnel, and documentation. For wholesale trade organizations, facilities must comply with Section III of the EAEU Good Distribution Practice Rules, approved by EAEU Council Decision No. 80 dated November 3, 2016 (hereinafter — GDP Rules, Decision No. 80).
The GDP Rules require an unbroken cold chain and documented evidence of storage conditions at every stage of product movement, including temporary storage during customs clearance.
The Position of Regulators Since 2012
The issue of «dual licensing» was formalized by Joint Letter No. 01-11/59384 of the Federal Customs Service and No. 04И-1149/12 of Roszdravnadzor dated November 30, 2012 «On the Procedure for Sampling and Storing Medicinal Products.»
In this letter, both agencies explicitly stated that the temporary storage of medicines — including under conditional release procedures — is permissible only in warehouses that meet Medicine Storage Rules or operate within the structure of licensed pharmaceutical warehouses. A warehouse owner’s right to handle medicines is confirmed by a pharmaceutical license issued by Roszdravnadzor.
The letter emphasized that requirements for temporary storage conditions must not differ from the general Medicine Storage Rules. Given that customs expertise can sometimes last several weeks, the warehouse must provide full pharmaceutical-grade conditions for the entire duration. The official stance of both agencies has been unambiguous since December 2012: an SVKh handling medicines must hold a pharmaceutical license.
Comparison of the Two Regulatory Systems
| Parameter | FCS Requirements for SVKh | Roszdravnadzor Requirements |
|---|---|---|
| Legal Basis | Federal Law No. 289-FZ, FCS Order No. 444 | Federal Law No. 61-FZ, Decree No. 547, Order No. 260n, Decision No. 80 |
| Authorization Document | Inclusion in the FCS Registry | Pharmaceutical Activity License |
| Objective of Control | Safeguarding cargo as a taxable asset | Preserving the quality and safety of medicinal products |
| Facility Requirements | Fencing, communication lines, inspection equipment | Climate control, zoning, minimum area of 150 sq. m. for wholesale trade |
| Personnel Requirements | No specialized requirements | Pharmaceutical education, designated person responsible for the quality system |
| Documentation | DO-1 and DO-2 reports | Temperature monitoring logs, SOPs, temperature mapping |
| Liability | Fines, removal from the SVKh registry | Fines + revocation of the pharmaceutical license |
Special Cases — Thermolabile Preparations
Cold-chain products (insulin, vaccines, monoclonal antibodies) must be stored at temperatures between +2°C and +8°C under continuous monitoring. It is physically impossible to maintain these conditions in a standard SVKh lacking refrigeration equipment.
Frozen biological products require temperatures of minus 20°C or lower. Any temperature breach triggers ice crystal formation, destroying the molecular structure of the drug.
Narcotic and psychotropic substances are subject to additional requirements under Federal Law No. 3-FZ dated January 8, 1998 «On Narcotic Drugs and Psychotropic Substances,» requiring dedicated storage areas equipped with advanced security systems.
The joint letter of 2012 specifically noted that sampling medicines for quality control must be performed in full compliance with storage condition requirements. The warehouse must be organized so that customs inspection and sampling do not disrupt the required temperature environment.
How Many Such Warehouses Exist in Russia
Exact official statistics are unavailable: registries are maintained by different agencies and are not synchronized with each other.
The FCS registry lists over 127,000 SVKh entries, encompassing all facility types — from small plots at customs posts to large logistics hubs. Only enclosed, climate-controlled warehouses are suitable for pharmaceutical products, making the actual pool significantly smaller.
Market participants estimate that between 30 and 50 warehouse complexes in Russia are simultaneously registered as SVKh operators and hold a pharmaceutical license for medicine storage. The vast majority are concentrated in the Moscow region and St. Petersburg.
In the Black Sea ports and along land border crossings with Kazakhstan and Belarus, specialized facilities are virtually non-existent. Importers are therefore forced to route shipments through Moscow or St. Petersburg, even when the final recipient is located in an entirely different region.
Consequences for Business
The scarcity of dual-licensed warehouses has created a seller’s market. Industry estimates show that the cost of a pallet space in an SVKh with a pharmaceutical license is 2 to 3 times higher than in a standard customs warehouse. Spaces are booked weeks ahead of cargo arrival.
Storing medicines in an SVKh without a pharmaceutical license violates the wholesale medicine trade rules established by Article 54 of Federal Law No. 61-FZ, which mandates compliance with GDP and storage regulations. Administrative liability under Part 1 of Article 14.4.2 of the Code of Administrative Offenses (KoAP RF) carries fines of 20,000 to 30,000 rubles for legal entities. The monetary penalty is relatively modest, but systematic or repeated violations create a genuine risk of wholesale trade license suspension.
Russia’s drug serialization and track-and-trace system (MDLP) logs every location where a product is stored. If a product’s serialization code appears at a facility without a pharmaceutical license, this can trigger additional regulatory inspections.
For biological products, any deviation from the regulated storage regime means the potential loss of the entire batch. The medicine may appear visually intact, but its therapeutic efficacy could be compromised or it could become unsafe for patients.
What to Do
Audit your supply chain. Verify whether your current SVKh holds a pharmaceutical license. Roszdravnadzor licenses are available in a public registry on the agency’s official website; verification takes five minutes.
Secure long-term operator contracts. Operators of dual-licensed warehouses favor long-term, predictable clients. Ad-hoc requests are processed on a space-available basis and come at premium rates.
Use preliminary customs declaration. This procedure reduces the time goods spend in the customs control zone to a few hours. If the declaration is submitted and accepted before the cargo physically arrives, release is achieved without delay.
Consider active thermal containers. Aviation-grade thermal containers such as Envirotainer function as mobile, autonomously powered refrigeration units, maintaining preset temperatures for 70 to 100 hours. This keeps the cargo safe even if it temporarily sits in a standard SVKh without cold-storage rooms.
Book early and document storage conditions. Reserve warehouse space at least two to three weeks before shipment arrival. Require temperature data loggers and detailed handover acts specifying storage conditions from the operator. This documentation serves as a legal safeguard in the event of subsequent claims.
The trend is clear: serialization systems make the movement of every single pack fully transparent, GDP requirements are tightening, and the workarounds that were common in the 2000s now carry real regulatory risks. Incorporating SVKh selection into supply chain management has become a necessity.
Regulatory Framework:
1. Federal Law No. 61-FZ dated April 12, 2010 «On the Circulation of Medicines» (as amended on July 23, 2025)
2. Federal Law No. 289-FZ dated August 3, 2018 «On Customs Regulation in the Russian Federation»
3. Federal Law No. 3-FZ dated January 8, 1998 «On Narcotic Drugs and Psychotropic Substances»
4. EAEU Council Decision No. 80 dated November 3, 2016 «On Approval of Good Distribution Practice Rules within the Eurasian Economic Union»
5. Government Decree No. 547 dated March 31, 2022 «On Approval of the Regulations on Licensing Pharmaceutical Activities» (as amended on November 6, 2024)
6. Ministry of Health Order No. 260n dated April 29, 2025 «On Approval of Rules for the Storage of Medicinal Products for Medical Use» (entered into force on September 1, 2025)
7. FCS Order No. 444 dated March 18, 2019 «On Approval of the Procedure for Performing Customs Operations when Placing Goods in a Temporary Storage Warehouse»
8. Joint Letter of the FCS (No. 01-11/59384) and Roszdravnadzor (No. 04И-1149/12) dated November 30, 2012 «On the Procedure for Sampling and Storing Medicinal Products»
9. Code of Administrative Offenses of the Russian Federation (KoAP RF), Article 14.4.2, Part 1 «Violation of Legislation on the Circulation of Medicines»