Veterinary medicine marking in Russia — Honest Sign system, checkout blocking and 2026 EDM requirements
According to the Higher School of Economics (HSE), illegal veterinary drugs accounted for 25% of the Russian market in 2022 and 23% in 2021. Counterfeit antibiotics, expired vaccines, and unregistered medications accumulated in veterinary pharmacies and agricultural holdings without any oversight. Neither manufacturers nor the state could trace a specific package from the factory to the farm.
From October 1, 2024, the Russian Government introduced mandatory marking for veterinary medicines. On September 1, 2025, a checkout blocking mode was activated: the sale of unmarked or non-compliant goods is blocked automatically. Starting March 1, 2026, unit-by-unit tracking via EDM (electronic document management) begins: every invoice must include the marking codes for each individual package. Below is a breakdown of how the system works, who is affected, and what steps are needed to stay compliant.
What the Market Looked Like Before Marking
From December 25, 2023, to August 31, 2024, Russia ran a voluntary pilot on veterinary medicine marking (Government Decree No. 2222 dated December 21, 2023). Manufacturers, importers, distributors, and retailers could obtain codes free of charge and test their business processes without the risk of penalties.
By June 2024, 23 manufacturers (around 45% of the total), 14 importers, 19 distributors, and 10 retail chains had joined the pilot. More than half of manufacturers and the vast majority of other participants never connected to the system.
Counterfeit products surfaced only through customer complaints or targeted Rosselkhoznadzor inspections. Tracing a specific package from factory to veterinary clinic was impossible. After mandatory GMP requirements for foreign manufacturers were introduced in 2023, the domestic market share exceeded 75%: production volumes grew from 28 million packages in 2020 to 50 million in 2024. Yet no one monitored the quality of those packages along their entire route to the end user.
What Changed From October 2024
Government Decree No. 675 dated May 27, 2024, «On Approval of the Rules for Marking Medicinal Products for Veterinary Use with Identification Means» (hereinafter Decree No. 675) introduced mandatory marking from October 1, 2024.
Who Is Covered
All participants in the supply chain are required to mark veterinary medicines:
manufacturers, including those operating under contract manufacturing arrangements
importers
wholesale distributors
retailers: veterinary pharmacies, pet shops
veterinary clinics and offices
agricultural holdings, poultry farms, and livestock facilities using medicines for their own operations
feed manufacturers using veterinary drugs in production
Exemptions: exports outside the EAEU; purchases under state secret transactions; private household plots (LPH); peasant (farm) households and agricultural cooperatives purchasing medicines for their own use. Medicines produced or imported before October 1, 2024, may be sold without marking until their expiration date.
Which Medicines Must Be Marked
All veterinary medicines with a valid marketing authorization (MA) must be marked. Decree No. 675 lists the applicable EAEU HS codes and OKPD2 codes.
Under the EAEU HS classification, the following must be marked from October 1, 2024: vitamins (2936 90 000 9), antibiotics (2941 90 000 9), organotherapeutic products (3001 20 900 0), antisera (3002 12 000 2, 3002 12 000 3, 3002 12 000 9), immunological products (3002 15 000 0), veterinary vaccines (3002 42 000 0), cultures of microorganisms (3002 90 300 0), medicinal products in primary packaging (3003 10 000 0, 3003 20 000 0, 3003 90 000 0), packaged medicinal products (3004), contraceptives (3006 60 000 1), insecticides and repellents for animals (3808 91 800 0).
The OKPD2 list covers: vitamin-containing preparations (21.10.51), antibiotics (21.10.54.120), pharmaceutical and chemical preparations (21.10.54.180), veterinary preparations (21.10.60.193), medicinal products (21.20.10), sera and vaccines (21.20.21.110, 21.20.21.130), veterinary vaccines (21.20.22), diagnostic reagents (21.20.23.190).
One exception: vaccines requiring storage at minus 60°C or below are exempt from marking.
Structure of the Marking Code
Each package receives a two-dimensional Data Matrix barcode containing four elements: a GTIN (14-digit Global Trade Item Number, issued by GS1 RUS), a serial number (13 characters), a verification key (4 characters), and a verification code (44 characters, a cryptographic signature per GOST standard).
The code is applied to the consumer or group packaging; application to an attached label is also permitted. The code must not be placed on structurally detachable parts of the packaging, transparent wrapping film, or external wrapping material.
The cost of a single marking code is set by Government Decree No. 577 dated May 8, 2019: 50 kopecks excluding VAT, 60 kopecks including VAT. No preferential pricing applies to veterinary medicines. By comparison, medicines from the Essential Medicines (VEM) list priced under 20 rubles receive codes free of charge. At an annual volume of 50 million packages, the industry spends approximately 30 million rubles on codes alone — before accounting for equipment, integration, and training costs.
Checkout Blocking Mode From September 1, 2025
From September 1, 2025, a blocking mode has been active at point-of-sale terminals for veterinary medicines. It was established by Government Decree No. 1944 dated November 21, 2023 (hereinafter Decree No. 1944), as amended by Decree No. 1606 dated November 22, 2024.
When a code is scanned, the cash register software sends a request to the GIS MT «Honest Sign» (Chestny Znak) system. A response arrives within 1.5 seconds: the sale is either approved or blocked by the system. No manual override is available to the cashier.
Sales are blocked in six cases: the code is absent from GIS MT; the product has already been withdrawn from circulation; no entry-into-circulation record exists; the expiration date has passed; the code format is invalid; or the product is banned by a competent authority. The last ground applies in offline mode as well — the rest are verified only when a connection is active.
If the internet connection is unavailable for more than 2 hours, the seller must log the fact and resolve the issue within 72 hours. During that period, the cash register operates using a local database of blocked codes, which must be updated regularly.
The blocking mode does not apply to sales via vending machines, remote sales with warehouse dispatch, or cases covered by Article 2 of Federal Law No. 54-FZ.
Implementation Timeline
| Date | Requirement | Who Is Affected |
|---|---|---|
| 01.09.2024 | Mandatory registration in GIS MT | All supply chain participants |
| 01.10.2024 | Mandatory code application | Manufacturers, importers |
| Until 31.10.2024 | Grace period for imports purchased before 30.09.2024 | Importers |
| 01.03.2025 | Submission of retail sales data via cash registers | Vet pharmacies, pet shops |
| 01.09.2025 | Checkout blocking mode | Retailers |
| 01.09.2025 | Submission of non-retail withdrawal data | Vet clinics, agricultural holdings |
| 01.03.2026 | Unit-by-unit tracking via EDM | All supply chain participants |
From March 1, 2026, every invoice during shipment or acceptance must include the marking code for each individual unit. Shipping a batch via a UPD (Universal Transfer Document) without codes from that date onwards will constitute a violation.
Fines and Penalties
Administrative Liability
Article 15.12 of the Code of Administrative Offenses (CAO) of the Russian Federation establishes sanctions for the production, circulation, and sale of goods without mandatory marking.
For production or entry into circulation without marking (Part 1): officials face fines from 5,000 to 10,000 ₽ with confiscation; legal entities from 50,000 to 100,000 ₽ with confiscation.
For storage, transportation, or sale without marking (Part 2): individuals are fined 2,000 to 4,000 ₽ with confiscation; officials 5,000 to 10,000 ₽ with confiscation; legal entities 50,000 to 300,000 ₽ with confiscation.
Article 15.12.1 of the CAO covers failure to submit data or violation of submission deadlines to GIS MT: a warning or a fine of 1,000 to 10,000 ₽ for officials, and 50,000 to 100,000 ₽ for legal entities.
Criminal Liability
Large-scale violations trigger Article 171.1 of the Criminal Code of the Russian Federation. For veterinary medicines, «large scale» means the value of unmarked goods exceeds 400,000 ₽; «especially large scale» exceeds 1,500,000 ₽.
Part 1 (large scale): a fine of up to 300,000 ₽, compulsory labor, or imprisonment for up to 3 years. Part 2 (especially large scale or organized group): a fine of 200,000 to 500,000 ₽ or imprisonment for up to 6 years with a fine of up to 1,000,000 ₽. The use of deliberately forged identification means also falls under Article 171.1.
What to Do
For Manufacturers:
Register in GIS MT «Honest Sign». If you participated in the pilot before August 31, 2024, your registration carries over. Verify that your data is current. The deadline for new participants is 7 calendar days from the start of operations; 30 days for remote or hard-to-reach locations.
Add medicines to the national product catalog. Provide the product name, dosage form, release form, composition, MA number, and storage conditions.
Join GS1 RUS and order codes. Obtain a GTIN for each medicine. Code cost: 60 kopecks including VAT. Calculate your volume based on the production plan.
Configure the code application process. Print quality requirements: grade 1.5 (C) or higher for in-house application; grade 2.5 (B) or higher when using a service provider (GOST R ISO/IEC 15415-2012).
Complete integration testing. Submit a testing request within 15 calendar days of registration. The GIS MT operator conducts testing within 15 days of receiving the readiness notification.
Submit entry-into-circulation data before selling each batch of marked medicines.
For Importers:
Complete steps 1–6 above, and additionally:
Agree with your foreign partner on where marking will be applied: at the overseas production site or at a temporary storage warehouse in Russia.
Include codes in customs declarations. Identification codes or an aggregated customs code must be entered in box 31 of the customs declaration (DT) per Customs Union Commission Decision No. 257 dated May 20, 2010.
Track transitional arrangements. Medicines produced or imported before October 1, 2024, may be sold without codes until their expiration date.
For Distributors and Veterinary Pharmacies:
Sign agreements with an EDM operator and a fiscal data operator (OFD) for data transmission to GIS MT.
Configure goods receiving. Scan codes upon batch arrival and confirm acceptance in your EDM system. Confirmation deadline: 3 business days.
Upgrade checkout equipment. Cash registers must support fiscal document format FFD 1.2 and operate in blocking mode. The blocking mode has been active since September 1, 2025.
Set up offline verification. Install a local module for operation when connectivity is unavailable. The blocked-code database must be updated regularly.
Prepare for unit-by-unit tracking (March 1, 2026). From that date, every outbound invoice must include the marking code for each package.
For Veterinary Clinics:
Register in GIS MT if you have not already done so.
Submit withdrawal data for each medicine used, starting September 1, 2025. Reason for withdrawal: «used in veterinary treatment.» Submission deadline: 3 business days.
Purchase only from registered suppliers and verify that each package bears a readable marking code upon receipt.
The veterinary medicine marking system has been rolled out in stages, with each phase more demanding than the last. Applying codes and registering in GIS MT was only the first step. The blocking mode, which took effect in September 2025, made it impossible to sell unmarked goods at retail. Unit-by-unit EDM tracking from March 2026 will close the final gap: the movement of every single package will be recorded at the wholesale level. For businesses, this means infrastructure investment; for the market — one where a quarter of all products were counterfeit — it means finally operating under a different set of rules.
Regulatory Framework:
1. Customs Union Commission Decision No. 257 dated May 20, 2010, «On Instructions for Completing Customs Declarations»
2. Government Decree No. 675 dated May 27, 2024, «On Approval of the Rules for Marking Medicinal Products for Veterinary Use with Identification Means»
3. Government Decree No. 1944 dated November 21, 2023 (as amended by Decree No. 1606 dated November 22, 2024), «On Approval of the List of Cases in Which the Sale of Unmarked Goods is Prohibited»
4. Government Decree No. 577 dated May 8, 2019, «On Approving the Fee for Providing Marking Codes»
5. Government Decree No. 2222 dated December 21, 2023, «On Conducting a Pilot on Marking Medicinal Products for Veterinary Use»
6. Code of Administrative Offenses of the Russian Federation, Articles 15.12, 15.12.1
6. Criminal Code of the Russian Federation, Article 171.1