Federal Law No. 299 Set 12 New EAEU Fees for Veterinary Drugs — Up to 821,000 Rubles per Registration
A manufacturer of a veterinary antiseptic with annual revenue of 15 million rubles could still fit registration into an 80,000-ruble state fee at the start of 2025. Today the same procedure costs 821,000 rubles — and that is before laboratory testing, dossier translation, or training an authorized person. For a small company, that figure determines whether bringing the product to market makes sense at all.
The increase happened in a single move, with no gradual tariff hikes. Federal Law No. 299-FZ of July 31, 2025 (hereinafter, Law No. 299) rewrote Article 333.32.1 of the Tax Code and, for the first time, established a separate fee schedule for veterinary medicinal products registered under the rules of the Eurasian Economic Union (hereinafter, the EAEU). Before this, state fees of this scale existed only in human pharmaceuticals.
How the Fee Was Calculated Before Autumn 2025
Until autumn 2025, expert evaluation for primary registration fit within tens of thousands of rubles, confirming an existing registration cost even less, and dossier amendments often went through with no evaluation fee at all. The regulator’s logic rested on two premises: that veterinary expert evaluation is less resource-intensive than medical evaluation, and that the veterinary drug market has historically had thinner margins.
This logic relied on the old financing model of FGBU VGNKI (the All-Russian State Center for Quality and Standardization of Veterinary Drugs and Feed), an institution under Rosselkhoznadzor that evaluates dossiers and samples. The low fees did not cover the actual cost of laboratory work, and part of the spending on modern equipment and reagents fell on the Center’s budget rather than on applicants.
What Law No. 299 Changed
The law took effect one month after its official publication, that is, at the end of August 2025, and established 12 separate fees for veterinary medicinal products under EAEU procedures. Rates rose severalfold compared with the previous domestic tariffs.
| Action | Fee |
|---|---|
| Expert evaluation of a veterinary drug for primary registration | ₽461,000 |
| Expert evaluation of documents for primary registration | ₽360,000 |
| Expert evaluation of a drug for registration confirmation | ₽164,000 |
| Expert evaluation of documents for registration confirmation | ₽149,000 |
| Expert evaluation of a dossier and samples for amendments | ₽323,000 |
| Expert evaluation of a dossier without samples for amendments | ₽191,000 |
| Amendments without expert evaluation of dossier or samples | ₽11,000 |
| Expert evaluation of documents for amendments | ₽231,000 |
| Expert evaluation of a drug to bring a dossier into EAEU compliance | ₽323,000 |
| Expert evaluation of documents to bring a dossier into EAEU compliance | ₽220,000 |
| Recognition of registration in states joining the EAEU later | ₽44,000 |
| Expert evaluation of documents for recognition of registration | ₽320,000 |
A full primary registration cycle now requires paying ₽821,000 in evaluation fees alone: ₽461,000 for evaluating the drug itself and ₽360,000 for evaluating the documents. A fee for issuing the registration certificate is usually added on top of this. For human medicines, that fee is ₽10,000 under the same Article 333.32.1, but the new Part 3 of the article, introduced by Law No. 299, does not separately mention this fee for veterinary drugs. Confirming the exact amount directly with Rosselkhoznadzor before filing is the safer approach.
Bringing an already registered dossier into EAEU compliance — mandatory by December 31, 2027 — costs ₽543,000: ₽323,000 for drug evaluation and ₽220,000 for document evaluation. Companies with portfolios of several dozen products are budgeting amounts over the next two years comparable to the cost of developing a new mid-priced product.
Certificate validity depends on which rules governed issuance. Certificates issued before March 13, 2024 are valid until their original expiry date, but no later than December 31, 2027. Certificates issued under the EAEU procedure are valid for five years. A product that completes the compliance process before the deadline will still require registration confirmation five years later — another ₽313,000 across two line items in the new fee table.
Feed Additives Sit in a Different System
Feed additive registration is calculated under a different provision, paragraph 144 of Article 333.33 of the Tax Code, and has stayed noticeably cheaper. The registration fee for an additive is ₽85,000. Amendments requiring expert evaluation cost ₽34,700; amendments without evaluation cost ₽7,700.
The almost tenfold gap compared with primary drug registration comes from the fact that feed additives do not have pharmacological activity in the classic sense, and their preclinical assessment is simpler. Since September 1, 2025, this registration procedure has been governed by Order of the Russian Ministry of Agriculture No. 316 of May 7, 2025.
What Laboratory Control at VGNKI Costs
The state fee covers the regulator’s work, not the laboratory tests often needed to confirm a product’s composition and safety. FGBU VGNKI maintains a separate price list for molecular genetic and chemical-toxicological studies, and rates there are noticeably lower than the registration fees.
Identifying a single genetically modified line (GM line) of plant origin — such as the Bt11 or MIR604 line in corn — costs about ₽5,500–5,600 excluding value-added tax (VAT) per study. Quantifying the same line costs more, in the range of ₽8,500–8,900. Determining vitamin B12 content in a feed additive by UV spectroscopy costs ₽3,702 excluding VAT, while a combined determination of fat-soluble vitamins A, D3, and E by high-performance liquid chromatography (HPLC) costs ₽18,517 excluding VAT per study. VAT of 22% is added on top, and a 2.0 multiplier applies to urgent work performed on weekends.
These rates apply in the post-registration period as well. When Rosselkhoznadzor collects batch samples during routine inspections, the certificate holder pays for testing at the same price list. If a batch fails to meet its declared specifications, VGNKI conducts a repeat evaluation at 50% of the base price. The cost of a quality failure effectively doubles — a direct incentive for thorough in-house quality control at the manufacturing stage.
EAEU GMP Certification Adds Another Expense
Starting March 1, 2026, Rosselkhoznadzor began issuing certificates of conformity for veterinary drug manufacturing under EAEU GMP rules, replacing the previous national approval. The fee for issuing such a certificate is set by Government Decree No. 1681 of October 29, 2025, at ₽23,300. This covers the document itself only. Inspectors’ travel expenses, document translation for foreign facilities, and the cost of the site inspection itself are not included.
The logic of the procedure changed as well. Before March 2026, the GMP inspection and license control were two separate reviews with different timelines and documentation. They are now merged into a single periodic conformity confirmation. For manufacturers with active licenses, this reduces the administrative workload. Preparation needs to be more thorough, though: one inspection covers both questions, and a finding against either one puts both statuses at risk simultaneously.
The volume of VGNKI’s inspection work shows how seriously the regulator takes this area. In 2025 alone, VGNKI specialists conducted 29 on-site inspections of foreign manufacturing sites across 15 countries, including China, France, India, and Switzerland. For a foreign manufacturer entering the Russian market, the queue is real. Budgeting less than six months for GMP certification is optimistic in most cases.
What to Do
Recalculate your registration portfolio budget. For each drug, list separately the cost of primary registration or confirmation and the cost of EAEU compliance if it has not yet been completed.
Divide dossiers into three groups by urgency. Drugs with registrations expiring in 2026–2027 should be filed first; the rest can be scheduled for a later date.
Budget for laboratory testing as a separate line item. Request VGNKI’s current price list for your product’s specific composition, since rates for identifying GM lines and vitamins vary widely by method.
Check the GMP certificate status of your manufacturing site. If it was issued under the old rules, confirm with Rosselkhoznadzor the procedure for switching to an EAEU certificate before filing a new registration dossier.
Compare the cost of registering a medicinal product against classifying it as a feed additive, if the composition allows it. The gap in the state fee reaches a tenfold difference.
A full cycle of bringing a new veterinary drug to the Russian market now costs hundreds of thousands of rubles in fees alone. The payback calculation is worth doing at the start, before filing, not after the invoice arrives.
Regulatory Framework:
1. Order of the Russian Ministry of Agriculture No. 316 of May 7, 2025, «On Approving the Procedure for State Registration of a Feed Additive…»
2. Federal Law No. 299-FZ of July 31, 2025, «On Amendments to Article 333.32.1 of Part Two of the Tax Code of the Russian Federation»
3. Tax Code of the Russian Federation (Part Two), Article 333.32.1, Article 333.33
4. Decree of the Government of the Russian Federation No. 1681 of October 29, 2025, «On Establishing the Fee for Issuing Certificates (Conclusions) of Conformity of Veterinary Medicinal Product Manufacturing with the Good Manufacturing Practice Rules of the Eurasian Economic Union»
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