EAEU Reference Member State — Comparing Fees, VAT and Examination Depth Across Five Countries
When a company decides to enter the Eurasian Economic Union (EAEU) market through the Mutual Recognition Procedure (MRP) or the Decentralized Procedure (DCP), the very first question leads to a dead end: where to submit? Technically, one can choose any of the five member states. But behind this «technical» decision stands a real bill: the difference in costs between the right and wrong choice can reach several tens of thousands of dollars. Plus a year of wasted time if Russia refuses to recognize a registration obtained in Bishkek.
Let us examine how the five regulatory systems are structured, how they actually differ, and by what criteria the choice should be made.
Why Choosing a Reference Member State Is a Strategy, Not a Formality
The rules for the registration of medicines in the EAEU are established in Decision of the Council of the Eurasian Economic Commission No. 78 dated November 3, 2016, «On the Rules for Registration and Examination of Medicines for Medical Use» (hereinafter — Rules No. 78). Under these rules, in both the Decentralized Procedure (DCP) and the Mutual Recognition Procedure (MRP), the applicant itself selects the Reference Member State (RMS).
The RMS conducts the primary examination of the dossier across all three assessment modules: quality, safety, and efficacy. The remaining member states, acting as Concerned Member States (CMS), generally accept this decision, but retain the right to raise objections if they identify a serious risk to public health.
This is precisely where the trap lies. If the examination in the RMS turns out to be superficial, a regulator with stricter standards is entitled to request additional data or refuse recognition. In practice, Russia — which accounts for approximately 85% of the total EAEU market volume — has repeatedly exercised this right in relation to registrations obtained in countries with less demanding examination systems.
The RMS is selected for the entire life cycle of the marketing authorisation (MA). This is a long-term decision, and the cost of a mistake grows with every year the product is on the market.
Five Systems — What to Look At
Regulatory systems are best evaluated across four parameters: the financial burden of entry, the stringency of examination, the severity of sanctions, and the state of infrastructure. All four affect the cost and reliability of registration.
Russia — Expensive, Strict, Authoritative
The Russian regulatory system rests on three pillars: Federal Law No. 61-FZ dated April 12, 2010, «On the Circulation of Medicines» (FZ-61), EAEU norms that take precedence over national legislation, and an extensive system of secondary legislation from the Ministry of Health and the Government of the Russian Federation. The regulators are the Ministry of Health of the Russian Federation and Roszdravnadzor (the Federal Service for Health Surveillance); the examination is conducted by the Scientific Centre for Expert Evaluation of Medicinal Products (SCEEMP).
The financial barrier to entry is the highest in the Union. Article 333.32.1 of the Tax Code of the Russian Federation fixes the base fee for the examination of quality and the benefit-risk ratio at 325,000 rubles. If clinical trials (CT) involving Russian sites are required for registration, an additional 110,000 rubles is charged for the examination of documents to obtain authorization to conduct them. Each subsequent dossier variation requiring examination costs another 75,000 rubles. Beyond official fees, a significant cost item is the GMP (Good Manufacturing Practice) inspection of the manufacturing site, conducted by the Federal State Institution «State Institute for Drugs and Good Practices» (FSI «GIDPs»): including inspectors’ travel and expert time, this adds tens of thousands of dollars on top.
The stringency of examination is high: SCEEMP experts analyze Module 3 of the dossier in detail and often raise requirements that exceed average European standards. For originator products and biosimilars, Russia does not always accept solely overseas clinical data, insisting on the inclusion of Russian clinical sites. This prolongs the path to a marketing authorisation.
The «Chestny ZNAK» track-and-trace system (MDLP — Monitoring of Drug Lot Movements) deserves separate mention. Mandatory serialization of every package requires investment in IT infrastructure and manufacturing equipment. An error in data transmission to the system can block the circulation of an entire drug batch.
The enforcement environment is severe. Article 6.33 of the Code of Administrative Offences of the Russian Federation (CAO RF) provides for fines of between 1 and 5 million rubles for legal entities for the circulation of falsified, counterfeit, or unregistered medicines, or administrative suspension of operations for up to 90 days. Where serious consequences occur, criminal liability arises under Article 238.1 of the Criminal Code of the Russian Federation, with real custodial sentences.
Overall, Russia remains the most expensive and demanding market in the Union — but also the most authoritative: registration here effectively opens doors to all other member states.
Kazakhstan — Transparent, Digital, But with Price Controls
The Kazakhstani system is based on the Code «On Public Health and the Healthcare System» (2020). The National Centre for Expert Evaluation of Medicines and Medical Devices (NCEEMD) acts as the expert body. Licensing is automated through the «E-licensing» portal (elicense.kz): this reduces corruption risk but raises formal stringency, since the system automatically rejects applications at the slightest format discrepancy.
Fees are pegged to the Monthly Calculation Index (MCI). The fee for issuing a marketing authorisation is nominal — 5 MCI; the main burden is payment for NCEEMD services under the state schedule, ranging from 300,000 to 600,000 tenge and above depending on the procedure type.
On January 1, 2026, Kazakhstan’s new Tax Code came into force (Law of the Republic of Kazakhstan No. 214-VIII dated July 18, 2025). The standard VAT rate rose from 12% to 16%, but a preferential rate was introduced for medicines: 5% in 2026, rising to 10% from 2027. Medicines within the Guaranteed Volume of Free Medical Care (GVFMC) and Compulsory Social Health Insurance (CSHI), as well as approximately 1,200 items for orphan and socially significant diseases, are fully exempt from VAT under Government Resolution of the Republic of Kazakhstan No. 1203 dated December 31, 2025. In practice, the tax burden for a specific product depends on its status and distribution channel — this must be calculated before market entry, not after.
An additional restraining factor is price regulation. The manufacturer is obliged to register a ceiling price, calculated by reference to a basket of comparator countries that includes Kyrgyzstan with its traditionally low prices. Marketing expenditure is excluded from the registered price, significantly constraining product promotion.
Administrative liability: Article 426 of the CAO RK provides for fines of up to 1,000 MCI for legal entities; a repeated violation within a year triggers suspension of the licence for up to 6 months.
Kazakhstan offers good procedural predictability and a high level of expertise, but price pressure and the tax reform make this market challenging for high-margin products.
Belarus — State-Run System with a Risk of Confiscation
The Belarusian system relies on Law No. 161-Z «On the Circulation of Medicines» and Law No. 213-Z «On Licensing» (in force since 2023). The expert function is performed by the RCETH — the Republican Centre for Examinations and Tests in Health Care.
Since 2021, Belarus has applied a 10% VAT rate on the import and sale of medicines, making it the first EAEU country to abolish the VAT exemption for this category. The cost of examination is governed by state price schedules and is at an average EAEU level. For importers, an additional risk is the volatility of the Belarusian ruble: ceiling selling prices are registered in the national currency.
The central risk of the Belarusian system is Article 13.3 of the Code of Administrative Offences of the Republic of Belarus, «Unlawful Business Activity.» The sanction provides not only for a fine of up to 500 basic units, but also for the confiscation of all income derived from such activity. If a product is found to be unregistered — for example, because the packaging does not match the dossier — the entire revenue from its sales is subject to forfeiture to the state budget. An operational error here is more costly than in any other country in the Union.
Kyrgyzstan — Low Barriers, But an Unstable Regulatory Environment
In 2024, Kyrgyzstan adopted new laws: No. 13 «On the Circulation of Medicines» and No. 14 «On Public Health Protection,» aimed at full harmonization with EAEU law. The Department of Medicines and Medical Devices (DMMD) is increasing oversight. Taken together, these are signs of a major regulatory overhaul.
The tax regime for medicines changed several times over the past two years. In August 2024, the Cabinet of Ministers abolished the preferential list of products exempt from VAT (Resolution No. 528), causing pharmacy prices to rise. A year later the exemptions were reinstated: Cabinet of Ministers Resolution No. 539 dated August 29, 2025 restored VAT exemption for listed medicines and medical devices. In December 2025, the exemptions were extended until December 31, 2027. Today, medicines on the approved list are VAT-free on import and supply — but this status is not guaranteed over a longer horizon.
The cost of expert work remains among the lowest in the EAEU. A serious constraint is laboratory capacity: there is insufficient equipment for bioanalytical testing, so the regulator either accepts results from foreign laboratories or extends timelines. For complex products, this creates meaningful uncertainty.
The strategic risk of using Kyrgyzstan as the RMS for complex products remains high. Russia and Belarus may request additional data or refuse recognition, citing insufficient depth of examination.
Armenia — Low Barriers, European Standards
Armenia offers a combination that is rare in the EAEU: low state fees alongside a reasonably high quality of examination. The Scientific Centre for Drug and Medical Technology Expertise (SCDMTE) operates to standards close to European norms.
The state fee amounts to 40,000 drams for the examination and registration of a medicine (approximately USD 100). The annual licence fee for wholesale trade is 100,000 drams. By these metrics, Armenia is the most affordable jurisdiction for maintaining a portfolio of marketing authorisations.
The enforcement environment is moderate: fines for violations have historically been low, and an increase to 800,000 drams (approximately USD 2,000) is under discussion. The standard 20% VAT rate applies to medicines as well, but without the specific regulatory pressure characteristic of other Union countries.
Comparison Table
| Parameter | Russia | Kazakhstan | Belarus | Kyrgyzstan | Armenia |
|---|---|---|---|---|---|
| Base registration fee | 325,000 RUB | 300,000–600,000 KZT | State price schedule | State price schedule | ~40,000 AMD (~USD 100) |
| VAT on medicines (2026) | 10% | 5% (0% for GVFMC/CSHI products) | 10% | 0% (approved list, until 31.12.2027) | 20% (standard rate) |
| Stringency of examination | Very high | High | Medium | Below medium | Medium |
| Risk of non-recognition by other EAEU states | Minimal | Low | Low | High | Low |
| Specific risks | MDLP serialization; local CT requirement | Price controls; VAT increase from 2027 | Revenue confiscation under CAO Art. 13.3 | Preferential regime instability; weak laboratory capacity | Moderate |
| Financial burden | Very high | High | Medium | Low | Low |
| Authority for Concerned Member States | Maximum | High | Medium | Low | Medium |
Three Scenarios for Choosing
The choice of RMS depends on the product type and market-entry strategy. There is no single universal answer, but there is a clear logic.
Innovative or Originator Product
Here, the choice falls on Russia. The high cost of examination and the requirement for local clinical data are offset by the fact that registration in the Russian Federation effectively opens doors to Kazakhstan and Belarus without further questions. For an originator or biosimilar where tens of millions of dollars are at stake, economizing on the RMS is impractical.
Generic Portfolio
Armenia or Kazakhstan. Armenia provides minimum costs with an adequate level of examination for generic products. Kazakhstan offers a transparent, digital procedure well regarded by other regulators. Both options provide a reasonable balance of cost and outcome reliability.
Food Supplements and Simple Generics
Kyrgyzstan or Armenia. Certificates of State Registration (CSR) for food supplements (FSs) issued in these countries are recognized across the entire EAEU territory. The procedure is noticeably faster and cheaper than through Rospotrebnadzor in Russia. For simple generics with limited commercial potential, the difference in entry costs can determine the product’s overall profitability.
What to Do
Identify target markets. If Russia is among them — and for most companies it is — assess the risk of non-recognition by the Russian regulator upfront. Request a preliminary consultation from the SCEEMP or from a regulatory partner with experience in the Russian market.
Calculate the total cost. Comparing fees alone is not enough. Factor in the cost of GMP inspection, expenses for local clinical data (where applicable), the cost of connecting to track-and-trace systems, and the fees of the Authorised Representative of the Manufacturer (ARM) in each country. For Russia, a GMP inspection of an overseas site alone can cost between USD 20,000 and USD 50,000.
Verify laboratory capacity. For products with non-standard analytical methods, confirm in advance that there is an accredited laboratory with appropriate equipment in the chosen RMS. This is particularly relevant for Kyrgyzstan.
Assess the tax burden over a three-year horizon. In Kazakhstan, VAT on medicines is increasing: 5% in 2026, 10% from 2027. In Kyrgyzstan, VAT exemptions have been extended to end-2027, but what happens after that date remains unknown. Build both scenarios into the financial model.
Prepare the dossier to maximum requirements. A dossier meeting Russian standards will be accepted by any EAEU member state. A dossier prepared only to the minimum requirements of Armenia or Kyrgyzstan may face additional queries in Russia and Belarus. The difference in dossier preparation costs is, as a rule, less than the cost of responding to queries and undergoing repeat examinations.
The logic of choosing a Reference Member State does not change when taxes and lists change. It is determined by where you are most likely to obtain a registration recognised in all your target markets.
Regulatory Framework:
1. Law of the Republic of Armenia «On State Duty»
2. Decision of the EAEU Council dated November 3, 2016, No. 78 «On the Rules for Registration and Examination of Medicines for Medical Use» (as amended in 2025)
3. Decision of the EAEU Council dated May 22, 2025, No. 34 «On Amendments to Decision of the EAEU Council No. 78»
4. Federal Law dated April 12, 2010, No. 61-FZ «On the Circulation of Medicines» (as amended July 23, 2025)
5. Tax Code of the Russian Federation, Article 333.32.1
6. Code of Administrative Offences of the Russian Federation, Article 6.33; Criminal Code of the Russian Federation, Article 238.1
7. Tax Code of the Republic of Kazakhstan (Law of the Republic of Kazakhstan No. 214-VIII dated July 18, 2025), Article 503
8. Resolution of the Government of the Republic of Kazakhstan dated December 31, 2025, No. 1203 (list of medicines exempt from VAT)
9. Code of Administrative Offences of the Republic of Kazakhstan, Article 426
10. Law of the Republic of Belarus No. 161-Z «On the Circulation of Medicines»; Code of Administrative Offences of the Republic of Belarus, Article 13.3
11. Law of the Kyrgyz Republic dated January 12, 2024, No. 13 «On the Circulation of Medicines»
12. Resolution of the Cabinet of Ministers of the Kyrgyz Republic dated August 29, 2025, No. 539 (lists of medicines exempt from VAT)