Russia Replaced Its Pricing Formula for Essential Medicines. Decree No. 805 Takes Effect in September 2025.
A manufacturer of a vital and essential drug can no longer rely on cost calculations as the primary argument for price registration. The regulator now compares the requested price against three benchmarks at once: actual sales of the drug in Russia, its import price, and the manufacturer’s minimum selling prices in eleven foreign countries, and registers the lowest of the three.
For a company introducing a new drug from the VED (Vital and Essential Drugs) list or preparing to re-register one already on the market, this means gathering data from the drug circulation monitoring system, customs statistics, and foreign price lists before submitting an application. Decree of the Government of the Russian Federation No. 805 dated May 30, 2025, «On Approval of the Methodology for Calculating Maximum Selling Prices of Manufacturers for Medicinal Products Included in the List of Vital and Essential Drugs for Medical Use» (hereinafter, Decree No. 805 or the Methodology) codified these rules. It came into force on September 1, 2025, and remains effective until September 1, 2031.
The relevance of the Methodology is confirmed by data from the analytical company RNC Pharma: in 2025 the retail pharmaceutical market in Russia grew to 1.89 trillion rubles, with monetary growth of 15.8% against growth of only 1.8% in packaging units. This gap between monetary and physical growth shows the market getting more expensive faster than consumption is growing, and the state has responded by tightening control over the prices of socially significant medications.
How Prices Were Registered Prior to September 2025
For fifteen years, VED prices were registered under the rules of Decree No. 865 dated October 29, 2010, and the methodology approved by Decree No. 979 dated September 15, 2015. The Government repealed both documents (with minor exceptions) and replaced them with a new pair of acts: Decree of the Government of the Russian Federation No. 462 dated April 8, 2025, «On State Regulation of Prices for Medicinal Products Included in the List of Vital and Essential Drugs for Medical Use» (hereinafter, Decree No. 462), and Decree No. 805.
The roles between the two documents are clearly divided. Decree No. 462 describes the procedure: who makes the decision, within what timeframe, and on the basis of which documents. Decree No. 805 is responsible only for the price arithmetic, meaning what data to collect and how to calculate it. The registration and re-registration service remains free of charge for the applicant, and the total timeframe for the Ministry of Health of the Russian Federation (Minzdrav of Russia) to process it cannot exceed 26 working days from the moment the application is submitted through the State Services portal (Gosuslugi) or the applicant’s account in the unified health information system.
What the Regulator Compares When Registering a New Price
The Methodology introduces three independent constraints, and the declared price cannot exceed the lowest of them.
The first constraint applies when there is no registered price for the required dosage. The cost per unit of active substance is calculated as the arithmetic mean of the prices of the two closest registered dosages of the same drug, then multiplied by the amount of active substance in the new package. This approach blocks artificial price inflation through the «splitting» of dosages that offer no therapeutic advantage and simply cost more.
The second constraint depends on where the drug is made. For manufacturers from EAEU (Eurasian Economic Union) member states, and for foreign drugs whose primary or secondary packaging is carried out (or planned) in Russia, the regulator uses the weighted average actual selling price for the reporting period. For other foreign drugs, the weighted average actual import price applies, customs duties and clearance fees included.
The third constraint is international reference pricing. The price cannot exceed the manufacturer’s minimum selling price in the country of production and in the eleven countries listed in Annex No. 3 to the Methodology: Belgium, Hungary, Greece, Spain, the Netherlands, Poland, Romania, Slovakia, Turkey, France, and the Czech Republic. Prices in foreign currency are converted to rubles at the average Central Bank of Russia exchange rate for the three calendar months preceding the application.
| Parameter | Before (until Sept 1, 2025) | Now (since Sept 1, 2025) |
|---|---|---|
| Regulatory acts | Decree No. 865 (2010) + Methodology under Decree No. 979 (2015) | Decree No. 462 (procedure) + Decree No. 805 (methodology) |
| Dosage limitation | Case-by-case guidance from the FAS (Federal Antimonopoly Service) on request | Linear interpolation formula based on the two closest registered dosages |
| Import limitation | Import price without a strict link to the monitoring system | Weighted average import price drawn from the drug circulation monitoring system |
| Reference countries | The country list changed through separate decisions | A closed list of 11 countries in Annex No. 3 |
| Service timeframe | Not fixed to a single unified deadline | No more than 26 working days |
Profitability of EAEU Manufacturers and Cases of Mandatory Price Reduction
For drugs made in EAEU states, the Methodology calculates product profitability separately. The rule applies not at initial registration but at re-registration: if a manufacturer raises the price because of higher raw material or overhead costs (cases «a» through «c» of paragraph 34 of the Rules approved by Decree No. 462), and actual profitability for the reporting period exceeds 30%, the requested price is cut back to that limit.
The price increase itself is capped by inflation at re-registration: the formula factors in the consumer price index for the past calendar year and the projected inflation rate from the federal budget law for the current year. An application for a price increase can be filed no more than once a calendar year, and only before October 1. For drugs priced under 100 rubles and from 100 to 500 rubles, the law separately lists the permitted grounds for an increase (higher costs of raw materials and supplies, changes in overhead costs, including the effects of currency swings and force majeure at suppliers). Either way, the ceiling stays at the inflation level and no higher.
A manufacturer must cut a registered price in four cases. The first: a price drop, in foreign currency terms, in a reference country. The second: a price cut for the reference drug, which pulls down the prices of the corresponding generics and biosimilars. The third and fourth are the so-called «second-generic» rule: the price of the first generic or biosimilar of a given INN (International Nonproprietary Name) cannot exceed the price of the second one registered later, calculated separately for foreign manufacturers and separately for EAEU manufacturers.
A manufacturer has 25 working days from the moment a ground for reduction arises to file the application. If it doesn’t file on its own, the FAS (Federal Antimonopoly Service) sends a notice and gives it 20 working days to bring the price into line. On refusal, the Ministry of Health removes the price from the state registry, which effectively halts legal sales of the drug in Russia.
Action Plan
Split your VED portfolio into three groups by type of price constraint. Separate EAEU-made drugs, foreign drugs packaged locally in Russia, and purely imported items — each group has its own primary price benchmark.
Collect data on minimum prices in the eleven reference countries now. The source needs to be a publicly accessible website that states currency and drug characteristics; data from humanitarian or charitable supplies doesn’t count.
Check actual profitability before filing for a price increase. If it’s approaching 30%, prepare your justification for overhead costs in advance, or the requested price will be cut automatically.
Set up ongoing monitoring of prices in the reference countries. A price drop abroad starts a 25-working-day clock to file for re-registration in Russia, and missing it risks forced removal from the registry.
Plan to file price-increase applications before October 1. A later filing pushes the increase to the following calendar year.
Decree No. 805 shifts the main burden of proof from the regulator to the applicant. A company that keeps current data on import prices, foreign price lists, and profitability on hand gets through registration within the allotted 26 working days. A company that gathers this data after the fact risks a FAS refusal to approve the price, and a much longer wait on resubmission.
Regulatory framework:
1. Federal Law No. 61-FZ dated 12.04.2010, «On the Circulation of Medicines» (Articles 60–63)
2. Decree of the Government of the Russian Federation No. 805 dated 30.05.2025, «On Approval of the Methodology for Calculating Maximum Selling Prices of Manufacturers for Medicinal Products Included in the List of Vital and Essential Drugs for Medical Use»
3. Decree of the Government of the Russian Federation No. 462 dated 08.04.2025, «On State Regulation of Prices for Medicinal Products Included in the List of Vital and Essential Drugs for Medical Use»