VED Prices Follow a Stricter Formula Since 2025. What Happens If a Manufacturer Skips Reregistration
The Register of Maximum Ex-Factory Prices for medicines on the VED (Vital and Essential Drugs) list works like a light switch. As long as the price is registered in it, the drug can be sold. As soon as the entry disappears, selling turns into a violation of the law, even if the warehouse is full and demand for the drug remains.
Some manufacturers delay mandatory price reductions, hoping to wait out an inconvenient period. In reality, each month of delay increases a different risk. The fine for overcharging is calculated from the entire revenue received over a year of sales — the amount can turn out to be much larger than the price difference on a single pack. Separately, the risk grows for distributors and pharmacies that keep selling the drug at the old price, unaware of an ongoing dispute between the manufacturer and the regulator.
How VED Prices Were Regulated Until 2025
State regulation of VED prices is built on Chapter 12 of Federal Law No. 61-FZ of April 12, 2010, «On Circulation of Medicines» (hereinafter — Law No. 61-FZ). Part 1 of Article 60 of the law lists the regulation tools: the VED list, the methodology for calculating maximum prices, state registration of these prices and maintenance of their register, markups for wholesale and retail trade, oversight, and liability for violations.
From 2010 until September 2025, the procedure for registration, reregistration, and maintenance of the register of maximum ex-factory prices was governed by Decree of the Government of the Russian Federation No. 865 of October 29, 2010, «On State Regulation of Prices for Medicines Included in the VED List» (hereinafter — Decree No. 865). The Federal Anti-Monopoly Service (FAS) and the Ministry of Health approved the price calculation methodology piecemeal, through separate acts. The discount for the brand’s country of origin, applied when comparing prices with other countries, was used without restriction, while the weighted average import price was purely informational and did not directly cap the maximum price.
Selling VED drugs without a registered price, or at a price exceeding the registered one, is directly prohibited by Part 8 of Article 61 of Law No. 61-FZ. This rule did not change in 2010, nor in 2025. It is precisely this rule that creates all the risk discussed below.
Here it is important not to confuse two different lists. The VED list itself is reviewed by the Government at least once a year, under Part 1 of Article 60 of Law No. 61-FZ. Adding or removing a drug from this list happens through a different procedure, unrelated to a dispute over a specific price. The risk discussed in this article concerns only the register of maximum ex-factory prices for drugs already included in the list.
What Changed Starting September 1, 2025
Starting September 1, 2025, the procedure for registration and reregistration of maximum ex-factory prices, and for maintaining their register, is governed by Decree of the Government of the Russian Federation No. 462 of April 8, 2025, «On State Regulation of Prices for Medicines Included in the VED List» (hereinafter — Decree No. 462). It replaced Decree No. 865 and consolidated the rules on registration, reregistration, and register maintenance into a single document. Applications are now submitted through the Unified Portal of State Services with an enhanced qualified electronic signature, and both the processing time and the list of required documents have been shortened.
Together with Decree No. 462, a new methodology for calculating maximum prices took effect, approved by Decree of the Government of the Russian Federation No. 805 of May 30, 2025 (hereinafter — Decree No. 805). The methodology remains in force until September 1, 2031, and changes the calculation in three respects.
When comparing prices with other countries, the discount for the brand’s country of origin is no longer taken into account. The basis is now the lowest price among foreign manufacturers on the approved list of countries. The weighted average actual import price has stopped being a purely informational figure: the proposed price can no longer exceed this value, calculated from drug traceability system data for the reporting period. On reregistration for a price increase, growth is capped by the previous year’s actual inflation rate, adjusted for the forecast figure from the budget law. For generics and biosimilars, the price is tied firmly to the price of the reference drug and to the second registered price for the same International Nonproprietary Name (INN).
Example. A manufacturer imported a pack of a drug at 420 rubles and registered the maximum ex-factory price at that level. Over the reporting period, the weighted average actual import price, according to monitoring system data, fell to 360 rubles as the ruble strengthened. Under the Decree No. 805 methodology, the proposed price can no longer exceed 360 rubles. If the manufacturer does not file a reregistration application and keeps shipping the goods at 420 rubles, FAS has grounds to treat 60 rubles per pack as excess revenue.
Part 4 of Article 61 of Law No. 61-FZ separately requires the holder of the marketing authorization (MAH) to file an application for a price decrease in four specific cases: the price of the drug in the manufacturer’s country has fallen in foreign currency, the price of the reference drug has fallen, or the price of the first generic has exceeded the calculated price of the second generic — for a foreign manufacturer or for a manufacturer from an EAEU (Eurasian Economic Union) member state. This is a specific list of four grounds, separate from Decree of the Government of the Russian Federation No. 1771 of October 31, 2020, which sets a special procedure for price regulation when economic or social conditions of production change, including a rise in the foreign exchange rate and higher raw material costs.
Decree No. 1771 is applied more broadly than a one-off decrease following a regulator’s complaint. It covers cases where production conditions and costs change, new pricing mechanisms are introduced, including reference pricing, or the foreign exchange rate fluctuates noticeably. It is a tool for revising the approach to a drug’s price during a systemic shift in the industry’s economic situation.
| Parameter | Until 01.09.2025 | From 01.09.2025 |
|---|---|---|
| Registration and register rules | Decree No. 865 of 29.10.2010 | Decree No. 462 of 08.04.2025 |
| Price calculation methodology | Scattered acts of FAS and the Ministry of Health | Single methodology under Decree No. 805, in force until 2031 |
| Brand country-of-origin discount | Taken into account when comparing prices | Not taken into account; the lowest price on the list of countries is used |
| Import price | Informational figure | Directly caps the maximum price |
| Filing applications | Paper-based document flow | Unified Portal of State Services, enhanced qualified signature |
What Continued Sales Without Reregistration Entail
If the MAH does not file the mandatory application for a price decrease required by Part 4 of Article 61, the registered price formally stays in the register unchanged. The drug does not disappear from the register automatically. The price at which it continues to be sold stops matching the price the law requires to be registered. This creates grounds for liability under Part 1 of Article 14.6 of the Code of the Russian Federation on Administrative Offenses (KoAP RF), for overcharging regulated prices.
The fine under this part is calculated at double the amount of the entire revenue obtained as a result of the price overcharge, for the whole period of the violation. The calculation period is capped at one year. Officials pay a separate fine of 50,000 rubles or face disqualification for up to three years; individuals pay 5,000 rubles. Part 2 of the same article covers underpricing and any other violation of pricing procedure: for legal entities, it carries a fixed fine of 100,000 rubles, regardless of turnover.
Price information is removed from the register on a different basis and through a different procedure. The register maintenance rules, approved by the same Decree No. 462, provide for removal on the MAH’s application if the drug is no longer in circulation on Russian territory, the shelf life of the last batch put into circulation has expired, or the marketing authorization itself has expired. Removal is tied to the drug’s legal status ending: an expired registration or exit from the market. A dispute with FAS over the size of the price does not by itself lead to removal from the register. As long as the marketing authorization remains valid and the drug is physically supplied, the entry in the register stays in place, even if the manufacturer fails to lower the price for years.
The risk for distributors and pharmacies arises precisely in this window. The price in the register formally stays as registered. It already exceeds the value the manufacturer was obliged to register. The retail tier may not know about the manufacturer’s dispute with the regulator and may keep selling the drug, falling under the same Part 1 of Article 14.6 of the KoAP RF as a participant in the supply chain.
A separate risk node is state contracts. The customer is required to buy VED drugs at prices not exceeding the registered ones, under Part 8 of Article 61 of Law No. 61-FZ and the requirements of Federal Law No. 44-FZ of April 5, 2013, «On the Contract System» (hereinafter — 44-FZ). If a FAS check finds that the actual delivery price exceeded the amount due, the customer has the right to terminate the contract unilaterally, on grounds under the Civil Code of the Russian Federation written into the contract text — Part 9 of Article 95 of 44-FZ.
Once such a decision takes effect, the customer is required to send FAS an application to include the supplier in the Register of Unscrupulous Suppliers (RNP), under Part 22.2 of Article 95 of 44-FZ. The RNP maintenance rules, approved by Decree of the Government of the Russian Federation No. 1062 of November 25, 2013, set a two-year period for keeping the record in the register. During that time, the company effectively loses access to procurement under 44-FZ and Federal Law No. 223-FZ.
Terminating a contract by mutual agreement does not trigger sending information to the RNP. Customers agree to this option reluctantly: they then have to explain to higher authorities why the contract was not fully performed.
What to Do
Audit your VED portfolio. Divide the drugs into three groups:
Green: the price has been recalculated under the Decree No. 805 methodology and confirmed
Yellow: one of the four grounds under Part 4 of Article 61 has arisen, and the application has not yet been filed
Red: the marketing authorization expires within the next 12 months
Recalculate the maximum prices under the current methodology. Compare the registered price against the weighted average actual import price and the lowest price on the list of foreign countries in Annex No. 3 to Decree No. 805.
File the price-decrease application before the audit, not after it. If one of the grounds under Part 4 of Article 61 has arisen, taking the initiative ahead of a FAS directive lowers the risk of a fine under Part 1 of Article 14.6 of the KoAP RF.
Assemble the economic justification in advance. A cost calculation, raw-material purchase contracts, and customs declarations will be needed if you have to challenge the price calculation proposed by FAS.
Review the terms of your current state contracts. Find the clauses on unilateral termination and force majeure, and check the deadlines for notifying the customer of a change in the price’s registration status. How these clauses are worded determines whether the company ends up in the RNP if a price mismatch is found.
Managing VED prices has long stopped being a one-off procedure carried out when a drug is registered. The Decree No. 805 methodology ties the maximum price to actual import and sales volumes, which means it has to be recalculated whenever the exchange rate or the supply structure shifts noticeably. A company that treats reregistration as a quarterly check spends less on fines and less often risks a place in the RNP than one that puts off the recalculation until a FAS directive arrives.
Regulatory basis:
1. Decree of the Government of the Russian Federation No. 1062 of 25.11.2013, «On the Procedure for Maintaining the Register of Unscrupulous Suppliers (Contractors, Performers)»
2. Federal Law No. 61-FZ of 12.04.2010, «On Circulation of Medicines»
3. Decree of the Government of the Russian Federation No. 462 of 08.04.2025, «On State Regulation of Prices for Medicines Included in the VED List»
4. Decree of the Government of the Russian Federation No. 805 of 30.05.2025, «On Approval of the Methodology for Calculating Maximum Ex-Factory Prices of Manufacturers for Medicines Included in the VED List»
5. Decree of the Government of the Russian Federation No. 1771 of 31.10.2020, «On the Specifics of State Regulation of Maximum Ex-Factory Prices of Manufacturers for Medicines Included in the VED List»
6. Code of the Russian Federation on Administrative Offenses, Article 14.6
7. Federal Law No. 44-FZ of 05.04.2013, «On the Contract System in the Procurement of Goods, Works and Services for State and Municipal Needs,» Article 95