The Russian Ministry of Health has published a draft government decree outlining the pricing rules for unregistered foreign medicines imported into Russia for providing medical care based on vital indications for specific patients. These medicines must have international nonproprietary names (INNs) listed in the vital and essential drugs (VED) list. If adopted, the document will take effect on September 1, 2025, and remain in force for six years. Currently, no similar pricing regulations exist.
To obtain an approved price for such a drug, the organization that imports it must submit two paper copies of an application to the Ministry of Health, including a Russian translation of the drug’s medical use instructions or a summary of product characteristics approved in the country of origin.
The regulator will determine the price of the unregistered medicine based on the volume of the imported drug in accordance with the 2021 Government Rules on the Import of Medicines for Medical Use.
When submitting the application, the importer must also provide detailed cost information, including transportation expenses, customs duties, the manufacturer’s price, exchange rate differences, and other associated costs.
The Ministry of Health must verify the completeness and accuracy of the application within two working days and then forward one copy of the documents to the Federal Antimonopoly Service (FAS) for a price validation review.
FAS must then either approve the proposed price or issue a denial with a justification. Grounds for rejection may include incomplete documentation or a proposed price exceeding the product’s cost in its country of origin.
Once the price is approved, the Ministry of Health will add the information to the official register of approved prices for unregistered drugs, which will be published on the Ministry’s website. The register must include the following details:
- Name of the applicant
- INN, or generic/chemical name of the unregistered medicine
- Trade name of the drug
- Dosage form and strength
- Manufacturer and country of origin
- Approved price
- Date and reference numbers of the Ministry and FAS decisions
In mid-February 2025, the Ministry also presented an updated methodology for calculating the maximum selling prices of medicines on the VED list. This proposal is intended to replace the current pricing rules adopted by the Russian government in September 2015. The new approach aims to move away from a uniform pricing formula toward an individualized calculation for each manufacturer, taking into account regulatory approval specifics. If adopted, this methodology would also come into effect on September 1, 2025.
Source: Vademecum, April 17, 2025
