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The Ministry of Health has set pricing rules for unregistered foreign medicines.
Published on: Apr 11, 2025
Reading Time: 5 min
The draft resolution will be open for public discussion until May 12.
The Russian Ministry of Health has developed a draft resolution that provides for new pricing rules for unregistered foreign drugs that are imported for the treatment of patients for individual vital indications, the international nonproprietary names (INN) of which are included in the list of vital and essential drugs (VED).
If the project is adopted, it will come into force on September 1, 2025. The document, which is planned to be adopted for 6 years, will eliminate a legal gap - there is currently no such regulation.
According to the draft, organizations importing such drugs will have to submit an application to the Ministry of Health in two paper copies. It must be accompanied by a translation of the instructions for use of the drug or its brief description approved in the country of manufacture. The applicant will also be required to indicate the cost of the drug, including transportation costs, customs duties, the cost of the drug from the manufacturer, exchange rate differences and other expenses.
The regulator must set prices taking into account the volume of imported medicine and in accordance with the Rules for the Import of Medicines for Medical Use, which the government approved in 2021. The Ministry of Health must check the documents provided within 2 working days, and then send one copy of the documents to the FAS to assess the validity of the price. The antimonopoly service will be able to either approve the cost or refuse, indicating the reasons to the applicant. The grounds for refusal may be incompleteness or failure to provide information and necessary documents, as well as an excess of the price of the declared cost of the drug in the country of the manufacturer.
The approved prices must be published in a special list on the website of the Ministry of Health. The register will include information about the applicant, the international name of the drug, its form, dosage, as well as the manufacturer and the country of manufacture.
Earlier, the Russian Ministry of Health developed a draft of a new methodology for calculating maximum selling prices for drugs included in the list of vital and essential drugs. Unlike the current unified methodology, approved in 2015, the new document assumes an individual price calculation for each manufacturer within the framework of the registration certificate for its drug. If approved, the document will come into force on September 1, 2025.
* Source : GxP News.