Registration of maximum selling prices
Registration of maximum manufacturer selling prices is a mandatory condition for the circulation of medicines included in the list of vital and essential drugs (VED) in the Russian Federation. This procedure is countryspecific. As of now, there are no prerequisites for harmonizing the process of registering maximum selling prices among the member states of the Eurasian Economic Union (EAEU).
The DOCLINX team possesses the necessary expertise for registering and re-registering maximum selling prices. Since 2010, our specialists have successfully conducted several hundred such procedures. We offer comprehensive support: from calculations and documentation preparation to interaction with authorized bodies — the Ministry of Healthcare of the Russian Federation and the Federal Antimonopoly Service (FAS) of Russia.
Why is registration of maximum selling prices necessary?
According to paragraph 8 of Article 61 of Federal Law No. 61-FZ "On Circulation of Medicines", it is prohibited to sell and dispense medicines included in the list of vital and essential drugs:
- for which the manufacturers have not registered a maximum selling price;
- at prices exceeding the registered or re-registered maximum selling prices for medicines, including value-added tax.
DOCLINX services will be needed in the following situations:
- your company is planning to produce a new medicine, a new dosage form, or strength;
- the manufacturing site of the medicine has changed or a new manufacturer has been added;
- the barcode or trade name of the medicine has changed;
- you have brought the dossier for the medicine in line with EAEU requirements;
- you need to increase the price of the medicine based on the projected inflation rate.
Features of the procedure for registering maximum selling prices
The price registration procedure requires close collaboration between the financial and accounting departments of the drug manufacturer. During the process, it is necessary to carefully select primary financial documents and data summaries, such as: customs declarations, goods invoices, information on expiration dates, and exchange rates at the time of product sales.
The procedure for registering the maximum selling price consists of the following stages:
- Determination of the reference drug, as well as its generics/biosimilars;
- Calculation of the proposed maximum selling price according to the methodology of the Russian Ministry of Healthcare;
- Coordination of the proposed price with the manufacturer;
- Preparation of an electronic application and formation of a dossier for submission;
- Submission of the dossier to the Russian Ministry of Healthcare;
- Support of the procedure in the Russian Ministry of Healthcare: responding to inquiries;
- Support of the procedure in the Federal Antimonopoly Service (FAS): communication with the executor, confirmation of calculations, provision of additional information, responding to inquiries;
- Receiving the electronic decision from the FAS;
- Publication of the maximum selling price on the Russian Ministry of Healthcare portal.
Features of the procedure for increasing the manufacturer's maximum selling price
For each drug, it is recommended to conduct an annual price increase procedure based on the inflation rate. To do this, it is necessary to submit an application for re-registration and relevant documents to the Russian Ministry of Healthcare by October 1 of the current year. It is important to note that re-registration is allowed no more than once per calendar year and cannot be carried out in the same year when the price was initially registered.
Duration of the procedure: 2-3 months.
Features of the procedure for increasing the manufacturer's maximum selling price after a drug is recognized as being in short supply
The procedure consists of the following order:
- The Federal Service for Surveillance in Healthcare (Roszdravnadzor) establishes the fact of a shortage or the risk of a shortage of the drug;
- The Russian Ministry of Health sends manufacturers a proposal to submit an application for a price increase;
- The FAS conducts an economic expert examination;
- The Russian Ministry of Health issues an order to register the price.
Changes to the registry entries of manufacturers' maximum selling prices
This procedure is necessary in the following cases:
- the registration certificate for the drug has been brought into compliance with the EAEU rules;
- the owner/holder of the registration certificate or its name has changed
- the manufacturer of the drug or its name has changed
- the barcode has changed
- the completeness of the drug has changed
Duration of the procedure: 1 month.
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Regulatory acts
- Federal Law No. 61-FZ of 12.04.2010 "On Circulation of Medicines"
- Decree of the Government of the Russian Federation No. 865 of 29.10.2010 "On state regulation of prices for medicines included in the list of vital and essential drugs"
- Decree of the Government of the Russian Federation No. 1771 of 31.10.2020 "On approval of the specifics of state regulation of maximum selling prices of manufacturers for medicines included in the list of vital and essential drugs, and on amendments to certain acts of the Government of the Russian Federation"
Useful links
State Register of Maximum Selling Prices
Monitoring of the range and prices of vital and essential medicines