Legal Support for the Registration and Reregistration of Maximum Manufacturer Prices for VED

Entities commercializing medicinal products included in the Vital and Essential Drugs (VED) List are legally mandated to establish maximum manufacturer prices. These prices must be formally registered with the Ministry of Health of the Russian Federation and cannot be exceeded during commercial circulation. Furthermore, companies must comply with the maximum wholesale and retail markups established by each constituent entity of the Russian Federation. Compliance with these registered maximum manufacturer prices is also mandatory when calculating the Initial Maximum Contract Price (IMCP) for public procurement tenders.

Wholesale and retail markups are calculated in accordance with the Rules for Establishing Maximum Wholesale and Retail Markups on Actual Manufacturer Prices for Medicinal Products Included in the VED List. These markups are applied based on the statutory maximum manufacturer price under effective legislation. Since January 1, 2021, manufacturers are strictly prohibited from selling medicinal products if their maximum manufacturer prices were not reregistered during 2019–2020 pursuant to the Mandatory Reregistration Rules. Consequently, the reregistration of maximum manufacturer prices for medicinal products remains an urgent operational requirement.

Legal Analysis of Grounds for Reregistering Maximum Manufacturer Prices

Specifically, the legislation mandates a reduction in the maximum manufacturer price for medicinal products included in the VED List under the following circumstances:

1. A reduction in the foreign currency price of the medicinal product in the country of origin and/or in countries where the drug is registered or supplied by the manufacturer;
2. A price reduction for reference medicinal products (applicable to corresponding generic, biosimilar, or follow-on biological products);
3. Where the maximum manufacturer price for the first foreign-manufactured generic or biosimilar product exceeds the manufacturer's maximum price for the second generic or biosimilar product;
4. Where the maximum manufacturer price for the first generic or biosimilar product from a Eurasian Economic Union (EAEU) member state exceeds the maximum manufacturer price for the second generic or biosimilar product from an EAEU member state.

Compilation of Documentation for Drug Price Reregistration

Effective legislation establishes the Methodology for Calculating Maximum Manufacturer Prices for Medicinal Products Included in the Vital and Essential Drugs List during State Registration and Reregistration, enacted by Government Decree No. 979 dated September 15, 2015.

Pursuant to these statutory frameworks, an application to reregister maximum manufacturer prices for VED must be submitted to the Ministry of Health, accompanied by the following documentation:

1. Formally executed application for price reregistration;
2. Historical pricing metrics established during initial registration (if previously registered);
3. Meticulous calculation sheets for the proposed maximum manufacturer price;
4. Robust cost justification metrics for medicinal products manufactured in foreign jurisdictions;
5. Evidentiary documentation verifying the applicant’s legal rights to the medicinal product.

Managing Price Reregistration Workflows with the Ministry of Health and the FAS

Applications may be submitted in hard copy or digitally via the "Gosuslugi" state portal. The statutory review period is 15 business days, during which the Ministry of Health coordinates and aligns the proposed pricing with the Federal Antimonopoly Service (FAS Russia). Upon expiration of this period, a formal determination on price reregistration is issued. However, the Ministry of Health may issue regulatory deficiency letters requesting additional documents and clarifications, which must be furnished within 10 business days from the request date; failure to comply may result in a threshold denial.

Once approved, the updated maximum manufacturer price for the VED product is officially recorded in the State Register of Medicines (GRLS).

Legal Risk Assessment and Price Justification Frameworks

It is critical to emphasize that post-approval variation and reregistration procedures for maximum manufacturer prices require compelling economic justification before the regulatory authority. Historically, a failure to demonstrate a reasonable pricing structure has led several global manufacturers to divest from the Russian market. To prevent drug shortages, the Government has implemented specialized mitigation protocols.

Specifically, FAS Guidance Letter No. TN/33468/22 dated April 7, 2022, dictates that when assessing whether to petition the Ministry of Health for price adjustments, marketing authorization holders (MAHs) must conduct a granular pricing analysis. They must differentiate between medicinal products eligible for standard annual upward indexing and those experiencing significantly altered economic conditions. To mitigate drug shortage risks, the latter may adjust prices exclusively under specific emergency protocols outlined in the Decree. In such cases, applicants must provide exhaustive economic and social criteria demonstrating the market pressures that present an imminent risk of a drug shortage.

Consequently, navigating the registration and reregistration of VED prices precludes a superficial, formalistic approach; it demands an individualized pricing justification that carefully balances patient access with the commercial viability of pharmaceutical manufacturers.

Comprehensive Legal Offerings for VED Price Registration and Reregistration

1. Analyzing active maximum manufacturer prices to determine the necessity of upward or downward price reregistration;
2. Advising on alternative reregistration pathways designed to protect the commercial interests of the marketing authorization holder (MAH);
3. Providing legal support throughout the compilation and formal submission of price reregistration dossiers and applications;
4. Evaluating pricing adjustment opportunities aligned with economic data to mitigate drug shortage risks.