The process of simplifying the registration of maximum selling prices for vital and essential drugs can be streamlined

The Ministry of Health has proposed changes to the draft resolution regulating prices for essential and vital drugs. The plan involves a reduction in the registration period for manufacturers’ maximum retail prices from 60 to 40 working days, as well as a decrease in the required documents from 12 to six. The proposed document introduces the option of providing the service electronically, including through the government services portal, with the changes expected to take effect from September 1, 2024.
A key aspect of the proposal is the introduction of electronic service delivery, including through the government services portal. The resolution also clarifies the pricing mechanism for immunobiological drugs and blood/plasma-derived products, taking into account requirements for reference medicinal products, without applying corresponding reducing coefficients to registered prices of reference medicinal products.
Applicants are now allowed to provide additional information to the Ministry of Health on their initiative. These changes aim to simplify the process and reduce bureaucratic barriers for drug manufacturers. The project also specifies the interaction with the Federal Antimonopoly Service (FAS). Under the new proposals, FAS is required to conduct a thorough economic analysis within 15 working days and promptly provide the Ministry of Health with a decisive verdict on whether to approve or reject the establishment of a maximum retail price. If information is incomplete, FAS is entitled to request any missing data, reducing the document submission period to seven days if needed.