To register prices for VED it is necessary to conduct a registration trial of the drug, which includes clinical trials and an examination of the quality, efficacy and safety of the drug.
After the successful completion of the registration trial, the drug is assigned a registration number and it becomes available for sale in Russia.
Further, the manufacturer of the drug applies for registration of the VED price to the Federal Service for Surveillance in Healthcare. This considers factors such as the cost of production, the level of competition on the market, the level of income of the population and other factors.
After reviewing the application, the Federal Service for Surveillance in Health Care determines the maximum retail price for the drug, which the manufacturer must comply with when selling in the Russian Federation.
Thus, the process of registering VED prices for Vital in Russia is strictly regulated and is aimed at ensuring the availability of medicines for the population.
Development of registration dossier, registration, licensing and certification
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