Resolution of the Government of the Russian Federation No. 637 dd. 23.05.2024 establishes that assessment of compliance with mandatory requirements for the application of prices for medicinal products included in the list of vital and essential medicinal products (VED) is carried out within the framework of regional state control by way of:

  • unscheduled inspections in coordination with the prosecutor’s office, which are carried out on the basis of risk indicators of violations or after the expiration of the term of execution of instructions to eliminate violations, in case of harm to the life and health of citizens and in a number of other cases;
  • on-site inspections;
  • unscheduled inspections without agreement with the prosecutor’s office.

On-site inspections of controlled persons and publicly accessible production facilities are conducted by bodies exercising regional state control (supervision) over the application of prices for VEDs.

Plans for such inspections are formed on a quarterly basis, no later than the 15th day of the month preceding the planned quarter.

The grounds for inclusion of controlled persons and production facilities in the plan are determined taking into account previous violations of mandatory requirements and repeated complaints about such violations.

If violations are identified during the inspection, an act is drawn up and an order to eliminate the violations is issued. If the violations are not eliminated within the established period of time, it is possible to conduct an unscheduled control event without coordination with the bodies.