The draft new order “On Approval of the List of Risk Indicators of Violation of Mandatory Requirements for Federal State Control in the Circulation of Medicinal Products for Veterinary Use” has been published on the regulation.gov.ru portal.
Recall that the current order of the Ministry of Agriculture of February 1, 2022 established only one indicator. Now a risk indicator is considered if the production facility is owned by two or more licensees.
Now the department proposes a new criterion in addition to it. This indicator provides for a discrepancy between the volume of imported or transferred veterinary drugs and the number of those entering the civil circulation. It is clarified that such a discrepancy will become a risk indicator if a discrepancy of more than 10% is detected during the calendar year.
Information about veterinary drugs is contained in the Galen module of the VetIS system of the ROSSELKHOZNADZOR .
Risk indicators are needed to make a decision on conducting and choosing the type of unscheduled control (surveillance) activity.