Russian Federation will use a risk-oriented approach regarding legal entities and individual entrepreneurs while performing the federal state supervision over the circulation of medicines for human use.
The Russian Government signed a Decree establishing the criteria for assigning a specific risk category to the subjects of state supervision, and the frequency of scheduled inspections depending on the assigned risk category.
The subjects of state supervision will be assigned a specific risk category by the decision of the Head (Deputy Head) of Roszdravnadzor based on established criteria. The Decree provides that Roszdravnadzor will maintain the lists of such subjects.
The adopted decisions will allow to improve the effectiveness of control and supervision in the area of circulation of medicines, while ensuring the optimal use of material, financial and human resources of federal state control authorities, and reduce the administrative pressure on small and medium-sized businesses during control and supervision activities.