The Resolution of the Government of Russia dd. 12.11.2012 No 1152 “On adopting the Regulation on the state control over the quality and safety of medical activity”, regulating the control measures in healthcare field, came into force.
According to the Regulation, the basic control functions are assigned to Roszdravnadzor which is obliged to conduct regular and unscheduled audits of medical institutions and review, inter alia, contracts for supply of pharmaceuticals and medical goods as well as contracts for conducting clinical trials and educational and/or scientific activiteis.
Besides, Roszdravnadzor will monitor whether there are cases of medical representatives violating the Law “On Fundamentals of Public Healthcare” by distributing pharmaceutical advertising aids in policlinics and hospitals and whether doctors provide patients with the samples of medicines free of charge.
The amendments into the Methodology are primarily aimed at more clear separation of the processes for registering and re-registering of maximum producers’ prices for ED. Besides, the amended Methodology directly stipulates that the price to be registered by the foreign producer should not exceed the minimum reference sales price in other states, including country of producer.The Ministry also posted its comments to the frequently asked questions with respect to the amended Methodology for determining maximum producers’ prices for ED.
The draft Order stipulates requirements to medical goods manufacturing, importation and exportation from Russia, storage, transportation and sales, assembly and tune-up as well as utilization and destruction. The requirements should be mandatory for all the the entities engaged in circulation of medical goods in the territory of Russia.
The State Duma Committee for healthcare intends to control the customs clearance process of biologically active supplements imported into Russia and the way they are registered with the state authorities. In particular, some of legislators suggest developing a separate regulation in respect of biologically active supplements circulation.
Also, according to the Committee representatives, control for biologically active supplements circulation should be passed to Roszdravnadzor.