The Ministry of Health will clarify the rules for registering prices for vital drugs

The Ministry of Health has developed and published a draft resolution of the Russian Government introducing changes to the rules for the state registration of manufacturers' maximum selling prices for vital and essential drugs (VEDs) and to the rules for maintaining the state register of such drugs. The document is under public discussion, which is scheduled to be completed in January 2017.

"The draft resolution of the Russian Federation proposes amendments to the rules for the state registration of manufacturers' maximum selling prices for VEDs, the rules for maintaining the state register of manufacturers' maximum selling prices for VEDs, and the methodology for calculating maximum selling prices for VEDs during their state registration and re-registration," states the explanatory note.

The draft clarifies the procedure for the state re-registration of maximum selling prices for drugs from foreign manufacturers that conduct packaging in Russia, as well as the procedure for determining the order of priority for state registration of prices for reproduced drugs (generics) and biosimilars of foreign production and production from member states of the Eurasian Economic Union.

The Russian Government tasked the Ministry of Health in July 2016 with working on the issue of prices for drugs included in the VED list to stimulate the localization of their production in Russia.