The Ministry of Health of the Russian Federation published a draft order “On approval of the list of reference drugs from the list of vital and essential drugs, that is approved annually by the Government of the Russian Federation.”
In accordance with the Instruction of the President of the Russian Federation No. Pr-2586 of 29.12.2016, the Russian Ministry of Health prepared a draft Decree of the Government of the Russian Federation “On state registration and re-registration of the maximum selling prices for the drugs included in the list of vital and essential drugs,” which requires to perform re-registration, under the new rules, of all previously registered maximum selling prices set by the manufacturers for the drugs included in the list of vital and essential drugs in the period from 2010 to 2017 by using different methodologies.
The adoption of this Decree is scheduled for Q3 2017.
The draft divides the process of re-registering the previously registered maximum selling prices for the drugs included in VED list into two stages:
- The first stage provides for re-registration of maximum selling prices for reference drugs included in VED list;
- After the registration of prices for reference drugs, the second stage provides for re-registration of maximum selling prices for reproduced drugs and bioanalogues included in VED list.