Changed State Price Regulation of Vital Medicines.
Legal Update No. 191
Goltsblat BLP advises that Russian Government Resolution No. 865 of 29 October 2010 “On State Price Regulation of Medicines Included on the Essential Medicine List” (the Resolution) comes into effect on 11 November 2010.
The Resolution was necessitated by the move to harmonise by-laws with the new Federal Law 61-FZ of 12 April 2010 “On Medicament Handling”.
For this purpose, the Resolution supersedes a number of previous by-laws regulating medicine prices, in particular Government Resolutions Nos. 782 of 9 November 2011 “On State Price Regulation of Medicines” and 619 of 17 October 2005 “On Improving State Price Regulation of Medicines”, and amends a number of others.
Also approved are rules for state registration of ceiling manufacturer’s prices for medications on the essential medicine list, rules for maintaining a state register of these ceiling prices and rules for fixing maximum wholesale and retail price mark-ups on actual manufacturer’s prices for medications on the essential medicine list in the constituent entities of the Russian Federation.
Most of the current requirements on registration of ceiling manufacturer’s prices for medications remain unchanged.
In contrast to the current regulatory framework, in order to register ceiling manufacturer’s prices for medications to be marketed for the first time and for original medications, Russian manufacturers are now required to submit a schedule of expenses incurred in developing, producing and selling medications in the format prescribed by the methodology for determining manufacturer’s prices.
In addition, the Russian Federation's Ministry of Industry and Trade has been instructed to develop and approve a procedure, subject to agreement with the Federal Tariff Service, for use by Russian manufacturers for booking income and expenses pertaining to production of vital medications separately from income and expense pertaining to production of other medications. This work is to be completed by 1 April 2011.
The Resolution provides Russian manufacturers with an opportunity to re-register the ceiling manufacturer’s price of a medication.
Such re-registration is permitted, no more than once per calendar year:
in the event of changes in prices of raw materials and consumables and increasing overheads;
by reference to the inflation rate forecast in the federal law on the federal budget for the relevant financial year and planning period.
Foreign manufacturers are not allowed to re-register their prices.
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