Article 61. State Registration of Manufacturers’ Maximum Ex-Works Prices for Vital and Essential Medicinal Products and Their Sale

1. The determined by the manufacturers of the medicinal products maximum ex-works prices for the medicinal products included in the list of vital and essential medicinal products shall be subject to state registration.

2. The maximum ex-works price for vital and essential medicinal products proposed by a manufacturer is subject to state registration, unless it exceeds the price for the same medicinal product calculated in accordance with the methodology for determination of the manufacturers’ maximum ex-works prices for vital and essential medicinal products, which shall be approved in the order prescribed by the Government of the Russian Federation. This method assumes the calculation of weight-average actual ex-works price, weight-average actual import price of the medicinal product during the year, preceding the date of presenting of manufacturer's maximum ex-works price to state registration, for medicinal products being in circulation in the Russian Federation, and the calculation by the Russian manufacturers of medicinal products of costs associated to developing, manufacturing, sales, specifying by foreign manufacturers of medicinal products of minimal manufacturer's ex-works price for the medicinal product in manufacturer's country and other countries, where it is registered, with taking into account the costs associated to customs clearance (customs duty and customs fees for the customs clearance) and transport charges for medicinal products which did not come in circulation in the Russian Federation and originator medicines. (as amended by Federal Law of October 11, 2010, No. 271-FZ)

2¹. In calculation of maximum ex-works price the following shall be taken into account along to the data specified in Clause 2 of this Article:

1) regarding to Russian manufacturer – the price on analogous (by international non-proprietary name, certain dosage form and dosage rate) medicinal products, manufactured in the Russian Federation or in case of absence of such - the price on analogous foreign medicinal products being in civil circulation in the Russian Federation;
2) regarding to foreign manufacturer -  the price on analogous (by international non-proprietary name, certain dosage form and dosage rate) medicinal products being in civil circulation in the Russian Federation”; (clause 2¹ introduced by Federal Law of October 11, 2010, No. 271-FZ)

2². On the ground of the statement submitted up to October 1 of each year by the Russian manufacturer of medicinal products, included in the list of vital and the most important medicinal products, registered maximum ex-works price for the medicinal product in case of change of prices for raw materials, indirect costs, as well as estimated inflation on the base of the federal budget for the respective financial period and scheduled period, may be re-registered, but not more than ones per calendar year  in the order established by the Clauses 2 and 2¹ of this Article. (clause 2² introduced by Federal Law of October 11, 2010, No. 271-FZ)

3. It is prohibited to sell medicinal products included in the list of vital and essential medicinal products, the manufacturer’s maximum ex-works price for which have not been registered.