Pursuant to the Resolution of the Cabinet of Ministers of Ukraine of 07/02/2014 No. 240 the Ministry of Health of Ukraine approved a Procedure for the calculation of wholesale prices for medicinal products (hereinafter - Procedure) by its order dated 08/20/2014 No. 584/1011.
The Procedure provides for the calculation based on external and internal referencing. Reference countries include the country of origin of the medicinal product, Bulgaria, Moldova, Poland, Slovakia, Czech Republic, Latvia, Hungary, and Serbia. It is determined in the Procedure that country of the manufacturer and / or the owner of the registration certificate for a medicinal product shall be considered as the country of origin. If the registration certificate for a medicinal product includes more than one manufacturer than the country of the owner of the registration certificate is recognized as the country of origin. Data on wholesale prices for a medicinal product from the reference countries and Ukraine can be obtained from the official sources of authorized state bodies in Ukraine and reference countries listed in the Annex to the approved Procedure.
In the case of the presence (availability) of data for wholesale prices for a medicinal product from at least two reference countries and Ukraine, a declared wholesale price for a medicinal product shall not exceed arithmetic mean of prices. In the case of the presence of the data from less than two reference countries and Ukraine, the calculation of wholesale prices shall be performed on the basis of information about the price level in the country of origin and legislation of Ukraine.
Domestic manufacturers, In the case of the presence (availability) of the data from at least two indicators shall calculate prices based on the following formula: price declared earlier multiplied by the producer price index of basic pharmaceutical products and pharmaceutical preparations (calculated by the State Statistics Service of Ukraine).
Declaration of wholesale prices for medicines that will be conducted for the first time can be carried out without the use of the mechanism of referencing relative prices.
The Procedure provides for that the State Inspection of Ukraine on Price Control will issue conclusions on the economic feasibility of calculating wholesale prices for medicinal products. Herewith it should be noted that according to the Resolution of 10/09/2014 No. 442, recently approved by the Cabinet of Ministers of Ukraine, such executive authority is subject to liquidation, and its powers will be entrusted to other bodies.
Please recall that the Resolution of the Cabinet of Ministers of Ukraine dated 07/02/2014 No. 240 provides for a duty of the applicants to re-declare wholesale prices on all medicinal products until 03/01/2015. Therefore, it is expected that after the entry into force of this Order the declaration of wholesale prices changes for medicinal products, which was temporarily suspended due to the termination of the resolution of the Cabinet of Ministers of Ukraine dated 08/13/2012 No. 794 until 07/15/2014, will be at last restored.
Source of information:http://www.l-a.com.ua/eng/news/1913/
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