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Russian authorities proposed to introduce liability for false drug prices

13 September 2017

GMP News

The Russian Ministry of Health proposed to introduce administrative liability for legal entities in case of false information provided during the state registration/re-registration of maximum selling prices for the medicines included in list of vital and essential drugs (VED).

Currently, the law does not stipulate any liability of legal entities (holders or owners of the registration certificate of medicinal product for human use, or party authorized by such holders or owners) for providing false information at the state registration (re-registration) of the manufacturer’s maximum selling prices for medicinal products included in the list of vital and essential drugs.

The draft federal law provides for amending the Russian Code of Administrative Offenses for submission of false information by the holder or owner of the registration certificate of medicinal product for human use (party authorized by such holders or owners) during the state registration (re-registration) of the manufacturer’s maximum selling prices for medicinal products included in the list of VED, changes to the register’s entry on the state registration of the manufacturer’s maximum selling price for medicinal product, which affected the results of economic analysis of the manufacturer’s maximum selling price of medicinal product for human use and led to unreasonable increase of the manufacturer’s maximum selling price for medicinal product.

According to the draft law, these offenses would entail the imposition of administrative fine on legal entities in the twofold the excess of the proceeds received from the sale of medicinal products as a result of unreasonable increase of the manufacturer’s maximum selling prices for medicinal products during the entire period in which the offense was committed, but no more than one year.

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