The Medical Alcohol Market to be Regulated
Legislative amendments aimed at regulation of the medical alcohol market has become effective in the new year.
First of all, the issue involves amendments to the Federal Law On State Regulation of Production and Circulation of Ethanol, Alcohol and Alcohol-Containing Products and on Limitation of Consumption (Drinking) of Alcoholic Products” and into the Russian Federation Administrative Offense Code” regulating relations in the sphere of accounting of production of the pharmaceutical substance of ethanol. As of 01.01.2017 retail sales of ethanol is prohibited, even in the form of pharmaceutical substance.
Besides, notions “alcohol containing drugs” and “alcohol-containing medical devices” are introduced. As of 01.01.2017 the Federal Law of 22.11.1995 № 171-FZ On Public Regulation of Manufacture and Circulation of Ethanol, Alcohol and Alcohol-Containing Products and on Limitation of Consumption (Drinking) of Alcoholic Products) does not apply to circulation of alcohol-containing medical devices, registered by an authorized federal executive body and included into the public register of medical devices and organizations (individual entrepreneurs), responsible for production and manufacture of medical devices, excluding production of alcohol-containing medical products in a liquid form containing an ethanol-based pharmaceutical substance.
Organizations manufacturing ethanol for production of alcohol containing drugs and alcohol containing medical products from 01.01.2017 are obliged to keep a record and declare the volumes of production, supply and (or) use for their own needs. Besides, such organizations should also be equipped with tools enabling account of manufacture and pass it to Unified State Automated Information System.