Approved by Senators
On June 29 the Council of Federation of the Russian Federation approved amendments introduced into clauses of two federal laws: FZ “On Drug Circulation” and “On State Regulation of Production and Turnover of Ethyl Alcohol, Alcohol and Alcohol-Containing Products and on Limitation of Consumption (Drinking) of Alcoholic Products”.
According to amendments introduced into clause 61 of the Federal Law “On Drug Circulation” and clause 3 of the Federal Law “On introduction of amendments into the Federal Law “On Drug Circulation”, ambiguity concerning the term “actual retail price” is removed. Besides, in part 4, clause 61 of the Federal law No 61-FZ the norm on the principles of marketing of drugs by wholesale and retail organizations is excluded, helping avoid ambiguity between the aforesaid part of the law and part 2, clause 63.
Besides, the document provides an opportunity to consider medical devices newly approved in the Russian Federation as reference devices based on own preclinical and clinical trials in circulation of the Russian Federation, if a reference drug is not in circulation, and its quality, efficacy and safety approved based on results of preclinical and clinical trials.
Amendments to the federal law “On State Regulation of Manufacture and Circulation of Ethyl Alcohol, Alcohol and Alcohol Containing Products and on Limitation of Consumption (Drinking) of Alcohol Products” include introduction of a system of public accounting (USAIS) for production and circulation of alcohol-containing drugs, medical ethanol and medical devices.
USAIS will cover manufacture of pharmaceutical substance (ethanol) and its purchase for production of alcohol containing drugs. It implies that manufacturers of products contiaining over 0.5% alcohol will have to sign up for USAIS.