On 30th of May, a round table will be held to discuss the novellas of the Federal Law №171-FL.
The provisions of the law «on the accounting and declaration of the volume of production, circulation and use of ethyl alcohol API, as well as alcohol-containing medicines» apply to all manufacturers of medicines and they are not exempt from installing meters, recording and declaring transactions for the purchase of ethyl alcohol, The Federal Service for Alcohol Market Regulation (FSAMR) believes.
After the entry into legal force of the law, the members of the ARPM had questions on the enforcement of Federal Law №171 concerning manufacturers of alcohol-containing medicines, and on 26 of April a meeting with a Head of the FSAMR automated systems department, Anton Gushchansky, was held.
Specialists of the ARPM expressed the opinion that there are contradictions in the text of the Federal Law №171. Based on the provisions of the Law, manufacturers of ethyl alcohol APIs and alcohol-containing medicines should establish automatic data transmitter and transfer data on the used ethyl alcohol API, as well as data on production and circulation of alcohol-containing products for accounting and declaration of volumes of production, purchases or their turnover to the Unified State Automated Information System (USAIS). Meanwhile, Subparagraph 4, Clause 2.1 of Article 8 states that: «Requirements for the installation of automatic data device of recording and transmitting information to the USAIS do not apply to purchase of ethyl alcohol, except for ethyl alcohol API, alcohol and alcohol-containing products for the purpose of using them as a raw material or auxiliary substances for the production of non-alcohol-containing products for technical purposes or for other purposes not related to the production and (or) circulation (excluding purchase) of ethyl alcohol, alcohol and alcohol-containing products».
As a result, for a further constructive dialogue and providing explanations for the enforcement of the provisions of Federal Law № 171-FL on 30th of May, a Round Table of FSAMR representatives with participants of the pharmaceutical market and major industry associations will be held.
Association of the Russian Pharmaceutical Manufacturers
Tel .: + 7 (495) 231 42 53