«Regulatory guillotine» of alcohol-containing medicines was launched

On January 17, a meeting of a working group from the expert and business community on the implementation of the “regulatory guillotine” in the production and turnover of alcoholic beverages took place. Ilya Lomakin-Rumyantsev, Director of the Center for Consumer Market Development at the Moscow School of Management Skolkovo, was elected Chairman of the working group. Olga Pentegova, Deputy Director General of the Association of Russian Pharmaceutical Manufacturers, represents the pharmaceutical industry.



“The reform will affect the entire pharmaceutical market, including the regulation of alcohol-containing products. One of its requirements is a comprehensive update of the mandatory requirements, namely, improving the legislative framework. We understand how important the “regulatory guillotine” is for both market participants and the regulator, how great is the number and significance of the accumulated problems,” Olga Pentegova emphasized.



The working group will have to consider a new regulatory structure in the sphere of production and turnover of alcohol products. The list of issues discussed includes: state control in the production and turnover of ethyl alcohol, alcohol and alcohol-containing products, supervision of the use of basic technological equipment, licensing control of production, supply, storage and retail sales, regulation in the field of advertising and retail.



The working group on the implementation of the “regulatory guillotine” in the field of alcohol production has been formed, thematic subgroups have been identified, one of which will consider the pharmaceutical area, namely the regulation of alcohol-containing drugs and pharmaceutical substances of ethyl alcohol (ethanol). Industry associations and pharmaceutical companies are invited to actively discuss this area.



Recall that in the framework of the “regulatory guillotine”, an inventory of all existing and mandatory business requirements will be held in order to understand whether they meet modern realities. If they comply, then the rules remain; if not, they are canceled or changed. The current regulatory acts contain more than 2 million mandatory requirements, among them there are still those that were adopted during the USSR. By January 1, 2021, the entire block of rules establishing mandatory requirements should be completely replaced by new ones. This will significantly reduce the administrative burden on the business, on the one hand, and on the other, increase the level of consumer safety.



Reference

The Association of Russian Pharmaceutical Manufacturers (ARPM) was founded in 2002. ARPM unites leading Russian pharmaceutical enterprises, which account for more than 90% of drugs manufactured in the country, about 45% of exports, more than 75% of domestic drugs in the Provision of Essential Medicines (PEM) program. The activity of the Association is aimed at promote the competitiveness of the domestic pharmaceutical industry and to facilitate the integration of the domestic pharmaceutical industry into the world market while maintaining and increasing the production and financial potential of the industry. ARPM is a member of the Chamber of Commerce and Industry of the Russian Federation, actively cooperates with relevant federal state authorities: the Ministry of Health of the Russian Federation, Federal Service for Surveillance in Healthcare (Roszdravnadzor), the Ministry of Industry and Trade of the Russian Federation, and the State Duma Committee for Health Protection. Representatives of the ARPM are members of the Council for the Development of the Pharmaceutical and Medical Industry under the Government of the Russian Federation.

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