ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of February 28, 2019 No. 217

About modification of the Regulations on licensing of production of medicines

The government of the Russian Federation decides:

Approve the enclosed changes which are made to the Regulations on licensing of production of medicines approved by the order of the Government of the Russian Federation of July 6, 2012 No. 686 "About approval of the Regulations on licensing of production of medicines" (The Russian Federation Code, 2012, No. 29, Art. 4116; 2013, No. 16, Art. 1970; 2018, No. 26, Art. 3864).

Approved by the Order of the Government of the Russian Federation of February 28, 2019 No. 217

Changes which are made to Regulations on licensing of production of medicines

1. Add with item 4 (2) the following content:

"4(2). In case of intention of the license applicant to perform production of alcohol-containing medicines, and also production of other medicines with use of pharmaceutical substance of ethyl alcohol (ethanol) or ethyl alcohol licensed requirements are imposed to the license applicant along with the licensed requirements specified in item 4 of this provision:

a) about equipment of reservoirs for acceptance of pharmaceutical substance of ethyl alcohol (ethanol) or ethyl alcohol automatic gages and accounting of concentration and amount of anhydrous alcohol in pharmaceutical substance of ethyl alcohol (ethanol) or in ethyl alcohol, amount of pharmaceutical substance of ethyl alcohol (ethanol) or ethyl alcohol according to the scheme of equipment of the specified equipment containing information on the specified equipments, automatic means and communications according to the list of information established by Federal Service for Alcohol Market Regulation and also with technical documentation of the manufacturer of automatic funds for these means;

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