ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of June 20, 2018 No. 702

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).

Approved by the Order of the Government of the Russian Federation of June 20, 2018 No. 702

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

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

"4(1). In case of intention of the license applicant to perform production of pharmaceutical substance of ethyl alcohol (ethanol) licensed requirements about equipment of the capital processing equipment used for production of pharmaceutical substance of ethyl alcohol (ethanol) are imposed to the license applicant along with the licensed requirements specified in item 4 of this provision (further - the equipment):

automatic gages and accounting of concentration and amount of anhydrous alcohol in pharmaceutical substance of ethyl alcohol (ethanol), amount of pharmaceutical substance of ethyl alcohol (ethanol), requirements to which are approved by the order of the Government of the Russian Federation of June 28, 2006 No. 396 "About requirements to automatic gages and accounting of concentration and amount of anhydrous alcohol in finished goods, amount of finished goods", sealed up (sealed) by Federal Service for Alcohol Market Regulation (further - automatic means), according to the scheme of equipment of the 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 technical documentation of the manufacturer of automatic funds for these means;

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