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

According to the Federal Law "About Licensing of Separate Types of Activity" Government of the Russian Federation decides:

1. Approve the enclosed Regulations on licensing of production of medicines.

2. Declare invalid the order of the Government of the Russian Federation of September 3, 2010 No. 684 "About approval of the Regulations on licensing of production of medicines" (The Russian Federation Code, 2010, No. 37, the Art. 4698).

Approved by the Order of the Government of the Russian Federation of July 6, 2012 No. 686

Regulations on licensing of production of medicines

1. This Provision establishes procedure for licensing of the activities for production of medicines performed by legal entities according to the Federal Law "About Drug Circulation".

2. Licensing of activities for production of medicines for medical application performs the Ministry of Industry and Trade of the Russian Federation, for veterinary application - Federal Service for Veterinary and Phytosanitary Surveillance (further - licensing authorities).

3. Activities for production of medicines include works on the list according to appendix No. 1.

4. The licensed requirements imposed to the license applicant on implementation of activities for production of medicines (further - the license), are:

a) availability at the license applicant of the rooms, buildings, constructions and other objects, technical means, the equipment and technical documentation belonging to it on the property right or on other legal cause necessary for accomplishment of the declared works conforming to the established requirements;

b) compliance of production of medicines for veterinary application to rules of proper production practice according to article 45 of the Federal law "About Drug Circulation";

(1)) compliance of production of medicines for medical application to rules of proper production practice of the Eurasian Economic Union;

c) availability according to article 45 of the Federal law "About Drug Circulation" of the industrial regulations approved by the head of the producer of medicines (license applicant) and including the list of the used pharmaceutical substances and excipients with indication of quantity of each of them, this about the used equipment and the description of engineering procedure and control methods at all production phases of medicines;

d) availability according to article 45 of the Federal law "About Drug Circulation" of the authorized person of the producer of medicines for veterinary application which in case of input of medicines for veterinary application in civil circulation performs confirmation of conformity of medicines for veterinary application to the requirements established in case of their state registration and guarantees that medicines are made for veterinary application according to rules of proper production practice, has education and the length of service conforming to requirements, the stipulated in Clause 45 Federal Laws "About Drug Circulation" in case of production of medicines for veterinary application and is certified according to the procedure, established by the Ministry of Agriculture of the Russian Federation;

(1)) availability of the authorized person (authorized persons) of the producer of medicines for medical application, being his worker which in case of input of medicines in civil circulation performs confirmation of conformity of medicines to the requirements established in case of their state registration and guarantees that medicines are made according to requirements of Rules of proper production practice of the Eurasian Economic Union which is certified and included in the register of authorized persons of producers of medicines of the Eurasian Economic Union according to the right of the Eurasian Economic Union;

e) availability of the workers who signed employment contracts, having respectively the higher or secondary professional pharmaceutical, chemical, chemical and technological, biological, biotechnological, medical or veterinary education responsible for production, marking and quality control of medicines.

4(1). In case of intention of the license applicant to perform production of pharmaceutical substance of ethyl alcohol (ethanol) along with the licensed requirements specified in item 4 of this provision the following licensed requirements are imposed:

a) equipment of reservoirs for acceptance of ethyl alcohol automatic gages and accounting of concentration and amount of anhydrous alcohol in ethyl alcohol, amount of ethyl alcohol;

b) software and hardware shall provide acceptance and information transfer about concentration and about amount of anhydrous alcohol in the ethyl alcohol used for production of the pharmaceutical substance of ethyl alcohol (ethanol), amount of this ethyl alcohol received with use of automatic gages and accounting of concentration and amount of anhydrous alcohol in ethyl alcohol, amount of ethyl alcohol;

c) equipment of the capital processing 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);

d) software and hardware shall provide acceptance and information transfer, received with use of 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), about amount of its production, delivery and (or) use for own needs;

e) availability on the property right, economic maintaining or operational management of the capital processing equipment for production of the ethyl alcohol registered according to article 14.1 of the Federal law "About State Regulation of Production and Turnover of Ethyl Alcohol, Alcoholic and Alcohol-containing Products and about Restriction of Consumption (Drinking) of Alcoholic Products";

e) reservoirs for acceptance of ethyl alcohol for production of pharmaceutical substance of ethyl alcohol (ethanol) shall be connected by the communications meeting the requirements established by federal executive body, the representative for control and supervision in the field of production and turnover of ethyl alcohol, alcoholic and alcohol-containing products with the capital processing equipment for production of ethyl alcohol (ethanol).

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

a) equipment of reservoirs for acceptance of pharmaceutical substance of ethyl alcohol (ethanol) 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);

b) software and hardware for production of alcohol-containing medicines, and also in production process of other medicines shall provide acceptance and information transfer, received with use of 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), about amount of its purchase;

c) equipment of the equipment for accounting of volume of turnover and use of pharmaceutical substance of ethyl alcohol (ethanol) for production of alcohol-containing medicines, and also in production process of other medicines with use of pharmaceutical substance of ethyl alcohol (ethanol) technical means of fixing and information transfer about production volume and turnover of alcohol-containing products in Unified State Automated Information System of accounting of production volume and turnover of ethyl alcohol, alcoholic and alcohol-containing products (further - Unified State Automated Information System);

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