of July 6, 2012 No. 686
About approval of the Regulations on licensing of production of medicines
1. Approve the enclosed Regulations on licensing of production of medicines.
Russian Prime Minister
Approved by the Order of the Government of the Russian Federation of July 6, 2012 No. 686
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.
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 technology, biological, biotechnology, 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 alcohol of ethyl (ethanol) along with the licensed requirements specified in item 4 of this provision the following licensed requirements are imposed:
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