Article 45. Manufacturing of Medicines

1. Manufacturing of medicines shall comply with good manufacturing practice and quality control of medicines approved by the Government of the Russian Federation.

2. Medicines in the Russian Federation shall be manufactured by manufacturers of medicines licensed to manufacture medicines.

3. Manufacture of medicines shall conform to the manufacturing regulations approved by the medicines manufacturer’s head and include a list of pharmaceutical substances and excipients indicating the quantity of each of them, information on the equipment, description of the technological processes and the control methods used at all manufacturing stages of the medicines.

4. Only pharmaceutical substances included in the state register of the medicines may be used for manufacture of medicines.

5. It is forbidden to manufacture:

1) medicines not included in the state register of medicines except for medicines manufactured for clinical trials and for export;
2) counterfeit medicines;
3) medicines with no license for manufacturing of medicines;
4) medicines with violation of good manufacturing practice.

6. When medicines are introduced into the civil circulation, an authorized representative of the manufacturer of medicines shall confirm the compliance of the medicines with the requirements established during their state registration and shall guarantee that the medicines have been manufactured in accordance with good manufacturing practice and quality control of medicines.

7. The authorized representative of the manufacturer of medicines shall be an employee, who has higher pharmaceutical, chemical or biological education or veterinary education for the manufacturing of the medicines for veterinary use, and at least five years' experience in the area of good manufacturing practice and quality control of medicines certified in the procedure established by the authorized federal executive body.

8. Manufacturers of medicines may sell or transfer medicines in the procedure established by the laws of the Russian Federation to:

1) other manufacturers of medicines for manufacturing of medicines;
2) wholesalers of medicines;
3) pharmacy institutions, veterinary pharmacy institutions, individual entrepreneurs licensed for pharmaceutical activity or for a medical activity;
4) research centres for research work;
5) medical institutions and veterinary institutions;
6) institutions that deal with the animals breeding, rearing and keeping.