Chapter 8. Manufacture and Marking of Medicines

Table of contents

Chapter 1. General Provisions (articles 1-4)
Chapter 2. Powers of Federal Executive Bodies and Executive Bodies of Constituent Entities of Russian Federation with Respect to Circulation of Medicines (articles 5-6)
Chapter 3. State Pharmacopeia (article 7)
Chapter 4. State Control over Circulation of Medicines (articles 8-9)
Chapter 5. Development, Preclinical testing of Medicines and Clinical Trials of Medicinal Products for Veterinary Use (articles 10-12)
Chapter 6. Performance of State Registration of Medicinal Products (articles 13-37)
Chapter 7. Clinical Trials of Medicinal Products for Medical use, Clinical Trial Contract, Rights of Patients Involved in Trials (articles 38-44)
Chapter 8. Manufacture and Marking of Medicines (articles 45-46)
Chapter 9. Import of Medicines into the Russian Federation and Export of Medicines from the Russian Federation (articles 47-51)
Chapter 10. Pharmaceutical Activity (articles 52-58)
Chapter 11. Destruction of Medicines (article 59)
Chapter 12. State Regulation of Prices for Medicinal Products for Medical Use (articles 60-63)
Chapter 13. Safety Monitoring of Medicinal Products Being in Circulation in the Russian Federation (articles 64-66)
Chapter 14. Information on Medicinal Products (article 67)
Chapter 15. Liability for Violation of Legislation of the Russian Federation for Medicines Circulation and Compensation for Harm to Human Health Caused by Administration of Med (articles 68-69)
Chapter 16. Final Provisions (articles 70-71)

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.

Article 46. Marking of Medicines

1. Medicinal products, except for medicinal products manufactured by the pharmacy institutions, veterinary pharmacy institutions, individual entrepreneurs licensed for pharmaceutical activity, shall come into circulation if:

1) their primary packaging “(except primary packaging of the herbal medicinal products) contains the name of the medicinal product (international nonproprietary , or chemical, or trade name), batch number, date of issue (for immunobiological medicinal products), shelf-life, dosage or concentration, volume, activity in units of activity or quantity of doses printed well readable in Russian; (as amended by Federal Law of October 11, 2010, No. 271-FZ)
2) their secondary (consumer) packaging contains printed, well readable Russian name of the medicinal product (international nonproprietary or chemical name and a trade name), name of the manufacturer of the medicinal product, batch number, date of issue (for immunobiological medicinal products), registration certificate number, shelf-life, mode of administration, dosage or concentration, volume, activity in units of activity or quantity of doses in the packaging, dosage form, dispensation conditions, storage conditions, caution notices. (as amended by Federal Law of October 11, 2010, No. 271-FZ)

2. Pharmaceutical substances shall come into circulation if their primary packaging states in well readable print in Russian the name of the pharmaceutical substance (international nonproprietary or chemical name and trade name), name of the manufacturer of the pharmaceutical substance, batch number and date of manufacture, quantity in a package, and units of measure, shelf-life and storage conditions.

3. Medicines as serums shall come into circulation having the indication of the animal, whose blood, blood plasma, organs or tissues were used to derive these medicines from.

4. The secondary (consumer) packaging of medicines manufactured from the blood, blood plasma, human organs and tissues shall have the following notice applied on to it: “No HIV-1, HIV-2, hepatitis type C virus antibodies and no surface antigen of hepatitis type B virus”.

5. A radiation danger symbol shall be applied on to the primary and secondary (consumer) packaging of radiopharmaceutical medicines.

6. The word “Homeopathic” shall be applied on to the secondary (consumer) packaging of homeopathic medicinal products.

7. The secondary (consumer) packaging of the herbal medicinal products shall contain the inscription “The product has passed radiation control”.

8. The primary and secondary (consumer) packaging of the medicinal products intended for clinical trials shall contain the inscription “For clinical trials”.

9. The packaging of the medicines meant exclusively for export shall be marked in compliance with the importing country requirements.

10. The shipping container, which is not intended for the consumers and in which the medicine is placed, shall be marked with the name and batch of the medicine, date of manufacture, quantity of the secondary (consumer) packages of the medicine, manufacturer of the medicine indicating his name and location (address, including country and (or) place of the medicine manufacture), as well as the shelf-life of the medicine and the conditions of its storage and transportation, necessary caution notices and handling symbols.

11. The words “For veterinary use” shall be applied on to the primary packaging and the secondary (consumer) packaging of the medicines for veterinary use.

12. A bar code shall be applied on to the secondary (consumer) packaging of the medicine.

Table of contents

Chapter 1. General Provisions (articles 1-4)
Chapter 2. Powers of Federal Executive Bodies and Executive Bodies of Constituent Entities of Russian Federation with Respect to Circulation of Medicines (articles 5-6)
Chapter 3. State Pharmacopeia (article 7)
Chapter 4. State Control over Circulation of Medicines (articles 8-9)
Chapter 5. Development, Preclinical testing of Medicines and Clinical Trials of Medicinal Products for Veterinary Use (articles 10-12)
Chapter 6. Performance of State Registration of Medicinal Products (articles 13-37)
Chapter 7. Clinical Trials of Medicinal Products for Medical use, Clinical Trial Contract, Rights of Patients Involved in Trials (articles 38-44)
Chapter 8. Manufacture and Marking of Medicines (articles 45-46)
Chapter 9. Import of Medicines into the Russian Federation and Export of Medicines from the Russian Federation (articles 47-51)
Chapter 10. Pharmaceutical Activity (articles 52-58)
Chapter 11. Destruction of Medicines (article 59)
Chapter 12. State Regulation of Prices for Medicinal Products for Medical Use (articles 60-63)
Chapter 13. Safety Monitoring of Medicinal Products Being in Circulation in the Russian Federation (articles 64-66)
Chapter 14. Information on Medicinal Products (article 67)
Chapter 15. Liability for Violation of Legislation of the Russian Federation for Medicines Circulation and Compensation for Harm to Human Health Caused by Administration of Med (articles 68-69)
Chapter 16. Final Provisions (articles 70-71)