Chapter 9. Import of Medicines into the Russian Federation and Export of Medicines from the Russian Federation

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 47. Procedure for Import of Medicines to the Russian Federation and Export of Medicines from the Russian Federation

1. Import of medicines into the Russian Federation shall be performed in the procedure established by the Government of the Russian Federation and in compliance with the laws of the Russian Federation.

2. The imported medicines shall be included into the state register of the medicines.

3. It is allowed to import into the Russian Federation a specific consignment of unregistered medicines to be used in clinical trials of medicinal products, for state expert examination of medicines for the purpose of state registration of medicinal products, or for delivery of health care in accordance with individual vital indications for the patient, on the basis of the permit granted by an authorized federal executive body due to applications of the parties mentioned in Article 48 hereof. This application shall be reviewed and the decision on the issue of the import permit of the specific consignment of unregistered medicines to be used in clinical trials of medicinal products, for state expert examination of medicines for the purpose of state registration of medicinal products or for delivery of health care in accordance with individual vital indications for the patient, or on the rejection of the above mentioned permit shall be taken within the time not exceeding five (5) business days. This permit shall be granted at no charge.

4. The medicines, the quality of which can be proved with the certificate of the manufacturer of medicines stating that the imported medicines is in compliance with the pharmacopeia monograph or, failing the latter, with the normative documentation or normative document, may be imported into the Russian Federation.

5. It is forbidden to import to the Russian Federation counterfeit medicines, poor quality medicines, or infringing medicines.

6. Counterfeit medicines and poor quality medicines are subject to confiscation and subsequent destruction or exportation from the territory of the Russian Federation, and infringing medicines are subject to confiscation and subsequent destruction. Destruction or exportation from the territory of the Russian Federation of counterfeit medicines, poor quality medicines, or infringing medicines shall be performed at the expense of the person that imported such medicines. The procedure for destruction of counterfeit medicines, poor quality medicines, or infringing medicines shall be determined by the Government of the Russian Federation.

7. The persons importing counterfeit medicines, poor quality medicines, or infringing medicines to the Russian Federation shall be liable in accordance with the legislation of the Russian Federation.

8. The export of medicines from the Russian Federation shall be performed without application of any restrictions imposed thereon in accordance with the Laws of the Russian Federation on state regulation of the foreign trade activity. The export from the Russian Federation of medicinal products meant for humanitarian aid (assistance) or help under emergency situations shall be performed on the basis of a resolution of the Government of the Russian Federation or a resolution of public authorities of the Russian Federation constituent entities on rendering assistance to a foreign state.

Article 48. Legal Entities Authorized to Import Medicines into the Russian Federation

Medicines may be imported to the Russian Federation by:

1) manufacturers of medicines for the purpose of in-house manufacture of medicines;
2) foreign developers of medicines and foreign manufacturers of medicines or other legal entities on the instructions of the developer of a medicines for the purpose of carrying out clinical trials of the medicinal product, state registration of the medicinal product, inclusion of the pharmaceutical substance in to the state register of medicines, quality control of medicines, subject to a permit from an authorized federal executive body to import a specific consignment of medicines;
3) wholesalers of medicines;
4) research centres, higher professional educational institutes, manufacturers of medicines for the development, study and control of the safety, quality and efficacy of medicines subject to a permit from an authorized federal executive body;
5) medical institutions and other institutions mentioned in Clauses 1 to 4 of this Article for delivery of health care in accordance with individual vital indications for a patient subject to a permit from an authorized federal executive body to import a specific consignment of medicinal products issued in the established order in the form of the electronic document signed with the electronic digital signature.

Article 49. Documents Submitted to Customs Authorities of the Russian Federation when Importing Medicines into the Russian Federation

1. When medicines are imported into the Russian Federation, the following documents shall be submitted to the customs authorities of the Russian Federation, in addition to the documentation provided for by the customs legislation of the Russian Federation:

1) certificate of manufacturer of a medicine stating that the imported medicine is in compliance with the pharmacopeia monograph or, failing the latter, with the normative documentation or normative document;
2) permit from an authorized federal executive body to import a specific consignment of medicine under the circumstances provided for in Clause 3 of Article 47 hereof.

2. The documents specified in Clause 1 sub-clauses 1 and 2 of this Article shall be submitted to the customs authorities of the Russian Federation on arrival of the medicines at the territory of the Russian Federation.

Article 50. Import of Medicinal Products into the Russian Federation for Personal Use and Other Non-Commercial Purposes

1. Medicinal products may be brought to the Russian Federation ignoring the requirements provided for by Clauses 1 to 4 of Article 47, Articles 48 and 49 hereof, if they are intended for:

1) personal use by the individuals who has arrived in the Russian Federation;
2) members of diplomatic corps or representatives of international organizations accredited in the Russian Federation;
3) treatment of passengers and crewmen of transport vehicles, train crews and transport vehicles drivers arriving in the Russian Federation;
4) treatment of participants of international cultural and sport events and of international expeditions;
5) treatment of the zoo animals, as well as of the animals brought into the Russian Federation to take part in sport and entertainment events.

2. In the circumstances provided for in Clause 1 of this Article, it is allowed to import into the Russian Federation medicinal products that are not registered in the Russian Federation.

3. Medicinal products meant for humanitarian aid (assistance) or help under emergency situations are imported to the Russian Federation in the order established by the Government of the Russian Federation. It is forbidden to import to the Russian Federation unregistered medicinal products meant for humanitarian aid (assistance) or help under emergency situations.

Article 51. Cooperation between the Federal Executive Body Authorized in the Area of Customs and Other Authorized Federal Executive Bodies

1. The authorized federal executive authorities make available to the federal executive body authorized in the area of customs a state register of medicines, as well as the information on issued permits to import a specific consignment of medicines in the cases provided for by Clause 3 of Article 47 hereof.

2. The federal executive body authorized in the area of customs shall inform the authorized federal executive bodies mentioned in Clause 1 of this Article on the import of medicines into the Russian Federation and export of the medicines from the Russian Federation in the form and in the order established by the Government of the Russian Federation.

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)