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.