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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of September 18, 2021 No. 1577

About approval of Rules of export of the drugs and psychotropic substances intended for humanitarian assistance (assistance) or the help in case of emergency situations, and recognition voided separate acts of the Government of the Russian Federation

According to Item 8.1 of article 28 of the Federal law "About Drugs and Psychotropic Substances" Government of the Russian Federation decides:

1. Approve the enclosed Rules of export of the drugs and psychotropic substances intended for humanitarian assistance (assistance) or the help in case of emergency situations.

2. Recognize to invalid:

the order of the Government of the Russian Federation of March 17, 2009 No. 232 "About procedure for export of the drugs and psychotropic substances intended for humanitarian assistance (assistance) or the help in case of emergency situations" (The Russian Federation Code, 2009, No. 12, the Art. 1434);

Item of 93 changes which are made to acts of the Government of the Russian Federation concerning activities of the Ministry of Health of the Russian Federation, approved by the order of the Government of the Russian Federation of September 4, 2012 No. 882 "About introduction of amendments to some acts of the Government of the Russian Federation concerning activities of the Ministry of Health of the Russian Federation" (The Russian Federation Code, 2012, No. 37, the Art. 5002);

Item of 6 changes which are made to acts of the Government of the Russian Federation, approved by the order of the Government of the Russian Federation of June 27, 2017 No. 754 "About introduction of amendments to some acts of the Government of the Russian Federation" (The Russian Federation Code, 2017, No. 27, the Art. 4052).

3. This resolution becomes effective since March 1, 2022. The rules approved by this resolution are effective till March 1, 2028.

Russian Prime Minister

M. Mishustin

Approved by the Order of the Government of the Russian Federation of September 18, 2021 No. 1577

Rules of export of the drugs and psychotropic substances intended for humanitarian assistance (assistance) or the help in case of emergency situations

1. These rules determine procedure for export from the Russian Federation of the drugs and psychotropic substances intended for humanitarian assistance (assistance) or the help in case of emergency situations.

2. Export of drugs and psychotropic substances for humanitarian assistance (assistance) or the help in case of emergency situations is performed based on the decision made by the Government of the Russian Federation.

3. For the purpose of humanitarian assistance (assistance) or the help in case of emergency situations export of the drugs and psychotropic substances included in lists II and III of the list of the drugs, psychotropic substances and their precursors which are subject to control in the Russian Federation and registered in accordance with the established procedure in the Russian Federation as medicines is allowed (further - narcotic medicines).

4. Export of narcotic medicines within the humanitarian assistance (assistance) for their subsequent voluntary conveyance to the party requesting the help is performed by the legal entities who are under authority of executive bodies of subjects of the Russian Federation in the field of health protection in the presence of license for activities on drug trafficking, psychotropic substances and their precursors, to cultivation of the narcocontaining plants (further - the license).

5. Export of narcotic medicines within the help in case of emergency situations for rendering to victims around emergency situation of emergency medical service is performed by the legal entities who are under authority of the Ministry of Health of the Russian Federation and the Ministry of the Russian Federation for civil defense, to emergency situations and natural disaster response in the presence of the license.

6. Export of the narcotic medicines intended for humanitarian assistance (assistance) or the help in case of emergency situations is performed in the presence of the confirmation of purpose of narcotic medicines issued by the Ministry of Health of the Russian Federation (further - confirmation of purpose) which shall contain the following data:

a) the name and the location of the legal entity who addressed for confirmation of purpose;

b) the name and dosage form of the exported narcotic medicines, and also their quantity;

c) effective period of confirmation of purpose.

7. The legal entities performing export of the narcotic medicines intended for humanitarian assistance (assistance) or the help in case of emergency situations for receipt of confirmation of purpose submit in the Ministry of Health of the Russian Federation the corresponding statement in which data on number and effective period of the license, and also on amount of the exported narcotic medicines are specified.

The procedure for issue of confirmation of purpose is established by the Ministry of Health of the Russian Federation.

The Ministry of Health of the Russian Federation sends to the Ministry of Internal Affairs of the Russian Federation the acknowledgment copy of purpose within 5 working days from the date of its issue.

8. The legal entity performing export of the narcotic medicines intended for humanitarian assistance (assistance) or the help in case of emergency situations provides their protection.

9. The head of the legal entity performing export of the narcotic medicines intended for humanitarian assistance (assistance) or the help in case of emergency situations appoints the persons responsible for their delivery and voluntary conveyance or use for rendering to victims around emergency situation of emergency medical service allowed in accordance with the established procedure to work with drugs and psychotropic substances.

The narcotic medicines used for rendering to victims around emergency situation of emergency medical service are considered and stored separately from other medicines.

10. Narcotic medicines which were not used and donated during rendering to victims around emergency situation of emergency medical service are subject to the return export.

11. The legal entities performing export of the narcotic medicines intended for humanitarian assistance (assistance) represent to the Ministry of Health of the Russian Federation and the Ministry of Internal Affairs of the Russian Federation the copy of the declaration on goods with marks of the customs authority (except as specified, when such data are the state secret) which performed making of customs transactions concerning narcotic medicines, and the customs authority located in the place of departure of such goods from the Russian Federation within 5 working days from the date of their export.

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