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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of September 29, 2010 No. 771

About procedure for import of medicines for medical application on the territory of the Russian Federation

(as amended on 28-12-2016)

According to the Federal Laws "About Drug Circulation" and "About Bases of State Regulation of Foreign Trade Activity" Government of the Russian Federation decides:

1. Approve the enclosed Rules of import of medicines for medical application to the territory of the Russian Federation.

2. Recognize invalid:

a) the order of the Government of the Russian Federation of July 16, 2005 N 438 "About procedure for import and export of the medicines intended for medical application" (The Russian Federation Code, 2005, N 30, the Art. 3172);

b) Item of 17 changes which are made to orders of the Government of the Russian Federation, approved by the order of the Government of the Russian Federation of February 14, 2009 N 108 (The Russian Federation Code, 2009, N 9, the Art. 1101);

c) Item of 5 changes which are made to orders of the Government of the Russian Federation on the questions connected with enhancement of state regulation of the prices of vital and major medicines approved by the order of the Government of the Russian Federation of August 8, 2009 N 654 "About enhancement of state regulation of the prices of vital and major medicines" (The Russian Federation Code, 2009, N 33, by the Art. 4086);

d) paragraphs of the fifth and sixth of the subitem "v" of Item 2 of the order of the Government of the Russian Federation of December 30, 2009 N 1116 "About modification of some orders of the Government of the Russian Federation on the questions connected with price regulation on vital and major medicines" (The Russian Federation Code, 2010, N 2, the Art. 179).

Russian Prime Minister

V. V. Putin

Approved by the Order of the Government of the Russian Federation of September 29, 2010 No. 771

Rules of import of medicines for medical application to the territory of the Russian Federation

1. These rules establish procedure for import to the territory of the Russian Federation for the medicines intended for medical application, except for medicines for the purpose of humanitarian assistance (assistance) or the help in case of emergency situations.

These rules do not extend to import of the drugs, psychotropic substances and their precursors included in Section 2.12 of the Single inventory to which prohibitions or import restrictions or export by the State Parties of the Customs union within the Eurasian economic community in trade with the third countries approved by the Decision N 19 on single non-tariff regulation of the Customs union of the Republic of Belarus, the Republic of Kazakhstan and the Russian Federation accepted by Interstate Council of Eurasian economic community of November 27, 2009 and in the list of the drugs, psychotropic substances and their precursors which are subject to control in the Russian Federation, approved by the order of the Government of the Russian Federation of June 30, 1998 N 681 are applied.

2. The following legal entities can import medicines on the territory of the Russian Federation:

a) the organizations - producers of medicines - for the purposes of self-produced medicines;

b) organizations of wholesale trade by medicines;

c) foreign developers of medicines and foreign producers of medicines or other legal entities at the request of developer of medicine - for performing clinical trials of medicine, implementation of state registration of medicine, inclusion of pharmaceutical substance in the state register of medicines and quality control of medicines in the presence of permission of the Ministry of Health of the Russian Federation to import of specific batch of medicines;

d) the scientific organizations, the educational organizations of the higher education and producers of medicines - for development, researches, control of safety, quality and efficiency of medicines in the presence of permission of the Ministry of Health and Social Development of the Russian Federation to import of specific batch of medicines for medical application;

e) the medical organizations, and also the organizations specified in subitems "a" - "" of this Item, - for delivery of health care according to vital testimonies of the specific patient in the presence of permission of the Ministry of Health of the Russian Federation.

3. Import to the territory of the Russian Federation of counterfeited, substandard and (or) counterfeit medicines is forbidden.

4. No. 1001 is excluded according to the Order of the Government of the Russian Federation of 05.12.2011

5. No. 1001 is excluded according to the Order of the Government of the Russian Federation of 05.12.2011

6. No. 1001 is excluded according to the Order of the Government of the Russian Federation of 05.12.2011

7. No. 1001 is excluded according to the Order of the Government of the Russian Federation of 05.12.2011

8. No. 1001 is excluded according to the Order of the Government of the Russian Federation of 05.12.2011

9. Medicines for medical application (both not registered in the Russian Federation, and registered) can be imported on the territory of the Russian Federation without the permission of the Ministry of Health of the Russian Federation if they are intended for the purpose of:

a) personal use of medicines by the physical persons which arrived to the Russian Federation. At the same time import to the Russian Federation of the medicines containing the strong and (or) toxic agents included respectively in the list of strong substances for the purposes of Article 234 and other articles of the Criminal Code of the Russian Federation and in the list of toxic agents for the purposes of Article 234 and other articles of the Criminal Code of the Russian Federation, approved by the order of the Government of the Russian Federation of December 29, 2007 No. 964 "About approval of lists of strong and toxic agents for the purposes of Article 234 and other articles of the Criminal Code of the Russian Federation, and also the large size of strong substances for the purposes of article 234 of the Criminal Code of the Russian Federation" is performed in the presence of the documents (verified copies of documents or certified extracts from them) confirming appointment to physical person of the specified medicines, except for medicines registered in the Russian Federation and released in the Russian Federation without recipe on medicine. The specified documents (their verified copies or certified extracts from them) shall contain data on the name and amount of the appointed medicine. If such documents (their verified copies or certified extracts from them) are constituted in foreign language, notarized transfer into Russian is applied to them;

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