ORDER OF THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION
AND THE FEDERAL SERVICE OF THE RUSSIAN FEDERATION ON SUPERVISION IN THE FIELD OF HEALTH CARE

of May 15, 2019 No. 3588

About approval of Administrative regulations of the Federal Service on supervision in the field of health care on provision of the state service in issue of the certificate on the right of import (export) of drugs, psychotropic substances and their precursors if they are medicines

According to the subitem "b" of item 4 of the Regulations on import to the Russian Federation and export from the Russian Federation of drugs, psychotropic substances and their precursors when implementing foreign trade activity with state members of the Eurasian Economic Union, the subitem "b" of Item 5 of the Regulations on import to the Russian Federation and export from the Russian Federation of the drugs, psychotropic substances and their precursors when implementing foreign trade activity with the states which are not members of the Eurasian Economic Union approved by the order of the Government of the Russian Federation of March 21, 2011 No. 181 "About procedure for import to the Russian Federation and export from the Russian Federation of drugs, psychotropic substances and their precursors" (The Russian Federation Code, 2011, No. 13, Art. 1769; No. 51, Art. 7534; 2012, No. 15, Art. 1787; No. 37, Art. 5002; No. 40, Art. 5454; 2013, No. 9, Art. 965; 2017, No. 2, Art. 375; No. 27, Art. 4052; 2018, No. 44, the Art. 6740), the order of the Government of the Russian Federation of May 16, 2011 No. 373 "About development and approval of administrative regulations of implementation of the state control (supervision) and administrative regulations of provision of the state services" (The Russian Federation Code, 2011, No. 22, Art. 3169; No. 35, Art. 5092; 2012, No. 28, Art. 3908; No. 36, Art. 4903; No. 50, Art. 7070; No. 52, Art. 7507; 2014, No. 5, Art. 506; 2017, No. 44, Art. 6523; 2018, No. 6 Art. 880; No. 25, Art. 3696; No. 36, Art. 5623; 46, of the Art. 7050) I order to No.:

Approve the enclosed Administrative regulations of the Federal Service on supervision in the field of health care on provision of the state service in issue of the certificate on the right of import (export) of drugs, psychotropic substances and their precursors if they are medicines.

Approved by the Order of the Federal Service on supervision in the field of health care of May 15, 2019, No. 3588

Administrative regulations of the Federal Service on supervision in the field of health care on provision of the state service in issue of the certificate on the right of import (export) of drugs, psychotropic substances and their precursors if they are medicines

I. General provisions

Subject of regulation of Administrative regulations

1. The administrative regulations of the Federal Service on supervision in the field of health care on provision of the state service in issue of the certificate on the right of import (export) of drugs, psychotropic substances and their precursors if they are medicines (further - the state service) establish terms and the sequence of ministerial procedures (actions) of the Federal Service for supervision in the field of health care (further - Roszdravnadzor), order of interaction between structural divisions of Roszdravnadzor, his officials, and also interactions of Roszdravnadzor with applicants, other public authorities and local government bodies, the organizations by provision of the state service.

2. The state service is provided:

1) when implementing foreign trade activity with the State Parties of the Customs union within EurAsEC - when importing to the Russian Federation and export from the Russian Federation of the drugs, psychotropic substances and their precursors (including separately packed up and the consolidated loads which are part, diagnostic, laboratory and other sets) which are medicines and the drugs deposited in the list, the psychotropic substances and their precursors which are subject to control in the Russian Federation, No. 681 approved by the order of the Government of the Russian Federation of June 30, 1998 (The Russian Federation Code, 1998, No. 27, Art. 3198; 2004, No. 8, Art. 663; No. 47, Art. 4666; 2006, No. 29, Art. 3253; 2007, No. 28, Art. 3439; 2009, No. 26, Art. 3183; No. 52, Art. 6572; 2010, No. 3, Art. 314; No. 17, Art. 2100; No. 24, Art. 3035; No. 28, Art. 3703; No. 31, Art. 4271; No. 45, Art. 5864; No. 50, Art. 6696, Art. 6720; 2011, No. 10, Art. 1390; No. 12, Art. 1635; No. 29, Art. 4466, 4473; No. 42, Art. 5921; No. 51, Art. 7534; 2012, No. 10, Art. 1232; No. 11, Art. 1295; No. 19, Art. 2400; No. 22, Art. 2864; No. 37, Art. 5002; No. 41, Art. 5625; No. 48, Art. 6686; No. 49, Art. 6861; 2013, No. 6, Art. 558; No. 9, Art. 953; No. 25, Art. 3159; No. 29, Art. 3962; No. 37, Art. 4706; No. 46, Art. 5943; No. 51, Art. 6869; 2014, No. 14, Art. 1626; No. 23, Art. 2987; No. 27, Art. 3763; No. 44, Art. 6068; No. 51, Art. 7430; 2015, No. 11, Art. 1593; No. 16, Art. 2368; No. 20, Art. 2914; No. 28, Art. 4232; No. 42, Art. 5805; 2016, No. 15, Art. 2088; 2017, No. 4, Art. 671; No. 10, Art. 1481; No. 23, Art. 3330; No. 30, Art. 4664; No. 33, Art. 5182; 2018, No. 14, Art. 1986; No. 27, Art. 4071; No. 53, the Art. 8650) (further - the list);

2) when implementing foreign trade activity with the states, not being members of the Customs union within EurAsEC:

a) when importing (export) of the drugs, psychotropic substances and their precursors (including separately packed up and the consolidated loads which are part, diagnostic, laboratory and other sets) which are medicines, made to the list, and also to Section 2.12 of the Inventory concerning which the allowing procedure for import to customs area of the Eurasian Economic Union and (or) export from customs area of the Eurasian Economic Union (The decision of Board of the Eurasian economic commission of April 21, 2015 No. 30) (The Official site of the Eurasian Economic Union of http://www.eaeunion.org/, 22.04.2015 is established; 17.06.2015; 02.09.2015; 07.10.2015; 18.11.2015; 18.05.2016; 03.06.2016; 15.06.2016; 31.08.2016; 28.09.2016; 17.11.2016; 17.01.2017; 03.07.2017; 08.08.2017; 05.09.2017; 16.11.2017; 15.12.2017; 27.04.2018; 18.06.2018; 19.10.2018; 30.01. 2019) (further - the Single inventory);

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