ORDER OF THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

of July 7, 2015 No. 421n

About approval of Administrative regulations of the Federal Service on supervision in health sector 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 Federal Law of July 27, 2010 No. 210-FZ "About the organization of provision of the state and municipal services" (The Russian Federation Code, 2010, No. 31, Art. 4179; 2011, No. 15, Art. 2038; No. 27, Art. 3873, 3880; No. 29, Art. 4291; No. 30, Art. 4587; No. 49, Art. 7061; 2012, No. 31, Art. 4322; 2013, No. 14, Art. 1651; No. 27, Art. 3480; No. 30, Art. 4084; No. 51, Art. 6679; No. 52, Art. 6961, 7009; 2014, No. 26, Art. 3366, No. 30, Art. 4264; 2015, No. 1, the Art. 67, 72) and the order of the Government of the Russian Federation of May 16, 2011 No. 373 "About development and approval of administrative regulations of execution of the state functions 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, 5, of the Art. 506) I order to No.:

1. Approve the enclosed Administrative regulations of the Federal Service on supervision in health sector 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.

2. Declare invalid the order of the Ministry of Health and Social Development of the Russian Federation of September 26, 2011 No. 1075n "About approval of Administrative regulations of Federal Service on Surveillance in Healthcare and Social Development on provision of the state service in issue of the certificate on the right of import (export) of drugs, psychotropic substances and their precursors" (registration No. 22480) is registered by the Ministry of Justice of the Russian Federation on December 2, 2011.

Approved by the Order of the Ministry of Health of the Russian Federation of July 7, 2015, No. 421n

Administrative regulations of the Federal Service on supervision in health sector 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 health sector 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, are developed for the purpose of improvement of quality and availability of provision of the specified state service, determine procedure and the standard of provision of the state service in issue of the certificate on the right of import (export) of drugs, psychotropic substances and their precursors by the Federal Service by supervision in health sector (further respectively - Administrative regulations, the state service, Roszdravnadzor).

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 freights 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, the Art. 2914) (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 freights 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 approved by the Decision of Board of the Eurasian economic commission of April 21, 2015 No. 30 "About measures of non-tariff regulation" is established (The Official site of the Eurasian Economic Union of http://www.eaeunion.org/, on April 22, 2015) (further - the inventory);

b) when importing (export) of the drugs, psychotropic substances and their precursors (including separately packed up and the consolidated freights which are part, diagnostic, laboratory and other sets) which are medicines, brought in the list and is not included in the single list.

Circle of applicants

3. Applicants on provision of the state service can be:

1) the state unitary enterprises - when importing (export) of the drugs and psychotropic substances entered in lists I and II of the list, and also precursors of the drugs and psychotropic substances (further - precursors) entered in the list I and the table I of the list IV of the list, in the presence of the corresponding license for implementation of the types of activity connected with drug trafficking, psychotropic substances and their precursors, cultivation of the narcocontaining plants.

Import (export) of the drugs, psychotropic substances and their precursors entered in the list I of the list is allowed only for their use in the scientific and educational purposes, and also expert activities.

2) legal entities - when importing (export) of the psychotropic substances entered in the list III of the list, in the presence of the corresponding license for implementation of the types of activity connected with drug trafficking, psychotropic substances and their precursors, cultivation of the narcocontaining plants, and precursors brought in tables II and III of the list IV of the list.

Requirements to procedure for informing on provision of the state service

4. Informing on procedure for provision of the state service is performed by Roszdravnadzor:

1) by means of placement of information, including on graphics of acceptance of applicants and phone numbers for reference (consultations), on the official Website of Roszdravnadzor: www.roszdravnadzor.ru;

2) on the Single portal of the state and municipal services (functions): www.gosuslugi.ru (further - the Single portal of the state and municipal services);

3) at information stands in reception of Roszdravnadzor for work with addresses of citizens;

4) on phone numbers for reference;

5) in mass media.

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