ORDER OF THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

of September 1, 2017 No. 585n

About approval of Administrative regulations of execution by the Federal Service on supervision in the field of health care of the state function on implementation of licensed control of pharmaceutical activities

According to orders of the Government of the Russian Federation of December 22, 2011 No. 1081 "About licensing of pharmaceutical activities" (The Russian Federation Code, 2012, No. 1, Art. 126; No. 37, Art. 5002; 2013, No. 16, Art. 1970; 2016, No. 40, the Art. 5738) and 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.:

Approve the enclosed Administrative regulations of execution by the Federal Service on supervision in the field of health care of the state function on implementation of licensed control of pharmaceutical activities.

Approved by the Order of the Ministry of Health of the Russian Federation of September 1, 2017, No. 585n

Administrative regulations of execution by the Federal Service on supervision in the field of health care of the state function on implementation of licensed control of pharmaceutical activities

I. General provisions

Name of the state function

1. The state function regulated by these Administrative regulations (further - Administrative regulations), is implementation of licensed control of the pharmaceutical activities performed by legal entities including the organizations of wholesale trade by medicines for medical application, the pharmaceutical organizations, the medical organizations and their separate divisions (the centers (departments) of general medical (family) practice, out-patient clinic, medical assistant's and medical and obstetrical centers) located in rural settlements in which there are no pharmaceutical organizations, and the individual entrepreneurs having the license for pharmaceutical activities (further respectively - the state function, licensed control).

The name of the federal executive body performing the state function

2. Licensed control is exercised by the Federal Service on supervision in the field of health care and territorial authorities of Roszdravnadzor (further - territorial authorities) which list is given in appendix No. 1 to Administrative regulations.

The list of the regulatory legal acts regulating execution of the state function

3. Execution of the state function is performed according to:

1) the Russian Federation Code of Administrative Offences of December 20, 2001 No. 195-FZ (The Russian Federation Code, 2002, No. 1, Art. 1; No. 18, Art. 1721; No. 30, Art. 3029; No. 44, Art. 4295, 4298; 2003, No. 1, Art. 2; No. 27, Art. 2700, 2708, 2717; No. 46, Art. 4434, 4440; No. 50, Art. 4847, 4855; No. 52, Art. 5037; 2004, No. 19, Art. 1838; No. 30, Art. 3095; No. 31, Art. 3229; No. 34, Art. 3529, 3533; No. 44, Art. 4266; 2005, No. 1, Art. 9, 13, 37, 40, 45; No. 10, Art. 762, 763; No. 13, Art. 1077, 1079; No. 17, Art. 1484; No. 19, Art. 1752; No. 25, Art. 2431; No. 27, Art. 2719, 2721; No. 30, Art. 3104, 3124, 3131; No. 40, Art. 3986; No. 50, Art. 5247; No. 52, Art. 5574, 5596; 2006, No. 1, Art. 4, 10; No. 2, Art. 172, 175; No. 6, Art. 636; No. 10, Art. 1067; No. 12, Art. 1234; No. 17, Art. 1776; No. 18, Art. 1907; No. 19, Art. 2066; No. 23, Art. 2380, 2385; No. 28, Art. 2975; No. 30, Art. 3287; No. 31, Art. 3420, 3432, 3433, 3438, 3452; No. 43, Art. 4412; No. 45, Art. 4633, 4634, 4641; No. 50, Art. 5279, 5281; No. 52, Art. 5498; 2007, No. 1, Art. 21, 25, 29, 33; No. 7, Art. 840; No. 15, Art. 1743; No. 16, Art. 1824, 1825; No. 17, Art. 1930; No. 20, Art. 2367; No. 21, Art. 2456; No. 26, Art. 3089; No. 30, Art. 3755; No. 31, Art. 4001, 4007, 4008, 4009; No. 31, Art. 4015; No. 41, Art. 4845; No. 43, Art. 5084; №46, of Art. 5553; No. 49, Art. 6034, 6065; No. 50, Art. 6246; 2008, No. 10, Art. 896; No. 18, Art. 1941; No. 20, Art. 2251, 2259; No. 29, Art. 3418; No. 30, Art. 3582, 3601, 3604; No. 45, Art. 5143; No. 49, Art. 5738, 5745, 5748; No. 52, Art. 6227, 6235, 6236, 6248; 2009, No. 1, Art. 17; No. 7, Art. 771, 777; No. 19, Art. 2276; No. 23, Art. 2759, 2767, 2776; No. 26, Art. 3120, 3122, 3131, 3132; No. 29, Art. 3597, 3599, 3635, 3642; No. 30, Art. 3735, 3739; No. 45, Art. 5265, 5267; No. 48, Art. 5711, 5724, 5755; No. 52, Art. 6406, 6412; 2010, No. 1, Art. 1; No. 11, Art. 1169, 1176; No. 15, 1743, 1751; No. 18, Art. 2145; No. 19, Art. 2291; No. 21, Art. 2524, 2525, 2526, 2530; No. 23, Art. 2790; No. 25, Art. 3070; No. 27, Art. 3416, 3429; No. 28, Art. 3553; No. 29, Art. 1308; No. 30, Art. 4000, 4002, 4005, 4006, 4007; No. 31, Art. 4155, 4158, 4164, 4191, 4192, 4193, 4195, 4198, 4206, 4207, 4208; No. 32, Art. 4298; No. 41, Art. 5192, 5193; No. 46, Art. 5918; No. 49, Art. 6409; No. 50, Art. 6605; No. 52, Art. 6984, 6995, 6996; 2011, No. 1, Art. 10, 23, 29, 33, 47, 54; No. 7, Art. 901, 905; No. 15, Art. 2039, 2041; No. 17, Art. 2310, 2312; No. 19, Art. 2714, 2715, 2769; No. 23, Art. 3260, 3267; No. 27, Art. 3873, 3881; No. 29, Art. 4284, 4289, 4290, 4291, 4298; No. 30, Art. 4573, 4574, 4584, 4585, 4590, 4591, 4598, 4600, 4601, 4605; No. 45, Art. 6325, 6326, 6334; No. 46, Art. 6406; No. 47, Art. 6601, 6602; No. 48, Art. 6728, 6730, 6732; No. 49, Art. 7025, 7042, 7056, 7061; No. 50, Art. 7342, 7345, 7346, 7351, 7352, 7355, 7362, 7366; 2012, No. 6, Art. 621; No. 10, Art. 1166; No. 15, Art. 1723; 1724; No. 18, Art. 2126, 2128; No. 19, Art. 2278, 2281; No. 24, Art. 3068, 3069, 3082; No. 25, Art. 3268; No. 29, Art. 3996; No. 31, Art. 4320, 4322, 4329, 4330; No. 41, Art. 5523; No. 47, Art. 6402, 6403, 6404, 6405; No. 49, Art. 6752, 6757; No. 50, Art. 6967; No. 53, Art. 7577, 7580, 7602, 7639, 7640, 7641, 7643; 2013, No. 4, Art. 304; No. 8, Art. 717, 718, 719, 720; No. 14, Art. 1641, 1642, 1651, 1657, 1658, 1666; No. 17, Art. 2029; No. 19, Art. 2307, 2318, 2319, 2323, 2325; No. 23, Art. 2871, 2875; No. 26, Art. 3207, 3208, 3209; No. 27, Art. 3442, 3454, 3458, 3465, 3469, 3470, 3477, 3478; No. 30, Art. 4025, 4026, 4027, 4028, 4029, 4030, 4031, 4032, 4033, 4034, 4035, 4036, 4040, 4044, 4059, 4078, 4081, 4082; No. 31, Art. 4191; No. 40, Art. 5032; No. 43, Art. 5443, 5444, 5445, 5446, 5452; No. 44, Art. 5624, 5633, 5643, 5644; No. 48, Art. 6161, 6158, 6159, 6163, 6164, 6165; No. 49, Art. 6327, 6341, 6342, 6343, 6344, 6345; No. 51, Art. 6683, 6685, 6695, 6696; No. 52, Art. 6948, 6953, 6961, 6980, 6981, 6986, 6994, 6995, 6999, 7002, 7010; 2014, No. 6, Art. 557, 558, 559, 566; No. 10, Art. 1087; No. 11, Art. 1092, 1096, 1097, 1098; No. 14, Art. 1553, 1561; No. 16, Art. 1834, 1921; No. 19, Art. 2317, 2324, 2325, 2326, 2327, 2330, 2333, 2335; No. 23, Art. 2927, 2928; No. 26, Art. 3366, 3368, 3377, 3379; No. 30, Art. 4211, 4214, 4218, 4224, 4228, 4233, 4244, 4248, 4256, 4259, 4264, 4278, 5615; No. 43, Art. 5801; No. 45, Art. 6142; No. 48, Art. 6636, 6638, 6642, 6651, 6653, 6654; No. 49, Art. 6928; No. 52, Art. 7541, 7545, 7547, 7548, 7549, 7550, 7557; 2015, No. 1, Art. 29, 35, 37, 47, 67, 68, 74, 81, 83, 84, 85; No. 6, Art. 885; No. 7, Art. 1023; No. 10, Art. 1405, 1411, 1416, 1427; No. 13, Art. 1804, 1805, 1811; No. 14, Art. 2011, 2021; No. 18, Art. 2614; 2619, 2620, 2623; No. 21, Art. 2981; No. 24, Art. 3367, 3370; No. 27, Art. 3945, 3950, 3966, 3972, 3983, 3990, 3995; No. 29, Art. 4346, 4354, 4356, 4359, 4362, 4374, 4376, 4391; No. 30, Art. 4657; No. 41, Art. 5629, 5637, 5642; No. 44, Art. 6046; No. 45, Art. 6205, 6208; No. 48, Art. 6706, 6710, 6711, 6716; No. 51, Art. 7249, 7250; 2016, No. 1, Art. 11, 28, 59, 62, 63, 76, 79, 84; No. 7, Art. 918; No. 9, Art. 1308; No. 10, Art. 1323; No. 11, Art. 1481, 1490, 1491, 1493; No. 14, Art. 1907, 1911; No. 15, Art. 2051, 2066; No. 18, Art. 2490, 2509, 2511, 2514, 2515; No. 23, Art. 3284, 3285; No. 26, Art. 3864, 3869, 3871, 3874, 3876, 3877, 3881, 3882, 3884, 3887, 3891; No. 27, Art. 4160, 4164, 4194, 4197, 4206, 4217, 4223, 4226, 4238, 4249, 4250, 4251, 4252, 4259, 4282, 4287, 4291, 4305; No. 28, Art. 4558; No. 48, Art. 6733, 6840; No. 50, Art. 6975; No. 52, Art. 7489, 7508; 2017, No. 1, Art. 12, 31, 47, 51; No. 7, Art. 1030, 1032; No. 9, Art. 1278; No. 11, Art. 1534; No. 15, Art. 2140; No. 17, Art. 2450, 2456, 2457, 2460; No. 18, Art. 2664; No. 22, Art. 3069; No. 23, Art. 3227; No. 24, Art. 3487; No. 27, Art. 3943, 3947; No. 30, Art. 4455; No. 31, Art. 4738, 4755, 4758, 4772, 4814, 4816, 4827, 4828);

2) the Federal Law of April 12, 2010 No. 61-FZ "About drug circulation" (The Russian Federation Code, 2010, No. 16, Art. 1815; No. 31, Art. 4161; No. 42, Art. 5293; No. 49, Art. 6409; 2011, No. 50, Art. 7351; 2012, No. 26, Art. 3446; No. 53, Art. 7587; 2013, No. 27, Art. 3477; No. 48, Art. 6165; 2014, No. 11, Art. 1098; No. 43, Art. 5797; No. 52, Art. 7540; 2015, No. 10, Art. 1404; No. 27, Art. 3951; No. 29, Art. 4359, 4367, 4388; No. 51, Art. 7245; 2016, No. 1, Art. 9; No. 23, Art. 3287; No. 27, the Art. 4238, 4283) (further - the Federal Law "About Drug Circulation");

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