ORDER OF THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

of September 21, 2016 No. 725n

About approval of Administrative regulations of the Ministry of Health of the Russian Federation on provision of the state service in state registration of medicines for medical application

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. 2873, 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. 3477, 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, Art. 67, 72; No. 10, Art. 1393; No. 29, Art. 4342, 4376; 2016, No. 7, the Art. 916), 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 Ministry of Health of the Russian Federation on provision of the state service in state registration of medicines for medical application.

2. Recognize invalid:

the order of the Ministry of Health of the Russian Federation of October 22, 2012 No. 428n "About approval of Administrative regulations of the Ministry of Health of the Russian Federation on provision of the state service in state registration of medicines for medical application (registration No. 28972) is registered by the Ministry of Justice of the Russian Federation on July 3, 2013;

item 4 of changes which are made to some orders of the Ministry of Health of the Russian Federation approved by the order of the Ministry of Health of the Russian Federation of October 7, 2013 No. 704n (registration No. 30377) is registered by the Ministry of Justice of the Russian Federation on November 14, 2013;

Item of 2 changes which are made to some orders of the Ministry of Health and Social Development of the Russian Federation and Ministry of Health of the Russian Federation approved by the order of the Ministry of Health of the Russian Federation of April 3, 2014 No. 152n (registration No. 32648) is registered by the Ministry of Justice of the Russian Federation on June 10, 2014.

Approved by the Order of the Ministry of Health of the Russian Federation of September 21, 2016, No. 725n

Administrative Regulations of the Ministry of Health of the Russian Federation on provision of the state service in state registration of medicines for medical application

I. General provisions

Subject of regulation of regulations

1. The administrative regulations of the Ministry of Health of the Russian Federation on provision of the state service in state registration of medicines for medical application (further respectively - Administrative regulations, the state service) establish terms and the sequence of ministerial procedures (actions) of the Ministry of Health of the Russian Federation (further - the Ministry) performed at the request of the legal entity or his authorized representative, order of interaction between structural divisions of the Ministry, his officials by provision of the state service.

Circle of applicants

2. Applicant on provision of the state service in state registration of medicines for medical application is the legal entity acting to own advantage or authorized to represent the interests of other legal entity and declaring medicine for medical application on state registration (further respectively - the applicant, medicine).

Requirements to procedure for informing on provision of the state service

3. Informing on procedure for provision of the state service is performed by the Ministry:

1) by means of placement of information on the official site of the Ministry on the Internet: www.rosminzdrav.ru (further - the official site of the Ministry), including information on graphics of acceptance of applicants and phone numbers for reference (consultations);

2) on the portal on maintaining the state register of medicines: http://grls.rosminzdrav.ru (further - the portal on maintaining the state register of medicines);

3) in the federal state information system "Single Portal of the State and Municipal Services (Functions)": www.gosuslugi.ru (further - the Single portal of the state and municipal services (functions);

4) on phone numbers for reference;

5) by means of publication in mass media.

4. Informing on procedure for provision of the state service is made by the Ministry of the address:

127994, Moscow, Rakhmanovsky Pereulok, 3.

Operating time: on weekdays from 9-00 to 18-00 o'clock (Friday from 9-00 to 16 o'clock 45 minutes). Lunch break from 12-00 to 12 o'clock 45 minutes.

Phone for reference: +7 (495) 628-44-53, (495) 627-29-44.

Phone of department of registration of medicines:

+7 (495) 627-24-00, ext. 2020, 2021, 2022, 2023.

Phone of department of regulation of the address of the registered medicines:

+7 (495) 627-24-00, ext. 2030, 2031, 2033, 2035.

5. Application forms and other documents processed directly by applicants, represented to the Ministry for receipt of the state service in electronic form shall be available to copying and filling in electronic form on:

1) official site of the Ministry;

2) Single portal of the state and municipal services (functions).

Use of the digital signature when giving in the Ministry of the statement and the electronic documents attached to it is performed from the moment of creation of the relevant information and telecommunication structure.

6. At information stands of the Ministry and the following information materials are posted on the official site of the Ministry:

1) information on procedure for provision of the state service, including information on the place of acceptance of applicants and the days and hours established for acceptance of applicants;

2) the list of the regulatory legal acts regulating provision of the state service.

7. The data containing in the state register of medicines for medical application are placed on the portal on maintaining the state register of medicines.

II. Standard of provision of the state service

Name of the state service

8. The state service in state registration of medicines for medical application (further - the state service).

The name of the federal executive body providing the state service

9. The state service is provided by the Ministry.

10. By provision of the state service Ministry has no right to demand from the applicant of implementation of actions the, including coordination necessary for receipt of the state service and connected with the appeal to other state bodies and the organizations, except for receipts of the services included in the list of services which are necessary and obligatory for provision of the state services approved by the Government of the Russian Federation.

Description of result of provision of the state service

11. Results of provision of the state service are:

1) issue (direction) to the applicant of the decision on state registration of medicine for medical application, the registration certificate of medicine effective period five years, the approved regulating documentation, the instruction on medical application of medicine and prototypes of primary package and secondary (consumer) package;

2) issue (direction) to the applicant of the decision on inclusion of the pharmaceutical substance made for realization in the state register of medicines for medical application (further - the state register of medicines);

3) issue (direction) to the applicant of the decision on impossibility to consider medicine in case of state registration as orphan medicine;

4) issue (direction) to the applicant of the decision on refusal in state registration of medicine with indication of causes of failure, including concerning medicine on which the conclusion of the commission of experts about impossibility to consider medicine in case of state registration as orphan medicine arrived;

5) issue (direction) to the applicant of the termless registration certificate of medicine;

6) issue (direction) to the applicant of the decision on modification of the documents containing in the registration file on the registered medicine;

7) issue (direction) to the applicant of the decision on modification of documents on the pharmaceutical substance made for realization and included in the state register of medicines;

8) issue (direction) to the applicant of the decision on refusal in modification of the documents containing in the registration file on the registered medicine;

9) issue (direction) to the applicant of the decision on refusal in modification of documents on the pharmaceutical substance made for realization and included in the state register of medicines;

10) execution (delivery) of the decision on cancellation of state registration of medicine and exception of medicine of the state register of medicines;

11) execution (delivery) of the decision on exception of the state register of medicines of the pharmaceutical substance made for realization;

12) entering into the state register of medicines of data on the registered medicine, including about the pharmaceutical substance which is part of the registered medicine about the pharmaceutical substance made for realization about confirmation of state registration of medicine, about the made changes in the documents containing in the registration file on medicine (if necessary) on the made changes in documents on the pharmaceutical substance made for realization (if necessary) on cancellation of state registration of medicine, about exception of the pharmaceutical substance made for realization of the state register of medicines.

Term of provision of the state service

12. Terms of provision of the state service:

1) registration, issue (direction) to the applicant of the decision on state registration of medicine and the registration certificate of medicine or the decision on refusal in state registration of medicine - 160 (hundred sixty) working days from the date of adoption of the statement for state registration of medicine;

2) registration, issue (direction) to the applicant of the decision on refusal in state registration of medicine concerning which the decision of the commission of experts about impossibility to consider medicine in case of state registration as orphan medicine is received, - 45 (forty five) working days from the date of adoption of the statement for state registration of medicine;

3) registration, issue (direction) to the applicant of the decision on inclusion of the pharmaceutical substance made for realization in the state register of medicines - 75 (seventy five) working days from the date of adoption of the statement for inclusion of the pharmaceutical substance made for realization in the state register of medicines;

4) registration, issue (direction) to the applicant of the decision on modification of the documents containing in the registration file on the registered medicine, or decisions on refusal in modification of the documents containing in the registration file on medicine - 90 (ninety) working days from the date of adoption of the statement for introduction of such changes;

5) registration, issue (direction) to the applicant of the decision on modification of documents on the pharmaceutical substance made for realization and included in the state register of medicines - 90 (ninety workers) days from the date of adoption of the statement for introduction of such changes;

6) registration, issue (direction) to the applicant of the termless registration certificate of medicine in case of confirmation of state registration - 90 (ninety) working days from the date of receipt of the statement for confirmation of state registration of medicine;

7) registration, issue (direction) to the applicant of the decision on cancellation of state registration of medicine and exception of medicine of the state register of medicines - 30 (thirty) working days from the date of giving by the holder or owner of the registration certificate of medicine or other legal entity of the statement for cancellation of state registration of medicine authorized by it;

8) registration, issue (direction) to the applicant of the decision on exception of the state register of medicines of the pharmaceutical substance made for realization - 30 (thirty) working days from the date of supply of medicine by developer or producer of medicine or other legal entity of the statement for exception of the pharmaceutical substance made for realization authorized by them from the state register of medicines.

9) registration, issue (direction) of the duplicate of the registration certificate of medicine - 10 (ten) working days from the date of giving by the holder or owner of the registration certificate of medicine or other legal entity of the statement for issue of the duplicate of the registration certificate of medicine authorized by them.

The terms specified in subitems 1 - 6 these Items, can be suspended according to Articles 16, of 19, of 29, of 30, 34 Federal Laws of April 12, 2010 No. 61-FZ "About drug circulation" (further - the Federal Law of April 12, 2010 No. 61-FZ).

The list of the regulatory legal acts governing the relations arising in connection with provision of the state service

13. The list of the regulatory legal acts governing the relations arising in connection with provision of the state service:

1) 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. 2873, Art. 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. 3477, 3480; No. 30, Art. 4084; No. 51, Art. 6679; No. 52, Art. 6961, Art. 7009; 2014, No. 26, Art. 3366; No. 30, Art. 4264; 2015, No. 1, Art. 67, 72; No. 10, Art. 1393; No. 29, Art. 4342, 4376; 2016, No. 7, Art. 916; No. 27, the Art. 4293) (further - the Federal Law of July 27, 2010 No. 210-FZ);

2) the Federal Law of April 12, 2010 No. 61-FZ (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, Art. 4367, 4388; No. 51, Art. 7245; 2016, No. 1, Art. 9; No. 23, Art. 3287; No. 27, Art. 4238, 4283);

3) Tax Code of the Russian Federation (part two) (Russian Federation Code, 2000, No. 32, Art. 3340, 3341; 2001, No. 1, Art. 18; No. 23, Art. 2289; No. 33, Art. 3413, 3421, 3429; No. 49, Art. 4554, 4564; No. 53, Art. 5015, 5023; 2002, No. 1, Art. 4; No. 22, Art. 2026; No. 30, Art. 3021, 3027, 3033; No. 52, Art. 5132, 5138; 2003, No. 1, Art. 2, 5, 6, 8, 11; No. 19, Art. 1749; No. 21, Art. 1958; No. 22, Art. 2066; No. 23, Art. 2174; No. 26, Art. 2567; No. 27, Art. 2700; No. 28, Art. 2874, 2879, Art. 2886; No. 46, Art. 4435, 4443, 4444; No. 50, Art. 4849; No. 52, Art. 5030; 2004, No. 15, Art. 1342; No. 27, Art. 2711, 2713, 2715; No. 30, Art. 3083, 3084, 3088; No. 31, Art. 3219, 3220, 3222, 3231; No. 34, Art. 3517, 3518, 3520, 3522, 3523, 3524, 3525, 3527; No. 35, Art. 3607; No. 41, Art. 3994; No. 45, Art. 4377; No. 49, Art. 4840; 2005, No. 1, Art. 9, 29, 30, 34, 38; No. 21, Art. 1918; No. 23, Art. 2201; No. 24, Art. 2312; No. 25, Art. 2427, 2428, 2429; No. 27, Art. 2707, 2710, 2713, 2717; No. 30, Art. 3101, 3104, 3112, 3117, 3118, 3128, 3129, 3130; No. 43, Art. 4350; No. 50, Art. 5246, 5249; No. 52, Art. 5581; 2006, No. 1, Art. 12, 16; No. 3, Art. 280; No. 10, Art. 1065; No. 12, Art. 1233; No. 23, Art. 2380, 2382; No. 27, Art. 2881; No. 30, Art. 3295; No. 31, Art. 3433, 3436, 3443, 3450, 3452; No. 43, Art. 4412; No. 45, Art. 4627, 4628, 4629, 4630; No. 47, Art. 4819; No. 50, Art. 5279, 5286; No. 52, Art. 5498; 2007, No. 1, Art. 7, 20, 31, 39; No. 13, Art. 1465; No. 21, Art. 2461, 2462, 2463; No. 22, Art. 2563, 2564; No. 23, Art. 2691; No. 31, Art. 3991, 4013; No. 45, Art. 5416, 5417, 5432; No. 46, Art. 5553, 5554, 5557; No. 49, Art. 6045, 6046, 6071; No. 50, Art. 6237, 6245, 6246; 2008, No. 18, Art. 1942, No. 26, Art. 3022; No. 27, Art. 3126; No. 30, Art. 3577, 3591, 3598, 3611, 3614, 3616; No. 42, Art. 4697; No. 48, Art. 5500, 5503, 5504, 5519; No. 49, Art. 5723, 5749; No. 52, Art. 6218, 6219, 6227, 6236, 6237; 2009, No. 1, Art. 13, 19, 22, 31; No. 11, Art. 1265; No. 18, Art. 2147; No. 23, Art. 2772, 2775; No. 26, Art. 3123; No. 29, Art. 3582, 3598, 3602, 3638, 3641, 3642, No. 30, Art. 3735, 3739; No. 39, Art. 4534; No. 44, Art. 5171; No. 45, Art. 5271; No. 48, Art. 5711, 5725, 5726, 5731, 5732, 5733, 5734, 5737; No. 51, Art. 6153, 6155; No. 52, Art. 6444, 6450, 6455; 2010, No. 15, Art. 1737, 1746; No. 18, Art. 2145; No. 21, Art. 2524; No. 31, Art. 4198; No. 32, Art. 4298; No. 40, Art. 4969; No. 45, Art. 5750, 5756; No. 46, Art. 5918; No. 47, Art. 6034; No. 48, Art. 6247, 6248, 6249, 6250, 6251; No. 49, Art. 6409; 2011, No. 1, Art. 7, 9, 21, 37, No. 11, Art. 1492, 1494, No. 17, Art. 2311, 2318; No. 23, Art. 3265; No. 24, Art. 3357; No. 26, Art. 3652; No. 30, Art. 4566, 4575, 4583, 4587, 4593, 4596, 4606; No. 48, Art. 6729, 6731; No. 49, Art. 7016, 7017, 7037, 7043, 7061, 7063; No. 50, Art. 7347, 7359; 2012, No. 10, Art. 1164; No. 14, Art. 1545; No. 18, Art. 2128; No. 19, Art. 2281; No. 24, Art. 3066; No. 25, Art. 3268; No. 26, Art. 3447; No. 27, Art. 3587, 3588; No. 29, Art. 3980; No. 31, Art. 4319, 4322, 4334; No. 41, Art. 5526, 5527; No. 49, Art. 6747, 6748, 6749, 6750, 6751; No. 50, Art. 6958; No. 53, Art. 7596, 7603, 7604, 7607, 7619; 2013, No. 14, Art. 1647; No. 19, Art. 2321; No. 23, Art. 2866, 2888, 2889; No. 27, Art. 3444; No. 30, Art. 4031, 4046, 4048, 4049, 4081, 4084; 2014, No. 8, Art. 737; No. 14, Art. 1544; No. 16, Art. 1835, 1838; No. 19, Art. 2313, 2314, 2321; No. 23, Art. 2930, 2936, 2938; No. 26, Art. 3372, 3373, 3393, 3404; No. 30, Art. 4420, 4222, 4239, 4240, 4245; No. 40, Art. 5315, Art. 5316; No. 43, Art. 5796, 5799; No. 45, Art. 6157, 6159; No. 48, Art. 6647, 6648, 6649, 6650, 6657, 6660, 6661, 6662, 6663; 2015, No. 1, Art. 5315, 5316, 5317, 5318, 5330, 5331, 5332, 5333; No. 10, Art. 1393, 1402; No. 14, Art. 2023; No. 24, Art. 3373, 3377; No. 27, Art. 3948, 3968, 3969; No. 41, the Art. 5632) (further - the Tax Code of the Russian Federation);

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