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The document ceased to be valid since February 12, 2021 according to the Order of the Ministry of Health of the Russian Federation of November 24, 2020 No. 1241n

It is registered

Ministry of Justice

Russian Federation

 On July 25, 2014 No. 33277

ORDER OF THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

of March 25, 2014 No. 130n

About approval of Administrative regulations of the Federal Service on supervision in the field of health care on provision of the state service in licensing of the pharmaceutical activities performed by the organizations of wholesale trade by medicines for medical application and the pharmaceutical organizations subordinated to federal executive bodies, the state academies of Sciences

(as amended of the Order of the Ministry of Health of the Russian Federation of 18.07.2016 No. 521n)

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. 3477, 3480; No. 30, Art. 4084; No. 51, Art. 6679; No. 52, the Art. 6952, 6961, 7009), 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 the field of health care on provision of the state service in licensing of the pharmaceutical activities performed by the organizations of wholesale trade by medicines for medical application and the pharmaceutical organizations subordinated to federal executive bodies, the state academies of Sciences.

2. Recognize invalid:

the order of the Ministry of Health and Social Development of the Russian Federation of December 31, 2006 No. 897 "About approval of Administrative regulations of Federal Service on Surveillance in Healthcare and Social Development on execution of the state function on licensing of pharmaceutical activities" (registration No. 8966) is registered by the Ministry of Justice of the Russian Federation on February 20, 2007;

the order of the Ministry of Health and Social Development of the Russian Federation of July 17, 2008 No. 338n "About modification of the Administrative regulations of Federal Service on Surveillance in Healthcare and Social Development on execution of the state function on licensing of pharmaceutical activities approved by the order of the Ministry of Health and Social Development of the Russian Federation of December 31, 2006 No. 897" (registration No. 12049) is registered by the Ministry of Justice of the Russian Federation on July 31, 2008;

the order of the Ministry of Health and Social Development of the Russian Federation of August 20, 2009 No. 604n "About modification of the Administrative regulations of Federal Service on Surveillance in Healthcare and Social Development on execution of the state function on licensing of pharmaceutical activities approved by the order of the Ministry of Health and Social Development of the Russian Federation of December 31, 2006 No. 897" (registration No. 16144) is registered by the Ministry of Justice of the Russian Federation on January 29, 2010.

Minister
V. I. Skvortsova

Approved by the order of the Ministry of Health of the Russian Federation of March 25, 2014, No. 130n

Administrative regulations of the Federal Service on supervision in the field of health care on provision of the state service in licensing of the pharmaceutical activities performed by the organizations of wholesale trade by medicines for medical application and the pharmaceutical organizations subordinated to federal executive bodies, the state academies of Sciences

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 licensing of the pharmaceutical activities performed by the organizations of wholesale trade by medicines for medical application and the pharmaceutical organizations subordinated to federal executive bodies, the state academies of Sciences (further - Administrative regulations) determine procedure and the standard of provision of the state service in licensing of pharmaceutical activities (further - the state service) the Federal Service by supervision in the field of health care (further - Roszdravnadzor) and territorial authorities of the Federal Service on supervision in the field of health care on subjects of the Russian Federation (further - territorial authorities of Roszdravnadzor).

2. The pharmaceutical activities in the field of drug circulation for medical application performed by the organizations of wholesale trade by medicines for medical application, and the pharmaceutical organizations subordinated to federal executive bodies, the state academies of Sciences (further respectively - medicines, pharmaceutical activities), performed by legal entities are subject to licensing within provision of the state service. As a part of pharmaceutical activities are carried out there (are) following works (services):

1) wholesale trade by medicines for medical application;

2) storage of medicines for medical application;

3) storage of medicines for medical application;

4) transportation of medicines for medical application;

5) transportation of medicines for medical application;

6) retail trade by medicines for medical application;

7) leave of medicines for medical application;

8) production of medicines for medical application.

Circle of applicants

3. Applicants on receipt of the state service (further - applicants) can be:

1) the legal entities (the organizations of wholesale trade by medicines and the pharmaceutical organizations subordinated to federal executive bodies, the state academies of Sciences) having intention to perform or performing pharmaceutical activities (further respectively - the license applicant, the licensee) or the representatives of the specified legal entities authorized in accordance with the established procedure;

2) the physical persons and legal entities which addressed for provision of data on the specific license for implementation of pharmaceutical activities and other information on provision of the state service.

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 (territorial authorities of Roszdravnadzor):

1) by means of placement of information, including on graphics of acceptance of applicants and phone numbers for reference (consultations):

on the official site of Roszdravnadzor on the Internet: www.roszdravnadzor.ru (further - the official site of Roszdravnadzor), the official sites of territorial authorities of Roszdravnadzor;

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

at information stands in reception of Roszdravnadzor (territorial authorities of Roszdravnadzor) for work with addresses of citizens;

2) on phone numbers for reference.

5. Informing on procedure for provision of the state service is made:

1) Roszdravnadzor for the address: 109074, Moscow, Slavyanskaya Ploshchad, 4, structure 1;

2) territorial authorities of Roszdravnadzor - to addresses according to appendix No. 1 to Administrative regulations.

Working hours of Roszdravnadzor: on weekdays - from 9-00 to 18-00 o'clock (on Fridays - from 9-00 to 16 o'clock 45 minutes).

Lunch break - from 13-00 to 13 o'clock 45 minutes.

Phones of Roszdravnadzor for reference: +7(495) 698-31-18; +7(495) 698-43-56; +7(499) 578-01-44; +7(499) 578-01-47.

The e-mail address - E-mail: info@roszdravnadzor.ru.

Service desk of Roszdravnadzor: +7(495) 698-16-14; +7(495) 698-45-38.

6. The application for provision of the state service with application of documents can be electronically directed by the applicant through the official site of Roszdravnadzor to the Internet or the Single portal of the state and municipal services (functions).

Application forms about the provision of the state service and the documents processed and represented by applicants to Roszdravnadzor (territorial authorities of Roszdravnadzor) for receipt of the state service in electronic form shall be available to copying and filling in electronic form on the official site of Roszdravnadzor, on the official sites of territorial authorities of Roszdravnadzor, the Single portal of the state and municipal services (functions).

7. Use of the digital signature when giving in Roszdravnadzor (territorial authorities of Roszdravnadzor) of the statement and the electronic documents attached to it is performed from the moment of creation of the relevant information and telecommunication structure.

8. At information stands of Roszdravnadzor and territorial authorities of Roszdravnadzor, on the official site of Roszdravnadzor and the official sites of territorial authorities of Roszdravnadzor the following information materials and documents are placed:

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 of the Russian Federation regulating provision of the state service;

3) the document form and statements used by Roszdravnadzor (territorial authorities of Roszdravnadzor) in the course of licensing of pharmaceutical activities;

4) the information necessary for filling of details of the order on money transfer for payment of the state fee provided by the Rules of specifying of information in details of orders on money transfer on account of payments in budget system of the Russian Federation approved by the order of the Ministry of Finance of the Russian Federation of November 12, 2013 No. 107n "About approval of Rules of specifying of information in details of orders on money transfer on account of payments in budget system of the Russian Federation" (registration No. 30913) is registered by the Ministry of Justice of the Russian Federation on December 30, 2013.

9. Information on the submitted applications, the course of consideration of documents and decision making on provision (refusal in provision) to the license for implementation of pharmaceutical activities (further - the license) and renewal (refusal in renewal) to the license shall be available to applicants and be posted on the official site of Roszdravnadzor, on the official sites of territorial authorities of Roszdravnadzor.

10. Data on the course (stage) of acceptance by Roszdravnadzor (territorial authorities of Roszdravnadzor) of the decision on provision (refusal in provision) the license, renewal (refusal in renewal) licenses, conducting check of compliance of the license applicant (licensee) to licensed requirements when implementing pharmaceutical activities are posted on the official Website of Roszdravnadzor: www.roszdravnadzor.ru, on the official sites of territorial authorities of Roszdravnadzor and, including, on the Single portal of the state and municipal services: www.gosuslugi.ru according to the procedure established by the Government of the Russian Federation.

11. The information relating to implementation of pharmaceutical activities, provided by parts 1 and 2 of article 21 of the Federal Law of May 4, 2011 No. 99-FZ "About licensing of separate types of activity" (The Russian Federation Code, 2011, No. 19, Art. 2716; No. 30, Art. 4590; No. 43, Art. 5971; No. 48, Art. 6728; 2012, No. 26, Art. 3446; No. 31, Art. 4322; 2013, No. 9, Art. 874; No. 27, of the Art. 3477), is posted on the official site of Roszdravnadzor, the official sites of territorial authorities of Roszdravnadzor and (or) at information stands in premises of the licensing body within 10 days from the date of:

1) official publication of the regulatory legal acts establishing mandatory requirements to licensing of pharmaceutical activities;

2) acceptances by Roszdravnadzor (territorial authorities of Roszdravnadzor) of the decision on provision, cancellation of the license, suspension, renewal of its action, and also renewal of the license;

3) receipts of data on liquidation of the legal entity or the termination of its activities as a result of reorganization, about the termination of activities by physical person as the individual entrepreneur;

4) introductions in legal force of the judgment about cancellation of the license.

II. Standard of provision of the state service Name of the State Service

12. The state service in licensing of the pharmaceutical activities performed by the organizations of wholesale trade by medicines for medical application and the pharmaceutical organizations subordinated to federal executive bodies, the state academies of Sciences.

The name of the federal executive body providing the state service

13. The state service is provided by Roszdravnadzor and territorial authorities of Roszdravnadzor.

14. Roszdravnadzor performs licensing of pharmaceutical activities regarding the activities performed by the organizations of wholesale trade by medicines for medical application.

Territorial authorities of Roszdravnadzor perform licensing of pharmaceutical activities regarding the activities performed by the pharmaceutical organizations subordinated to federal executive bodies, the state academies of Sciences.

Federal executive bodies, the address to which is necessary for provision of the state service,

15. The following federal executive bodies, the address to which is necessary for provision of the state service, participate in provision of the state service:

1) Federal Tax Service (FNS of Russia);

2) Federal Registration Service (Federal Registration Service);

3) Federal Service for the Oversight of Consumer Protection and Welfare (Rospotrebnadzor);

4) Federal Treasury (Federal Treasury).

Requirements to establishment of prohibition to demand from the applicant of implementation of actions the, including approvals necessary for receipt of the state service and connected with the appeal to other state bodies

16. Roszdravnadzor and territorial authorities of Roszdravnadzor have no right to demand from the applicant of implementation of actions the, including approvals necessary for receipt of the state service and connected with the address to the federal executive bodies specified in Item 15 of Administrative regulations.

Description of result of provision of the state service

17. Results of provision of the state service are:

1) provision (refusal in provision) licenses;

2) renewal (refusal in renewal) licenses;

3) issue of the duplicate of the license, copy of the license;

4) provision of data from the register of licenses.

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