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The document ceased to be valid since April 13, 2021 according to the Order of the Ministry of Agriculture of the Russian Federation of February 26, 2021 No. 99

It is registered

Ministry of Justice

Russian Federation

On May 27, 2016 No. 42305

ORDER OF THE MINISTRY OF AGRICULTURE OF THE RUSSIAN FEDERATION

of March 18, 2016 No. 98

About approval of Administrative regulations of Federal Service for Veterinary and Phytosanitary Surveillance on provision of the state service in licensing of activities for production of medicines for veterinary 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. 3873, 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, Art. 3480; No. 30, Art. 4084; No. 51, Art. 6679; No. 52, Art. 6952, Art. 6961, Art. 7009; 2014, No. 26, Art. 3366; No. 30, Art. 4264; 2015, No. 1, Art. 67, Art. 72; No. 29, Art. 4342, Art. 4376; 2016, No. 7, the Art. 916), the Rules of development and approval of administrative regulations of provision of the state services approved by the order of the Government of the Russian Federation of May 16, 2011 No. 373 (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, to No. 5, of the Art. 506), I order:

1. Approve the enclosed Administrative regulations of Federal Service for Veterinary and Phytosanitary Surveillance on provision of the state service in licensing of activities for production of medicines for veterinary application.

2. Recognize invalid:

the order of the Ministry of Agriculture of the Russian Federation of June 11, 2009 No. 222 "About approval of Administrative regulations of execution of the state function by Federal Service for Veterinary and Phytosanitary Surveillance on licensing of production of the medicines intended for animals" (registration number 14171) is registered by the Ministry of Justice of the Russian Federation on June 30, 2009;

Item 1 of the order of the Ministry of Agriculture of the Russian Federation of August 17, 2010 No. 287 "About introduction of amendments to orders of the Ministry of Agriculture of the Russian Federation of June 11, 2009 No. 222, of July 8, 2009 No. 265" (registration number 18516) is registered by the Ministry of Justice of the Russian Federation on September 22, 2010.

Minister

A. N. Tkachyov

Approved by the Order of the Ministry of Agriculture of the Russian Federation of March 18, 2016, No. 98

Administrative regulations of Federal Service for Veterinary and Phytosanitary Surveillance on provision of the state service in licensing of activities for production of medicines for veterinary application

I. General provisions

Subject of regulation of Administrative regulations

1. The administrative regulations of Federal Service for Veterinary and Phytosanitary Surveillance (further - Rosselkhoznadzor) on provision of the state service in licensing of activities for production of medicines for veterinary application (further - Regulations) establish terms and the sequence of ministerial procedures (actions) when implementing licensing of activities for production of medicines for veterinary application (further - production of medicines), and also order of interaction between territorial administrations and structural divisions of Rosselkhoznadzor, their officials, interactions of Rosselkhoznadzor with legal entities and physical persons, other public authorities, organizations and the organizations by provision of the state service.

Circle of applicants

2. By provision by Rosselkhoznadzor of the state service in licensing of activities for production of medicines for veterinary application (further - the state service) applicants are:

1) the legal entities having intention to perform or performing activities for production of the medicines registered in the territory of the Russian Federation (further respectively - the license applicant, the licensee), or legal successors of the legal entities performing activities for production of medicines (further - legal successors of licensees);

2) the physical persons and legal entities which filed petition for provision of data on the specific license for production of medicines (further - the license) from the register of licenses.

On behalf of applicants - legal entities persons according to constituent documents of legal entities without power of attorney, and also representatives owing to the powers based on the power of attorney can act.

Requirements to procedure for informing on provision of the state service

3. Rosselkhoznadzor location: Orlikov Pereulok, 1/11, Moscow, 107139.

Working schedule of Rosselkhoznadzor: Monday - Thursday from 09:00 to 18:00, Friday from 09:00 till 16:00. Lunch break: 12:00 - 12:45. Saturday, Sunday, non-working holidays - days off.

Issue to applicants of licenses is made by Rosselkhoznadzor on Tuesdays and Thursdays from 13:00 till 17:00.

4. Information on addresses and telephone numbers for enquiries of Rosselkhoznadzor can be received on telephone numbers for enquiries, on the official site of Rosselkhoznadzor on the Internet to the address: http://www.fsvps.ru. E-mail address of Rosselkhoznadzor: info@svfk.mcx.ru.

5. Telephone number for enquiries (phones) of Rosselkhoznadzor: +7(499) 975-30-42, of +7(495) 607-51-43.

6. Information on Rosselkhoznadzor location, graphics of its work, addresses of the official sites, e-mail addresses, numbers of the telephone numbers for enquiries and phones informants participating in provision of the state service is placed:

on the official site of Rosselkhoznadzor on the Internet to the address: http://www.fsvps.ru;

in the federal state information system "Single Portal of the State and Municipal Services (Functions)" on the official site on the Internet to the address: www.gosuslugi.ru;

at the stand which is in premises of Rosselkhoznadzor, in the place of provision of the state service.

7. Information is provided to applicants concerning provision of the state service, data on the course of provision of the specified service by duly government civil servants of Rosselkhoznadzor by means of placement of information/data on the official site of Rosselkhoznadzor on the Internet and on telephone numbers for enquiries of Rosselkhoznadzor of +7(495) 607-51-43, of +7(499) 975-30-42, and also with use of the federal state information system "Single Portal of the State and Municipal Services (Functions)".

II. Standard of provision of the state service

Name of the state service

8. The state service in licensing of activities for production of medicines for veterinary application (further - medicines).

The name of the federal executive body providing the state service

9. Powers on provision of the state service are performed by Rosselkhoznadzor.

10. By provision of the state service within interdepartmental interaction the documents necessary for provision of the state service, available Federal Treasury, the Federal Registration Service, FNS of Russia are requested.

Description of result of provision of the state service

11. Results of provision of the state service are:

1) provision of the license on paper or in electronic form (depending on the method specified in the statement for provision of the license) with entering of data into the register of licenses or the direction to the applicant of the notification on refusal in provision of the license or letter on return of the statement for provision of the license and the documents attached to it;

2) renewal of the license and provision of the renewed license on paper or in electronic form (depending on the method specified in the statement for renewal of the license) and entering of data into the register of licenses, or the direction to the applicant of the notification on refusal in renewal of the license or letter on return of the statement for renewal of the license;

3) cancellation of the license based on receipt of the statement of the licensee for the termination of activities for production of medicines, the direction to the applicant of the termination letter of action of the license and entering of data into the register of licenses;

4) provision of the duplicate of the license, copy of the license, on paper or in electronic form (depending on the method specified in the statement for provision of the duplicate or the copy of the license) and in case of issue of the duplicate of the license entering of data into the register of licenses;

5) provision to interested persons of data from the register of licenses in paper or electronic type (depending on the method specified in the statement for provision of data from the register of licenses).

The term of provision of the state service, term of issue (direction) of the documents which are result of provision of the state service

12. The term of provision of the state service and issue (direction) of the documents which are result of provision of the state service:

1) decision making about provision (about refusal in provision) licenses - forty five working days from the date of acceptance by Rosselkhoznadzor of properly issued application for provision of the license and documents (data), stipulated in Item 14 Regulations;

2) decision making about renewal (about refusal in renewal) licenses - ten working days from the date of acceptance by Rosselkhoznadzor of properly issued application for renewal of the license and documents (data) provided by Items 15 - 17 Regulations, in cases of reorganization of the legal entity in the form of transformation or legal entities in the form of merge, change of its name, the location address, or receipt of properly issued application for the termination of activities for production of medicines to one or several addresses specified in the license;

3) decision making about renewal (about refusal in renewal) licenses - thirty working days from the date of acceptance by Rosselkhoznadzor of properly issued application for renewal of the license and documents (data) provided by Items 18, 19 Regulations in cases of intention of the licensee to perform activities for production of medicines for the address of the place of its implementation which is not specified in licenses, or changes of the list of the performed works constituting activities for production of medicines specified in the license;

4) provision of the duplicate of the license, copy of the license - three working days from the date of receipt by Rosselkhoznadzor of the statement for issue of the duplicate of the license or the copy of the license and documents (data) provided by Items 21, 22 Regulations;

5) issue (direction) of the license - three working days after day of signing of the license and its registration in the register of licenses;

6) provision of data from the register of licenses - five working days from the date of receipt by Rosselkhoznadzor of the statement for provision of data from the register of licenses according to Item 23 of Regulations;

7) decision making about cancellation of the license based on receipt according to Item 20 of Regulations of the statement of the licensee on the termination of activities for production of medicines - ten working days from the date of receipt by Rosselkhoznadzor of the statement for the termination of activities for production of medicines;

8) decision making about return of the statement for provision/renewal of the license and the documents attached to it - three working days after the 30-days term specified in Items 64 and 88 of Regulations in case of the notification of the applicant on need of elimination of the revealed violations or discrepancy of the submitted documents to provisions of Items 14 - 19 Regulations;

9) elimination by the applicant of the revealed violations and (or) submission of documents which are absent if application for provision (renewal) of the license is issued with violation of the established requirements and (or) documents are submitted not in full - thirty days from the date of documentary confirmation in receipt by the applicant of the notification on need of elimination of the revealed violations and (or) submission of documents which are absent, according to Items 64 and 88 of Regulations.

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

13. Provision of the state service is performed according to:

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, Art. 4367, Art. 4388; No. 51, Art. 7245; 2016, No. 1, Art. 9);

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, Art. 3477; 2014, No. 30, Art. 4256; No. 42, Art. 5615; 2015, No. 1, Art. 11, Art. 72; No. 27, Art. 3951; No. 29, Art. 4339, Art. 4342, Art. 4389; 2016, No. 1, Art. 51);

The Federal Law of December 26, 2008 No. 294-FZ "About protection of the rights of legal entities and individual entrepreneurs when implementing the state control (supervision) and municipal control" (The Russian Federation Code, 2008, No. 52, Art. 6249; 2009, No. 18, Art. 2140; No. 29, Art. 3601; No. 48, Art. 5711; No. 52, Art. 6441; 2010, No. 17, Art. 1988; No. 18, Art. 2142; No. 31, Art. 4160, Art. 4193, Art. 4196; No. 32, Art. 4298; 2011, No. 1, Art. 20; No. 17, Art. 2310; No. 23, Art. 3263; No. 27, Art. 3880; No. 30, Art. 4590; No. 48, Art. 6728; 2012, No. 19, Art. 2281; No. 26, Art. 3446; No. 31, Art. 4320; Art. 4322; No. 47, Art. 6402; 2013, No. 9, Art. 874; No. 27, Art. 3477; No. 30, Art. 4041; No. 44, Art. 5633; No. 48, Art. 6165; No. 49, Art. 6338; No. 52, Art. 6961; No. 52, Art. 6979, Art. 6981; 2014, No. 11, Art. 1092; No. 11, Art. 1098; No. 26, Art. 3366; No. 30, Art. 4256; No. 42, Art. 5615; No. 48, Art. 6659; 2015, No. 1, Art. 53, Art. 64, Art. 72, Art. 85; No. 14, Art. 2022; No. 27, Art. 3950; No. 29, Art. 4339, Art. 4362, Art. 4372, Art. 4389; No. 48, Art. 6707; 2016, No. 11, Art. 1495);

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