ORDER OF THE MINISTRY OF AGRICULTURE OF THE RUSSIAN FEDERATION

of July 8, 2009 No. 265

About approval of Administrative regulations of execution of the state function by Federal Service for Veterinary and Phytosanitary Surveillance on licensing of pharmaceutical activities in the field of drug circulation, intended for animals

According to the order of the Government of the Russian Federation of November 11, 2005 N 679 "About procedure for development and approval of administrative regulations of execution of the state functions (provision of the state services)" (The Russian Federation Code, 2005, N 47, Art. 4933; 2007,, N 50, of Art. 6285; 2008, N 18, 2063) I order to the Art.:

approve the enclosed Administrative regulations of execution of the state function by Federal Service for Veterinary and Phytosanitary Surveillance on licensing of pharmaceutical activities in the field of drug circulation, intended for animals.

Appendix

to the order of the Ministry of Agriculture of the Russian Federation of July 8, 2009 No. 265

Administrative regulations of execution of the state function by Federal Service for Veterinary and Phytosanitary Surveillance on licensing of pharmaceutical activities in the field of drug circulation, intended for animals

I. General provisions

1.1 The administrative regulations of execution by Federal Service for Veterinary and Phytosanitary Surveillance (further - Rosselkhoznadzor) the state function on licensing of the pharmaceutical activities performed in the field of drug circulation, intended for animals (further - Regulations) determine the sequence of actions (ministerial procedures) of execution of the state function for licensing of pharmaceutical activities in the field of drug circulation intended for animals (further - pharmaceutical activities).

1.2. The state function on licensing of pharmaceutical activities (further - the state function) is performed by Rosselkhoznadzor and its territorial authorities (further - territorial administrations of Rosselkhoznadzor).

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

The Federal Law of 26.12.2008 N 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, N 52, the Art. 6249);

Tax Code of the Russian Federation (Chapter 25. 3) (Russian Federation Code, 2000, N 32, Art. 3340; 2004, N 45, Art. 4377; 2005, N 1, Art. 29, Art. 30; N 30, of Art. 3117; N 50, of the Art. 5246);

Civil Procedure Code of the Russian Federation (Russian Federation Code 2002, N 46, Art. 4532; 2003, N 27, Art. 2700; 2004, N 24, Art. 2335; N 31, of Art. 3230; N 45, of Art. 4377; 2005, N 1, Art. 20; N 30, of Art. 3104; 2006, N 1, Art. 8; N 50, of Art. 5303; 2007, N 31, Art. 4011; N 41, of Art. 4845; N 43, of Art. 5084; N 50, of Art. 6243; 2008, N 24, Art. 2798; N 29, of Art. 3418; N 30, of Art. 3603; N 48, of Art. 5518; 2009, N 7, Art. 775);

The order of the Government of the Russian Federation of 30.06.2004 N 327 "About approval of regulations on Federal Service for Veterinary and Phytosanitary Surveillance" (The Russian Federation Code, 2005, N 33, Art. 3421; 2006, N 26, Art. 2846; N 52, of Art. 5587; 2007, N 46, Art. 5578; 2008, N 5, Art. 400; N 25, of Art. 2980; N 46, of Art. 5337; 2009, N 6, Art. 738).

1.4. Licensing of pharmaceutical activities represents complex of the actions connected with provision of the license for implementation of pharmaceutical activities (further - the license), renewal of the document confirming license availability, suspension of action of the license in case of administrative suspension of operations of licensees for violation of licensed requirements and conditions, with renewal or cancellation of the license, cancellation of the license, control of observance by licensees of licensed requirements and conditions when implementing of the licensed type of activity, entering data into the register of licenses, and also provision in accordance with the established procedure to interested persons of data from the register of licenses and other information on licensing.

1.5. Provision of the license and issue of the document confirming availability of the license or the notification on refusal in provision of the license is result of execution of the state function (about renewal of the license, suspension, renewal or cancellation of the license, cancellation of the license).

1.6. Applicants (license applicants, licensees) within these Regulations are the individual entrepreneurs and legal entities performing the pharmaceutical activities including wholesale, retail trade by the medicines intended for animals (further - medicines), production of medicines.

On behalf of applicants - individual entrepreneurs the representatives acting owing to the powers based on the power of attorney or the agreement can act. On behalf of applicants - legal entities persons acting according to constituent documents of legal entities without power of attorney can act; representatives owing to the powers based on the power of attorney or the agreement.

1.7. Rosselkhoznadzor performs licensing:

1) wholesale trade by medicines;

2) the wholesale and retail trade by medicines performed by one legal entity or the individual entrepreneur;

3) the retail trade by medicines performed by the legal entity or the individual entrepreneur in the region of activities of two or more territorial administrations of Rosselkhoznadzor.

1.8. Territorial administrations of Rosselkhoznadzor perform licensing of retail trade by medicines by one legal entity or the individual entrepreneur whose separate divisions are located in the region of activities of one territorial administration of Rosselkhoznadzor.

II. Requirements to procedure for execution of the state function by Rosselkhoznadzor

Procedure for informing on rules of execution of the state function

2.1. Acceptance from applicants of the statement and documents for receipt of the license, and also renewal of the document confirming license availability is performed by Rosselkhoznadzor to the address: Moscow, Orlikov Pereulok, 1/11 (in the cases specified in item 1.7.).

The postal address for the direction of documents and addresses: Orlikov Pereulok, 1/11, Moscow, 107139, Rosselkhoznadzor.

Phones for reference and preliminary record for delivery of documents: +7(499) 975 30 42; +7(495) 607 84 51;

Acceptance from applicants of the statement and documents for receipt of the license, and also renewal of the document confirming license availability (in the case specified in item 1.8.) it is performed by the relevant territorial administrations of Rosselkhoznadzor to the address of the place of implementation of activities. The list of addresses and phones of territorial administrations of Rosselkhoznadzor is posted on the official Website of Rosselkhoznadzor: http://www.fsvps.ru.

1) official publication of the regulatory legal acts establishing mandatory requirements to the licensed type of activity;

2) acceptances by the licensing body of the decision on provision, renewal, suspension, renewal of action and about cancellation of the license;

3) obtaining from the Federal Tax Service 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;

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