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

According to orders of the Government of the Russian Federation of November 11, 2005 N679 "About Procedure for 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, 2005, N 47, the Art. 4933), of June 30, 2004 N321 "About Approval of the Regulations on the Ministry of Health and Social Development of the Russian Federation" (The Russian Federation Code, 2004, N 28, Art. 2898; 2005, N 2, Art. 162; 2006, N 19, the Art. 2080) and of June 30, 2004 N323 "About Approval of the Regulations on Federal Service on Surveillance in Healthcare and Social Development" (The Russian Federation Code, 2004, N 28, 2900, N 33, of the Art. 3499) I order to the Art.:

1. Approve the enclosed Administrative regulations of Federal Service on Surveillance in Healthcare and Social Development on execution of the state function on licensing of pharmaceutical activities.

2. (R. U. Habriyev) to provide to Federal Service on Surveillance in Healthcare and Social Development carrying out licensing of pharmaceutical activities according to the Administrative regulations approved by this order.

3. To impose control of execution of this order on the deputy minister of health care and social development of the Russian Federation V. I. Starodubov.

Approved by the order of the Ministry of Health and Social Development of the Russian Federation of December 31, 2006 No. 897

Administrative regulations of Federal Service on Surveillance in Healthcare and Social Development on execution of the state function on licensing of pharmaceutical activities

I. General provisions

1.1. The administrative regulations of Federal Service on Surveillance in Healthcare and Social Development on execution of the state function on licensing of pharmaceutical activities (further - Regulations) are developed on basis:

The Federal Law of December 26, 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, Art. 6249; 2009, N 18, Art. 2140; N 29, of the Art. 3601);

Tax Code of the Russian Federation (Russian Federation Code, N 31, 03.08. 1998, Art. 3824; N32 07.08.2000, of the Art. 3340),

in compliance:

with the order of the Government of the Russian Federation of 19.06.2002 N438 "About the Unified State Register of Legal Entities" (The Russian Federation Code, 01.07. 2002, N 26, Art. 2585);

with the order of the Government of the Russian Federation of 26.02.2004 N110 "About Enhancement of Procedures of State Registration and Registration of Legal Entities and Individual Entrepreneurs" (The Russian Federation Code, 08.03. 2004, N 10, Art. 864);

with the order of the Government of the Russian Federation of 16.10.2003 N630 "About the Unified State Register of Private Entrepreneurs, Storage Precautions in Unified State Registers of Legal Entities and Individual Entrepreneurs of Documents (Data) and Their Transfer on Permanent Storage to the Public Records Offices, and also about Modification and Amendments in Orders of the Government of the Russian Federation of 19.06.2002 N438 and 439" (The Russian Federation Code, 27.10.2003, N43, of the Art. 4238);

with the order of the Government of the Russian Federation of 11.11.2005 N679 "About Procedure for 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, 21.11. 2005, N 47, Art. 4933),

within the powers established by the Regulations on Federal Service on Surveillance in Healthcare and Social Development approved by the order of the Government of the Russian Federation of 30.06.2004 N323 (The Russian Federation Code, 2004, N 28, the Art. 2900).

1.2. Licensing of the pharmaceutical activities performed by the organizations of wholesale trade by the medicines intended for medical application and drugstores of the federal organizations of health care (further - licensing of pharmaceutical activities) is the state function performed by Federal Service on Surveillance in Healthcare and Social Development and represents the actions connected with provision of licenses for implementation of pharmaceutical activities, renewal of the documents confirming availability of licenses, suspension of action of licenses in case of administrative suspension of operations of licensees for violation of licensed requirements and conditions, with renewal or cancellation of licenses, cancellation of licenses, control of observance by licensees when implementing of the licensed types of activity of the relevant licensed requirements and conditions, maintaining registers of licenses and also with provision in accordance with the established procedure to interested persons of data from registers of licenses and other information on licensing.

Prolongation of effective period of the license is performed according to the procedure of renewal of the document confirming license availability.

1.3. Licensed requirements and conditions when implementing pharmaceutical activities are:

1) availability at the license applicant (licensee) belonging to it on the property right or on other legal cause of the rooms and the equipment necessary for implementation of pharmaceutical activities and conforming to the requirements established to them;

6) availability at the head of the license applicant (licensee) whose activities are directly connected with acceptance, storage, leave, production and destruction of medicines, the higher pharmaceutical education, length of service in at least 3 years and the certificate of the specialist;

7) availability at the individual entrepreneur - the license applicant (licensee) of the higher or secondary pharmaceutical education and the certificate of the specialist;

8) availability at the license applicant (licensee) of workers whose activities are connected with production, acceptance, storage, leave and sale of the medicines having the higher or secondary pharmaceutical education and certificates of the specialist;

9) advanced training of specialists with pharmaceutical education at least once in 5 years.

1.4. The pharmaceutical activities performed by legal entities and individual entrepreneurs in the sphere of the address of the medicines intended for medical application including wholesale, retail trade by medicines and production of medicines are subject to licensing.

1.5. In case of execution of the state function on licensing of pharmaceutical activities the following ministerial procedures are performed:

II. Requirements to procedure for execution of the state function

2.1. The decision on provision of the license and issue of the document confirming license availability which shall contain the following data is result of licensing:

1) the name of the licensing body;

2) complete and (if is available) the abbreviated name, including trade name, and form of business of the legal entity, the place of its stay, the address of places of implementation of pharmaceutical activities, the state registration number of record about creation of the legal entity;

3) surname, name and (if is available) middle name of the individual entrepreneur, the place of his residence, the address of places of implementation of pharmaceutical activities, data of the document proving his identity, the primary state registration number of record about state registration of the individual entrepreneur;

4) the licensed type of activity - pharmaceutical activities;

5) license effective period;

6) identification taxpayer number;

7) license number;

8) decision date about provision of the license.

The license for implementation of pharmaceutical activities is provided for 5 (five) years.

2.2. Reception of applications and documents for receipt of the license for implementation of pharmaceutical activities, its renewal, and also issue of the documents confirming license availability is made to the address:

Federal Service on Surveillance in Healthcare and Social Development, the department performing licensing of pharmaceutical activities: 109074, Moscow, Slavyanskaya Ploshchad of 4, structure 1. Operating time: on weekdays from 10-00 till 16-00. Lunch break from 13-00 till 14-00.

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