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:

article 34 of the Federal Law of 22.06.1998 N86-FZ "About Medicines" (The Russian Federation Code, 1998, N 26, the Art. 3006),

provisions of the Federal Law of 08.08.2001 N128-FZ "About Licensing of Separate Types of Activity" (The Russian Federation Code, 13.08. 2001, N33 (part I), Art. 3430),

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);

The Federal Law of 30.12.2001 N195-FZ "Russian Federation Code of Administrative Offences" (The Russian Federation Code, 07.01. 2002, N1 (h 1), Art. 1);

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 06.07.2006 N416 "About Approval of the Regulations on Licensing of Pharmaceutical Activities" (The Russian Federation Code, 17.07. 2006, N 29, Art. 3250);

with the order of the Government of the Russian Federation of 26.01.2006 N45 "About the Organization of Licensing of Separate Types of Activity" (The Russian Federation Code, 06.02. 2006, N 6, Art. 700);

with the order of the Government of the Russian Federation of 11.04.2006 N208 "About Approval of the Document Form, Confirming License Availability" (The Russian Federation Code, 17.04. 2006, N 16, Art. 1746);

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;

2) observance by the licensee performing wholesale trade by medicines, requirements of article 29 of the Federal law "About Medicines" and rules of wholesale trade by medicines;

3) observance by the licensee performing retail trade by medicines, requirements of article 32 of the Federal law "About Medicines" and rules of sale of the medicines approved according to article 26 of the Law of the Russian Federation "About consumer protection";

4) observance by the licensee performing production of medicines, rules of production of the medicines approved according to article 17 of the Federal law "About Medicines", and requirements to quality control of the medicines made in pharmaceutical institutions;

5) observance by the licensee of requirements about prohibition of sale of the medicines which became useless medicines of the expired, counterfeited medicines and medicines which are illegal copies of the medicines registered in the Russian Federation and also about destruction of such medicines according to article 31 of the Federal law "About Medicines";

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;

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