ORDER OF THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

of August 2, 2012 No. 61n

About approval of Administrative regulations of the Ministry of Health of the Russian Federation on provision of the state service in issue of import permits on the territory of the Russian Federation and export out of limits of the territory of the Russian Federation of the biological materials received when performing clinical trial of medicine for medical application

According to the Federal Law of July 27, 2010 N 210-FZ "About the organization of provision of the state and municipal services" (The Russian Federation Code, 2010, N 31, Art. 4179; 2011, N 15, Art. 2038; N 27, of the Art. 3873, 3880; N 29, of Art. 4291; N 30, of Art. 4587; N 49, of the Art. 7061) and the order of the Government of the Russian Federation of May 16, 2011 N 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, N 22, Art. 3169; 5092) I order to N 35, of the Art.:

Approve the enclosed Administrative regulations of the Ministry of Health of the Russian Federation on provision of the state service in issue of import permits on the territory of the Russian Federation and export out of limits of the territory of the Russian Federation of the biological materials received when performing clinical trial of medicine for medical application.

Approved by the Order of the Ministry of Health of the Russian Federation of August 2, 2012, No. 61n

Administrative regulations of the Ministry of Health of the Russian Federation on provision of the state service in issue of import permits on the territory of the Russian Federation and export out of limits of the territory of the Russian Federation of the biological materials received when performing clinical trial of medicine for medical application

I. General provisions

Subject of regulation of Administrative regulations

1. The administrative regulations of the Ministry of Health of the Russian Federation on provision of the state service in issue of import permits on the territory of the Russian Federation and export out of limits of the territory of the Russian Federation of the biological materials received when performing clinical trial of medicine for medical application (further - Administrative regulations), are developed for the purpose of improvement of quality and availability of provision of the specified state service, determine procedure and the standard of provision of the state service in issue of import permits on the territory of the Russian Federation and export out of limits of the territory of the Russian Federation of the biological materials received when performing clinical trial of medicine for medical application (further - the state service).

Action of Administrative regulations extends to the following biological materials: samples of biological liquids, fabrics, secrets and waste products of the person, physiological and pathological allocations, dabs, scrapings, washouts, microorganisms, biopsy material.

2. Import to the territory of the Russian Federation and export out of limits of the territory of the Russian Federation of the biological materials received when performing clinical trial of medicine for medical application (further - import (export) of biological materials), is performed for their studying in the territory of the Russian Federation and (or) outside the territory of the Russian Federation based on the permission issued by the Ministry of Health of the Russian Federation (further respectively - the Ministry, permission). Permission is issued for submission to customs authorities of the Russian Federation.

Circle of applicants

3. Applicants on provision of the state service (further - applicants) are the following legal entities performing the organization of performing in accordance with the established procedure clinical trials of medicines for medical application (further - clinical trial):

1) developer of medicine for medical application or the legal entity authorized by it on the organization of performing clinical trial;

2) educational institution of higher education and (or) educational institution of additional professional education which activities provide possibility of participation in the organization of carrying out or performing clinical trials;

3) the research organization which activities provide possibility of participation in the organization of carrying out or performing clinical trials.

Requirements to procedure for informing on provision of the state service

4. Informing on provision of the state service is performed by the Ministry:

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 the Ministry on the Internet: www.minzdravsoc.ru;

2) in the Federal state information system "Single Portal of the State and Municipal Services (Functions)": www.gosuslugi.ru (further - the Single portal of the state and municipal services (functions));

3) at information stands in reception of the Ministry of the address: 127994, Moscow, GSP-4, Rakhmanovsky Pereulok, 3;

4) on phone numbers for reference: (495) 628-44-53;

5) in the Federal information system "State Register of Medicines": http://grls.rosminzdrav.ru (further - the State register of medicines);

6) in mass media.

5. Working hours of the Ministry:

on weekdays from 9-00 to 18-00, on Friday and holiday days from 9-00 till 16-45.

Lunch break from 12-00 till 12-45.

Phone for reference: (495) 628-44-53.

E-mail address: grls@rosminzdrav.ru.

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