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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of September 3, 2010 No. 673

About approval of Rules of 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

(The last edition from 15-10-2014)

According to article 40 of the Federal law "About Drug Circulation" Government of the Russian Federation decides:

Approve the enclosed Rules of 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.

Russian Prime Minister

V. Putin

Approved by the Order of the Government of the Russian Federation of September 3, 2010 No. 673

Rules of 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

1. These rules establish procedure for import to the territory of the Russian Federation and export out of limits of the territory of the Russian Federation of biological materials (samples of the biological liquids, fabrics, secrets and waste products of the person, physiological and pathological allocations, dabs, scrapes, washouts, microorganisms, biopsiyny material) received when performing clinical trial of medicine for medical application (further - import (export) of biological materials).

2. 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.

The import permit (export) of biological materials is issued for performing clinical trials of medicine for medical application when which carrying out biological materials will be received.

The import permit (export) of biological materials is issued for submission to customs authorities of the Russian Federation.

3. Import on the territory of the Russian Federation and export the biological materials received when performing clinical trial of medicine for medical application out of limits of the territory of the Russian Federation the following legal entities performing the organization of performing in accordance with the established procedure clinical trials of medicines for medical application can (further - the organization applicant):

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

b) the educational organizations of the higher education and (or) the organization of additional professional education which activities provide possibility of participation in the organization of carrying out or performing clinical trials of medicines for medical application;

c) the scientific organizations which activities provide possibility of participation in the organization of carrying out or performing clinical trials of medicines for medical application.

4. Are necessary for receipt of the import permit (export) of biological materials by the organization applicant represented to the Ministry of Health of the Russian Federation on paper or electronically:

a) the statement for import (export) of biological materials including the following data:

data on clinical trial of medicine for medical application with indication of the protocol of clinical trial and the purposes of clinical trial of medicine containing in it for medical application, terms of performing clinical trial in which receipt of biological materials is supposed;

state in which performing clinical trials of medicines for medical application, the location and full name of the organization to which it is planned to perform import (export) of biological materials is planned;

purpose of import (export) of biological materials;

type of the imported (exported) biological material;

quantity of units of each type of the imported (exported) biological material;

type of packaging for each type of the imported (exported) biological material;

b) reasons for calculation of quantity of units of each type of the imported (exported) biological material proceeding from the protocol of clinical trial of medicine for medical application and number of the patients participating (participating) in clinical trial of medicine for medical application;

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