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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

(as amended on 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, scrapings, washouts, microorganisms, biopsy 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;

c) the copy of the permission to performing clinical trial of medicine issued in accordance with the established procedure for medical application in which receipt of biological material, in case of carrying out such research in the territory of the Russian Federation is supposed;

d) copies of constituent documents, certificates on state registration of the legal entity and the certificate on registration in tax authority of the organization applicant. If the foreign legal entity in case of performing clinical trial of medicine for medical application in the territory of the Russian Federation acts as the organization applicant, the documents confirming accreditation of representation of the foreign legal entity in the territory of the Russian Federation are submitted.

4.1. The Ministry of Health of the Russian Federation has no right to require from the organization applicant of submission of the copy of the permission provided by the subitem "v" of item 4 of these rules, and also copies of the certificate on state registration of the legal entity and the certificate on statement of the organization applicant on accounting in tax authority provided by the subitem of of item 4 of these rules. The organization applicant has the right to provide copies of the specified documents on own initiative.

5. The Ministry of Health of the Russian Federation within 10 working days from the date of adoption of documents, stipulated in Item 4 these rules:

a) performs completeness and reliability of the data containing in the submitted documents, and in case of non-presentation by the organization applicant of the copy of the permission provided by the subitem "v" of item 4 of these rules - also verification of presence of such permission based on the issued permissions to performing clinical trials of medicines this the register;

and. Requests 1) and receives according to the procedure of interdepartmental information exchange from the Federal Tax Service information on the fact of entering of data on the organization applicant into the Unified State Register of Legal Entities and on the fact of statement of the organization applicant on accounting in tax authority if the organization applicant, being the Russian legal entity, did not provide the copy of the certificate on state registration of the legal entity and the certificate on registration in tax authority;

b) makes the decision on issue of the import permit (export) of biological materials or the decision on refusal in issue of the import permit (export) of biological materials;

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