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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 Russian Federation and export from the Russian Federation of the biological materials received when performing clinical trial of medicine for medical application

(as amended on 18-12-2020)

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 Russian Federation and export from 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 Russian Federation and export from 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 Russian Federation and export from 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 Russian Federation and (or) outside the Russian Federation based on the conclusion (the allowing document) issued by the Ministry of Health of the Russian Federation according to the decision of Board of the Eurasian economic commission of May 16, 2012 to No. 45 "About single form of the conclusion (the allowing document) for import, export and transit of the separate goods included in the single inventory to which measures of non-tariff regulation in trade with the third countries, and methodical instructions for its filling are applied" (further - the conclusion).

The conclusion is issued for performing clinical trials of medicine for medical application when which carrying out biological materials will be received.

The conclusion is issued for submission to customs authorities of the Russian Federation.

3. Import into the Russian Federation and export the biological materials received when performing clinical trial of medicine for medical application from 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 conclusion by the organization applicant represented to the Ministry of Health of the Russian Federation on paper or by means of the federal state information system "Single Portal of the State and Municipal Services (Functions)" (further - the single portal) in electronic form (packet of electronic documents) signed by the strengthened qualified digital signature, the following documents:

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 other documents confirming need of import (export) of biological materials for the declared amount, the countries of source of biological materials issued according to the legislation;

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;

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