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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of April 21, 2018 No. 480

About approval of Rules of export from the Russian Federation of the biological material received when performing clinical trial of biomedical cellular product for its studying for the purpose of this clinical trial

According to part 12 of article 29 of the Federal law "About Biomedical Cellular Products" Government of the Russian Federation decides:

Approve the enclosed Rules of export from the Russian Federation of the biological material received when performing clinical trial of biomedical cellular product for its studying for the purpose of this clinical trial.

Russian Prime Minister

D. Medvedev

Approved by the Order of the Government of the Russian Federation of April 21, 2018 No. 480

Rules of export from the Russian Federation of the biological material received when performing clinical trial of biomedical cellular product for its studying for the purpose of this clinical trial

1. These rules determine procedure for export from the Russian Federation of the biological material received when performing clinical trial of biomedical cellular product for its studying for the purpose of this clinical trial (further - biological material).

2. Export from the Russian Federation of biological material is performed based on the conclusion (the allowing document) of the Ministry of Health of the Russian Federation (further - the conclusion) issued in the form approved by the decision of Board of the Euroasian economic commission of May 16, 2012 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".

The conclusion is issued for the term which is not exceeding 1 years irrespective of the number of movements of biological material through border of the Russian Federation.

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

The payment for issue of the conclusion is not levied.

3. Export from the Russian Federation of biological material is performed by the organization performing the organization of performing clinical trial of biomedical cellular product (further - the organization).

4. For receipt of the conclusion the organization represents to the Ministry of Health of the Russian Federation on paper or electronically:

a) the statement for export of biological material containing the following data:

the complete and reduced names and the address of the organization, contact information;

details of the permission to performing clinical trial of biomedical cellular product issued by the Ministry of Health of the Russian Federation in the course of which carrying out receipt of biological material is supposed;

state in which studying of biological material, the location and full name of the organization of foreign state to which it is planned to perform export of biological material is planned;

purpose of export of biological material;

type of biological material;

quantity of units of each type of the exported biological material;

type of packaging for each type of the exported biological material;

b) the draft of the conclusion which is drawn up according to the decision of Board of the Euroasian economic commission specified in Item 2 of these rules;

c) reasons for calculation of quantity of units of each type of the exported biological material proceeding from the protocol of clinical trial of biomedical cellular product and number of the patients participating (participating) in clinical trial of biomedical cellular product;

d) data on state registration of the organization and its statement on accounting in tax authority. If the foreign legal entity acts as the organization the documents confirming accreditation of representation of the foreign legal entity in the territory of the Russian Federation are submitted;

e) the copy of the license for implementation of the licensed type of activity or data on availability of the license for implementation of the licensed type of activity (if it is stipulated by the legislation the Russian Federation);

e) the copy of the agreement (contract), and in case of lack of the agreement (contract) - the copy of other document confirming intentions of the parties;

g) the informed consent of the patient or his legal representatives on movement of samples of biological material.

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