ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of August 31, 2017 No. 1061

About approval of Rules of export from the Russian Federation of the biomedical cellular products intended for the humanitarian assistance (assistance) or the help in case of emergency situations

According to part 8 of article 43 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 biomedical cellular products intended for the humanitarian assistance (assistance) or the help in case of emergency situations.

Approved by the Order of the Government of the Russian Federation of August 31, 2017 No. 1061

Rules of export from the Russian Federation of the biomedical cellular products intended for the humanitarian assistance (assistance) or the help in case of emergency situations

1. These rules establish procedure for export from the Russian Federation of the biomedical cellular products intended for the humanitarian assistance (assistance) or the help in case of emergency situations (further - export of biomedical cellular products).

2. Export of biomedical cellular products is performed in the presence of confirmation of the export of biomedical cellular products issued by the Ministry of Health of the Russian Federation in form according to appendix No. 1.

Confirmation of export of biomedical cellular products is issued for submission to customs authorities of the Russian Federation.

The payment for issue of confirmation of export of biomedical cellular products is not levied.

3. The legal entities performing the organization of rendering in accordance with the established procedure the humanitarian assistance (assistance) or the help in case of emergency situations can export biomedical cellular products (further - the organization applicant).

4. For receipt of confirmation of export of biomedical cellular products the organization applicant represents to the Ministry of Health of the Russian Federation on paper or electronically:

a) the statement for export of biomedical cellular products including the following data:

data on the location and full name of the organization applicant;

type of the exported biomedical cellular product;

quantity of units of each type of the exported biomedical cellular product;

type of packaging for each type of the exported biomedical cellular product;

purpose of export of biomedical cellular product;

state - the receiver of the humanitarian assistance (assistance) or the help in case of emergency situations and the organization, authorized to accept biomedical cellular products;

b) reasons for calculation of quantity of units of each type of the exported biomedical cellular product;

c) specifications on the exported biomedical cellular products.

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

a) carries out assessment of completeness and reliability of data and the documents submitted according to item 4 of these rules. In case of submission of data and documents in incomplete amount the Ministry of Health of the Russian Federation provides the organizations applicants of 3 working days for elimination of the revealed shortcomings;

b) makes the decision on issue of confirmation of export of biomedical cellular products or the decision on refusal in issue of such confirmation;

c) issues the organizations applicants confirmation of export of biomedical cellular products or notifies in writing the organization applicant on refusal in issue of such confirmation with indication of causes of failure.

6. The basis for refusal in issue of confirmation of export of biomedical cellular products are submission of data and documents in incomplete amount and (or) unauthenticity submitted the data and documents.

7. The statement for export of biomedical cellular products and results of the decision accepted on it by the Ministry of Health of the Russian Federation are subject to registration in the register of the issued confirmations of export of biomedical cellular products and decisions on refusal in issue of confirmation of export of biomedical cellular products which is conducted by the Ministry of Health of the Russian Federation.

8. In case of need increases in quantity of the exported biomedical cellular products within the actions for humanitarian assistance (assistance) or help in case of emergency situations the organization applicant submits in the Ministry of Health of the Russian Federation the application for export of additional quantity of biomedical cellular products issued according to requirements, stipulated in Item 4 these rules, and the documents provided by subitems "b" and "v" of the specified Item.

9. The Ministry of Health of the Russian Federation within 10 working days from the date of receipt of documents, stipulated in Item 8 these rules:

a) carries out assessment of completeness and reliability of data and the documents submitted according to Item 8 of these rules. In case of submission of data and documents in incomplete amount the Ministry of Health of the Russian Federation provides the organizations applicants of 3 working days for elimination of the revealed shortcomings;

b) makes the decision on issue of amendment to confirmation of export of biomedical cellular products or the decision on refusal in issue of such amendment with indication of causes of failure;

c) issues the organizations applicants amendment to confirmation of export of biomedical cellular products or notifies in writing the organization applicant on refusal in issue of such amendment with indication of causes of failure.

10. Amendment to confirmation of export of biomedical cellular products is issued in form according to appendix No. 2.

The payment for issue of amendment to confirmation of export of biomedical cellular products is not levied.

11. The basis for refusal in issue of amendment to confirmation of export of biomedical cellular products are submission of documents in incomplete amount and (or) unauthenticity submitted the data and documents.

12. The statement for export of additional quantity of biomedical cellular products and results of the decision accepted on it by the Ministry of Health of the Russian Federation are subject to registration in the register specified in Item 7 of these rules.

13. In case of receipt in the Ministry of Health of the Russian Federation of information on suspension or the termination of implementation of actions for humanitarian assistance (assistance) or the help in case of emergency situations the Ministry makes the decision on suspension of action of confirmation of export of biomedical cellular products (amendment to the specified confirmation) for the term of suspension of implementation of actions for humanitarian assistance (assistance) or the help in case of emergency situations or makes the decision on cancellation of confirmation of export of biomedical cellular products (amendment to the specified confirmation).

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