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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of September 3, 2010 No. 675

About approval of Rules of import to the territory of the Russian Federation of the medicines intended for humanitarian assistance (assistance) or the help in case of emergency situations

(as amended on 04-09-2012)

According to 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 of the medicines intended for humanitarian assistance (assistance) or the help in case of emergency situations.

 

Prime Minister

Russian Federation V. Putin

Approved by the Order of the Government of the Russian Federation of September 3, 2010 No. 675

Rules of import to the territory of the Russian Federation of the medicinal reparat intended for humanitarian assistance (assistance) or the help in case of emergency situations

1. These rules determine procedure for import to the territory of the Russian Federation of the medicines intended for humanitarian assistance (assistance) or the help in case of emergency situations (further - the humanitarian assistance).

2. The medicines imported on the territory of the Russian Federation intended for humanitarian assistance shall be registered and included in the state register of medicines for medical application.

3. Import of the medicines intended for humanitarian assistance is performed in the presence of the permission issued to the applicant by the Ministry of Health of development of the Russian Federation (further - permission).

Permission is issued for submission to customs authorities.

4. For receipt of permission it is necessary to submit in the Ministry of Health of the Russian Federation the application with appendix of the following documents:

a) the document containing data on the imported medicines in 2 copies in the form approved by the Ministry of Health of the Russian Federation;

b) copies of constituent and registration documents (the charter, the certificate on state registration, the certificate on registration in tax authority);

c) the letter of authorized body of the executive authority of the subject of the Russian Federation on support of humanitarian action on import of the medicines intended for rendering to this subject the Russian Federation the humanitarian assistance with the obligation to exercise control of target non-commercial use of load;

d) the copy of the document confirming humanitarian character of load (donative, the agreement);

e) the copy of the document (specifications, the invoice) confirming intention to direct the medicines intended for humanitarian assistance to the receiver (with indication of the manufacturing organization, the manufacturing country, form of release, quantity, expiration date of medicines);

e) the copy of the plan of target distribution of the medicines intended for the humanitarian assistance (with indication of complete data of receivers and quantity of the transferred load) approved by governing body of health care of the subject of the Russian Federation - in case of humanitarian assistance (assistance);

g) the document issued by the Ministry of the Russian Federation for civil defense, to emergency situations and natural disaster response, confirming need and feasibility of import of the medicines intended for humanitarian assistance (with indication of quantity, packing, dosage, concentration of medicines), - in case of assistance in case of emergency situations.

4.1. The Ministry of Health of the Russian Federation has no right to require from the applicant of submission of the documents provided by subitems (except for the copy of the charter) and item 4 of these rules. The applicant has the right to provide them on own initiative.

5. If the applicant is physical person, he represents the copy of the identity document, and the document confirming need of import of medicines for the purpose of delivery of health care according to vital indications to the specific patient.

6. Copies of the documents specified in items 4 and 5 these rules are represented with presentation of originals.

If originals of documents are constituted in foreign language, they are represented with the translation into Russian certified in accordance with the established procedure.

7. The Ministry of Health of the Russian Federation in time, not exceeding 10 working days from the date of receipt of the statement for issue of permission with necessary documents:

a) performs completeness and reliability of the data containing in the documents submitted by the applicant;

b) makes the decision on registration of permission or on refusal in its registration (with indication of causes of failure);

c) issues to the applicant permission or notifies in writing the applicant on refusal in issue of permission (with indication of causes of failure).

8. Effective period of permission constitutes 1 year.

9. The bases for refusal in issue of permission are:

a) lack of state registration of any medicine intended for humanitarian assistance;

b) representation not in full the documents provided by these rules;

c) submission of false information by the applicant.

10. The statement for issue of permission and the decision of the Ministry of Health of the Russian Federation made on it are subject to registration in the register of the issued decisions which maintaining is performed by the Ministry of the form approved by it.

11. The expiration date of the medicines intended for humanitarian assistance shall constitute at least 12 months estimated from date of issue of permission.

If necessary to provide the need for specific medicines the Ministry of Health of the Russian Federation has the right to resolve import of the medicines intended for humanitarian assistance with expiration date less than 12 months estimated from date of issue of permission in case of the corresponding appeal to the Ministry of authorized body of the executive authority of the subject of the Russian Federation.

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info

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