THE ORDER OF THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION AND THE FEDERAL SERVICE OF THE RUSSIAN FEDERATION ON SUPERVISION IN THE FIELD OF HEALTH CARE

of January 15, 2024 No. 39

About approval of the Procedure for issue of export permits out of limits of the territory of the Russian Federation of separate types of goods of medical appointment according to the list according to appendix No. 6 to the Order of the Government of the Russian Federation of March 9, 2022 No. 312 "About introduction on a temporary basis allowing procedure for export of separate types of goods out of limits of the territory of the Russian Federation"

According to the paragraph of Item 3 and item 4 of the order of the Government of the Russian Federation of March 9, 2022 No. 312 "About introduction on a temporary basis of allowing procedure for export of separate types of goods out of limits of the territory of the Russian Federation" I order the sixth:

1. Approve the enclosed Procedure for issue of export permits out of limits of the territory of the Russian Federation of separate types of goods of medical appointment according to the list according to appendix No. 6 to the order of the Government of the Russian Federation of March 9, 2022 No. 312 "About introduction on a temporary basis of allowing procedure for export of separate types of goods out of limits of the territory of the Russian Federation".

2. To impose control of execution of this order on the deputy manager of the Federal Service on supervision in the field of the health care supervising control of the address of medical products.

3. This order is effective till December 31, 2025 inclusive.

Approved by the Order of the Federal Service of the Russian Federation on supervision in the field of health care of January 15, 2024, No. 39

Procedure for issue of export permits out of limits of the territory of the Russian Federation of separate types of goods of medical appointment according to the list according to appendix No. 6 to the Order of the Government of the Russian Federation of March 9, 2022 No. 312 "About introduction on a temporary basis allowing procedure for export of separate types of goods out of limits of the territory of the Russian Federation"

1. Issue of the export permit of separate types of goods of medical appointment according to the list according to appendix No. 6 to the order of the Government of the Russian Federation of March 9, 2022 as No. 312 "About introduction on a temporary basis of allowing procedure for export of separate types of goods out of limits of the territory of the Russian Federation" (further - the export permit, goods) is performed by the Federal Service on supervision in the field of health care based on the statement of the legal entity or the individual entrepreneur (further - the applicant) provided to Roszdravnadzor in paper form with application of documents, specified in item 4 of this Procedure on the electronic medium or through the automated information system of Roszdravnadzor (if technically possible) (further - the statement).

2. The statement is constituted in Russian, drawn up on the form of the applicant (in the presence), signed by the applicant (the head of the legal entity, the individual entrepreneur or person authorized by them with appendix of the power of attorney signed by the head of the legal entity or the individual entrepreneur), certified by the applicant's seal (in the presence), contains date and registration (outgoing) number.

The application submitted through the automated information system of Roszdravnadzor is signed by the strengthened qualified digital signature of the applicant.

3. Are specified in the statement:

a) the name of the legal entity, surname, name, middle name (in the presence) the individual entrepreneur, identification taxpayer number, the primary state registration number or the primary state registration number of the individual entrepreneur, the address within the location of the legal entity, registration address at the place of residence of the individual entrepreneur, and also the postal address, the e-mail address (in the presence), contact phone number;

b) description of goods, planned to export out of limits of the Russian Federation, with indication of model (if is available), execution option (if is available), picking (if is available), accessories (if are available), quantities, serial number, number of series or batch number, date of production (production), term of its validity (operation);

c) whether has the goods planned to export out of limits of the Russian Federation, medical appointment;

d) whether the goods are the medical product registered in the territory of the Russian Federation, data on date and number of the registration certificate on medical product according to the state register of medical products and the organizations (individual entrepreneurs) performing production and production of medical products <1> (on consumable materials, component parts, components - if is available);

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<1> Item 6 of Rules of maintaining the state register of medical products and the organizations (individual entrepreneurs) performing production and production of the medical products approved by the order of the Government of the Russian Federation of September 30, 2021 No. 1650.

e) code of medical product according to the single Commodity nomenclature of the foreign economic activity of the Eurasian Economic Union approved by the Decision of Council of the Eurasian economic commission of September 14, 2021 No. 80 "About approval of the single commodity nomenclature of foreign economic activity of the Eurasian Economic Union and the Common customs tariff of the Eurasian Economic Union, and also about change and recognition voided some decisions of council of the Eurasian economic commission" with the changes made by the Decision of Board of the Eurasian economic commission of January 11, 2022 No. 7, which is obligatory for the Russian Federation according to the Agreement on the Eurasian Economic Union of May 29, 2014 ratified by the Federal Law of October 3, 2014 No. 279-FZ "About ratification of the Agreement on the Eurasian Economic Union" (The agreement became effective for the Russian Federation on January 1, 2015) - concerning medical products;

e) code of type of medical product in nomenclature classification of medical products <2> - concerning medical products.

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<2> Part 2 of article 38 of the Federal Law of November 21, 2011 No. 323-FZ "About bases of protection of public health in the Russian Federation".

4. Are enclosed to the application:

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