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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of August 9, 2021 No. 1321

About approval of Rules of import to the territory of the Russian Federation of the medical products specified in Items 1, 2 and 5 parts 5 of article 38 of the Federal law "About Bases of Protection of Public Health in the Russian Federation" (except for the medical products specified in subitems "a", "v" and "g" of Item 11 of article 4 of the Agreement on the single principles and rules of the address of medical products (products of medical appointment and medical equipment) within the Eurasian Economic Union of December 23, 2014)

According to part 6 of article 38 of the Federal law "About Bases of Protection of Public Health in the Russian Federation" Government of the Russian Federation decides:

1. Approve the enclosed Rules of import to the territory of the Russian Federation of the medical products specified in Items 1, 2 and 5 parts 5 of article 38 of the Federal law "About Bases of Protection of Public Health in the Russian Federation" (except for the medical products specified in subitems "a", "v" and "g" of Item 11 of article 4 of the Agreement on the single principles and rules of the address of medical products (products of medical appointment and medical equipment) within the Eurasian Economic Union of December 23, 2014).

2. This resolution becomes effective since March 1, 2022 and is effective till January 1, 2027.

Russian Prime Minister

M. Mishustin

Approved by the Order of the Government of the Russian Federation of August 9, 2021 No. 1321

Rules of import to the territory of the Russian Federation of the medical products specified in Items 1, 2 and 5 parts 5 of article 38 of the Federal law "About Bases of Protection of Public Health in the Russian Federation" (except for the medical products specified in subitems "a", "v" and "g" of Item 11 of article 4 of the Agreement on the single principles and rules of the address of medical products (products of medical appointment and medical equipment) within the Eurasian Economic Union of December 23, 2014)

1. These rules establish procedure for import to the territory of the Russian Federation of the medical products specified in Items 1, 2 and 5 parts 5 of article 38 of the Federal law "About Bases of Protection of Public Health in the Russian Federation" (except for the medical products specified in subitems "a", "v" and "g" of Item 11 of article 4 of the Agreement on the single principles and rules of the address of medical products (products of medical appointment and medical equipment) within the Eurasian Economic Union of December 23, 2014).

2. Medical products are not subject to registration according to the Federal Law "About Bases of Protection of Public Health in the Russian Federation":

a) made in the territory of state member of the Eurasian Economic Union by individual orders of patients only for private use to which special requirements according to the appointment issued by the health worker are imposed;

b) imported on customs area of the Eurasian Economic Union for carrying out researches (testing), including in the scientific purposes;

c) imported on customs area of the Eurasian Economic Union for delivery of health care to participants of the international cultural, sporting events and to participants of the international expeditions, and also for holding exhibitions;

d) imported on customs area of the Eurasian Economic Union as the humanitarian assistance in the cases determined by the legislation of state members of the Eurasian Economic Union;

e) imported on the territory of the Russian Federation for delivery of health care according to vital testimonies of the specific patient based on the permission issued in the procedure established by the Federal Law "About Bases of Protection of Public Health in the Russian Federation" by the authorized federal executive body performing functions on control and supervision in the field of health protection;

e) the representing stackings, sets, sets and first-aid kits consisting of the registered medical products (except for the medical products connected with power source or equipped with power source) and (or) the medicines combined by general packaging on condition of preserving secondary (consumer) package or primary package of medicine if secondary (consumer) package is not provided, the producer (manufacturer) of each of the products and (or) medicines entering the specified stackings, sets, sets and first-aid kits and on condition of preserving its marking.

3. Import of the medical products specified in subitems "a", "b" and "e" of Item 2 of these rules can be performed by the legal entity or physical person registered as the individual entrepreneur, data on which contain in the register of notifications on the beginning of their activities in the field of the address of medical products which maintaining is provided by the Rules of submission of notifications on the beginning of implementation of separate types of business activity and accounting of the specified notifications approved by the order of the Government of the Russian Federation of July 16, 2009 No. 584 "About notifying procedure for the beginning of implementation of separate types of business activity".

The medical products specified in the subitem "an" of Item 2 of these rules when importing to the Russian Federation shall have in set of the shipping documentation the copy of the appointment issued by the health worker which confirms need of use of the imported medical product for the specific patient with indication of its surname, name and middle name (in the presence).

4. Import of the medical products specified in the subitem "v" of Item 2 of these rules is performed by participants and organizers of exhibitions, international cultural and sporting events, and also the international expeditions.

5. Import of the medical products specified in the subitem "g" of Item 2 of these rules is performed according to the order of the Government of the Russian Federation of December 4, 1999 No. 1335 "About approval of the Procedure for humanitarian assistance (assistance) of the Russian Federation".

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