ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of June 26, 2024 No. 860

About modification of the Order of the Government of the Russian Federation of May 31, 2023 No. 894

The government of the Russian Federation decides:

1. Approve the enclosed changes which are made to the order of the Government of the Russian Federation of May 31, 2023 No. 894 "About approval of Rules of marking of separate types of medical products means of identification and the features of implementation of the state information system of monitoring of turnover of goods which are subject to obligatory marking by means of identification concerning separate types of medical products" (The Russian Federation Code, 2023, No. 23, Art. 4204; 2024, No. 15, Art. 2031).

2. Determine that:

till February 28, 2025 (inclusive) participants of turnover of separate types of medical products have the right to mark means of identification of glove medical (codes of the single Commodity nomenclature of foreign economic activity of the Eurasian Economic Union 3926 20 000 0, 4015 12 000 1, 4015 12 000 9, 4015 19 000 0, codes of the All-Russian Product Classifier by types of economic activity 14.12.30. 160, 22.19.60.111, 22.19.60.113, 22.19.60.119, 22.19.71.190, 22.29.10.120, 32.50.13.190, 32.50.50. 190, codes of type of medical product according to nomenclature classification of medical products 122540, 122560, 122610, 122630, 122640, 129800, 129900, 130220, 139310, 139350, 139360, 156530, 169840, 185700, 185720, 185830, 185850, 201590, 201600, 201610, 205280, 205290, 257300, 298450, 311720, 316120, 318420, 320790, 321530, 322780, 323740, 326340, 329770, 349230, 351490, 388560) on condition of submission of data on marking of such gloves medical means of identification in the state information system of monitoring of turnover of goods, the separate types of medical products which are subject to obligatory marking by means of identification according to Rules of marking by means of identification, the means of identification approved by the order of the Government of the Russian Federation of May 31, 2023 No. 894 "About approval of Rules of marking of separate types of medical products and the features of implementation of the state information system of monitoring of turnover of goods which are subject to obligatory marking by means of identification concerning separate types of medical products";

the operator of the state information system of monitoring of turnover of goods, subject to obligatory marking by means of identification, provides provision to the participants of turnover of separate types of medical products performing marking of gloves medical means of identification according to the paragraph the second this Item, codes of marking necessary for forming of means of identification, on condition of submission of all data necessary for registration of gloves medical, provided by the paragraph the second this Item, in the state information system of monitoring of turnover of goods, subject to obligatory marking by means of identification, according to Rules of marking of separate types of medical products means of identification, the means of identification approved by the order of the Government of the Russian Federation of May 31, 2023 No. 894 "About approval of Rules of marking of separate types of medical products and the features of implementation of the state information system of monitoring of turnover of goods which are subject to obligatory marking by means of identification concerning separate types of medical products".

3. To the Ministry of Industry and Trade of the Russian Federation to carry out assessment of application of the mandatory requirements introduced by this resolution in 2027.

4. This resolution becomes effective from the date of its official publication, except for Item 1 of this resolution which becomes effective since March 1, 2025.

Approved by the Order of the Government of the Russian Federation of June 26, 2024 No. 860

Changes which are made to the Order of the Government of the Russian Federation of May 31, 2023 No. 894

1. Add Item 3 with subitems "e" - "and" the following content:

"e) the participants of turnover of separate types of the medical products having the existing registration certificate on medical product, performing input in turnover of gloves medical put funds of identification for consumer packaging, including by means of drawing on such consumer packaging of the label containing means of identification, gloves medical and represent to information system of monitoring of the data on drawing means of identification and input in turnover of gloves medical (codes of the single Commodity nomenclature of foreign economic activity of the Eurasian Economic Union 3926 20 000 0, 4015 12 000 1, 4015 12 000 9, 4015 19 000 0, codes of the All-Russian Product Classifier by types of economic activity 14.12.30. 160, 22.19.60.111, 22.19.60.113, 22.19.60.119, 22.19.71.190, 22.29.10.120, 32.50.13.190, 32.50.50. 190, codes of type of medical product according to nomenclature classification of medical products 122540, 122560, 122610, 122630, 122640, 129800, 129900, 130220, 139310, 139350, 139360, 156530, 169840, 185700, 185720, 185830, 185850, 201590, 201600, 201610, 205280, 205290, 257300, 298450, 311720, 316120, 318420, 320790, 321530, 322780, 323740, 326340, 329770, 349230, 351490, 388560) according to the Rules approved by this resolution since March 1, 2025;

g) participants of turnover of separate types of medical products represent to information system of monitoring according to the Rules approved by this resolution, data on conclusion from turnover of separate types of the medical products specified in the subitem "e" of this Item since March 1, 2025, data on turnover of separate types of medical products according to the Rules approved by this resolution since September 1, 2025;

h) till March 31, 2025 (inclusive) participants of turnover of separate types of medical products perform marking of gloves medical, specified in the subitem "e" of this Item, acquired till February 28, 2025 (inclusive), imported (imported) and issued by customs authorities since March 1, 2025 according to customs procedure of release for internal consumption or reimport, to the offer of such gloves medical for realization (sale), enter into information system of monitoring of the data on marking of such gloves medical means of identification and introduce them into circulation according to the Rules approved by this resolution;

i) participants of turnover of separate types of medical products in the presence as of March 1, 2025 in the territory of the Russian Federation unrealized gloves medical, specified in the subitem "e" of this Item, made in the territory of the Russian Federation or imported on the territory of the Russian Federation till the February 28, 2025 (inclusive) having the right to enable (inclusive) till August 31, 2025 the realization of such gloves medical not marked means of identification or to perform marking by means of identification of such gloves medical and to represent data on marking by means of identification to information system of monitoring according to the Rules approved by this resolution.

At the same time participants of turnover of separate types of medical products which acquired such gloves medical for implementation of activities in the field of health care and the rendering the social and medical services having the right to perform storage, transportation, voluntary conveyance of gloves medical, provided by paragraph one of this subitem, not marked means of identification and realization (sale) of such gloves medical according to paragraph one of this subitem.

When implementing marking by means of identification of gloves medical in case, the specified in paragraph one of this subitem, the participant of turnover of separate types of medical products registers such gloves medical in subsystem of the national catalog of the marked goods of information system of monitoring and specifies data, stipulated in Item 41(1) Rules, approved by this resolution, provides their marking with means of identification, and also represents data on their marking by means of identification to information system of monitoring according to the Rules approved by this resolution.

Payment of the codes of marking necessary for forming of means of identification of gloves medical, specified in paragraph one of this subitem, is performed according to the Rules approved by this resolution.".

2. In Item 6:

a) the paragraph one to state in the following edition:

"6. Determine that in the territory of the Russian Federation input in turnover of separate types of medical products without drawing on consumer packaging, including by means of drawing on such consumer packaging of the label containing means of identification, separate types of medical products and without representation in information system of monitoring of data on marking of separate types of medical products is allowed by means of identification before the dates established by subitems "an" and "e" of Item 3 of this resolution from which drawing funds of identification for consumer packaging, including by means of drawing on such consumer packaging of the label containing means of identification, such separate types of medical products and representation in information system of monitoring of data become obligatory, except as specified the specified in paragraphs one of the subitem "d" and paragraph one of the subitem "i" of Item 3 of this resolution.";

b) "the paragraph of the fourth subitem "d" to add paragraph two after words with words "and paragraph one of the subitem "i";

c) word in paragraph three "the subitem "g" of Item 3" shall be replaced with words "subitems "g" and "z" of Item 3";

d) add with the paragraph of the following content:

"concerning gloves medical till March 31, 2025 (inclusive).".

3. In Rules of marking of separate types of the medical products means of identification approved by the specified resolution:

a) to state the paragraph of the forty seventh of Item 2 in the following edition:

"goods" - the separate types of medical products having the existing registration certificate regarding obezzarazhivatel - air purifiers (including the equipment, the bactericidal installations and retsirkulyator applied to filtering and purification of air in rooms), footwear orthopedic and supplementary corrective elements for footwear orthopedic (including insoles, semi-insoles), hearing aids, except parts and accessories, stents of coronary, computer tomographs, sanitary and hygienic products used in case of incontience, gloves medical corresponding to codes of the single Commodity nomenclature of foreign economic activity of the Eurasian Economic Union (further - the commodity nomenclature) 3926 20 000 0, 4015 12 000 1, 4015 12 000 9, 4015 19 000 0, 8421 39 200 8, 8421 39 800 6, 8539 49 000 0, 9018 20 000 0, 9021 10 100 0, 9021 40 000 0, 9021 90 900 1, 9022 12 000 0, 9022 13 000 0, 9022 14 000 0, 9022 19 000 0, 9619 00 890, to codes of the All-Russian Product Classifier by types of economic activity 14.12.30. 160, 17.22.12.130, 22.19.60.111, 22.19.60.113, 22.19.60.119, 22.19.71.190, 22.29.10.120, 26.60.11.111, 26.60.11.113, 26.60.11.119, 26.60.14.120, 28.25.14.110, 32.50.13.190, 32.50.22.150, 32.50.22.151, 32.50.22.152, 32.50.22.155, 32.50.22.156, 32.50.22.157, 32.50.22.190, 32.50.22. 195, 32.50.50.190 and to codes of type of medical product according to nomenclature classification of medical products 113850, 122540, 122560, 122610, 122630, 122640, 126750, 129800, 129900, 130220, 131980, 135190, 135820, 139310, 139350, 139360, 142570, 152690, 152700, 155760, 155800, 155820, 156530, 169840, 173110, 182750, 185700, 185720, 185830, 185850, 201590, 201600, 201610, 202800, 202810, 204370, 205280, 205290, 209360, 210000, 218190, 228560, 233730, 233860, 233900, 250220, 250230, 250250, 250260, 257300, 273880, 280360, 280730, 282030, 292620, 298450, 302870, 311720, 316120, 318420, 320550, 320560, 320790, 321530, 322780, 323740, 326340, 329770, 331320, 331330, 331830, 336330, 343410, 343540, 343580, 343610, 349230, 351490, 356150, 375930, 388560;";

b) Item 28:

after the paragraph of the fourth to add with the paragraph of the following content:

"Since March 1, 2025 participants of turnover of goods represent to information system of monitoring of the data on identification codes, and (or) codes of identification of group packagings, and (or) codes of identification of sets, and (or) codes of identification of shipping packages when implementing input in turnover and in case of conclusion from turnover of gloves medical.";

c) add with Item 41 (1) the following content:

"41(1). For registration of gloves of the medical marked goods in subsystem of the national catalog the participant of turnover of goods represents the following data on the registered goods:

a) identification taxpayer number of the applicant;

b) commodity code (in the presence);

c) full name of goods;

d) trademark (in the presence);

e) 10-unit code of the commodity nomenclature;

e) production country code according to the All-Russian qualifier of the countries of the world;

g) category of goods;

h) goods type;

i) quantity of units of the use in consumer packaging;

j) product size;

k) structure;

l) number of the registration certificate on medical product and the name of model of medical product;

m) number and date of the declaration of conformity (in the presence);

o) expiration date or service life, the number of months (for service life).";

d) in Item 43 of the word "in Items 37 - 41" shall be replaced with words "in Items 37 - 41(1)";

e) third Item 44 after the words "and (or) 41," to add the paragraph with the words "and (or) 41(1)".

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