ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of May 27, 2024 No. 675

About approval of Rules of marking of medicines for veterinary application by 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 medicines for veterinary application

The government of the Russian Federation decides:

1. Approve the enclosed Rules of marking of medicines for veterinary application by means of identification.

2. Determine that participants of turnover of medicines for veterinary application according to the Rules approved by this resolution:

a) give to the state information system of monitoring of turnover of goods, subject to obligatory marking by means of identification (further - information system of monitoring), the statement for registration in information system of monitoring since September 1, 2024, but no later than 7 calendar days from the date of emergence of need of implementation by the participant of turnover of medicines for veterinary application of the activities connected with input in turnover and (or) turnover, and (or) conclusion from turnover of medicines for veterinary application concerning which the input prohibition in turnover, and (or) turnover, and (or) conclusion from turnover of medicines for veterinary application not marked by means of identification (except for participants of turnover of medicines for veterinary application is established, the provisions of Items 3 and 7 of article 2 of the Federal law "About Use of the Control and Cash Equipment when Implementing Calculations in the Russian Federation" falling under action (further - participants of turnover of medicines for veterinary application in the remote or hardly accessible areas). At the same time participants of turnover of medicines for veterinary application in the remote or hardly accessible areas perform registration in information system of monitoring within 30 calendar days from the date of emergence of need of implementation of the activities connected with input in turnover by them and (or) turnover, and (or) conclusion from turnover of medicines for veterinary application;

b) provide no later than 15 calendar days from the date of registration in information system of monitoring readiness of own software and hardware for information exchange with information system of monitoring and send to the operator of information system of monitoring the request for passing of testing of information exchange electronically;

c) for work on ensuring readiness of own software and hardware for information exchange with information system of monitoring and for passing of testing of information exchange electronically after registration in information system of monitoring send electronically to the operator of information system of monitoring the request for provision of remote access to the issue registration device placed in infrastructure of information system of monitoring;

d) pass test of information exchange of own software and hardware and information system of monitoring according to the procedure posted on the official site of the operator of information system of monitoring on the Internet concerning the transactions connected with marking of medicines for veterinary application, their input in turnover, turnover and conclusion from turnover according to the Rules approved by this resolution no later than 15 calendar days from the date of readiness of own software and hardware for information exchange with information system of monitoring and the direction of the request according to the subitem "b" of this Item.

3. Determine that:

a) concerning the medicines for veterinary application having the existing registration certificate of medicine for veterinary application (codes of the single Commodity nomenclature of foreign economic activity of the Eurasian Economic Union 2936 90 000 9, 2941 90 000 9, 3001 20 900 0, 3002 12 000 2, 3002 12 000 3, 3002 12 000 9, 3002 15 000 0, 3002 42 000 0 (except for the vaccines having temperature condition of storage and transportation minus 60 degrees Celsius or below), 3002 90 300 0, 3003 10 000 0, 3003 20 000 0, 3003 90 000 0, 3004, 3006 60 000 1, 3808 91 800 0 and codes of the All-Russian Product Classifier by types of economic activity 21.10. 51, 21.10.54. 120, 21.10.54. 180, 21.10.60. 193, 21.20. 10, 21.20.21. 110, 21.20.21.130 (except for the vaccines having temperature condition of storage and transportation minus 60 degrees Celsius or below), 21.20. 22, 21.20.23. 190), the participants of turnover of medicines for veterinary application performing input in turnover of the specified medicines for veterinary application put funds of identification for consumer packaging of the specified medicines for veterinary application, including by means of drawing on such consumer packaging of the label containing means of identification and represent to information system of monitoring of the data on drawing means of identification and input in turnover of the specified medicines for veterinary application according to the Rules approved by this resolution since October 1, 2024. At the same time the participants of turnover of medicines for veterinary application performing input in turnover of medicines for the veterinary application having the right to represent to information system of monitoring of the data on input in turnover about turnover and conclusion from turnover of medicines for veterinary application according to the Rules approved by this resolution from the date of entry into force of this resolution;

b) participants of turnover of medicines for veterinary application represent to information system of monitoring according to the Rules approved by this resolution, data on conclusion of medicines for veterinary application from turnover by retail sale since March 1, 2025, data on conclusion of medicines for veterinary application from turnover in the way which is not retail sale since September 1, 2025 and data on turnover of medicines for veterinary application since March 1, 2026. At the same time participants of turnover of medicines for veterinary application have the right to represent to information system of monitoring of the data on turnover and conclusion from turnover of medicines for veterinary application according to the Rules approved by this resolution from the date of entry into force of this resolution;

c) participants of turnover of medicines for veterinary application in the remote or hardly accessible areas have the right to represent the data specified in the Section VIII of the Rules approved by this resolution within 30 calendar days:

from the date of shipment (transfer or acceptance) medicines for veterinary application by transfer (acceptance) of medicines for veterinary application within the transactions providing transition of the property right to the specified goods and also within commission agreements, and (or) agency agreements, and (or) works agreements, and (or) agreements of the order;

from the date of conclusion of medicines for veterinary application from turnover in case of conclusion of medicines for veterinary application from turnover;

from the date of return of medicines for veterinary application in turnover in case of such return;

from the date of modification of the data provided by Sections III, IV and VIII of the Rules approved by this resolution, according to the procedure, provided by the Section IX of the Rules approved by this resolution (if changes were made to such data);

d) participants of turnover of medicines for veterinary application in the presence for them as of October 1, 2024 in the territory of the Russian Federation the unrealized medicines for veterinary application made in the territory of the Russian Federation or imported on the territory of the Russian Federation till the September 30, 2024 (inclusive) having the right to enable the realization (sale) of such medicines for veterinary application not marked means of identification before the termination of their expiration date;

e) participants of turnover of medicines for veterinary application till October 31, 2024 (inclusive) perform marking of the medicines for veterinary application acquired till September 30, 2024 (inclusive) and issued by customs authorities since October 1, 2024, imported (imported) and placed under customs procedures of release for internal consumption or reimport to the offer of these medicines for veterinary application for realization (sale) and enter into information system of monitoring of the data on marking of such medicines for veterinary application by means of identification according to the Rules approved by this resolution.

4. Registration in the information system used for the purpose of carrying out experiment according to the order of the Government of the Russian Federation of December 21, 2023 No. 2222 "About carrying out in the territory of the Russian Federation experiment on marking by means of identification of medicines for veterinary application" (further - experiment), legal entities and individual entrepreneurs who as of August 31, 2024 are participants of experiment is equated to registration in information system of monitoring according to the subitem "an" of Item 2 of this resolution.

If the data provided within the experiment by participants of turnover of medicines for veterinary application to the information system used for the purpose of carrying out experiment do not meet the requirements of the Rules approved by this resolution, participants of turnover of medicines for veterinary application represent to information system of monitoring missing and (or) urgent data till September 30, 2024 (inclusive).

5. Determine that the operator of information system of monitoring provides:

a) the organization of testing of information exchange of software and hardware of participants of turnover of medicines for veterinary application and information system of monitoring no later than 15 calendar days from the date of obtaining from participants of turnover of the medicines for veterinary application registered in information system of monitoring, the notification of the readiness to information exchange with information system of monitoring;

b) provision to participants of turnover of medicines for veterinary application of remote access to the issue registration devices placed in infrastructure of information system of monitoring on the conditions provided by the Rules approved by this resolution no later than 30 calendar days from the date of obtaining from participants of turnover of the medicines for veterinary application registered in information system of monitoring, the request for provision of remote access to the issue registration device electronically.

6. Determine that in the territory of the Russian Federation input in turnover of medicines for veterinary application without drawing funds of identification for consumer packaging of the specified medicines for veterinary application, including by means of drawing on such consumer packaging of the label containing means of identification, and representation in information system of monitoring of data on marking of medicines for veterinary application by means of identification is allowed before the date established by the subitem "an" of Item 3 of this resolution since which drawing funds of identification for consumer packaging of such medicines for veterinary application, including by means of drawing on such consumer packaging of the label containing means of identification, and representation in information system of monitoring of data become obligatory, except as specified specified in subitems "g" and "d" of Item 3 of this resolution.

Turnover and conclusion from turnover of the unmarked medicines for veterinary application made in the territory of the Russian Federation or imported (imported) on the territory of the Russian Federation in case of import from the territory of the Eurasian Economic Union within cross-border trade or release by customs authorities in case of their room under customs procedures of release for internal consumption or reimport (in case of their production out of the territory of the Russian Federation) till September 30, 2024 (inclusive), are allowed before the termination of expiration date of such medicines for veterinary application.

Till October 31, 2024 release by customs authorities imported (imported) and placed under customs procedures of release for internal consumption or reimport of the unmarked medicines for veterinary application specified in the subitem "d" of Item 3 of this resolution is (inclusive) allowed.

7. Operation of this resolution does not extend to medicines for veterinary application on which according to the Rules approved by this resolution, and international treaties of the Russian Federation requirements about obligatory marking by means of identification do not extend.

8. Determine that since October 1, 2024 provision to the participant of turnover of medicines for veterinary application of the codes of marking necessary for forming of means of identification, is performed by the operator of information system of monitoring on paid basis according to the Rules approved by this resolution.

9. From the date of entry into force of this resolution according to the decision of the participant of turnover of medicines for veterinary application provision to it the codes of marking necessary for forming of means of identification, can be performed by the operator of information system of monitoring before the corresponding date, the stipulated in Item 3 presents of the resolution with which drawing funds of identification for consumer packaging of medicines for veterinary application becomes obligatory. Such codes of marking are provided by the operator of information system of monitoring on a grant basis. At the same time the participant of turnover of medicines for veterinary application who received marking codes on a grant basis provides their transformation to means of identification and submits in information system of monitoring the report on drawing means of identification and data on input in turnover of medicines for veterinary application till September 30, 2024 (inclusive).

The service in provision of code of marking is recognized the information system of monitoring rendered by the operator at the time of introduction the case provided by paragraph one of this Item to them in information system of monitoring of information on input of medicines for veterinary application in turnover specified by the participant of turnover of medicines for veterinary application in the notification on input of the corresponding medicines for veterinary application in turnover.

At the same time the operator of information system of monitoring enters into information system of monitoring information on input in turnover of medicines for veterinary application after obtaining from the participant of turnover of medicines for veterinary application of the report on drawing means of identification.

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