ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of July 21, 2020 No. 1079

About modification of the Order of the Government of the Russian Federation of December 14, 2018 No. 1556

The government of the Russian Federation decides:

Approve the enclosed changes which are made to the order of the Government of the Russian Federation of December 14, 2018 No. 1556 "About approval of the Regulations on monitoring system of movement of medicines for medical application" (The Russian Federation Code, 2018, No. 53, Art. 8641; 2019, No. 37, Art. 5162; 2020, No. 2, Art. 196).

Approved by the Order of the Government of the Russian Federation of July 21, 2020 No. 1079

Changes which are made to the Order of the Government of the Russian Federation of December 14, 2018 No. 1556

1. In Item 1 (4) and the paragraph third Item 1 (the words "or at a discount" to exclude 5).

2. In the Regulations on monitoring system of movement of medicines for medical application approved by the specified resolution:

a) in Item 2:

the fourth to add the paragraph with the words "and submissions of the documents and data provided by part 1 of article 52.1 of the Federal law "About Drug Circulation" to the Federal Service on supervision in the field of health care or receipt of the permission provided by part 7 of article 52.1 of the Federal law "About Drug Circulation" (in case of production of immunobiological medicines)";

the fifth to state the paragraph in the following edition:

"in case of production out of the territory of the Russian Federation - the transactions made with medicines from passing of production stage of packing (packaging) of medicines to primary package of medicine (concerning medicines for which secondary (consumer) package of medicine is not provided) and secondary (consumer) package of medicine before placement of medicines in pharmaceutical warehouse and submissions of the documents and data provided by part 2 of article 52.1 of the Federal law "About Drug Circulation" to the Federal Service on supervision in the field of health care or receipt of the permission provided by part 7 of article 52.1 of the Federal law "About Drug Circulation" (in case of production of immunobiological medicines);";

to declare the paragraph of the sixth invalid;

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

"the identifier of the subject of drug circulation" - the unique code assigned by monitoring system for the subject of drug circulation following the results of its registration in monitoring system on the basis of the data on identification taxpayer number transferred by the subject of drug circulation for each address of the place of implementation of activities according to the license for production of medicines, the license for pharmaceutical activities, the license for activities for drug trafficking, psychotropic substances and their precursors, to cultivation of the narcocontaining plants and the license for medical activities (in the presence of such license) or code of the taxpayer in country of incorporation and country code of registration (for the subjects of drug circulation which are not recognized by tax residents of the Russian Federation);";

the paragraph the twenty fifth after the words "application and" to add with words "transfer on";

the twenty ninth to declare the paragraph invalid;

add with the paragraph of the following content:

"the issuer of means of identification" - the producer of medicines performing production stage of packing (packaging) of medicine with drawing funds of identification for secondary (consumer) package of medicine (and in case of its absence - on primary package of medicine), - in case of medicine production in the territory of the Russian Federation, either the holder or the owner of the registration certificate of medicine (further - the registration certificate) - in case of production of medicine out of the territory of the Russian Federation, or representative office of the foreign organization in the territory of the Russian Federation which is the holder or the owner of the registration certificate - in case of production of medicine out of the territory of the Russian Federation.";

b) add item 4 with the paragraph of the following content:

"In case of import to the Russian Federation in case of production out of the territory of the Russian Federation (except for the medicines imported from state members of the Eurasian Economic Union) batches of medicine drawing two-dimensional bar code by the seal method on the material carrier (label) which is not allowing department of the material carrier (label) containing means of identification from packaging of medicine without damages with the subsequent drawing the material carrier (label) on secondary (consumer) packages of medicine (in case of their absence - primary packages of medicine) under customs locks which address is specified as the address of the place of implementation of activities in the license for pharmaceutical organization activity performing wholesale trade by medicines is allowed.";

c) Items 9 (1) - 9(3) to state in the following edition:

"9(1). The issuer of means of identification after receipt of code of marking provides its transformation to means of identification, drawing funds of identification for secondary (consumer) package of medicine (and in case of its absence - on primary package of medicine) or on the material carrier (label) and transfers to monitoring system of the data on drawing means of identification according to paragraph one of Item 35 or Item 36 of this provision no later than approach of one of the following dates:

input in medicine turnover, on packaging (label) of which the means of identification transformed from the corresponding code of marking in case of production of medicines in the territory of the Russian Federation is applied;

delivery of medicine to the place of arrival in the territory of the Russian Federation and submissions of the customs declaration on goods in the procedure of release for internal consumption or submission of the customs declaration on goods in the procedure of release for internal consumption of the medicine marked under customs locks according to the paragraph the second item 4 of this provision in case of production of medicines out of the territory of the Russian Federation (except for the medicines imported from state members of the Eurasian Economic Union);

import to the Russian Federation to pharmaceutical warehouse of medicine in case of production of medicines out of the territory of the Russian Federation - concerning the medicines imported from state members of the Eurasian Economic Union.

The payment of service in provision of code of marking to the operator of monitoring system provided by the order of the Government of the Russian Federation of May 8, 2019 No. 577 "About approval of the amount of payment for rendering services in provision of the codes of marking necessary for forming of means of identification and ensuring monitoring of movement of the goods which are subject to obligatory marking by means of identification and also about procedure for its collection" is made by the issuer of means of identification before the date of receipt of code of marking or within 180 calendar days from the date of receipt of code of marking, but no later than approach of one of the following dates:

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