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 government of the Russian Federation decides:

1. Approve the enclosed Regulations on monitoring system of movement of medicines for medical application.

1(1). Determine that the legal entities and individual entrepreneurs who are subjects of drug circulation according to the Provision approved by this resolution (further - subjects of drug circulation):

perform the registration in monitoring system of movement of medicines for medical application (further - monitoring system) from January 1, 2020 to February 29, 2020 (inclusive) or after February 29, 2020 within 7 calendar days from the date of origin at subjects of drug circulation of need of implementation of the activities connected with the address of medicines for medical application (further - medicines) in the presence of the right to perform such activities;

no later than 21 calendar days from the date of registration in monitoring system provide readiness of the information systems for information exchange with monitoring system and send to the operator of monitoring system the request for passing of testing of information exchange with indication of producers of software and hardware of information systems;

pass test of information exchange of the information systems and monitoring system according to the procedure posted on the official site of the operator of monitoring system on the Internet concerning marking of medicines, input in turnover of medicines, their turnover and conclusion from turnover according to the Provision approved by this resolution during 2 calendar months from the date of readiness of the information systems for information exchange with monitoring system;

bring since July 1, 2020 in monitoring system of the data on all transactions made with medicines according to the Provision approved by this resolution.

1(2). Registration in information system in which information support of carrying out experiment according to the order of the Government of the Russian Federation of January 24, 2017 No. 62 "About carrying out experiment on marking by control (identification) signs and to monitoring of turnover of separate types of medicines for medical application" was performed of the legal entities and physical persons registered as individual entrepreneurs who as of January 1, 2020 are subjects of drug circulation is equated to registration in monitoring system.

If within the data experiment, provided by subjects of drug circulation to information system in which information support of carrying out experiment was performed, and also the documents submitted by them to the Federal Service on supervision in the field of health care do not meet the requirements to the data and documents provided by the Provision approved by this resolution, such subjects of drug circulation since January 1, 2020 enter missing and (or) urgent data in monitoring system, and submit missing and (or) urgent documents to the Federal Service on supervision in the field of health care till July 1, 2020 (inclusive).

1(3). The subjects of drug circulation which are producers of medicines concerning which they perform the technology transactions corresponding to production stages of packing (packaging) of medicines (in case of medicine production in the territory of the Russian Federation), either holders (owners) of registration certificates of medicines or representative offices of the foreign organizations in the territory of the Russian Federation which are holders (owners) of registration certificates of medicines (in case of production of medicine out of the territory of the Russian Federation), before input of medicines in turnover:

enter into monitoring system data on medicines according to the Provision approved by this resolution;

direct with use of monitoring system to the operator of monitoring system the request (electronically) to receipt of devices of registration of issue of codes of marking or provision to it remote access no later than May 1, 2020 or within 7 calendar days from the date of registration in monitoring system in case of origin at subjects of drug circulation of need of implementation of the activities connected with the address of medicines in the presence of the right to perform such activities;

provide since July 1, 2020 drawing funds of identification for primary package of medicine (if the secondary package is not provided) and on secondary (consumer) package of medicine, except for the provisions specified in paragraph five of this Item;

provide since April 1, 2024 drawing on medicines with the international non-proprietary name "Ethanol" of funds of identification for secondary (consumer) package if such packaging is individual secondary (consumer) package of this medicine, and in case of lack of secondary (consumer) package or availability of packaging in which there are more than one unit of the specified medicine in primary package, means of identification is applied on primary package;

have the right since January 1, 2020 to put funds of identification of medicine for primary package of medicine (if the secondary package is not provided) and for secondary (consumer) package of medicine.

At the same time if subjects of drug circulation put since January 1, 2020 funds of identification of medicine for primary package of medicine (if the secondary package is not provided) and for secondary (consumer) package of medicine, they represent data on drawing means of identification to monitoring system.

1(4). The subjects of drug circulation performing medical activities and conclusion from turnover of medicines in case of delivery of health care and also the subjects of drug circulation releasing medicines free of charge according to the recipe on medicines direct with use of monitoring system to the operator of monitoring system the request (electronically) to receipt of registrars of disposal no later than February 15, 2020 or within 7 calendar days from the date of registration in monitoring system in case of origin at subjects of drug circulation of need of implementation of the activities connected with the address of medicines in the presence of the right to perform such activities.

1(5). Determine that the operator of monitoring system provides:

equipment of subjects of drug circulation, stipulated in Item 1(3) these resolutions, devices of registration of issue of codes of marking or provision of remote access to such devices of registration of issue placed in infrastructure of the operator of monitoring system by it on the conditions provided by the Provision approved by this resolution no later than 30 calendar days from the date of obtaining from subjects of drug circulation of the request for receipt of such devices or remote access to them;

equipment of the subjects of drug circulation performing medical activities and conclusion from turnover of medicines in case of delivery of health care and also the subjects of drug circulation releasing medicines free of charge according to the recipe on medicines, registrars of disposal on the conditions provided by the Provision approved by this resolution no later than 30 calendar days from the date of obtaining from subjects of drug circulation of the request for receipt of such devices;

the organization of testing of information exchange of information systems of subjects of drug circulation and monitoring system no later than 30 calendar days from the date of obtaining from subjects of drug circulation of the request for passing of testing of information exchange.

1(6). Determine that the operator of monitoring system at the request of subjects of drug circulation provides marking codes since January 1, 2020.

1(7). Determine that the payment for rendering by the operator monitoring system of service in provision of codes of marking is levied since July 1, 2020.

2. The realization of this resolution is enabled by the corresponding federal executive bodies within the number of their workers and budgetary appropriations provided by it in the federal budget on management and management in the field of the established functions established by the Government of the limiting Russian Federation.

3. This resolution becomes effective from the date of its official publication, except for the provisions specified in item 4 of this resolution.

4. The regulations on monitoring system of movement of medicines for medical application approved by this resolution concerning producers of medicines regarding drawing on primary package (concerning medicines for medical application for which the secondary package is not provided) and secondary (consumer) package of medicines for medical application of means of identification, and also concerning the legal entities and individual entrepreneurs performing production, storage, import to the Russian Federation, leave, realization, transfer, application and destruction of medicines for medical application regarding introduction of information on medicines for medical application in monitoring system of movement of medicines for medical application No. 425-FZ "About introduction of amendments to the Federal law "About Drug Circulation" becomes effective from the date of entry into force of paragraphs two and the fifth subitem "b" of Item 7 of article 1 of the Federal Law of December 28, 2017.

Approved by the Order of the Government of the Russian Federation of December 14, 2018 No. 1556

Regulations on monitoring system of movement of medicines for medical application

I. General provisions

1. This Provision determines:

a) procedure for drawing means of identification of medicine for medical application (further - medicines), requirements to its structure and format of information which means of identification of medicine, and its characteristics contains;

b) procedure for creation, development, commissioning, operation and conclusion from operation of monitoring system of movement of medicines (further - monitoring system);

c) monitoring system order of interaction with other state information systems and information systems of the legal entities and individual entrepreneurs specified in parts 7 and 10 of article 67 of the Federal law "About Drug Circulation";

d) procedure for entering into monitoring system by the legal entities and individual entrepreneurs performing production, storage, import to the Russian Federation, leave, realization, transfer, application and destruction of medicines, information on medicines and its structure;

e) procedure for provision of information and information access containing in monitoring system;

e) the purposes of access of federal executive bodies and executive bodies of subjects of the Russian Federation to information on subjects of drug circulation, about medicines and about turnover of such medicines, necessary for accomplishment of tasks and implementation of the functions assigned to federal executive bodies and executive bodies of subjects of the Russian Federation, statistical information on medicines and on their turnover and also to public information;

g) structure of information provided according to part 10 of article 67 of the Federal law "About Drug Circulation".

2. The concepts used in this Provision mean the following:

"aggregation" - process of consolidation of medicines at any stage of the address of medicines the subject of drug circulation in tertiary (transport) packaging of medicines with drawing the corresponding code of identification of tertiary (transport) packaging of medicines and with preserving information in monitoring system on interrelation of means of identification or codes of identification of each medicine enclosed in such packaging with code of identification of tertiary (transport) packaging of medicines;

"input in turnover of medicines":

in case of production in the territory of the Russian Federation - the transactions made with medicines from passing of production stage of packing (packaging) of medicines and marking of packagings of medicines means of identification before completion of production stage of the issuing quality control and submission of the documents and data provided by part 1 of article 52.1 of the Federal law "About Drug Circulation" in 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);

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 and marking of packagings of medicines means of identification 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);

paragraph of the sixth ceased to be valid

"secondary (consumer) package of medicine" - the packaging arriving to the consumer and the employee for placement of single primary package of medicine (individual secondary (consumer) package) or combining several primary packages of medicines;

"conclusion from turnover of medicines" - realization, sale and leave (including according to the recipe) medicines to the consumer, application, transfer on destruction, loss and write-off of medicines, sampling, export of the medicines which are earlier imported into the Russian Federation (re-export), and also conclusion from turnover for other reasons;

"global identification number of trade item" - the unique code assigned for group of goods at their description in the information resource providing accounting and storage of reliable data about goods on the corresponding commodity nomenclature;

the paragraph the tenth ceased to be valid according to the Order of the Government of the Russian Federation of 20.03.2020 No. 311

the paragraph the eleventh ceased to be valid according to the Order of the Government of the Russian Federation of 20.03.2020 No. 311

"the application identifier" - the prefix representing set of 2 or more signs located at the beginning of element line and which is unambiguously determining appointment and format of the data field following prefix;

"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);

"individual serial number of trade item" - the digital or alphanumeric sequence;

"identification code" - the serial global identification number of trade item representing the unique identifier of packaging of medicine created by way of addition to global identification number of trade item of individual serial number of trade item;

"code of identification of tertiary (transport) packaging of medicine" - the symbolical sequence created according to the requirements provided by the Section III of this provision;

"marking code" - the unique sequence of symbols consisting of code of identification and code of check, created for the purposes of identification of packaging of medicines for medical application;

"check code" - the sequence of symbols created as a result of cryptographic transformation of code of identification and allowing to reveal falsification of code of identification in case of its check with use of the fiscal store and (or) technical means of check of code of check;

"the medicines marked by means of identification" - medicines on which packaging means of identification with observance of requirements of this provision and authentic data about which (including data on the means of identification and (or) material carriers (labels) containing means of identification applied on them) contain in monitoring system are applied;

"marking of packagings of medicines means of identification" - drawing the means of identification transformed from the corresponding codes of marking, on packaging of medicine or drawing material carriers (labels) containing the funds of identification transformed from the corresponding codes of marking for packaging of medicine with observance of requirements of this provision;

"the description of medicine" - the list of the characteristics placed by the subject of drug circulation in the appropriate information resource providing accounting and storage of reliable data about goods on the corresponding commodity nomenclature;

"primary package of medicine" - means or complex of the means which are providing protection of medicines against damage and losses, impacts of the environment, pollution and having direct contact with medicines;

"the registrar of disposal" - the technical tool of information exchange intended for transfer to monitoring system of data on conclusion from turnover of medicines, including the hardware-software cryptography (cryptographic) technical tool of check of codes of check concerning which the Federal Security Service of the Russian Federation issues the document on its compliance to the established requirements to the cryptographic (cryptographic) means of information protection operating concerning the cryptography (cryptographic) tools intended for check of codes of marking;

the paragraph of ceased to be valid according to the Order of the Government of the Russian Federation of 20.03.2020 No. 311

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