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

The government of the Russian Federation decides:

1. Conduct in the territory of the Russian Federation within implementation of the priority project "Implementation of the Automated Monitoring System of Movement of Medicines from the Producer to the Final Consumer for Protection of the Population against Counterfeited Medicines and Operational Removal from Turnover of Counterfeit and Substandard Medicines" experiment on marking by control (identification) signs and to monitoring of turnover of separate types of medicines for medical application (further - experiment) to the period from February 1, 2017 to December 31, 2019.

2. Approve the enclosed Regulations on carrying out experiment on marking by control (identification) signs and to monitoring of turnover of separate types of medicines for medical application.

3. Determine that:

the federal executive bodies authorized on ensuring carrying out experiment are the Ministry of Health of the Russian Federation, the Ministry of Industry and Trade of the Russian Federation, the Federal Service on supervision in health sector and the Federal Tax Service;

the operator of information system performing information support of carrying out experiment till October 31, 2018 is the Federal Tax Service.

3(1). Agree with the offer of Operator-TsRPT limited liability company that the specified society on a grant basis is the operator of information system performing information support of carrying out experiment since November 1, 2018.

3(2). Registration in information system in which information support of carrying out experiment, legal entities and individual entrepreneurs who are subjects of drug circulation according to Item 2 of the Regulations on monitoring system of movement of medicines for the medical application approved by 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" (further - Regulations on monitoring system) (except for the legal entities and individual entrepreneurs who are subjects of drug circulation according to the Item "and" of the order of the Government of the Russian Federation of December 14, 2018 No. 1557 "About features of implementation of monitoring system of movement of medicines for medical application") will be performed, and who as of December 31, 2019 are participants of experiment, is equated to registration in the monitoring system of movement of medicines for medical application performed according to Regulations on monitoring system.

If within the data experiment, provided by the specified subjects of drug circulation to information system in which information support of carrying out experiment will be performed, and also the documents submitted by them to the Federal Service on supervision in health sector do not meet the requirements to the data and documents established by Regulations on monitoring system, such subjects of drug circulation since January 1, 2020 enter missing and (or) urgent data in monitoring system of movement of medicines for medical application, and submit missing and (or) urgent documents to the Federal Service on supervision in health sector.

4. To the Ministry of Health of the Russian Federation, the Ministry of Industry and Trade of the Russian Federation, the Federal Service on supervision in health sector and the Federal Tax Service to carry out assessment of results of experiment and to provide the corresponding reports to the Government of the Russian Federation on February 1, 2019, on July 1, 2019 and on February 1, 2020.

5. Carrying out experiment is performed within the budgetary appropriations provided to the Ministry of Health of the Russian Federation, the Ministry of Finance of the Russian Federation, the Ministry of Industry and Trade of the Russian Federation, the Federal Service on supervision in health sector and the Federal Tax Service in the federal budget for the corresponding financial year on management and management in the sphere of the established functions.

Approved by the Order of the Government of the Russian Federation of January 24, 2017 No. 62

Regulations on carrying out experiment on marking by control (identification) signs and to monitoring of turnover of separate types of medicines for medical application

1. This Provision establishes procedure for carrying out experiment on marking by control (identification) signs and to monitoring of turnover of separate types of the medicines for medical application which are in civil circulation in the territory of the Russian Federation (further - experiment).

2. The purposes of implementation of marking of medicines control (identification) signs are:

a) counteraction to illegal production of medicines in the territory of the Russian Federation;

b) counteraction to illegal import of medicines to the territory of the Russian Federation;

c) counteraction to illicit trafficking in medicines in the territory of the Russian Federation;

d) counteraction of unfair competition in the sphere of turnover of medicines;

e) standardization and unification of accounting procedures of deliveries and distribution of the medicines including which are purchased for the state needs.

3. The purposes of experiment are:

a) determination of efficiency and effectiveness of the developed control system behind movement in the territory of the Russian Federation medicines from the producer (importer) to the final consumer in general and each of participants of the market of the medicines separately for goal achievement specified in Item 2 this provision;

b) determination of changes which need to be brought in the regulatory legal acts of the Russian Federation regulating the sphere of the address of medicines in case of decision making about implementation of monitoring of turnover of separate types of medicines;

c) determination of technical capabilities of information system in which information support of carrying out experiment, and need of its further development will be performed.

4. Marking of medicines control (identification) signs for the purpose of carrying out experiment is performed by producers of medicines with use of two-dimensional bar code.

Drawing the specified marking does not require modification of the registration file on medicine.

5. The experiment is made on voluntary basis based on requests of subjects of drug circulation during the period from February 1, 2017 to December 31, 2019.

For participation in experiment the medicines intended for providing persons sick with hemophilia, mukovistsidozy, by hypophysial nanizm, disease to Gosha, malignant new growths lymphoid, haematogenic and related it fabrics, multiple sclerosis, persons after organ transplantation and (or) fabrics are priority.

6. For carrying out experiment by the Ministry of Health of the Russian Federation in coordination with the Ministry of Industry and Trade of the Russian Federation, the Ministry of Telecom and Mass Communications of the Russian Federation, the Federal Service on supervision methodical recommendations by which are established affirm as health sector and the Federal Tax Service including:

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