Document from CIS Legislation database © 2003-2024 SojuzPravoInform LLC

ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of February 9, 2022 No. 137

About carrying out in the territory of the Russian Federation experiment on marking of separate types of medical products means of identification

(as amended of the Order of the Government of the Russian Federation of 28.02.2023 No. 322)

The government of the Russian Federation decides:

1. Conduct from February 15, 2022 to August 31, 2023 in the territory of the Russian Federation experiment on marking of separate types of medical products by means of identification (further - experiment).

2. Approve enclosed:

Regulations on carrying out in the territory of the Russian Federation experiment on marking of separate types of medical products means of identification;

the list of separate types of the medical products which are subject to marking by means of identification within the experiment on marking of separate types of medical products means of identification.

3. Determine that the federal executive bodies authorized on ensuring carrying out experiment are the Ministry of Industry and Trade of the Russian Federation, the Ministry of Labour and Social Protection of the Russian Federation, the Ministry of Health of the Russian Federation, the Ministry of digital development, communication and mass communications of the Russian Federation, Federal Security Service of the Russian Federation, the Federal Tax Service, the Federal Customs Service, the Federal Service on supervision in health sector, Federal Accreditation Service and Social Insurance Fund of the Russian Federation (further - authorized bodies).

4. Agree with the offer of Operator-TsRPT limited liability company on implementation by the specified society on a grant basis of functions of the operator of the information system used for the purpose of carrying out experiment (further - information system).

5. Recommend to the operator of information system to develop till April 1, 2022:

a) requirements to information system;

b) requirements to ensuring the information security containing in information system, and information security when using information and communication technologies within the experiment.

6. Provide to the Ministry of Industry and Trade of the Russian Federation:

a) coordination of creation and functioning of information system and coordination of work of participants of turnover of separate types of the medical products participating in experiment;

b) till April 29, 2022 approval of requirements to information system, and also requirements to ensuring the information security containing in information system, and information security when using information and communication technologies within the experiment;

c) till April 29, 2022 development and approval in coordination with authorized bodies of methodical recommendations about carrying out experiment;

d) till April 29, 2022 development and approval in coordination with authorized bodies of the scheduled plan of carrying out experiment;

e) evaluating results of experiment and submission of the corresponding reports to the Government of the Russian Federation till November 1, 2022 and till April 28, 2023.

7. And to Social Insurance Fund of the Russian Federation when implementing powers in the established spheres of maintaining to provide to the Federal Tax Service, the Federal Customs Service, the Federal Service on supervision in health sector, Federal Accreditation Service information exchange of the information systems with information system with use of information which is earlier placed in them, and also accounting of the data transferred by participants of experiment to information system within the experiment including regarding accounting of the data containing in subsystem of the national catalog of the marked goods of information system.

8. Realization by authorized bodies of the actions provided by this resolution is performed within the established number of staff of the workers and budgetary appropriations provided on management and management in the sphere of the established functions.

9. For the purpose of ensuring information exchange of authorized bodies the information system is connected on a grant basis to single system of interdepartmental electronic interaction according to the order of the Government of the Russian Federation of September 8, 2010 No. 697 "About single system of interdepartmental electronic interaction".

Russian Prime Minister

M. Mishustin

Approved by the Order of the Government of the Russian Federation of February 9, 2022 No. 137

Regulations on carrying out in the territory of the Russian Federation experiment on marking of separate types of medical products means of identification

1. This Provision establishes procedure for carrying out in the territory of the Russian Federation experiment on marking of separate types of medical products means of identification (further - experiment).

2. The purposes of experiment are:

a) determination and coordination with the federal executive bodies and Social Insurance Fund of the Russian Federation authorized on ensuring carrying out experiment and also with producers, importers of separate types of the medical products, the organizations of wholesale and retail trade (further - participants of turnover) the scope of information about goods allowing to identify unambiguously commodity unit of separate types of medical products;

b) testing of opportunities of use of technology of drawing means of identification for separate types of medical products and structure of information containing in them;

c) approbation of completeness and sufficiency of mechanisms of marking of separate types of medical products means of identification for ensuring counteraction to illegal import, production and turnover of separate types of medical products, including counterfeit, and also for increase in collecting of taxes and customs payments;

d) the organization of effective interaction of public authorities, including regulatory authorities, with participants of turnover;

e) efficiency evaluation and effectiveness of the information system used for the purpose of carrying out experiment;

e) determination of technical capabilities of the information system used for the purpose of carrying out experiment, including its integration with the state information systems of the federal executive bodies and Social Insurance Fund of the Russian Federation authorized on ensuring carrying out experiment;

g) implementation by participants of turnover of primary filling of subsystem of the national catalog of the marked goods of the information system used for the purpose of carrying out experiment, the data on goods allowing to identify unambiguously commodity unit of separate types of medical products;

h) development of offers on introduction of amendments to the legislation of the Russian Federation regulating turnover of separate types of medical products;

i) the analysis of feasibility of introduction of obligatory marking of separate types of medical products means of identification proceeding from possibility of application of the relevant technology solutions.

3. Participants of experiment are:

a) the federal executive bodies and Social Insurance Fund of the Russian Federation authorized on ensuring carrying out experiment;

b) participants of turnover;

c) operator of information system.

Warning!!!

This is not a full text of document! Document shown in Demo mode!

If you have active License, please Login, or get License for Full Access.

With Full access you can get: full text of document, original text of document in Russian, attachments (if exist) and see History and Statistics of your work.

Get License for Full Access Now

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info

Effectively work with search system

Database include more 50000 documents. You can find needed documents using search system. For effective work you can mix any on documents parameters: country, documents type, date range, teams or tags.
More about search system

Get help

If you cannot find the required document, or you do not know where to begin, go to Help section.

In this section, we’ve tried to describe in detail the features and capabilities of the system, as well as the most effective techniques for working with the database.

You also may open the section Frequently asked questions. This section provides answers to questions set by users.

Search engine created by SoyuzPravoInform LLC.