ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of December 22, 2023 No. 2261

About carrying out in the territory of the Russian Federation experiment on traceability of medicines for the medical application and raw materials used for production of medicines for medical application

The government of the Russian Federation decides:

1. Conduct from December 29, 2023 to August 31, 2025 in the territory of the Russian Federation experiment on traceability of medicines for the medical application and raw materials used for production of medicines for medical application (further respectively - medicines, raw materials, experiment).

2. Approve enclosed:

Regulations on carrying out in the territory of the Russian Federation experiment on traceability of medicines for the medical application and raw materials used for production of medicines for medical application;

the list of traceable medicines for the medical application and raw materials used for production of medicines for medical application.

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 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 the field of health care (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 January 15, 2024:

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:

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