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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of February 22, 2023 No. 292

About approval of the Regulations on procedure for carrying out experiment on implementation of retail trade the medicines for medical application released according to the recipe on medicine, by remote method

The government of the Russian Federation decides:

1. Approve the enclosed Regulations on procedure for carrying out experiment on implementation of retail trade by the medicines for medical application released according to the recipe on medicine, remote method.

2. Determine that participants of experiment on implementation of retail trade the medicines for medical application released according to the recipe on medicine, by remote method (further - experiment) are:

Ministry of Health of the Russian Federation;

authorized executive bodies of subjects of the Russian Federation - Moscow, the Belgorod region, the Moscow region;

the medical organizations and the pharmaceutical organizations conforming to the requirements established according to part 4 of article 55.1 of the Federal law "About Drug Circulation".

3. Authorized executive bodies of the subjects of the Russian Federation specified in Item 2 of this resolution approve procedure for selection of the medical organizations and pharmaceutical organizations for participation in experiment, and also make such selection and approve the list of the medical organizations and the list of the pharmaceutical organizations conforming to the requirements established by this resolution according to part 4 of article 55.1 of the Federal law "About Drug Circulation", and being participants of experiment, with placement of the specified lists on the official sites on the Internet.

4. The implementation of actions, provided by this resolution, is performed by the Ministry of Health of the Russian Federation within the established number of staff of employees of the Ministry and budgetary appropriations provided to the Ministry on management and management in the field of the established functions.

5. This resolution becomes effective since March 1, 2023 and is effective till March 1, 2026.

Russian Prime Minister

M. Mishustin

Approved by the Order of the Government of the Russian Federation of February 22, 2023 No. 292

Regulations on procedure for carrying out experiment on implementation of retail trade the medicines for medical application released according to the recipe on medicine, by remote method

1. This Provision establishes procedure for carrying out experiment on implementation of retail trade by the medicines for medical application released according to the recipe on medicine (further - medicine), remote method (further - experiment), requirements to the medical organizations and the pharmaceutical organizations, being participants of experiment, procedure of retail trade by medicines by remote method, requirements to delivery of medicines to citizens, rules of issue of permission to implementation of retail trade by medicines by remote method.

2. In this Provision the following concepts are used:

"subjects of the Russian Federation" - Moscow, the Belgorod region, the Moscow region;

"authorized executive bodies of subjects of the Russian Federation" - authorized executive bodies of subjects of the Russian Federation - Moscow, the Belgorod region, the Moscow region, being participants of experiment.

3. The purposes of experiment are working off of the mechanism of retail trade medicines by remote method and possibility of further implementation and use of such trade on permanent basis in all territory of the Russian Federation.

4. The experiment is made on voluntary basis based on requests of the medical and pharmaceutical organizations given to authorized executive bodies of subjects of the Russian Federation in the procedure established by them.

The medical and pharmaceutical organizations in case of adoption of the decision on refusal of participation in experiment by them submit to authorized executive body of the subject of the Russian Federation the corresponding address in writing on paper or by means of the Internet (further - Internet network).

5. Ministry of Health of the Russian Federation:

performs methodical maintenance of experiment, including methodical maintenance of activities of the medical organizations and pharmaceutical organizations participating in experiment for registration, use and storage of the recipes on medicine including created in the form of electronic documents;

represents to the Government of the Russian Federation:

the preliminary report on results of carrying out experiment - till December 31, 2025;

the final report on results of carrying out experiment and the offer on introduction of amendments to the legislation on drug circulation - till April 30, 2026.

Authorized executive bodies of subjects of the Russian Federation perform monitoring of carrying out experiment and submission to the Ministry of Health of the Russian Federation:

quarterly reports on the course of carrying out experiment - no later than the 15th following reporting quarter;

intermediate and final reports on the course of carrying out experiment - till December 1, 2025 and till April 1, 2026 respectively.

6. The medical organizations for participation in experiment shall be connected to the state information system in the field of health care of the subject of the Russian Federation and (or) medical information system of the medical organizations interacting with single state information system in the field of health care.

The medical organizations, being participants of experiment, shall provide entering of data on purpose of medicine into the state information system in the field of health care of the subject of the Russian Federation and (or) medical information system of the medical organizations, and also assignment to the issued recipes on medicines of the unique numbers created by means of the state information system in the field of health care of the subject of the Russian Federation and (or) medical information system of the medical organizations and informing patients on such numbers.

7. The pharmaceutical organizations for participation in experiment shall be connected to the state information system in the field of health care of the subject of the Russian Federation, and also provide permission to implementation of retail trade by medicines by remote method, stipulated in Item the 15th this provision (further - permission).

8. Within the experiment by remote method retail trade can be performed by the medicines (including released according to the recipe on medicine created in electronic form in personal account of the citizen on the single portal of the state and municipal services and (or) on the regional portal of the state and municipal services) included in the list of medicines and pharmakoterapevtichesky groups of the medicines permitted to realization within the experiment, approved by the Ministry of Health of the Russian Federation based on criteria of inclusion of medicines and pharmakoterapevtichesky groups of the medicines in the specified list established by the Government of the Russian Federation.

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