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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of May 16, 2020 No. 697

About approval of Rules of issue of permission to implementation of retail trade by medicines for medical application by remote method, implementation of such trade and delivery of the specified medicines to citizens and introduction of amendments to some acts of the Government of the Russian Federation concerning retail trade by medicines for medical application by remote method

(as amended on 31-05-2021)

According to part 1.1 of article 55 of the Federal law "About Drug Circulation" Government of the Russian Federation decides:

1. Approve enclosed:

Rules of issue of permission to implementation of retail trade by medicines for medical application by remote method, implementation of such trade and delivery of the specified medicines to citizens;

changes which are made to acts of the Government of the Russian Federation concerning retail trade by medicines for medical application by remote method.

2. To the Ministry of Health of the Russian Federation to organize within 6 months from the date of the introduction of this resolution in force monitoring of application of the Rules approved by this resolution and to provide to the Government of the Russian Federation after the specified term the report on its results.

3. This resolution becomes effective from the date of its official publication.

Acting as Russian Prime Minister

A. Belousov

Approved by the Order of the Government of the Russian Federation of May 16, 2020 No. 697

Rules of issue of permission to implementation of retail trade by medicines for medical application by remote method, implementation of such trade and delivery of the specified medicines to citizens

1. These rules establish approval procedure on implementation of retail trade by medicines for medical application by remote method, requirements to the pharmaceutical organizations which can perform such trade, procedure of such trade, and also delivery of the specified medicines to citizens.

2. By remote method retail trade by medicines for medical application (further - medicines), except for the medicines released according to the recipe on medicine, narcotic medicines and psychotropic medicines, and also alcohol-containing medicines with volume fraction of ethyl alcohol over 25 percent can be performed.

3. Implementation of retail trade by medicines by remote method includes acceptance, forming, storage and delivery of orders for medicines, and also leave of medicines.

4. Calculations in case of payment of medicines and services in their delivery are performed at the choice of the buyer in cash or non-cash form by advance payment of the order or its payment in the place of receipt of the order.

5. Retail trade by medicines by remote method is performed by the pharmaceutical organizations (except for individual entrepreneurs) having the license for implementation of pharmaceutical activities with indication of the performed work (the rendered service) on retail trade as medicines and owning such license at least one year (further - the pharmaceutical organization), in the presence:

a) ceased to be valid

b) the equipped rooms (places) for storage of the created orders according to the Rules of proper practice of storage and transportation of medicines for medical application approved by the order of the Ministry of Health of the Russian Federation;

c) the website on the Internet (further - Internet network) or stipulated in Item 5(1) these rules of the agreement with the legal entity who is the owner of the aggregator of information on goods (services) according to the Law of the Russian Federation "About consumer protection" (further - the owner of the aggregator). Availability of mobile application is allowed;

d) own mail and messenger service having the equipment providing maintenance of necessary temperature condition for delivery of thermolabile medicines or agreements with the other persons performing delivery with use of such equipment;

e) the electronic payment system and (or) mobile payment terminals intended for carrying out electronic payments including by means of bank cards, it is direct in the place of rendering service.

5(1). When implementing retail trade by medicines by remote method the pharmaceutical organization has the right to sign the agreement providing with the owner of the aggregator:

a) provision to the buyer of opportunity to study the offer of the pharmaceutical organization on the conclusion of the agreement of retail purchase and sale of medicines on the website in Internet network or in mobile application, belonging to the owner of the aggregator;

b) acceptance by the owner of the aggregator of the order for the pharmaceutical organization about the conclusion of the agreement of retail purchase and sale of medicines, and also the conclusion the owner of the aggregator from name and at the expense of the pharmaceutical organization of the agreement of retail purchase and sale of medicines with the buyer with possibility of advance payment of the order.

5(2). The pharmaceutical organization has the right to conclude specified in Item 5 (1) these rules the agreement with several owners of aggregators.

The owner of the aggregator has the right to conclude specified in Item 5 (1) these rules the agreement with several pharmaceutical organizations.

6. The list of the documents confirming compliance of the pharmaceutical organization to requirements, stipulated in Item 5 these rules, and represented according to Item 7 of these rules affirms the Federal Service on supervision in the field of health care.

7. Issue of permission to implementation of retail trade by medicines by remote method (further - permission) is performed by the Federal Service on supervision in the field of health care by means of including information and communication technologies according to the procedure, established by administrative regulations.

The form of permission to implementation of retail trade by medicines by remote method affirms the Federal Service on supervision in the field of health care.

For receipt of permission the pharmaceutical organization sends including by means of information and communication technologies (in particular by means of Internet network and (or) mobile application) to the Federal Service on supervision in the field of health care the statement for receipt of permission (further - the statement) with application of documents (data) confirming compliance of the pharmaceutical organization to the requirements specified in Item 5 of these rules.

The statement and documents (data) (the data represented electronically) signed attached to it and certified according to the strengthened qualified digital signature are represented electronically according to the procedure, established by administrative regulations. The application form affirms the Federal Service on supervision in the field of health care.

8. Are specified in the statement:

a) full trade name of the pharmaceutical organization (in Russian);

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