Experiment on Remote Sale of Prescription Medicines

26 April 2023
Anzhelika Kalashyan
Associate
Nadezhda Fedotova
Associate

On 22 February 2023 the Government has approved the rules for conducting an experiment on the remote sale of prescription medicines1. The experiment is carried out in the territory of Moscow, Moscow and Belgorod regions from 1 March 2023 to 1 March 2026.

As part of the experiment, medical organizations will keep records on information about the medicine, as well as the unique number of its prescription issued to the patient, into the EGISZ2. Pharmacy organizations connected to the EGISZ and having permission to retail medicines remotely will be able to sell such medicines according to their prescriptions. The list of such medicines has been approved by the Ministry of Health of Russia3 and includes more than 900 INN.

Participation in the experiment is confirmed by official publishing of a list of pharmacy organizations on the official website of the Roszdravnadzor.

To participate in the experiment, pharmacy organizations must meet the following requirements:

Requirement for a pharmacy organization

Documents and information confirming compliance with the requirement 4

Availability of premises (places) equipped in accordance with the rules of good practice and transportation of medicines5 for storing orders

(1)   Documents on the availability (in accordance with the BTI plan) of premises on the right of ownership or on another legal right for storing formed orders with specification of numbers;

(2)   Documents on the availability of equipment used in the process of storing generated orders (turnover balance sheet, invoices, receipts, inventories, cards, etc.), namely: air conditioning systems; cold rooms and (or) refrigerators; ventilation systems; thermohygrometers (psychrometers) or other equipment used to register indoor temperature and humidity

Availability of own website or an agreement with the owner of the website, or a mobile app

Information about the availability of own website with links to download the distribution kit or app or an agreement with the owner of the website, which provides for:

(1)   the possibility to get acquainted with the offer of the pharmacy chain;

(2)   acceptance of an order, as well as the conclusion of a website on behalf of and at the expense of a pharmacy organization of a purchase and sale agreement with the buyer with the possibility of pre-payment of the order

Availability of own courier service, provided with the necessary equipment to comply with the temperature regime during delivery of orders, or a contract with entities meeting such requirements

(1)   In the presence of own courier service – documents on the availability of equipment (thermocontainers, thermoboxes, cooler bags (including medical ones), loggers, temperature sensors, etc.), ensuring the maintenance of necessary temperature regime for delivery of medicines (turnover balance sheet, waybills, commodity receipts, inventories, cards, etc.);

(2)   In the absence of own courier service – an agreement with other entities who have equipment that ensures the maintenance of necessary temperature regime for delivery of thermolabile medicines

Availability of an electronic payment system or mobile payment terminals to accept payments directly at the place of delivery

(1)   Registration numbers of cash register equipment intended for electronic payments, including using bank cards, directly at the place of delivery;

(2)   Documents confirming the registration of a pharmacy organization in the electronic payment system

Placement in the EGISZ of information about employees of a pharmacy organization

A special document is not required, confirmation is carried out through the information system

When accepting orders, pharmacy organizations and owners of aggregators are obliged to ensure the confidentiality of personal data of buyers and prescriptions issued to them, as well as inform the buyer about the indications for the use of the medicine, its price, expiration date, release conditions, storage rules and interaction with other medicines. If necessary, the buyer may also request the documents confirming the quality of medicines together with the order.

In order to receive the order, the buyer or his representative will need to present an identity document for the purpose of identifying him with the person specified in the recipe. It will be possible to refuse the delivered prescription medicine up to the time of payment, however, delivery services must be paid in full (except in cases of delivery of medicines of inadequate quality).

1 Decree of the Government of the Russian Federation No. 292 dated 22.02.2023 “On approval of the Regulations on the procedure for conducting an experiment on the implementation of retail sale of medicines for medical use, dispensed by prescription for a medicine, by remote means”// URL: http://publication.pravo.gov.ru/Document/View/0001202302250002
2 Unified state information system in the field of healthcare
3 Order of the Ministry of Health of the Russian Federation No. 36n dated 01.02.2023 “On approval of the list of medicines and pharmacotherapeutic groups of medicines authorized for sale as part of an experiment on retail sale of prescription medicines for medical use remotely”
4 According to the Draft Order of Roszdravnadzor “On approval of the list of documents confirming the compliance of a pharmacy organization with the requirements that give the right to retail sale of prescription medicines for medical use remotely” (project ID: 01/02/03-23/00136652) // URL: https://regulation.gov.ru/projects#npa=136652
5 Order of the Ministry of Health of the Russian Federation No. 646n dated 31.08.2016 “On approval of the rules of good practice of storage and transportation of medicines for medical use”