On September 8, 2020, the Administrative Regulations of the Federal Service for Surveillance in Healthcare (Roszdravnadzor) on the Provision of the State Service for Issuing Permits for the Distance Retail Sale of Medicinal Products for Medical Use, approved by Order of Roszdravnadzor No. 5161 dated June 19, 2020 (hereinafter the "Administrative Regulations"), entered into force.

As a reminder, pursuant to Paragraph 7 of the Rules for Issuing Permits for the Distance Retail Sale of Medicinal Products for Medical Use, the Execution of Such Trade, and the Delivery of Said Medicinal Products to Citizens, approved by Decree of the Government of the Russian Federation No. 697 dated May 16, 2020, Roszdravnadzor issues permits for the distance retail sale of medicinal products (hereinafter the "Permit") utilizing, inter alia, information and communication technologies.

A pharmacy organization is eligible to obtain the Permit subject to satisfying the following criteria:

• Maintaining at least 10 places of business for pharmaceutical activities within the Russian Federation;
• Operating equipped premises (facilities) for storing assembled orders;
• Maintaining an active website in the "Internet" information and telecommunications network;
• Operating an in-house courier service equipped to maintain the required temperature conditions for delivering temperature-sensitive (thermolabile) medicinal products, or executing an agreement with a courier delivery service possessing such equipment;
• Deploying an electronic payment system and/or mobile payment terminals.

Additionally, the pharmacy organization must hold a license to engage in the retail sale of medicines, obtained no later than one year from the date of the decision to conduct distance sales and the submission of the corresponding application.

The Administrative Regulations specify the procedure for granting Permits to conduct the distance retail sale of medicinal products.

The territorial bodies of Roszdravnadzor shall decide on the issuance of (or refusal to issue) and dispatch the Permit within five business days from the date of receipt of the Permit application.

The applicant must specify in the application its full corporate name, Primary State Registration Number (OGRN), Taxpayer Identification Number (INN), the corporate address of the applicant and all its structural units, the addresses of its trading locations, license information, and the website URL.

The applicant must attach the following to the application:

• Copies of documents (information) confirming the existence of at least 10 places of business for pharmaceutical activities within the Russian Federation;
• Documentary evidence verifying the availability of equipped premises (facilities) for storing assembled orders in accordance with the Rules of Good Storage and Transportation Practices for Medicinal Products for Medical Use, approved by Order of the Ministry of Health of the Russian Federation No. 646n dated August 31, 2016;
• Copies of documents or information confirming the availability of a website in the "Internet" information and telecommunications network or a mobile application;
• Proof of an in-house courier service equipped to maintain the required temperature conditions for delivering temperature-sensitive medicinal products, or a valid contract with a third-party delivery service possessing such equipment;
• Certificates or records confirming the deployment of an electronic payment system and/or mobile payment terminals intended for electronic transactions, including bank card payments.

The applicant shall submit all the aforementioned documents electronically together with an inventory, executed with an enhanced qualified electronic signature. To facilitate the submission of the electronic application and supporting documents (information), the applicant must be registered on the Unified Portal of State Services (Gosuslugi).

During the application review process, the regulatory authority shall electronically notify the applicant of the receipt and registration of the application, the commencement of the review procedure, and the completion and results of the review.

The authority shall issue the Permit free of state duty.

The grounds for refusing to issue the Permit include:

• Omission of the required information specified above from the application;
• Inaccuracy or unreliability of the submitted data;
• Failure to provide the mandatory supporting documents.

If the applicant identifies typographical errors and/or mistakes in the issued Permit, the applicant shall submit an application for their correction. Upon reviewing the application and confirming its merits, the authority shall draft a reissued Permit, which the head (or deputy head) of the territorial body of Roszdravnadzor shall sign within one business day.

Interested parties are entitled to appeal the actions or omissions of officials of the territorial bodies of Roszdravnadzor through out-of-court (administrative) proceedings, including in cases involving the violation of deadlines for registration and/or application review, refusal to accept documents, or demands for additional documents not prescribed by the Administrative Regulations.