On September 8, 2020, the Administrative Regulations of the Federal Service for Surveillance in Healthcare on the provision of state services for issuing a permit for the retail sale of medicinal products for medical use remotely, approved by order of the Federal Service for Surveillance in Healthcare N 5161 (hereinafter referred to as the “Administrative Regulations”), came into force.
Recall that in accordance with clause 7 of the Rules for issuing a permit for retail trade of medicinal products for medical use remotely, for the implementation of such trade and delivery of these medicinal products to citizens, approved by the Government of the Russian Federation dated May 16, 2020 N 697, the issuance of a permit for the implementation of the retail sale of medicinal products remotely (hereinafter referred to as the “Permit”) is carried out by the Federal Service for Surveillance in Healthcare through, inter alia, electronic technologies.
Obtaining a Permit is possible if the pharmacy organization has:
- at least 10 locations where pharmaceutical activities are carried out on the territory of the Russian Federation;
- equipped rooms (places) for storing;
- its own courier service, which has the equipment to maintain the required temperature for the delivery of thermolabile drugs or an agreement with a courier service that has such equipment;
- electronic payment system and (or) mobile payment terminals.
A pharmacy organization must have a license to carry out retail trade in medicines, obtained no later than 1 year from the date of the decision on remote sales and the submission of the corresponding application.
The Administrative Regulations specified the procedure for granting Permit for the remote retail sale of medicines.
The decision to issue (to refuse to issue) and the issuance of the Permit is made within 5 working days from the date the application for obtaining the Permit is received by the territorial bodies of the Federal Service for Surveillance in Healthcare.
The applicant must indicate in the application his full name, Main State Registration Number, Taxpayer Identification Number, the address of the applicant and all its structural units, addresses of places of trade, information on the license, website address.
The application must be accompanied by:
- copies of documents (information) confirming the presence of at least 10 locations for carrying out pharmaceutical activities on the territory of the Russian Federation;
- copies of documents (information) confirming the availability of equipped premises (places) for storing generated orders in accordance with the Rules of Good Practice for the Storage and Transportation of Medicines for Medical Use, approved by order of the Ministry of Health of the Russian Federation N 646n dated August 31, 2016;
- copies of documents (information) confirming the presence of the site in the information and telecommunications network “Internet” or the presence of a mobile application;
- copies of documents (information) confirming the existence of its own courier service, which has equipment that ensures the maintenance of the required temperature regime for the delivery of thermolabile medicines, or an agreement with a courier delivery service that has such equipment;
- copies of documents (information) confirming the existence of an electronic payment system and (or) mobile payment terminals designed for electronic payments, including using bank cards.
All these documents are submitted with a list in electronic form by signing with an enhanced qualified electronic signature. To ensure the possibility of submitting an application and documents (information), the applicant must be registered on the Unified Portal of Public Services.
When considering an application, the applicant is notified in electronic form about the acceptance and registration of the application, about the beginning of the procedure for considering the application, about the end, and the results of the consideration.
A Permit is granted without collecting a state fee.
The grounds for a refusal to issue a Permit are:
- absence in the application of the necessary information given above;
- unreliability of such information;
- lack of documents required to be attached to the application.
If the applicant reveals typos and (or) errors in the issued Permit, the applicant submits an application for their correction. After consideration of the application, if it is justified, a draft of the reissued Permit must be prepared, which is signed by the head of the territorial body of Federal Service for Surveillance in Healthcare (deputy's head) within 1 working day.
Interested parties have the right to appeal against the actions (inaction) of officials of the territorial bodies of Federal Service for Surveillance in Healthcare in the (extrajudicial) procedure, including in the event of a violation of the terms of registration and/or consideration of the application, refusal to accept documents or request additional documents not provided for by the Administrative Regulations.
September 14, 2020
Associate of BRACE Law Firm ©