By the Decree of the Government of Russia dated June 30, 2020 N 955, the order of the introduction into the circulation of medicinal products for medical use until January 1, 2021, were approved.
This document establishes that the introduction into circulation of medicinal products for medical use manufactured in the period from July 1, 2020, to October 1, 2020, without applying identification means, as well as the import of these medicinal products, are carried out based on the agreement of the Federal Service for Surveillance in Healthcare of import to the Russian Federation.
To obtain approval by the applicant (manufacturer or holder of the registration certificate), an application is submitted electronically in the information system of the Federal Service for Surveillance in Healthcare with:
• document attached to the application confirming the applicant's authority;
• justification of the impossibility of applying identification means on the packaging of the medicinal product;
• copies of contracts for the supply and installation of equipment for applying identification means to each of the production sites specified in the application;
• plan for the implementation of a monitoring system indicating the final date of the manufacturer's readiness to apply the identification tool.
The validity period of such an agreement is 45 days.
The decision to approve the introduction of a medicinal product into circulation is made by an interdepartmental commission for issuing approvals for the circulation of a medicinal product under the Federal Service for Surveillance in Healthcare. Information about the issued approvals within one working day is posted on the official website of the Federal Service for Surveillance in Healthcare in the form of a register of approvals.
On July 3 of this year, the Federal Service for Surveillance in Healthcare, is the conformity with the requirements specified in the decree of the Government of Russia, approved a form for approving the import and putting into circulation of unmarked drugs, as well as the procedure for the activities of the interdepartmental commission under the Federal Service for Surveillance in Healthcare for the issuance of approvals for the circulation of the medicinal product.
In particular, the approval form for the import into the Russian Federation, the introduction into civil circulation of the medicinal product, approved by order of the Federal Service for Surveillance in Healthcare N 5645 dated July 3, 2020, contains information on the date and number of the relevant decision by the interagency commission, information on the registration certificate the medicinal product, its name, and place of manufacture, as well as the holder of the registration certificate or manufacturer. This consent must contain information on the period of its validity.
By the decree of the Federal Service for Surveillance in Healthcare dated July 3, 2020 N 5645, the regulation on the interdepartmental commission was approved, which makes the appropriate decision on the possibility/impossibility of issuing an approval, according to which such a commission includes the chairman, executive secretary and members of the commission. The functioning of the commission is carried out in the composition of at least 10 people.
Decisions are made by the commission at meetings competent with at least half of the composition approved by the head of Federal Service for Surveillance in Healthcare. Decisions are made by a simple majority vote. One member of the commission has one vote. Meetings of the interdepartmental commission are held as needed.
When deciding on the possibility (impossibility) of issuing an agreement, the interdepartmental commission takes into account the proposals of experts, expert organizations, which it has the right to involve if necessary.
Also, the commission is empowered to change the number of units of a medicinal product declared for obtaining approval, as well as to hear explanations from applicants and collect other information necessary for making a decision.
A decision on the possibility of issuing an approval is carried out if the holder or owner of the registration certificate has taken measures to ensure the application of identification means on medicinal products (registration in the federal state system for monitoring the movement of medicinal products, the conclusion of contracts for the supply and installation of equipment for applying identification means, as well as contracts for the development of software for information interaction with the monitoring system. Also, the applicant must provide justifications for the impossibility of applying identification means to the medicinal product and develop an action plan for the implementation of the monitoring system with the obligatory designation of the date of such implementation.
Expectedly that the decree, concretized by the Federal Service for Surveillance in Healthcare, will expand the possibilities of putting drugs into circulation until the beginning of 2021.
September 2, 2020
Associate of BRACE Law Firm ©
Anna Ivanova
