Decree of the Government of the Russian Federation No. 955, dated June 30, 2020, approved the specific procedures for introducing medicinal products for medical use into commercial circulation until January 1, 2021.

The specified document establishes that the market introduction and importation of medicinal products for medical use manufactured between July 1, 2020, and October 1, 2020, without identification marks, require prior import approval into the Russian Federation from the Federal Service for Surveillance in Healthcare (Roszdravnadzor).

To obtain approval, the applicant (either the manufacturer or the marketing authorization holder) must electronically submit an application through the Roszdravnadzor information system, attaching the following documents:

• evidence confirming the applicant's authority;

• a detailed justification concerning the impossibility of applying identification marks to the packaging of the medicinal product;

• copies of agreements for the supply and installation of serialization tracking equipment at each manufacturing site specified in the application;

• an action plan for implementing the monitoring system, specifying the final target date of the manufacturer's readiness to apply identification marks.

Such approval remains valid for a period of 45 days.

An interdepartmental commission responsible for issuing drug circulation approvals under Roszdravnadzor renders decisions regarding the approval to introduce a medicinal product into circulation. Roszdravnadzor publishes information on the issued approvals within one business day on its official website in the form of an approval registry.

On July 3 of the current year, pursuant to the requirements of the aforementioned Russian Government Decree, Roszdravnadzor approved both the approval form for the importation and market introduction of unlabeled medicinal products and the operational guidelines for the interdepartmental commission under the Federal Service for Surveillance in Healthcare tasked with issuing approvals for the circulation of medicinal products.

Specifically, the approval form for importing a medicinal product into the Russian Federation and introducing it into commercial circulation, approved by Roszdravnadzor Order No. 5645 dated July 3, 2020, contains details regarding the date and reference number of the corresponding decision made by the interdepartmental commission, information on the marketing authorization of the medicinal product, its name and manufacturing site, as well as the marketing authorization holder or manufacturer. This approval must explicitly state its validity period.

Roszdravnadzor Order No. 5645 dated July 3, 2020, also approved the regulations governing the interdepartmental commission that determines the feasibility or infeasibility of issuing approvals. Pursuant to these regulations, the commission comprises a chairperson, an executive secretary, and commission members. The commission must maintain a functional composition of no fewer than 10 individuals.

The commission adopts decisions during sessions that achieve a legal quorum when at least half of the total membership approved by the Head of Roszdravnadzor is present. The commission passes resolutions by a simple majority vote, allocating one vote per commission member. The interdepartmental commission convenes sessions on an as-needed basis.

When evaluating the feasibility or infeasibility of issuing an approval, the interdepartmental commission takes into account proposals from independent experts and expert organizations, which it retains the right to engage as necessary.

Furthermore, the regulations vest the commission with the authority to modify the quantity of medicinal product units requested in the application for approval, to hear oral testimonies and clarifications from applicants, and to collect any other information requisite for rendering its final decision.

The commission issues a favorable decision on granting approval provided that the marketing authorization holder or owner has implemented measures to ensure the application of identification marks to the medicinal products. Such measures encompass registration in the federal state system for monitoring the movement of medicinal products, execution of contracts for the supply and installation of serialization tracking equipment, and execution of software development contracts to facilitate information exchange with the monitoring system. Additionally, the applicant must supply clear justifications regarding the current impossibility of applying identification marks to the medicinal product and formulate an action plan for integrating the monitoring system, explicitly defining the target implementation date.

We anticipate that these regulatory innovations introduced by the Russian Government and further specified by Roszdravnadzor will expand the strategic pathways for introducing medicinal products into commercial circulation during the transitional period leading up to the beginning of 2021.