Russian Government Resolution 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 stipulates that the market entry and importation of medicinal products for medical use manufactured between July 1, 2020, and October 1, 2020, without identification markings, require prior regulatory approval for import into the Russian Federation from the Federal Service for Surveillance in Healthcare (Roszdravnadzor).

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

• Evidence confirming the applicant’s authority;

• A formal justification detailing the inability to apply identification markings to the product packaging;

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

• An action plan for implementing the tracking system, specifying the final date by which the manufacturer will achieve readiness to apply the unique identifiers.

Such regulatory approval shall remain valid for a period of 45 days.

The Interdepartmental Commission for Issuing Approvals for the Circulation of Medicinal Products under Roszdravnadzor renders the decision to approve the commercial launch of a pharmaceutical product. Roszdravnadzor publishes information on granted 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 Resolution, Roszdravnadzor approved both the official approval form for importing and introducing unmarked medicinal products into circulation and the operational guidelines for the Interdepartmental Commission under the Federal Service for Surveillance in Healthcare regarding the issuance of product circulation approvals.

Specifically, the approval form for importation into the Russian Federation and introduction into commercial circulation—ratified by Roszdravnadzor Order No. 5645 dated July 3, 2020—discloses the date and reference number of the relevant Interdepartmental Commission decision, marketing authorization data, the product name, manufacturing site details, and information regarding the marketing authorization holder or manufacturer. This approval document must explicitly state its expiration date.

Roszdravnadzor Order No. 5645 dated July 3, 2020 also approved the regulations governing the Interdepartmental Commission that evaluates the feasibility of issuing or denying approvals. According to these regulations, the commission comprises a chairperson, an executive secretary, and commission members, requiring a minimum panel of 10 individuals to function.

The commission adopts decisions during sessions that achieve a quorum of at least half of the total membership approved by the Head of Roszdravnadzor. The body passes resolutions via a simple majority vote, with each member holding one vote. The Interdepartmental Commission convenes sessions on an as-needed basis.

In assessing whether to grant or deny an approval, the Interdepartmental Commission considers proposals from independent experts and expert organizations, which it retains the authority to engage as necessary.

Furthermore, the regulations empower the commission to modify the quantity of pharmaceutical units requested in the application, hear testimonies from applicants, and collect any additional information required to reach a determination.

The commission will issue a favorable decision if the marketing authorization holder or owner has implemented measures to ensure the eventual serialization of the medicinal products. Such measures include registering with the federal state system for monitoring the movement of medicinal products (MDLP), executing contracts for the supply and installation of serialization equipment, and entering into software development agreements for data integration with the monitoring system. Additionally, the applicant must submit a justification for the current inability to apply unique identifiers and devise an action plan for tracking system integration, explicitly defining the target deployment date.

We anticipate that these regulatory updates introduced by the Russian Government and further detailed by Roszdravnadzor will expand the avenues for pharmaceutical market entry through the beginning of 2021.