The Ministry of Health of the Russian Federation has developed a draft order amending the list of diseases, medical conditions, and corresponding medicinal products containing narcotic drugs or psychotropic substances permitted for import into the Russian Federation to provide life-saving medical care to specific patients or patient groups (originally approved by Order of the Ministry of Health of the Russian Federation No. 80n dated February 13, 2020).

The draft regulation proposes to repeal Government Decree of the Russian Federation No. 278 dated March 16, 1996, "On the Procedure for the Import into the Russian Federation and Export from the Russian Federation of Potent and Toxic Substances That Are Not Precursors of Narcotic Drugs and Psychotropic Substances."

Under the draft framework, importers must obtain an electronic license issued by the Ministry of Industry and Trade (Minpromtorg), authenticated via an enhanced electronic signature, to import these substances.

To secure a license through the Federal State Information System "Unified Portal of State and Municipal Services (Functions)" or the "Single Window" information system, applicants must submit the following documents and information in electronic form:

• A completed license application;
• A copy of the foreign trade agreement (contract), including any appendices and/or amendments thereto (for a single-transaction license), or, in the absence of a formal foreign trade agreement, a copy of another document confirming the parties' intent;
• Proof of tax registration or corporate state registration.

The regulatory authorities may refuse to issue a license on the following grounds:

• The inclusion of incomplete or inaccurate data within the application materials submitted by the applicant;
• The termination or suspension of one or more foundational documents required for license issuance;
• Potential violations of the international obligations of Eurasian Economic Union (EAEU) member states resulting from the execution of the underlying contract;
• The exhaustion, absence, or depletion of applicable volume or tariff quotas (for quota-controlled goods).

If an applicant modifies its corporate governance documents (such as altering its legal structure, corporate name, or registered address) or if an individual applicant changes their passport data, the licensee must promptly request the termination of the current license and apply for a new one, enclosing an application and documentation confirming the relevant modifications.

Crucially, the regulatory authority retains the right to suspend or terminate a license under the following circumstances:

• An electronic request submitted directly by the licensee;
• Unreported amendments to the corporate governance documents of a legal entity or changes to an individual applicant's passport data;
• The discovery of falsified or inaccurate information within the initial application materials;
• The termination or suspension of one or more underlying documents upon which the license was granted;
• A breach of the international obligations of an EAEU member state during the execution of the underlying contract;
• The revocation of a business license for activities directly linked to the turnover of the regulated goods;
• The identification of regulatory errors or non-compliance during the issuance process that would have otherwise barred approval;
• Failure by the licensee to comply with the licensing conditions stipulated by international treaties or EAEU member state regulations;
• The issuance of a binding judicial decree or court order.

The regulatory authority may reinstate a suspended license once the licensee remedies the non-compliance that triggered the suspension. However, a license suspension does not constitute grounds for extending the overall validity period of the license.