Medical items being exported from the US to Russia, Belarus, and occupied regions of Ukraine may require an export license. The sanctions set forth under Sections 746.5, 746.6, 746.8, and 746.10 of the Export Administration Regulations (15 CFR Parts 730-774, “EAR”) are designed to include the prohibition of medical item exports that support military involvement in the ongoing conflict in Ukraine. There is a policy of denial for The Ministries of Defense of both the Russian Federation and Belarus. However, license applications for health and safety, medical, and humanitarian items destined for civilian facilities are reviewed and may be approved on a case-by-case basis.

You will need to consider these 8 things for your application for these types of items.

1. Accurate HTS Classifications.
2. Confirm if the item is controlled by the HS and where in the EAR this is referenced.
3. Include only quantities that will be used over not more than 1 year.
4. Certification that the exported product(s) are for civilians in a civilian facility.
5. What roles other parties play that don’t provide direct patient care.
6. Technical description of the product(s).
7. Include a narrative of how the item is used in direct patient care.
8. Scope the license to minimize potential diversion.

Successful license applications are those that confirm that the items are for direct patient care for civilian use only and are not directly or indirectly to be utilized for the benefit of the Russian or Belarusian governments or defense sectors, including battlefield casualty treatment. BIS will analyze the proposed scope of the transactions before referring the application for interagency review consistent with Executive Order 12981.

Given the nuance of these license requirements, BIS has published further guidance for exporters on how to manage these applications.

Applications must be accurate, complete, and thoughtfully prepared to be approved.

Contact our Export Advisory Group for assistance.