On July 19, 2023, the Bureau of Industry and Security (“BIS”) in the US Commerce Department published much-anticipated guidance for license applications involving medical-related items destined to Russia, Belarus, and the Occupied/Covered Regions of Ukraine (Crimea, Donetsk People’s Republic, and Luhansk People’s Republic). 

The guidance is just over three pages long, and we recommend that companies submitting applications for medical-related items to these destinations review the document in full.  While BIS has been communicating many of the points made in this guidance informally or in the context of live license applications, this public, more formalized guidance is a welcome development.

The guidance comes on the heels of a significant expansion of licensing requirements under the Export Administration Regulations (“EAR”) on May 19, which targeted exports, reexports, or in-country transfers of broad categories of items to or within Russia or Belarus, including various types of medical devices and other medical-related products (see our blog post here).  This was in addition to pre-existing licensing requirements under the EAR applicable to the supply of certain other types of medical-related items to or within the above-listed destinations.   

The guidance is styled as “best practices” that applicants are “encouraged” to follow, not as instructions or requirements for applications.  That said, BIS states that following the guidance will assist the agencies (BIS and the other agencies involved in the interagency review process) in processing applications more efficiently and expeditiously.  

On the other hand, the realities of commercial transactions and medical supply chains may not always lend themselves to easily following this guidance.  This underscores the importance of clearly explaining those realities in license applications, often in an accompanying letter of explanation.


Ms. Contini focuses her practice on export controls, trade sanctions, and anti-boycott laws. This includes advising US and multinational companies on trade compliance programs, risk assessments, licensing, review of proposed transactions and enforcement matters. Ms. Contini works regularly with companies across a wide range of industries, including the pharmaceutical/medical device, oil and gas, and nuclear sectors.


Ms. Lis has extensive experience advising companies on US laws relating to exports and reexports of commercial goods and technology, defense trade controls and trade sanctions — including licensing, regulatory interpretations, compliance programs and enforcement matters. She also has advised clients on national security reviews of foreign investment administered by the Committee on Foreign Investment in the United States (CFIUS), including CFIUS-related due diligence, risk assessment, and representation before the CFIUS agencies.