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Balkans-Related Sanctions

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Balkans-Related Sanctions

1140. In light of the designation of Orka Holding, are U.S. persons authorized to engage in transactions related to the provision of medicine, medical devices, and medical services involving Orka Holding and its subsidiaries?

Yes.  As a general matter, humanitarian trade is not the target of U.S. sanctions.  Concurrent with the designation of Orka Holding AD, OFAC issued Western Balkans General License (GL) 3, which authorizes all transactions involving Orka Holding AD related to:  (1) the production, manufacturing, sale, transport, or provision of agricultural commodities, agricultural equipment, medicine, medical devices, replacement parts and components for medical devices, or software updates for medical devices; (2) the prevention, diagnosis, or treatment of any disease or medical condition; or (3) the conducting of clinical trials or other medical research.  Importantly, the authorization also applies to any entity in which Orka Holding AD owns, directly or indirectly, individually or in the aggregate, a 50 percent or greater interest.

Non-U.S. persons generally do not risk exposure to sanctions for engaging in transactions with blocked persons where those transactions would not require a specific license if engaged in by a U.S. person.  As such, non-U.S. persons generally would not face sanctions risk for engaging in activities authorized for U.S. persons by Western Balkans GL 3.

Released on November 16, 2023