On November 2, 2015, the U.S. Treasury Department's Office of Foreign Assets Control ("OFAC") announced an expansion of the List of Medical Supplies (“List”) eligible for export or reexport to Iran under the general license at Section 560.530(a)(3) of the Iranian Transactions and Sanctions Regulations (“ITSR”), 31 CFR Part 560.
ITSR § 560.530 sets forth a policy of permitting the export and reexport to Iran of certain EAR99 agricultural commodities, medicines and medical devices either by general or specific license. The general license in § 560.530(a)(3) authorizes “covered persons” to export or reexport EAR99 “medical supplies” identified in the List to the Government of Iran or any individual or entity in Iran (or person in a third country purchasing for resale to any of the foregoing) and to engage in related transactions such as shipping, insurance, financing, receipt of payment, and entry into contracts (including executory contracts), provided certain requirements are satisfied.
The definition of a “covered person” depends upon whether the item is subject to the jurisdiction of the U.S. Export Administration Regulations (“EAR”), 15 CFR Part 730 et seq. For items subject to the EAR, a covered person is any person (U.S. or non-U.S. person), wherever located globally. For items not subject to the EAR, a covered person is any U.S. person (i.e., any entity established under U.S. law and its non-U.S. branches, any U.S. citizen or green card holder wherever located or employed, and any person physically in the United States) as well as any non-U.S. entity owned or controlled by a U.S. person.
OFAC’s action has added a large number of new entries to the List, especially items related to cardiology, obstetrics and maternity care, and radiology. A new category of Inherited Preventative Care items (which includes genetic testing products) was also added.
Covered persons interested in supplying products to Iran under the general license for EAR99 “medical supplies” should (i) review the List to confirm whether the products are described therein, and (ii) review the transaction to confirm that it would satisfy the requirements for use of the general license, which are set forth in the regulations.