Cuba

Cuba

Cuba

Cuba

Clinical Trial Application

n/a

Mandated Coverage

OFAC RESTRICTED COUNTRY - NO CLINICAL TRIAL COVERAGE ALLOWED

Significant sanctions remain in respect of Cuba. For example, Group remain subject to a range of financial, export, procurement, and other US sanctions if it:

(i) does business with Cuban or Cuba-related entities or individuals that appear on the US Treasury Department’s List of Specially Designated Nationals and Blocked Persons (known as the “SDN List”);
(ii) does business that involves movement of targeted goods between the US and Cuba.

Therefore the detailed characteristics of each and every transaction must be clearly understood, documented and checked against the full range of financial crime and sanctions tools before any assessment can be made as to whether business can be conducted.

No Group entity domiciled in the US, no US employee, citizen, permanent resident, shareholder, investor, or any other form of US business partner can be involved in any way in undertaking or engaging business with Cuba unless covered by a general license. No items relating to Cuba can be tabled or discussed with any such parties unless covered by a general license. It is Hyperion’s responsibility and, in particular, those undertaking such business transactions, to ensure that this prohibition is maintained.

Standard Limits

n/a

Tail Coverage

n/a

Data Required to Quote

n/a

Belarus

Belarus

Clinical Trial Application

Belarus Clinical Trial Quote Request

Clinical Trials Quote Request

Mandated Coverage

Yes. Only one state insurance carrier in Belarus.

Standard Limits

20.000 €/patient
Limit per protocol = 20.000 x number of patients

Tail Coverage

n/a

Data Required to Quote

• Clinical Trial Quote Request
• LAST Protocol and Informed Consent Form in Russian
• Patient Information Sheet in Russian
• Investigator Brochure in Russian
• Local CRO details (Contact Person Name, Address, Telephone Number and E-Mail Address)
• Sponsor Banking Details or Premium Wire Confirmation
• Three (3) years of claims history for harm caused or reimbursement of injured parties while carrying out clinical studies in Belarus. If no claims, please provide the following on your company letterhead, signed and dated: "We confirm that in the last three years (name of Sponsor) did not incur any claims related to clinical trials."
• Site List of clinical sites in Belarus, if the MoH approval letter is unavailable

Please allow additional time for processing. Typically up to 3 weeks for issuance of documents

Belarus requires payment and payment confirmation documentation PRIOR to release of certificate. No refund for policy cancellation. A letter of guarantee can be provided in order to obtain the necessary MoH approval.