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

Saudi Arabia

Saudi Arabia

Clinical Trial Application

Saudi Arabia Clinical Trial Quote Request

Clinical Trials Quote Request

Mandated Coverage


Yes

SFDA Regulations & Requirements for Conducting Clinical Trials on Drugs specifies Subjects Insurance is required for Phase II & III, but not Phase IV studies. There is no mention about Phase 0 or 1 studies, so it is unclear if these studies are permitted in Saudi Arabia or not. Please confirm with your CRO or Ethics Committee.

Standard Limits

n/a

Tail Coverage

n/a

Data Required to Quote

THE PROCESS TO ISSUE DOCUMENTS IS SLOW. PLEASE ALLOW ENOUGH TIME AS WE ARE NOT ABLE TO EXPEDITE DOCUMENTS. It is very SLOW due to the intermediaries involved. Submission should be made to Newfront at least one month before documents are required.

Please note that only a Policy is provided. Certificates are not provided for Saudi Arabia.

• Clinical Trial Quote Request
• Protocol and Informed Consent Form in English
• Local CRO/Legal Representative details (Contact Person Name, Address, Telephone Number and E-Mail Address)

The Local CRO/Legal Representative must provide the following documents:
• Letter of Appointment issued by the Local CRO/Legal Representative in Saudi Arabia addressed to Saudi broker
• Commercial Registration (CR) with the Saudi Chamber of Commerce
• National Address Registration (NAR) by logging into https://address.gov.sa/sa/ar/
to register the national address in Saudi Arabia
• VAT Certificate
• Complete a "Know Your Client (KYC)" application form - to be provided separately by Newfront
• Copy of Passport/ID of Local CRO/Legal Representative