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Colombia

Clinical Trial Application	Colombia Clinical Trial Quote Request
Mandated Coverage	Yes
Standard Limits	n/a
Tail Coverage	n/a
Data Required to Quote	• Clinical Trial Quote Request • Protocol and Informed Consent Form in English • Protocol Title in Spanish • Local Legal Representative details (Contact Person Name, Telephone Number and E-mail Address) • Site List required in Spanish if a generic statement that all sites are covered by the policy is insufficient for the EC - Note that Colombian tax is 16%. There is currently no mechanism set up in Colombia for payment of taxes on non-admitted business - The carrier would evidence the tax on the policy, however they would not collect this so the Sponsor needs to be aware that this may become payable in the future

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