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Bulgaria

Clinical Trial Application	Bulgaria Clinical Trial Quote Request Clinical Trials Quote Request
Mandated Coverage	Yes
Standard Limits	50.000 BGN/patient 1.000.000 BGN/protocol
Tail Coverage	1 year
Data Required to Quote	• Clinical Trial Quote Request • Protocol and Informed Consent Form in English • Protocol Title in Bulgarian • Site List in Bulgarian and English, inclusive of Full Name(s) of Principal Investigator(s), the Hospital(s)/Site Location(s) Address(es) with Area Code • Local CRO details (Contact Person Name, Address, Telephone Number and E-Mail Address) Once coverage is bound and Policy documents are issued to the Sponsor, Sponsor must review for accuracy, sign and then mail original wet-inked documents to the carrier. Carrier will countersign and send to Local CRO along with the Certificates. Newfront will provide the carrier contact information separately for mailing documentation.

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