Nigeria

Clinical Trial Application	Nigeria Clinical Trial Quote Request Clinical Trials Quote Request
Mandated Coverage	Yes. It is recommended that Sponsor use an experienced or local CRO in Nigeria
Standard Limits	n/a
Tail Coverage	n/a
Data Required to Quote	Process is SLOW in Nigeria. Please allow for additional time. Submission should be made at least one month before documents are required • Clinical Trial Quote Request • Protocol and Informed Consent Form in English • Local CRO details (Contact Person Name, Address, Telephone Number and E-mail Address) • Completed, signed and dated Clinical Trial Proposal form (To be provided separately) • Provide completed Anti-Money Laundering document which is required (To be provided separately) - Regulatory Approval (RA) from the National Agency for Food & Drugs Administration and Control (NAFDAC), which can be provided after release of the policy documents, but is absolutely required unless the Sponsor does not have approval at the time of submission - Nigeria requires a local quotation so the premium will be subject to change by the local Nigerian office - Nigeria is a cash before cover country, which means Policy documents only released after premium payment received by the carrier; Sponsor pays the Carrier directly once invoice is provided and Carrier will confirm receipt of funds - No refunds for policy cancellation

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.