Colombia

Colombia

Colombia

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

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.