Australia

Clinical Trial Application	Australia Clinical Trial Quote Request
Mandated Coverage	No, but is typically preferred by EC
Standard Limits	AUD 10M or AUD 20M depending on territory where study is taking place. PLEASE CONFIRM WITH YOUR CRO for limit required
Tail Coverage	12 months but 72 months in respect of Western Australia and/or Queensland.
Data Required to Quote	• Clinical Trial Quote Request • Protocol and Informed Consent Form in English • Local CRO or Institution name (Contact Person Name, Address, Telephone Number and E-Mail Address) • Local CRO GST (Goods and Services Tax) Number. ABN (Australian Business Number) is also sufficient If Sponsor has a local entity to be listed without the Local CRO on policy, a Goods & Services Tax (GST) will be required for the local sponsor entity. If none available, there is a tax implication. The same trial in New Zealand can be added to this policy for additional premium. Please check with your CRO beforehand to advise if a shared policy is acceptable.

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.