Switzerland

Clinical Trial Application	Switzerland Clinical Trial Quote Request Clinical Trials Quote Request
Mandated Coverage	Yes
Standard Limits	CHF 10,000,000 CHF 1,000,000 Per Patient
Tail Coverage	20 years
Data Required to Quote	• Clinical Trial Quote Request • Protocol and Informed Consent Form in English • Protocol Title in German, French or Italian • Legal Representative Details of Sponsor (Contact Person Name, Address, Telephone Number and E-Mail Address) in Switzerland are are now required unless your CRO states this is NOT a requirement for your study. - Switzerland has always required non-Swiss sponsored studies to have engaged a Swiss-based legal representative, but most Sponsors have not been required to comply in recent years. - Due to current demands for the Legal Representative to be shown, please check with your CRO PRIOR to binding coverage. - Swiss Ethics have released certificate/policy templates that must be followed. As part of this new format, Swiss Ethics require that the Insurers include in all policies the classification of the medicinal product i.e. Category A, B or C. - Insurers do not hold descriptions for each class and cannot provide any advice on how a trial should be categorized. - Categorization is considered to be a technical, medical and scientific decision, and if in any doubt over which category the trial should fall into, the Sponsor should seek advice from the Ethics Committees in such cases

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.