France

Clinical Trial Application	France Clinical Trial Quote Request Clinical Trials Quote Request
Mandated Coverage	Yes
Standard Limits	1.000.000 €/patient 6.000.000 €/protocol 10.000.000 €/year
Tail Coverage	10 years
Data Required to Quote	• Clinical Trial Quote Request • Protocol and Informed Consent Form in English • Protocol Title in French • Site List in English, inclusive of Full Name(s) of Principal Investigator(s), the Hospital(s)/Site Location(s) Address(es) with Area Code. This information is for the carrier files only. Will not be listed on the policy documents. • Local CRO or EU Representative details (Contact Person Name and Telephone Number). Will be referenced on the Policy declaration page and the Certificate • Provide EudraCT Number for Drug studies or EUDAMED No. for Medical Device studies, if not already included in Protocol

Clinical Trial Application	n/a
Mandated Coverage	Yes
Standard Limits	USD 2,000,000
Tail Coverage	12 months
Data Required to Quote	• Clinical Trial Quote Request • Protocol and Informed Consent Form • Local CRO/Legal Representative details (Contact Person Name, Address, Telephone Number and E-Mail Address) o Legal Representative details of the Sponsor in UAE to include authenticated documents proving ownership e.g. complete T/L, Share Certificate, Share Register, MOA, AOA, Annual Report, Ownership Chart etc. The document must clearly show the ownership % or holding shares and if there is any entity in the ownership pattern who holds >25% shareholding, futher ownership docs are required until the natural person with owning or controlling interests of >25% are identified. o Completed KYC AML form