Croatia

Clinical Trial Application	Croatia Clinical Trial Quote Request Clinical Trials Quote Request
Mandated Coverage	Yes, but conditions are not defined by the local law
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 Croatian • Site List in Croatian and English, inclusive of Full Name(s) of Principal Investigator(s), the Hospital(s)/Site Location(s) Address(es) with Area Code • Local CRO details (Contact Person Name, Address, Telephone Number and E-Mail Address) - Policy and Certificate to be countersigned by Sponsor and carrier will deliver to local CRO

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