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	Bulgaria Clinical Trial Quote Request Clinical Trials Quote Request
Mandated Coverage	Yes
Standard Limits	50.000 BGN/patient 1.000.000 BGN/protocol
Tail Coverage	1 year
Data Required to Quote	• Clinical Trial Quote Request • Protocol and Informed Consent Form in English • Protocol Title in Bulgarian • Site List in Bulgarian 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) Once coverage is bound and Policy documents are issued to the Sponsor, Sponsor must review for accuracy, sign and then mail original wet-inked documents to the carrier. Carrier will countersign and send to Local CRO along with the Certificates. Newfront will provide the carrier contact information separately for mailing documentation.