Nigeria

Clinical Trial Application	Nigeria Clinical Trial Quote Request Clinical Trials Quote Request
Mandated Coverage	Yes. It is recommended that Sponsor use an experienced or local CRO in Nigeria
Standard Limits	n/a
Tail Coverage	n/a
Data Required to Quote	Process is SLOW in Nigeria. Please allow for additional time. Submission should be made at least one month before documents are required • Clinical Trial Quote Request • Protocol and Informed Consent Form in English • Local CRO details (Contact Person Name, Address, Telephone Number and E-mail Address) • Completed, signed and dated Clinical Trial Proposal form (To be provided separately) • Provide completed Anti-Money Laundering document which is required (To be provided separately) - Regulatory Approval (RA) from the National Agency for Food & Drugs Administration and Control (NAFDAC), which can be provided after release of the policy documents, but is absolutely required unless the Sponsor does not have approval at the time of submission - Nigeria requires a local quotation so the premium will be subject to change by the local Nigerian office - Nigeria is a cash before cover country, which means Policy documents only released after premium payment received by the carrier; Sponsor pays the Carrier directly once invoice is provided and Carrier will confirm receipt of funds - No refunds for policy cancellation

Clinical Trial Application	Netherlands Clinical Trial Quote Request Clinical Trials Quote Request
Mandated Coverage	Yes. www.ccmo.nl/en/insurance
Standard Limits	450.000 €/patient 3.500.000 €/protocol Effective July 1, 2015, new limits required are: 650.000 €/patient 5.000.000 €/protocol
Tail Coverage	4 years from the end of patient treatment
Data Required to Quote	• Clinical Trial Quote Request • Protocol and Informed Consent Form in English • Protocol Title in Dutch - There are TWO insurance requirements. - Local admitted clinical trial insurance satisfies the G1 patient indemnity insurance requirement according to WMO - The G2 is the liability insurance of Sponsor, which can be covered via a global product liability policy - Therefore to satisfy G2, if the Sponsor has a Master Product Liability policy through Newfront, Newfront can provide a certificate