Netherlands

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

Clinical Trial Application	Colombia Clinical Trial Quote Request
Mandated Coverage	Yes
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 Spanish • Local Legal Representative details (Contact Person Name, Telephone Number and E-mail Address) • Site List required in Spanish if a generic statement that all sites are covered by the policy is insufficient for the EC - Note that Colombian tax is 16%. There is currently no mechanism set up in Colombia for payment of taxes on non-admitted business - The carrier would evidence the tax on the policy, however they would not collect this so the Sponsor needs to be aware that this may become payable in the future