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	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