Netherlands

Netherlands Clinical Trial Quote Request

Clinical Trials Quote Request

Yes. www.ccmo.nl/en/insurance

450.000 €/patient
3.500.000 €/protocol

Effective July 1, 2015, new limits required are:
650.000 €/patient
5.000.000 €/protocol

4 years from the end of patient treatment

• 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

Belarus Clinical Trial Quote Request

Clinical Trials Quote Request

Yes. Only one state insurance carrier in Belarus.

20.000 €/patient
Limit per protocol = 20.000 x number of patients

n/a

• Clinical Trial Quote Request
• LAST Protocol and Informed Consent Form in Russian
• Patient Information Sheet in Russian
• Investigator Brochure in Russian
• Local CRO details (Contact Person Name, Address, Telephone Number and E-Mail Address)
• Sponsor Banking Details or Premium Wire Confirmation
• Three (3) years of claims history for harm caused or reimbursement of injured parties while carrying out clinical studies in Belarus. If no claims, please provide the following on your company letterhead, signed and dated: "We confirm that in the last three years (name of Sponsor) did not incur any claims related to clinical trials."
• Site List of clinical sites in Belarus, if the MoH approval letter is unavailable

Please allow additional time for processing. Typically up to 3 weeks for issuance of documents

Belarus requires payment and payment confirmation documentation PRIOR to release of certificate. No refund for policy cancellation. A letter of guarantee can be provided in order to obtain the necessary MoH approval.