Colombia

Colombia

Colombia

Colombia

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

Netherlands

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