Netherlands

Netherlands

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

Belgium

Belgium

Clinical Trial Application

Belgium Clinical Trial Quote Request

Clinical Trials Quote Request

Mandated Coverage

Yes

Standard Limits

Between 400.000 and 600.000 €/patient
Between 3.000.000 and 5.000.000 €/protocol

Tail Coverage

3 years

Data Required to Quote

• Clinical Trial Quote Request
• Protocol and Informed Consent Form in English
• Protocol Title in French
• Local EU Representative details (Contact Person Name, Address, Telephone Number and E-Mail Address). Not required if Sponsor is domiciled in the EU.