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

Poland Clinical Trial Quote Request

Clinical Trials Quote Request

Yes

FOR DRUG STUDIES
2.000.000 € up to 50 patients
5.000.000 € more than 50 patients

FOR MEDICAL DEVICE STUDIES
50.000 € for up to 10 patients
100.000 € for 11 to 25 patients
200.000 € for 26 to 50 patients
400.000 € for 52 to 100 patients
500.000 € for more than 100 patients

FOR OTHER STUDIES
Clinical trials which are not regulated by local law
OPTION A
5.000.000 PLN/protocol
500.000 PLN/patient
OPTION B
10.000.000 PLN/protocol
1.000.000 PLN/patient

10 years maximum after the event causing the injury
3 years after the patient is aware of his problem

• Clinical Trial Quote Request
• Protocol and Informed Consent Form in English
• Protocol Title in Polish

Only a Policy is issued for Poland