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

Poland

Poland

Clinical Trial Application

Poland Clinical Trial Quote Request

Clinical Trials Quote Request

Mandated Coverage

Yes

Standard Limits

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

Tail Coverage

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

Data Required to Quote

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

Only a Policy is issued for Poland