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.

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