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

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.