Poland

Poland

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

Belarus

Belarus

Clinical Trial Application

Belarus Clinical Trial Quote Request

Clinical Trials Quote Request

Mandated Coverage

Yes. Only one state insurance carrier in Belarus.

Standard Limits

20.000 €/patient
Limit per protocol = 20.000 x number of patients

Tail Coverage

n/a

Data Required to Quote

• Clinical Trial Quote Request
• LAST Protocol and Informed Consent Form in Russian
• Patient Information Sheet in Russian
• Investigator Brochure in Russian
• Local CRO details (Contact Person Name, Address, Telephone Number and E-Mail Address)
• Sponsor Banking Details or Premium Wire Confirmation
• Three (3) years of claims history for harm caused or reimbursement of injured parties while carrying out clinical studies in Belarus. If no claims, please provide the following on your company letterhead, signed and dated: "We confirm that in the last three years (name of Sponsor) did not incur any claims related to clinical trials."
• Site List of clinical sites in Belarus, if the MoH approval letter is unavailable

Please allow additional time for processing. Typically up to 3 weeks for issuance of documents

Belarus requires payment and payment confirmation documentation PRIOR to release of certificate. No refund for policy cancellation. A letter of guarantee can be provided in order to obtain the necessary MoH approval.