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	Nigeria Clinical Trial Quote Request Clinical Trials Quote Request
Mandated Coverage	Yes. It is recommended that Sponsor use an experienced or local CRO in Nigeria
Standard Limits	n/a
Tail Coverage	n/a
Data Required to Quote	Process is SLOW in Nigeria. Please allow for additional time. Submission should be made at least one month before documents are required • Clinical Trial Quote Request • Protocol and Informed Consent Form in English • Local CRO details (Contact Person Name, Address, Telephone Number and E-mail Address) • Completed, signed and dated Clinical Trial Proposal form (To be provided separately) • Provide completed Anti-Money Laundering document which is required (To be provided separately) - Regulatory Approval (RA) from the National Agency for Food & Drugs Administration and Control (NAFDAC), which can be provided after release of the policy documents, but is absolutely required unless the Sponsor does not have approval at the time of submission - Nigeria requires a local quotation so the premium will be subject to change by the local Nigerian office - Nigeria is a cash before cover country, which means Policy documents only released after premium payment received by the carrier; Sponsor pays the Carrier directly once invoice is provided and Carrier will confirm receipt of funds - No refunds for policy cancellation