Netherlands

Netherlands Clinical Trial Quote Request

Clinical Trials Quote Request

Yes. www.ccmo.nl/en/insurance

450.000 €/patient
3.500.000 €/protocol

Effective July 1, 2015, new limits required are:
650.000 €/patient
5.000.000 €/protocol

4 years from the end of patient treatment

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

- There are TWO insurance requirements.
- Local admitted clinical trial insurance satisfies the G1 patient indemnity insurance requirement according to WMO
- The G2 is the liability insurance of Sponsor, which can be covered via a global product liability policy
- Therefore to satisfy G2, if the Sponsor has a Master Product Liability policy through Newfront, Newfront can provide a certificate

Mexico Clinical Trial Quote Request

Yes

n/a

n/a

THE PROCESS IN MEXICO IS SLOW. PLEASE ALLOW UP TO TWO MONTHS FOR DOCUMENTS TO BE PROCESSED. Please provide all documentation outlined below otherwise the process is further delayed.

PLEASE PROVIDE THE FOLLOWING INFORMATION
• Clinical Trial Quote Request
• Protocol and Informed Consent Form in English and Spanish
• Protocol Title in Spanish
• The following documents to be provided by the Sponsor:
(i) Copy ID of the legal representative of the Sponsor (this should be the same as the person completing the form)
(ii) Proof of address of the sponsor (not older than 3 months)
(iii) Document confirming the legal establishment of the sponsor --->
Legal representative details of the Sponsor in Mexico
Note the Legal Representative will be responsible for providing the following documents:
(i) Copy of the Memorandum of Association registered upon the Property & Commerce Public registry
(ii) Copy of the Fiscal Identification Schedule (RFC)
(iii) Copy of an Official Identification and Notary’s Testimony of the local CRO
(iv) Copy of a Domicile Voucher