Mexico

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

France Clinical Trial Quote Request

Clinical Trials Quote Request

Yes

1.000.000 €/patient
6.000.000 €/protocol
10.000.000 €/year

10 years

• Clinical Trial Quote Request
• Protocol and Informed Consent Form in English
• Protocol Title in French
• Site List in English, inclusive of Full Name(s) of Principal Investigator(s), the Hospital(s)/Site Location(s) Address(es) with Area Code. This information is for the carrier files only. Will not be listed on the policy documents.
• Local CRO or EU Representative details (Contact Person Name and Telephone Number). Will be referenced on the Policy declaration page and the Certificate
• Provide EudraCT Number for Drug studies or EUDAMED No. for Medical Device studies, if not already included in Protocol