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Section 1: Requester Information
Section 2: Foreign Site Information
Section 3: Product(s) Information
Product Name and DIN (Drug Identification Number):
Dosage Form Class
Sterile (Yes No)
Section 4: Reason for request
Section 5: Site Reference File
Site Reference File available? (Yes No)
Section 6: Confirmation
Has as inspection been conducted, within the last three years, by a Qualified or Regulatory Authority, as defined in the document Guidance on Evidence to Demonstrate Drug Compliance for Foreign Sites, which covered the activity(ies) and dosage form(s) requested at the aforementioned foreign site? (Yes No)
If so, by whom was it conducted?
Name of Authorized Signing Official