CBER Export Certification
Submission Requirements for Requesting Certificates for Exporting Products to Foreign Countries
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- General Instructions
- Guidance
- Guidance for Industry - FDA Export Certificates
- Guidance for Industry - Exports Under the FDA Export Reform and Enhancement Act of 1996
- FDA Forms Distribution Page for CBER
- Certificate to Foreign Government Requests (PDF - 201 KB)
- Certificate to Foreign Government Requests (Word)
- Certificate of Exportability Requests (PDF - 403 KB)
- Certificate of Exportability Requests (Word)Certificate of a Pharmaceutical Product (PDF - 328 KB)
- Certificate of a Pharmaceutical Product (Word)
- Non-clinical Research Use Only Certificate (PDF - 311 KB)
- Non-clinical Research Use Only Certificate (Word)
For information on export certificates for Devices regulated by the Center for Devices Radiological Health (CDRH), contact CDRH, Division of Program Operations (HFZ-307), 9200 Corporate Boulevard, Rockville, MD 20850 at (240) 276-0132.
For information on export certificates for Drugs regulated by the Center for Drugs Evaluation and Research (CDER), contact CDER, Division of Manufacturing Quality (HFD-321), 10903 New Hampshire Avenue., W051, Silver Spring, MD 20993 at (301) 796-3217.
For information on export certificates for Drugs regulated by the Center for Veterinary Medicine (CVM), contact CVM, Division of Compliance (HFV-235), 7519 Standish Place, Rockville, MD 20855 at (301) 276-9212.