CBER Export Certification

Submission Requirements for Requesting Certificates for Exporting Products to Foreign Countries

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• General Instructions
• 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)

• Use of new paper to deter falsification of or tampering with FDA-issued export certificates
  • Letter to Export Certificate Requester - 1/1/1999 (PDF, 38 KB)
  • Letter to Export Certificate Requester - 1/1/1999 (Text)

For information on export certificates for Devices regulated by the Center for Devices Radiological Health (CDRH), contact CDRH, Division of Program Operations (HFZ-305), 2094 Gaither Road, Rockville, MD 20850 at (301)594-4699.

For information on export certificates for Drugs regulated by the Center for Drugs Evaluation and Research (CDER), contact CDER, Division of Labeling and Nonprescription Drug Compliance (HFD-310), 7520 Standish Place, Rockville, MD 20855-2737 at (301) 594-0063.