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U.S. Department of Health and Human Services

International Programs

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Export Certificates

The Federal Food, Drug, & Cosmetic Act (FD&C Act) provides certain obligations for FDA with regard to the issuance of export certificates for FDA-regulated products. This page contains information and links to guidance documents and other resources relating to implementation of these obligations.

General Guidance:
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm125822.pdf
FDA Export Certificates: Guidance for Industry - FDA Export Certificates

 

For the export of Food :
http://www.fda.gov/Food/InternationalActivities/Exports/default.htm

 

For the export of Biologics
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/
ComplianceActivities/BiologicsImportingExporting/ucm228593.htm

 

General information on CDER Small Business and Industry Assistance (CDER SBIA): Import and Export of Human Drugs and Biologics
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm052787.htm