Vaccines, Blood & Biologics

FDA Forms: Certificates for Exporting

The Division of Case Management (DCM) within CBER's Office of Compliance and Biologics Quality (OCBQ) directs and coordinates CBER's export programs, including review of requests for export of unapproved biological products. You can send questions pertaining to the importation of CBER-regulated products to CBERExportCert@fda.hhs.gov.

We recommend that you submit your certificate requests using CBER's Biologics Export Certification Application and Tracking System (BECATS). You can learn more about BECATS by visiting our Biologics Export Certification Application and Tracking System (BECATS): Questions and Answers webpage. However, we recognize that there may be instances when paper submission is necessary. So, the following table provides FDA Forms required for the exportation of FDA-regulated products. If your PDF form is not working, you may need to upgrade your software to a newer version of Adobe Reader. Adobe Reader can be downloaded for Free at http://get.adobe.com/reader/.

To learn more about each form, visit our Description of FDA Forms for Export Certification webpage. To learn more about how to complete these forms, visit our How to Complete FDA Forms for Export Certification webpage.

Form Date Food and Drug Administration Forms Format Contact Info
3613 03/2012 Supplementary Information Certificate to Foreign Government Requests (PDF - 506KB)

You may contact CBER’s Import/Export Team via email at CBERExportCert@fda.hhs.gov
Or
by phone at 301-827-6201

3613a 03/2012 Supplementary Information Certificate of Exportability Requests (PDF - 527KB)
3613b 03/2012 Supplementary Information Certificate of a Pharmaceutical Product (PDF - 585KB)
3613c 03/2012 Supplementary Information Non-Clinical Research Use Only Certificate (PDF - 467KB)

Page Last Updated: 03/30/2015
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