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  3. Guidance, Compliance & Regulatory Information (Biologics)
  4. Compliance Actions (Biologics)
  5. Exporting CBER-Regulated Products
  6. How to Complete FDA Export Certificate Forms
  1. Exporting CBER-Regulated Products

How to Complete FDA Export Certificate Forms

General Instructions for Completing FDA Export Certificate Forms:

FDA/CBER will only issue export certificates for final products that will be exported from the United States. In addition to issuing export certificates for licensed, approved or cleared products, the FDA will also issue export certificates for unapproved products that meet the requirements of Sections 801(e) or 802 of the Act.

On October 1, 1996, CBER was given the authority to charge $175 for the first two certificates and $85 for any subsequent certificates issued for the same product(s) in response to the same certificate request. Please do not submit a check with your request, as FDA will bill you quarterly for issued certificates.

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.

When completing a certificate request in paper format, please type certificate requests or print clearly. In most cases, one product will be listed per certificate. However, products that were licensed, approved or cleared under the same BLA, NDA, PMA or 510(k) application or similar unapproved CBER-regulated products may be listed on the same certificate based on the available space for a one page certificate. Certificate requests for listing multiple products will be evaluated on a case-by-case basis.

If information is omitted in the application by the requester or if clarification is needed on the supplied information, the requester will be contacted via telephone, email, or electronic notification in BECATS. If the requester does not provide the necessary information within 48 hours, the request for certificates will be returned and will need to be resubmitted for FDA review.

You may enclose a completed mailing form and mailing supplies to expedite the return of Certificates.

  • Please note that issuance of a "Certificate to Foreign Government", "Certificate of Exportability" or "Certificate of a Pharmaceutical Product" will not preclude regulatory action by FDA, if warranted, against products covered by the Certificate.
  • Please note that a "Certificate to Foreign Government", "Certificate of Exportability" or "Certificate of a Pharmaceutical Product" is issued by FDA solely for export purposes and may not be used for domestic advertising.

CBER Contact Information:

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 CBER-regulated products. You can send questions pertaining to the importation of CBER-regulated products to CBERExportCert@fda.hhs.gov.

Paper requests and supporting documents can be sent to:

Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Compliance and Biologics Quality
Division of Case Management
10903 New Hampshire Ave.
Building 71, Room G112
Silver Spring, MD 20993-0002
 

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