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 In this section:

                Exporting CBER-Regulated Products

Exporting CBER-Regulated Products

                        BECATS External User Guide - Modify a Pharmaceutical Product Application Step-by-step Instructions
          BECATS External User Guide- Search for a Certificate of a Pharmaceutical Product Application Step-by-Step Instructions
          BECATS External User Guide-How to Enter a Certificate of a Pharmaceutical Product Application
          Biologics Export Certification Application and Tracking System (BECATS) Frequently Asked Questions
          How to Enter a Certificate to Foreign Government (CFG) Application
          How to Modify the CFG Application
          How to Search for a CFG Application
          Letter to Industry about BECATS
          Importing CBER-Regulated Products into the United States
          Certificate to Foreign Government for Device Not Exported from the United States (CBER) Home
          Vaccines, Blood & Biologics
          Guidance, Compliance & Regulatory Information (Biologics)
          Compliance Actions (Biologics)
          Exporting CBER-Regulated Products
          CBER Export CertificationExporting CBER-Regulated Products CBER Export Certification
  
  	
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    Print**Submission Requirements for Requesting Certificates for Exporting Products to Foreign Countries**

Background:

Firms exporting products from the U.S. are often asked by foreign customers or foreign governments to supply a certification relating to products subject to the Federal Food, Drug, and Cosmetic Act and other acts the Food and Drug Administration (FDA) administers. Under the FDA Export Reform and Enhancement Act of 1996 (the Act), FDA is authorized to issue certificates for drugs, animal drugs, and devices within 20 days of receipt of a request for such a certificate. A fee of up to $175 may be charged for each certificate issued. In addition to issuing export certificates for approved or licensed products, the FDA will also issue export certificates for unapproved products that meet the requirements of Sections 801(e) or 802 of the Act.

Key Resources

General Questions
	FDA Export Certificates
	Exports Under the FDA Export Reform and Enhancement Act of 1996
	FDA Forms
	Enter a Certificate to Foreign Government (CFG) Application Step-by-Step Instructions
	Biologics Export Certification Application and Tracking System (BECATS) Frequently Asked Questions
	Letter to Industry about BECATS

                                                                                  Content current as of:
      03/29/2018Exporting CBER-Regulated Products

          
                        BECATS External User Guide - Modify a Pharmaceutical Product Application Step-by-step Instructions
          BECATS External User Guide- Search for a Certificate of a Pharmaceutical Product Application Step-by-Step Instructions
          BECATS External User Guide-How to Enter a Certificate of a Pharmaceutical Product Application
          Biologics Export Certification Application and Tracking System (BECATS) Frequently Asked Questions
          How to Enter a Certificate to Foreign Government (CFG) Application
          How to Modify the CFG Application
          How to Search for a CFG Application
          Letter to Industry about BECATS
          Importing CBER-Regulated Products into the United States
          Certificate to Foreign Government for Device Not Exported from the United States (CBER)
 
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