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 In this section:

        Compliance Actions (Biologics)

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 ProductsCompliance Actions (Biologics) Exporting CBER-Regulated Products
  	
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    Print**Who directs and coordinates the export program for CBER-Regulated products?**

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.

**Why does CBER no longer notarize my certificates for export?**

As provided by 21 United States Code (USC) 381(e), FDA certifies in writing that certain regulated articles may be exported from the United States, however FDA is not required to notarize export certificates. Issued certificates include the original signature of an authorized FDA Official and, except for cosmetic certificates, an embossed Department of Health & Human Services federal seal, and should not require further verification or authentication. Therefore, on March 1, 2014, CBER issued a letter to industry announcing its procedural change to cease notarizing FDA exports certificates.

The U.S. Department of State, Office of Authentications, provides both Authentication and Apostille Certificates for a variety of documents to individuals, institutions,and government agencies. Should a country or economic area require such services, you are encouraged to contact that office at 600 19th Street, NW, Washington,DC 20006. For more information, please visit their website: http://travel.state.gov/content/travel/english/legal-considerations/judicial/authentication-of-documents/office-of-authentications.html

CBER-Regulated Products: Export Certification Program and Related FDA Forms

Information pertaining to CBER's Export Certification Program and FDA Forms for Export Certification can be found using the links provided below.

How to Complete FDA Export Certificate Forms
	Description of FDA Forms for Export Certification
	FDA Forms: Certificates for Exporting
	Export and Import Guidance Documents
	Investigational New Drugs: Export Requirements for Unapproved New Drug Products (Final Rule)
	Inspection References
	Letter to Industry: Ceasing Notarization of Export CertificatesBiologics Export Certification Application and Tracking System (BECATS): Frequently Asked Questions

We recommend that you submit your certificate requests using CBER's Biologics Export Certification Application and Tracking System (BECATS). To learn more about BECATS, click on the links below.

Letter to Industry about BECATS
	Biologics Export Certification Application and Tracking System (BECATS) Frequently Asked Questions
	Enter a Certificate to Foreign Government (CFG) Application Step-by-Step Instructions
	How to Enter a Certificate to Foreign Government (CFG) Application
	How to Modify the CFG Application
	How to Search for a CFG ApplicationSub-Topic Paragraphs
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			Center for Biologics Evaluation and Research
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		ocod@fda.hhs.gov
		
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		For Updates on Twitter, follow @fdacber
	Resources for You (Biologics)
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			Report a Problem to the Center for Biologics Evaluation & Research
			Recalls (Biologics)
			CBER-Regulated Products: Shortages and Discontinuations
			Biologics Products & Establishments

                                                                                  Content current as of:
      01/25/2021
                  
                   
Regulated Product(s)
		 BiologicsExporting 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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