Exporting CBER-Regulated Products
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 Reference, Guides & Field Activities Letter to Industry: Ceasing Notarization of Export Certificates
Biologics 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 Application