U.S. flag An official website of the United States government
  1. Home
  2. Vaccines, Blood & Biologics
  3. Guidance, Compliance & Regulatory Information (Biologics)
  4. Compliance Actions (Biologics)
  5. Exporting CBER-Regulated Products
  6. Letter to Industry: Ceasing Notarization of Export Certificates
  1. Exporting CBER-Regulated Products

Letter to Industry: Ceasing Notarization of Export Certificates

Food and Drug Administration
Center for Biologics Evaluation and Research
1401 Rockville Pike
Rockville, MD 20852-1448

February 26, 2014

Dear CBER Export Certificate Applicant,

I am writing to inform you about a procedural change whereby the United States Food and Drug Administration (FDA) will no longer notarize export certificates. We plan to stop notarizing these beginning March 1, 2014.

As provided by 21 United States Code (USC) 38l(e), FDA certifies in writing that certain regulated articles may be exported from the United States. While FDA is not required to notarize export certificates, we had generally been doing so. Although FDA has discontinued notarizing export certificates, the 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. For more information about FDA's export certificate program, please visit our website at: http://www.fda.gov/lnternationalPrograms/ExportsandExportCertificates.

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://www.state.gov/m/a/auth/index.htm.

For more infonnation about FDA's CBER export certificate program, please visit our webpage at: http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatorylnformation/ComplianceActivities/
BiologicslmportingExporting/default.htm
. Send CBER export certificate questions to CBERexportcert@fda.hhs.gov

Please share this procedural change with other officials within your firm who deal with export certification, as well as the relevant foreign government entities with whom you deal. We appreciate your assistance in disseminating this information in a timely manner. Thank you in advance for your cooperation.

Mary A. Malarkey
/signature/
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research

Resources For You