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Submission Requirements for Requesting Certificates for Exporting Products to Foreign Countries

This article was edited and reviewed by FindLaw Attorney Writers | Last reviewed March 26, 2008

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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.

General Instructions:

  • The "Certificate to Foreign Government" is for the export of products legally marketed in the United States. Certificate requests should include the information listed in Supplementary Information - Certificate to Foreign Government Requests (PDF, Text). Please ensure that the Exporter's Certification Statement is signed by a responsible official of the exporting firm and is enclosed with the certificate request.

  • The "Certificate of Exportability" is for the export of products not approved for marketing in the United States (unapproved products) that meet the requirements of Sections 801(e) or 802 of the Act. Certificate requests should include the information listed in Supplementary Information - Certificate of Exportability Requests (PDF, Text). Please ensure that the Exporter's Certification Statement is signed by a responsible official of the exporting firm and is enclosed with the certificate request.

  • The "Certificate of a Pharmaceutical Product" conforms to the format established by the World Health Organization(WHO) and is intended for use by the importing country when the product in question is under consideration for a roduct license that will authorize its importation and sale or for renewal, extension, amending or reviewing a license. WHO Certificate requests should include the information listed in Supplementary Information - Certificate of a Pharmaceutical Product Requests (PDF, Text). Please ensure that the Exporter's Certification Statement is signed by a responsible official of the exporting firm and is enclosed with the certificate request.

  • Please type certificate requests or print clearly.

  • In most cases, one product will be listed per certificate. However, products that were approved under the same PLA, NDA, PMA or 510(k) application or similar unapproved 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 or FAX. 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.

  • Questions may be directed to the Import/Export Team at 301-827-6201.

  • Send the request and supporting documents to:
    Food and Drug Administration
    Center for Biologics Evaluation and Research
    Office of Compliance, Division of Case Management
    1401 Rockville Pike, Attention: HFM-610
    Rockville, MD 20852-1448
    or via FAX at 301-594-0940

  • 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.

  • You may enclose a completed FEDEX form to expedite the return of Certificates.

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.

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.

Last Updated: 5/11/98

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