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U.S. Department of Health and Human Services

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Percentage of export certificates for drug related products issued within 20 days

Dictionary: Export Certificates are not required by FDA in order to export a product, however, many countries require Export Certificates issued by FDA in order for products to be registered or imported into that country. FDA issues Export Certificates at the request of entities exporting products from the U.S. Certificates are issued by FDA in order to facilitate the export of U.S. animal drug and feed products into other countries, and to provide clear and current direction to foreign governments seeking official assurance that products exported to their counties meet specific U.S. regulations. CVM issues three types of Export Certificates:

  • The "Certificate to Foreign Government" is for the export of products legally marketed in the U.S.
  • The “Certificate of Exportability” is for the export of products not approved for marketing in the U.S. (unapproved products) that meet the requirements of Sections 801(e) or 802 of the Act, and are not in conflict with the laws of the country to which they are intended for export.
  • 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 product license that will authorize its importation and sale or for renewal, extension, amending or reviewing a license.

Information is current as of June 30, 2020.

Fiscal Year - 2020

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TimeTargetPercentage
Oct - Dec 201980100
Jan - Mar 20208097
Apr - Jun 202080100
Jul - Sept 2020N/ATBD

FY 2020 YTD: 99%

Number of export certificates for drug related products issued in 20 days

Fiscal Year - 2020
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TimeTargetNumber
Oct - Dec 2019N/A145
Jan - Mar 2020N/A95
Apr - Jun 2020N/A154
Jul - Sept 2020N/ATBD

FY 2020 YTD: 394

Number of export certificates requests for drug related products received

Fiscal Year - 2020
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TimeTargetNumber
Oct - Dec 2019N/A145
Jan - Mar 2020N/A98
Apr - Jun 2020N/A154
Jul - Sept 2020N/ATBD

FY 2020 YTD: 397

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.

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