Certificate of a Pharmaceutical Product (CPP)

  • A Certificate of Pharmaceutical Product (CPP) is a document that allows human drug products to be exported (including biological drugs).
  • The World Health Organization (WHO) credential requirements are met by this certificate (CPP). It also includes information on the pharmaceutical regulation or marketing status in the United States.
  • The FDA issues a Certificate of Pharmaceutical Product (CPP) for drugs that are not approved for sale in the United States but can be legally exported to another country. Certification is meant for a drug that fulfills the standards of 801(e)(1) of the Food, Drug, and Cosmetic Act [21 U.S.C. 381(e)(1)] and for a foreign-made drug (i.e. made from outside the U.S. and exported from the U.S.).
  • CPP is valid for twenty-four (24) months from the date of issue. For all certifications, a new CPP application will be submitted.

FDA documents received by mail Regular Service

Fee

Processing time

  • Must be paid by a check or money order.
  • Must include UPS or USPS Return.
  • Must fill the US Department of State form.

FDA documents received by mail Expedited Service

Fee

Processing time

  • Billing is available.
  • Shorter processing time.
  • Credit card payment is OK.
  • No need for the US Department of State form.
  • Return FedEx or UPS is required, or add $12.
  • Track your history and your annual spending online
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FDA documents received online Regular Service

Fee

Processing time

  • Must be paid by a check or money order.
  • Must include UPS or USPS Return.
  • Must fill the US Department of State form.

FDA documents received online Expedited Service

Fee

Processing time

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  • No need to ship your document. You may upload it here.
  • Billing is available.
  • Shorter processing time.
  • Credit card payment is OK.
  • US Department of State fee is included.
  • No need for the US Dept. of State form.
  • Track your history and spending online.