- 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.
Apostille Certificate of Pharmaceutical Products
FDA Apostille provides attestation service for Certificate of Pharmaceutical Products issued by US Food & Drug Administration and destined for use in the Hague Convention Participating Countries. We obtain Apostille for Certificate of Pharmaceutical Products from the US Department of State in Washington DC.
Certificate of Pharmaceutical Products Legalization
FDA Apostille assists corporations to authenticate Certificate of Pharmaceutical Products from the US Department of State and the embassy of the destination country in Washington DC. Embassy legalization is required to acknowledge documents destined for use in the Non-Hague Participating Countries.