Apostille FDA Export Certificates
Foreign governments or businesses often request to see the Certificate of Good Manufacturing Practices (eGMP) from enterprises that export products from the United States. The governments or foreign businesses want to be sure the products that are being exported to them have met specific U.S. regulations. Some exports are regulated by the Food and Drug Administration (FDA). A certificate issued by the FDA contains information concerning the products regulatory or marketing status.
FDA issues the following types of Export Certificates:
- The “Certificate of Exportability” is issued for the export of human drugs and biologics, animal drugs, and devices that cannot be legally distributed in the United States, but meet the requirements of section 801(e) or 802 of the Federal Food, Drug and Cosmetic Act and may be legally exported. If the product meets the requirements of Sections 801(e) or 802, the products must be labeled as such. Cost for this is $175 for the first copy and $15 for each additional copy.
- The “Certificate of Free Sale” or “Certificate of Export for Seafood” is for food, including dietary supplements, food additives, biologics, medical devices, infant formula, plant and dairy foods, beverages, and cosmetic products that may be legally sold or distributed, without restriction, in the United States
- The “Health Certificates for Food/Feed” currently required primarily by the European Union (EU), are usually specific to the food being exported. FDA does not issue export certificates that certify compliance with another country’s requirements. For dairy, honey and eggs, the U.S. Department of Agriculture offers certification services for use abroad. The National Oceanic and Atmospheric Administration (NOAA) Seafood Inspection Program offers certification for the export of seafood.
- The “Specified Risk Materials of Bovine, Ovine and Caprine Origin Certificate” is used in the United States for the export of gelatin. These certificates are used in consideration of the raw material that may transmit spongiform encephalopathies.
- 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 considering whether to license the product in question for sale in that country. Unapproved human drug products aren’t issued a Certificate of Exportability, instead they are issued a Certificate of a Pharmaceutical Product, containing a special notation that the product is unapproved.
- The “Non-clinical Research Use Only Certificate” is for the export of a product, material, or component, for non-clinical research use only, that is not intended for human use and which may be marketed in, and legally exported from the United States under the Federal Food, Drug and Cosmetic Act. They will be labeled in accordance with 21 CFR 809.10(c)(2) or 21 CFR 312.160 stating how they are being used within the United States.
