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June 2002; Updated December 2004 and May 2007
| Commodity | Links / Info | FDA Points of Contact |
|---|---|---|
| Cosmetics and Colors | General and Product-Specific Certificates Requests for Exporting Cosmetics |
Lark Lambert HFS-100 Office of Cosmetics and Colors Center for Food Safety and Applied Nutrition 5100 Paint Branch Parkway College Park, MD 20740 phone (301) 436-1126 fax (301) 436-2961 |
| Dietary Supplements, Infant Formulas & Medical Foods (includes Vitamins, Minerals, Amino Acids, Herbals...) |
Certificate of Free Sale Requests for Certificate of Free Sale for Dietary Supplements, Infant Formulas, & Medical Foods Food Export Certificate Application (available in PDF) |
Robert Moore, HFS-810 Office of Nutrition, Labeling and Dietary Supplements Center for Food Safety and Applied Nutrition 5100 Paint Branch Parkway College Park, MD 20740 phone (301) 436-1441 fax (301) 436-2636 |
| EU Animal Health and Specified Risk Material Certificates | Specified Risk Materials of Bovine, Ovine and Caprine Origin Certificate | Esther Lazar, HFS-316 Office of Food Safety Center for Food Safety and Applied Nutrition 5100 Paint Branch Parkway College Park, MD 20740 phone (301) 436-1485 fax (301) 436-2632 |
| Food Additives | Certificate of Free Sale | Diane Gilliam, HFS-200 Office of Food Additive Safety Center for Food Safety and Applied Nutrition 5100 Paint Branch Parkway College Park, MD 20740 phone (301) 436-1200 fax(301) 436-2973 |
| Plant and Dairy Foods and Beverages | Certificate of Free Sale Requests for exports of all standardized and related foods excluding seafood |
Elizabeth Claverie Williams, HFS-317 Office of Food Safety, Center for Food Safety and Applied Nutrition 5100 Paint Branch Parkway College Park, MD 20740 phone (301) 436-1630 fax (301) 436-2651 |
| Seafood | Certificate of Export for Seafood |
Roshelle King, HFS-400 Office of Food Safety, Division of Seafood Center for Food Safety and Applied Nutrition 5100 Paint Branch Parkway College Park, MD 20740 phone (301) 436-1416 fax (301) 436-2601 |
| Product | Links / Info | FDA Points of Contact |
|---|---|---|
| Biologics | Certificate of a Pharmaceutical Product - Export of an Unapproved 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.
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 Act. These non-clinical research use only materials will be labeled in accordance with 21 CFR 809.10(c)(2) or 21 CFR 312.160, as appropriate, and exported as they are presently being sold or offered for sale in the United States. Certificate to Foreign Government is for the export of human drugs and biologics, animal drugs, and devices that can be legally marketed in the United States. Certificate of Exportability is for the export of human biologics and devices that cannot be legally marketed in the United States, but meet the requirements of sections 801(e) or 802 of the Act and may be legally exported. Submission Requirements for Requesting Certificates for Exporting Products to Foreign Countries |
Kim Cressotti, Attention: HFM-624 Division of Case Management Office of Compliance Center for Biologics Evaluation and Research 1401 Rockville Pike Rockville, MD 20852-1448 phone (301) 827-6203 fax (301) 827-5707 |
| Drugs | Certificate of a Pharmaceutical Product - Export of an Unapproved 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. | Jocelyn Harris, HFD-323 Office of Compliance Center for Drug Evaluation and Research 11919 Rockville Pike Rockville, MD 20852 phone (301) 827-8983 fax (301) 827-9069 |
| Devices | 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 Act. These non-clinical research use only materials will be labeled in accordance with 21 CFR 809.10(c)(2) or 21 CFR 312.160, as appropriate, and exported as they are presently being sold or offered for sale in the United States.
Certificate to Foreign Government is for the export of human drugs and biologics, animal drugs, and devices that can be legally marketed in the United States. Certificate of Exportability is for the export of human drugs and biologics, animal drugs, and devices that cannot be legally marketed in the United States, but meet the requirements of sections 801(e) or 802 of the Act and may be legally exported. |
Leila Lawrence Regulatory Policy and Systems Branch Office of Compliance Center for Devices and Radiological Health 9200 Corporate Boulevard Rockville, MD 20850 phone (240) 276-0132 |
| Veterinary Drugs and Feed | Certificate of a Pharmaceutical Product - Export of an Unapproved 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.
Certificate to Foreign Government is for the export of human drugs and biologics, animal drugs, and devices that can be legally marketed in the United States. Certificate of Exportability is for the export of human drugs and biologics, animal drugs, and devices that cannot be legally marketed in the United States, but meet the requirements of sections 801(e) of the Act and may be legally exported. |
Kim Bell, HFV-235 Division of Compliance Center for Veterinary Medicine Food & Drug Administration 7519 Standish Place Rockville, MD 20855-2773 phone (240) 276-9212 fax (240) 276-9241 |
