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| FDA EXPORT CERTIFICATES FOR U.S. PRODUCTS Export America, September 2000 Updated September 2002 by Patterson Brown | |||
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| Authored by Abdul Quader Shaikh and Rachael Farber Trade Information Center, Trade Development WHEN MIGHT I USE AN FDA EXPORT CERTIFICATE? Very often, foreign customers or foreign governments will request that U.S. exporters submit an export certificate when they ship FDA-regulated products such as: pharmaceutical drugs, medical devices, animal drugs and feed, foods, dietary supplements, cosmetics and infant formula. FDA export certificates are for export purposes only and may not be used in domestic advertising or promotion. At the request of U.S. exporters, the Food and Drug Administration (FDA) will issue export certificates under Section 801(e)(4) of the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. 321) for human drugs and biological products, animal drugs, and medical devices that meet the applicable requirements of the Act (FDCA). FDA certifies that these products meet domestic U.S. requirements and are eligible for sale in the United States. In addition to issuing export certificates for legally marketed drugs and devices, FDA issues export certificates for such products (other than foods, dietary supplements, and cosmetics) that meet the requirements of FDCA but may not otherwise be marketed, sold, offered for sale, or distributed in U.S. interstate commerce. Certificates for unapproved products subject to the FDCA should not be issued if the manufacturing facility(ies) do not comply with current Good Manufacturing Practice Regulations (cGMP). Although FDA is not required by law to issue certificates for foods, animal feeds, feed additives and cosmetics that can be marketed, sold, and distributed in the United States, the agency issues export certificates to this effect and intends to continue to provide this service as resources permit. FDA should not issue a certificate when FDA has advised the firm that products do not meet the applicable requirements of the Act or if FDA has initiated an enforcement action. WHAT KIND OF CERTIFICATES OF EXPORTS DOES FDA ISSUE? The FDA issues several types of export certificates to U.S. companies for the following products: --Human drugs (pharmaceuticals), biologics, animal drugs and foods, cosmetics and medical devices. “Certificate to Foreign Government” is the certificate title used for products that may be legally marketed, sold, offered for sale, or distributed in the United States. “Certificate of a Pharmaceutical Product” (conforms to the “WHO Certification Scheme on the Quality of Pharmaceutical Products Moving into International Commerce”) is issued when a human drug or biological product conforms to the World Health Organization’s certification requirements. “Certificate of Exportability” is issued for products that may not be marketed, distributed, or sold in the United States under section 801(e) or 802 of the Act, but which may be legally exported. This certificate is issued for unapproved products provided the product meets the specifications of the foreign purchaser, is not in conflict with the laws of the country to which it is intended for export, is labeled on the outside of the shipping package that is intended for export and is not sold or offered for sale in domestic commerce, thereby meeting section 801(e) of the Federal Food, Drug, and Cosmetics Act --Food products, dietary supplements, and cosmetics “Certificate of Free Sale” is issued for export products that are marketed or sold, offered for sale or distributed in the United States. --Animal-derived products for shipment to European Union “EU Export Health Certificates” are provided for certain animal-derived exports to the European Union. The FDA only certifies to domestic (U.S.) requirements and currently is certifying seafood, dairy products, game meats, shell eggs, gelatin, fish meat, pet foods, honey, and animal sausage casings. WHAT ARE THE COSTS AND HOW LONG DOES IT TAKE? Costs and turnaround time can vary so you are advised to contact the specific office/center handling your request. Some examples of fees, charges and types of certificates issued include: “Certificate of Free Sale” for foods, dietary supplements and cosmetics normally costs $10. “Certificate of Exportability”, “Certificate of a Pharmaceutical Product” and “Certificate to Foreign Government” can vary by product area but may cost up to $175 if FDA issues a certificate within 20 days of receiving a request. Again, the FDA Center or office handling your request can provide you with specific cost and procedural information. The Center for Veterinary Medicine does not charge for certificates for animal foods or feed additives. HOW CAN I OBTAIN AN FDA EXPORT CERTIFICATE FOR MY PRODUCT? You must submit an application to the Food and Drug Administration (FDA), however, the type of application and information you will be required to provide may differ according to the type of certificate requested and the commodity being exported. To find information on the Internet: Generic information on the application process and other requirements for obtaining export certificates can be found on the Food and Drug Administration (FDA) Internet website at: http://www.fda.gov/default.htm. Please be aware that some of the information found on the web may have been superseded by recent compliance policy guidance and/or changes in the Federal Food, Drug, and Cosmetics Act. Exporters are urged to contact the appropriate FDA office/center to confirm that they are using current procedures for their product/commodity. Other FDA Internet sites that may provide useful information and forms include: Center for Biologics Evaluation and Research (CBER): http://www.fda.gov/cber/index.html; http://www.fda.gov/cber/exportcert.htm Center for Devices and Radiological Health (CDRH): http://www.fda.gov/cdrh/index.html CDRH contacts: http://www.fda.gov/cdrh/international/export.html Center for Drug Evaluation and Research (CDER): http://www.fda.gov/cder/; http://www.fda.gov/cder/regulatory/default.htm Center for Veterinary Medicine (CVM): http://www.fda.gov/cvm/sitemap/sitemap.html Center for Food Safety & Applied Nutrition (CFSAN): http://vm.cfsan.fda.gov/list.html; http://vm.cfsan.fda.gov/~lrd/certific.html; http://vm.cfsan.fda.gov/~lrd/fr960404.html CFSAN Q&A: http://vm.cfsan.fda.gov/~dms/qa-top.html CFSAN Cosmetics Export: http://vm.cfsan.fda.gov/~dms/cos-cert.html General export guidance: http://www.fda.gov/opacom/fedregister/frexport.html (guidance document explains the basic requirements and procedures for exporting and importing). Certificate Comprehensive Policy Guide CPG 7150.01:http://www.fda.gov/ora/compliance_ref/cpg/cpggenl/cpg110-100.html Center for Veterinary Medicine (CVM) website: there are supplementary application forms available online for downloading and use in applying for export certificates through CVM: http://www.fda.gov/cvm/default.html The application process: FDA has product-specific requirements and processing centers. Each FDA center (see below) may have its own internal procedures and/or requirements for issuing a certificate, requesting a certificate, rescinding a certificate and processing requests. It is important to contact the appropriate office/center for specific instructions on processing your request. Some examples of useful supporting documentation for your request are listed below: --An original label or, if no labels have been printed, a detailed draft version of the current label --Sufficient information for each product for which a certificate is requested so the reviewer can properly identify the product and actual manufacturer of each product. --If the product was ever recalled, state the recall number and closeout date. --Country(ies) for which the Certificates are requested. --Indications of what product information should appear on the certificate, if the country destination should be listed on the certificate and the total number of certificates requested. --If the product being exported is human tissue intended for transplantation, a "Certificate to Foreign Government" (For Human Tissue Intended for Transplantation) signed by a responsible official of the exporting firm enclosed with the certificate request. --The mailing address for those requesting a certificate (for each category of products). Additionally, application requirements and specific FDA contact information for obtaining different types of certificates follows. “Certificate of Free Sale”, “Certificate to Foreign Government” and/or “Certificate of Exportability” To request a “Certificate of Free Sale,” “Certificate to Foreign Government” or “Certificate of Exportability,” the individual representing the exporting company will need to submit a request to the appropriate office/center. Each center may establish its own internal procedure and requirements. However, the individual submitting a request for certification. Provide a written statement that: --Identifies the product or products to be exported; and --Demonstrates that the products to be exported: (i) meet the requirements of the Act (801 (e) or section 802) or (ii) may be legally marketed, sold, offered for sale, or distributed in interstate commerce. --Provide a written statement acknowledging that he or she is subject to the provisions of Title 18, section 1001 of the United States Code which makes it a criminal offense to“ knowingly and willfully make a false and fraudulent statement or to make or use a false document in any matter within the jurisdiction of a department or agency of the United States or to knowingly and willfully falsify, conceal, or cover up by any trick, scheme or device a material fact in any matter within the jurisdiction of a department or agency of the United States." “Certificate of a Pharmaceutical Product”(WHO format) A separate application must be made for each drug. Before preparing your application, consult with the importing country to determine exactly what type of information is required for the certificate. If you are requesting a certificate for more than one country, you must provide the container label, package label and package inserts for each country. The application for certificate must include country of destination, U.S. trade name or generic name of the product, container label, name and address of manufacturing facilities, etc. Please refer to the center issuing the certificate (see below) for specific details on the application requirements. An application for a Pharmaceutical Product to cover Pharmaceutical drugs should be sent to: Food and Drug Administration Center for Drug Evaluation and Research (CDER) Certification Program HFD-310 7520 Standish Place, Room 166 Rockville, MD 20855 (301) 594-3150 There may be occasions where a “Certificate of a Pharmaceutical Product” is needed for a Veterinary or Human Biological Drug. Such requests should be handled through the Appropriate FDA center [Center for Veterinary Medicine (CVM) or Center for Biologics Evaluation and Research (CBER)]. Contact Information: FDA’s Center for Food Safety and Applied Nutrition (CFSAN) has five offices processing requests for “Certificate of Free Sale”. These are structured by product/commodity type. --Cosmetics and colors to: Office of Cosmetics and Colors, HFS-100 --Food grade chemicals and food additives to: Office of Pre-market Approval, HFS-200 --Standardized and related foods excluding seafood: Office of Plant and Dairy Foods and Beverages, HFS-300 --All seafood: Office of Seafood, HFS-400 --All dietary supplements, vitamins, minerals and herbal preparations, infant formulas, and medical foods: Office of Nutritional Products, Labeling and Dietary Supplements , HFS-800 It is important to direct your request for a certificate to the appropriate office and location within CFSAN by selecting the Office Heading and HFS code that applies to your specific product or commodity. Send CFSAN requests to: {Insert the Office and HFS code for the product/commodity} U.S Food and Drug Administration Center for Food Safety and Applied Nutrition 5100 Paint Branch Parkway College Park, MD 20740-3835 http://www.cfsan.fda.gov You can you expect to get a response from CFSAN on your “Certificate of Free Sale” request in approximately four to six weeks. As stated earlier there is a charge of $10.00 per certificate for which you will be billed separately. DRUGS: Center for Drug Evaluation and Research Office of Compliance Import/Export International Drug Team HFD-316, Room 156 7520 Standish Place, Room 166 Rockville, MD 20855 301 594-3150 BIOLOGICS: Center for Biologics Evaluation and Research Office of Compliance and Biologics Quality Division of Case Management 1401 Rockville Pike HFM-624 Rockville, MD 20852-1448 (301) 827-6201 MEDICAL DEVICES: Center for Devices and Radiological Health Office of Compliance Information processing and Office Automation Branch HFZ-307 9200 Corporate Blvd. Rockville, MD 20850 ANIMAL DRUGS: Center for Veterinary Medicine Division of Compliance HFV-235 7500 Standish Place Rockville, MD 20855 301 827-0153 EU Health Certificates: CFSAN “EU Export Health Certificate” Information: http://vm.cfsan.fda.gov/~frf/sfeuexp.html FDA, CFSAN maintains lists of US FDA-EU Export Certificate Seafood Processors for use by European Union (EU) Member States in certification of individual shipments of U.S. fish and fishery products into EU markets (under the provisions outlined in Commission Decision 95/328/EC and as specified in Article 11(4) of Council Directive 91/493/EEC and Article 9(3) of Council Directive 91/492/EEC.) FDA CFSAN also maintains lists for game meat, dairy products, shell egg and gelatin processors. The CFSAN web site [http://vm.cfsan.fda.gov/~lrd/fr960404.html] has more information and links regarding these lists. The lists are updated on a quarterly basis. For additional information on game meat, dairy products, shell egg and gelatin processor lists contact: (202) 205-4400. For additional seafood information contact: FDA's Office of Seafood, Tel: (202) 418-3160 National Marine Fisheries Service (NMFS), Tel: (301) 713-2355 |
These Monthly columns are featured in "Export America", a monthly Commerce Department publication that provides assistance for the exporter looking to expand into new markets. The Trade Information Center staff provides in-depth, technical answers to practical questions that exporters ask. For subscriptions to this publication, please visit the Export America Website.  Trade Information Center, U.S. Department of Commerce Fax: (202) 482-4473 Contact TIC | About Us | Site Map | FAQs | Privacy Statement | Endorsement Policy | ||
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