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COMPLIANCE POLICY GUIDECompliance Policy Guidance for FDA StaffSec. 110.100 Certification for Exports (CPG 7150.01)INTRODUCTION:This compliance guidance document is an update to the Compliance Policy Guides Manual (August 1996 edition). It is a revised CPG and will be included in the next printing of the Compliance Policy Guides Manual. It is intended for FDA personnel and is available electronically to the public. This guidance document represents the agency's current thinking on requests for certification for exports according to certain procedure and provisions of the Federal Food, Drug, and Cosmetic Act. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulation, or both. BACKGROUND:Firms exporting products from the U.S. are often asked by foreign customers or foreign governments to supply a certification relating to products subject to the Federal Food, Drug, and Cosmetic Act (the Act) and other statutes administered by the Food and Drug Administration (FDA). Certification is the process by which a formal or official attestation is made concerning the regulatory status of a product, or the system by which a commodity is manufactured. Requests for certification have variously asked for verification that the products being exported: (1) are freely marketed in the U.S.; (2) are in compliance with U.S. laws and regulations; (3) are in compliance with the importing country's requirements; (4) meet certain national or international standards, such as quality standards; or (5) do not contain specific contaminants. This certification process may include issuance of a certificate to accompany the exported product. This compliance policy guide does not cover requests for certification, under the third category above for compliance with the importing country’s requirements, such as European Union Export Health Certificates. FDA has historically issued a number of different types of certificates, e.g., Certificates of Free Sale, Certificates for Export, Certificates to Foreign Governments. With expanding world trade, ongoing international harmonization initiatives (such as the Codex Committee on Food Import and Export Inspection and Certification Systems, and the World Health Organization’s Certification Scheme on the Quality of Pharmaceutical Products), and new international agreements, FDA is receiving an increasing number of requests to issue more certificates for U.S. products. Beginning January 1, 1999, FDA adopted a new format for FDA export certificates in order to deter counterfeiting and falsification, and to allow for easier authentication of certificates. The new format features the use of several security measures in the paper used for export certificates. The new certificate also utilizes a new document control coding system. The system consists of a nine character alphanumeric code located in the center, on the back of the certificate. Each code has a unique prefix identifier for each center export program office and document. The following are examples:
POLICY:FDA's long term goal is to reduce or eliminate export certificates by finding other means to assure other countries of the acceptability of FDA regulated products. However, the agency recognizes the current importance of providing export certificates. For commodities regulated by FDA under authority of the Federal Food, Drug, and Cosmetic Act, or other acts administered by FDA, it is the U.S. agency with regulatory oversight of the certification process. Under section 801(e)(4) of the Act, FDA is required to issue certificates for human drugs and biologics, animal drugs, and devices that meet the applicable requirements of the Act. If FDA issues a certificate within 20 days of receipt of a request for such a certificate, the agency may charge a fee of up to $175. 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 intends to continue to provide this service as resources permit. In addition to issuing export certificates for products that are approved, licensed, or otherwise in compliance with the applicable requirements of the Act, FDA also issues, pursuant to section 801(e)(4) of the Act, export certificates for products other than foods, dietary supplements, and cosmetics that meet the requirements of sections 801(e) or 802 of the Act but that may not otherwise be marketed, sold, offered for sale, or distributed in interstate commerce. GUIDANCE:Persons requesting an export certificate have the burden and responsibility to provide information that will assist FDA in determining whether a certificate may be issued. The following guidance has been developed to improve agency uniformity and consistency in providing export certificates: 1. Certificates for human drugs, biologics, animal drugs, and medical devices that may be legally marketed, sold, offered for sale, or distributed in the United States should be entitled, "Certificate to Foreign Government", unless required to bear a different name. Certificates for human drug products, including human biological drugs, that conform to the World Health Organization’s certification requirements should be entitled "Certificate of a Pharmaceutical Product". Certificates for food products and cosmetics are generally entitled "Certificates of Free Sale". Certificates for products that may not be marketed, distributed, or sold in the United States, but which may be legally exported under section 801(e) or 802 of the Act, should be entitled, "Certificate of Exportability". 2. The appropriate center compliance director or his/her designee may issue certificates. 3. If authentication of the certificate is required, the certificate may be notarized or certified under seal of the Department of Health and Human Services in accordance with 21 CFR 5.22, or both. 4. Each center may establish its own internal procedure and requirements for an exporter to request a certificate, internal procedures for rescinding a certificate, and procedures for processing a request for a certificate. However, the individual representing the exporting company and submitting a request for certification pursuant to section 801(e)(4) of the Act should, at a minimum: a. Provide a written statement that: (1) identifies the product or products to be exported; and (2) demonstrates that the products to be exported-- (i) meet the requirements of section 801(e) or section 802 of the Act; or (ii) may be legally marketed, sold, offered for sale, or distributed in interstate commerce. b. Provide a written statement acknowledging that he or she is subject to the provisions of Title 18, section 1001 of the United States Code (U.S.C.). This statutory provision makes it a criminal offense to knowingly and willfully make a false or fraudulent statement, or make or use a false document, in any matter within the jurisdiction of a department or agency of the U.S. The provision also makes it a criminal offense 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. 5. A certification issued pursuant to section 801(e)(4) of the Act may contain the following elements (specific examples are attached): a. A statement that each specific product identified is subject to FDA jurisdiction; b. A statement indicating the compliance status of the system by which the product is required to be manufactured for approved or licensed products, or products exported under section 802 of the Act (may also indicate that the agency does not certify compliance with our laws for specific lots of product); c. A statement indicating the premarket clearance status for a product requiring pre-market approval (e.g., new drugs, new animal drugs, licensed biologics, approved/cleared devices), or for a product subject to certification (e.g., colors); d. A statement that the named product(s): (1) may be exported under section 801(e) or section 802 of the Act; or (2) may be legally marketed, sold, offered for sale, or distributed in interstate commerce. e. A statement that the certificate is valid for a period of twenty-four (24) months from the date authorized. The requestor should be notified that the issuance of a certificate by FDA does not preclude regulatory action, if warranted, by FDA against any product that is covered by such a certificate. Additionally, the requestor should be informed that a certificate or similar statement issued by FDA is for export purposes only and may not be used in domestic advertising or promotion. REGULATORY GUIDANCE:FDA should not issue a Certificate to Foreign Government or a Certificate for Quality of a Pharmaceutical Product under section 801(e)(4) of the Act for products when FDA has advised the firm that products do not meet the applicable requirements of the Act. Additionally, such certificates should not be issued if FDA has initiated an enforcement action (e.g., seizure/injunction). FDA may notify a firm of violations of the Act by means of regulatory correspondence (e.g., warning letter, Notice of Intent to Revoke Letter), or through a regulatorymeeting with the firm. Examples of circumstances for which certificates would not be issued include: Failure of the manufacturing facility(ies) to operate in compliance with the current Good Manufacturing Practice regulations (unless the particular exported product is not affected by the specific GMP deficiencies); manufacturing facility(ies) not registered or listed with FDA; and manufacturing facility(ies) for which FDA has no inspectional information. Products may be eligible for a Certificate of Exportability if they meet the applicable requirements of sections 801(e) or 802 of the Act. Certificates of Exportability for products subject to section 802 of the Act should not be issued if the manufacturing facility(ies) do not comply with current Good Manufacturing Practice regulations, unless the particular exported product is not affected by the specific GMP deficiencies. Certificates of Free Sale, provided for food and cosmetic products, should not be issued when products are removed from sale or not eligible for legal sale in the U.S. (i.e., the product is under seizure or the firm is under injunction). FDA should consider whether it is appropriate to issue a Certificate to Foreign Government or Certificate for Quality of a Pharmaceutical Product under section 801(e)(4) of the Act for specific products that are the subject of a recall by the manufacturer. Products that are the subject of a recall may be eligible for a Certificate of Exportability if they meet the requirements of sections 801(e) or 802 of the Act. FDA intends to pursue regulatory action, including criminal prosecution, against anyone responsible for causing the submission of false or misleading information, substitution of a product under a certificate, counterfeiting or altering a certificate, or the misuse of a certificate. Attachments:Model Certificate to Foreign Government Model Certificate of Exportability - Section 802 Model Certificate of Exportability - Section 801(e)Sample WHO Certificate for Quality of a Pharmaceutical Product (PDF version) Issued: 10/1/80 Revised: 6/1/89, 8/15/94, 10/29/96, 4/14/2000
Attachments:CERTIFICATE TO FOREIGN GOVERNMENT [Return to List] NAME OF MANUFACTURER OR DISTRIBUTER, ADDRESS NAME OF PRODUCT(S) (GENERIC NAME IF APPLICABLE) COUNTRY OF DESTINATION (OPTIONAL) PREMARKET APPROVAL IDENTIFIER (IF APPLICABLE, I.E., NDA, NADA, PMA NUMBER, 510(k) NUMBER, LICENSE NUMBER) The product(s) described above and the plant(s) where it is produced are subject to the jurisdiction of the FDA under the Federal Food, Drug, and Cosmetic Act. It is certified that the above listed product(s) may be marketed in, and legally exported from, the United States of America at this time. The manufacturing plant(s) in which the product(s) is produced is subject to periodic inspections. The last such inspection showed that the plant(s), at that time, appeared to be in substantial compliance with current good manufacturing practice requirements for the product(s) listed above. _____________________________ This certificate expires on (insert - date 24 months from date notarized). County of ________________ Certificate No.
Certificate of Exportability (Section 802)[Return to List] The Food and Drug Administration certifies that the product(s) described below is subject to its jurisdiction under the Federal Food, Drug, and Cosmetic Act (the Act). Such product(s), which is not approved for marketing in the United States, may be legally exported provided it meets the requirements of Section 802 of the Act. Under Section 802 of the Act, a drug or device not approved for marketing in the United States may be exported if it is manufactured, processed, packaged, and held in substantial conformity with current good manufacturing practice requirements. The manufacturing plant(s) in which the product(s) is produced is subject to periodic inspections. The last such inspection showed that the plant(s), at that time, appeared to be in substantial compliance with current good manufacturing practice requirements for the product(s) listed below. The company has certified to the Food and Drug Administration that: * The product(s) accords to the specifications of the foreign purchaser; * The product(s) is not in conflict with the laws of the country to which it is intended for export; * The shipping package for the product(s) is labeled on the outside that it is intended for export; and * The product(s) is not sold or offered for sale in the United States. Based on the information above, the product(s) listed below may be exported pursuant to Section 802 of the Act. NAME OF PRODUCT [NAME OF COMPANY], [ADDRESS] (GENERIC NAME IF APPLICABLE) COUNTRY OF DESTINATION (OPTIONAL) ______________________________ _______________________________ ________________________________ This certificate expires on (insert - date 24 months from date notarized). Certificate No.
Certificate of Exportability (Section 801(e)) [Return to List]
The Food and Drug Administration certifies that the product(s) described below is subject to its jurisdiction under the Federal Food, Drug, and Cosmetic Act (the Act). The product(s) described below may not be sold or offered for sale in the United States. The company has certified to the Food and Drug Administration that: * The product(s) accords to the specifications of the foreign purchaser; * The product(s) is not in conflict with the laws of the country to which it is intended for export; * The shipping package for the product(s) is labeled on the outside that it is intended for export; and * The product(s) is not sold or offered for sale in the United States. Based on the information above, the product(s) listed below may be exported pursuant to Section 801(e) of the Act. NAME OF PRODUCT [NAME OF COMPANY], [ADDRESS] (GENERIC NAME IF APPLICABLE) COUNTRY OF DESTINATION (OPTIONAL) ___________________________ This certificate expires on (insert - date 24 months from date notarized). County of __________________________ Certificate No. Sample WHO Certificate for Quality of a Pharmaceutical Product[Return to List] |