Zdrowie i gospodarka · 7.09.1994

Certification for Exports; Revised Compliance Policy Guide; Availability

The Food and Drug Administration (FDA) is announcing the availability of a revised Compliance Policy Guide (CPG) 7150.01 entitled, ``Certification for Exports.'' Firms exporting products from the United States 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 and other acts that FDA administers. FDA has historically issued a number of different types of such certificates, e.g., Certificates of Free Sale, Certificates for Export, Certificates to Foreign Governments, and most recently the European Union Health Certificate for Fishery Products. With expanding world trade, ongoing international harmonization initiatives, and developing international agreements, pressures on FDA to issue more certificates for U.S. products are escalating. Therefore, FDA has revised the CPG to clarify that it is the responsibility of the certificate requestor to provide information that will allow FDA to issue a Certificate for Export and to provide guidance on the preparation of such certificates, including model forms. The revised guidance will improve agency uniformity and consistency in provid