GISTnet Glossary—free sale certificate

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free sale certificate

A document issued by a government agency confirming that a food, beverage, drug, medical or cosmetic product is approved for unrestricted sale in the country of origin and/or export. Certain nations require a certificate of free sale issued by the origin country government on specified imported product categories. The U.S. government does not issue free sale certificates. Instead, the U.S. FDA will issue a "letter of comment" relating to products under its jurisdiction in lieu of a "free sale certificate."

(U.S. usage) The USG does not, per se, issue a free sale certificate. Instead:
(1) With respect to pharmaceuticals, upon request of an exporter or his agent, the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), will issue a Certificate of Pharmaceutical Product. For more information, refer to New Drug Application.
(2) With respect to processed foods and cosmetics, upon request of an exporter or his agent, the USFDA, Center for Food Safety and Applied Nutrition (CFSAN), will issue a Certificate For Export. For more information, refer to http://www.fda.gov/oia/foodcosm.htm.