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Export Certificates for FDA-Regulated Products Under Review

Friday, November 14, 2014
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration is accepting comments through Jan. 13, 2015, on the proposed extension of the following types of export certificates for FDA-regulated products.

- certificates to foreign governments – for the export of products legally marketed in the United States

- certificates of exportability  – for the export of products not approved for marketing in the U.S. that meet the requirements of sections 801(e) or 802 of the Federal Food, Drug and Cosmetic Act

- certificates of a pharmaceutical product – conform to the format established by the World Health Organization and intended for use by the importing country when the product in question is under consideration for a product license that will authorize its importation and sale or for renewal, extension, amending or reviewing a license

- non-clinical research use only certificates – for the export of a non-clinical research use only product, material or component that is not intended for human use and that may be marketed in and legally exported from the U.S.

For the first three types of certificates, manufacturers are requested to self-certify that they are in compliance with all applicable requirements of the F&DC Act, not only at the time they submit their request to the appropriate center but also at the time they submit the certification to the foreign government.

The appropriate FDA centers will review product information submitted by firms in support of their certificates and any suspected case of fraud will be referred to FDA’s Office of Criminal Investigations for follow up. Making or submitting to FDA false statements on any documents may incur penalties of up to $250,000 in fines and up to five years’ imprisonment.

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