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Export Certificates for Regulated Drugs and Medical Devices Under Review

Monday, February 09, 2015
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration is accepting through March 9 comments on the following types of export certificates it issues for FDA-regulated pharmaceuticals, biologics and medical devices.

- certificates to foreign governments for the export of products legally marketed in the U.S.

- certificates of exportability for the export of products not approved for marketing in the U.S. that meet certain requirements

- certificates of pharmaceutical products, which are 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 renewing, extending, 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 may be marketed in and legally exported from the U.S.

FDA states that for the first three types of certificates it will continue to rely on self-certification by manufacturers that they are in compliance with all applicable requirements, not only at the time they submit their request but also at the time they submit the certification to the foreign government.

In addition, 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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