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FDA export certificate fee is $175 for first, $90 for second certificate.

This article was originally published in The Tan Sheet

Executive Summary

OTC DRUG EXPORT CERTIFICATE FEE IS $175 FOR FIRST, $90 FOR SECOND certificate with attachments for the same product issued in response to the same initial request. Subsequent certificates with attachments will cost $40, FDA states in a Nov. 6 Federal Register notice. The agency is requesting comment on the fee schedules by Feb. 6. The Center for Drug Evaluation & Research will require a fee payment of $15 for "second and subsequent certificates without attachments issued for the same product in response to the same request," the notice states.

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