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Canadian drug user fees for product applications become effective Sept. 1.

This article was originally published in The Tan Sheet

Executive Summary

CANADIAN DRUG USER FEE SYSTEM WILL BE EFFECTIVE SEPT. 1 for premarket approval submission evaluations. Slated for publication in Part II of the Canada Gazette the week of Aug. 28, the "cost recovery" final regulation outlines fees that must be paid by prescription and nonprescription drug manufacturers for the review of drug-related submissions by the Canadian Health Protection Branch (HPB). The submissions evaluation fees are expected to bring in $25 mil. a year for HPB.

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