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Canadian risk management-based regulatory scheme proposed for natural products.

This article was originally published in The Tan Sheet

Executive Summary

CANADA's "HIGHER/LOWER SAFETY" NATURAL PRODUCT DESIGNATION would allow certain natural health products to be eligible for marketing with only a post-market notification to the regulatory authority, while the remainder would be subject to pre-market assessments, the Canadian Advisory Panel on Natural Health Products says in a final report issued May 13. "The distinction between the two regulatory channels lies in the amount of available knowledge accepted in understanding and limiting potential risks, and in supporting any health benefit claims," the report says.

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