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February 11, 2009
Health Canada - Natural Health Product Monograph Probiotics

You can trust that Source Nutraceutical, Inc. will always keep you informed on the latest revisions to Canadian Food, Drug and NHP reguations.

Health Canada has recognized the need to address probiotics and associated claims based on recent industry activity and the lack of information available.

This monograph provides a review to provide some answers and outlines required materials to be submitted with their PLA forms. It is to be submitted to the NHPD upon request only (either directly or by authorized citation of an approved Master File).

The NHPD defines probiotic source material as the strain identifier of the bacterial or yeast species (Health Canada 2006). Product licence applicants must identify the strain of each bacterial or yeast species in their product in both the PLA and on the product label.

This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) for natural health product (NHP) market authorization of probiotics. It is not intended to be a comprehensive review of all probiotic organisms and possible health claims associated with them.