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ARCHIVED - Cover Letter - The Inspectorate's Annex to the Natural Health Products Compliance and Enforcement Policy (POL-0093)

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Health Products and Food Branch Inspectorate
Graham Spry Building, 3rd Floor
250 Lanark Avenue
Address Locator 2003B
OTTAWA, Ontario
K1A 0K9

Date August 27, 2010

To: All Interested Parties

I am pleased to inform you that the document entitled "Annex to the Natural Health Products Compliance and Enforcement Policy for exempt NHPs under the Natural Health Products (Unprocessed Product Licence Applications) Regulations (NHP-UPLAR) (POL-0093) is now available on the Compliance and Enforcement website. This annex is to be used in conjunction with the Natural Health Products Compliance and Enforcement Policy (POL-0044).

The purpose of this annex is to provide some clarification with respect to compliance and enforcement actions for exempt NHPs, as defined under the NHP-UPLAR. The NHP-UPLAR allow for the legal sale of certain NHPs for which Health Canada has not yet issued a product licence but has completed an initial assessment to ensure that information supporting the safety, quality and efficacy of the product has been provided, and that specific safety criteria have been met. These exempt NHPs are exempt from the prohibition against sale without a product licence as set out in s.4 of the NHPR.

This annex to the NHP C&E Policy will remain in effect for 30 months and will be removed upon the repeal of the NHP-UPLAR.

Inquiries about this document can be addressed to the Drug Compliance Verification and Investigation Unit, Fax: (613) 946 - 5636 or by E-Mail: DCVIU_UVCEM@hc-sc.gc.ca.

Original signed by

Diana Dowthwaite
Director General