We are pleased to inform you that on Friday August 27, 2010, the documents entitled “Natural Health Products (NHP) Compliance and Enforcement Policy” (POL-0044), “Annex to the NHP Compliance and Enforcement Policy for exempt NHPs under the Natural Health Products (Unprocessed Product Licence Applications) Regulations (NHP-UPLAR) (POL-0093)” as well as “Questions and Answers for the Natural Health Products Compliance and Enforcement Policy” will be available on the Compliance and Enforcement section of Health Canada’s website at the following address: http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/prodnatur/index-eng.php.
The NHP Compliance and Enforcement Policy describes the compliance and enforcement approach respecting natural health products (NHPs) under the Food and Drugs Act (FDA) and the Natural Health Products Regulations (NHPR) and is to be used in conjunction with the Compliance and Enforcement Policy 0001. This policy replaces the previous policy “Compliance Policy for Natural Health Products” last revised in 2008 as well as the “Compliance Guide for NHPs” (Version 2.1, 2007).
The implementation of this new NHP C&E Policy is being followed by a six month compliance promotion transition period. This period of compliance promotion will allow for the transition from the old policy to the new policy regarding the product licensing requirements for NHPs. As such, regulated parties that have already taken steps to come into compliance with the product licensing requirements and have an active submission number with the NHPD will be considered a lower priority for enforcement, unless a risk to health or additional non-compliances are identified. This position is consistent with the position which was outlined in the previous Compliance Policy for NHPs (2008). During this period, compliance and enforcement efforts will focus on regulated parties that have not taken steps to come into compliance and/or products that pose a risk to health.
This policy is also being implemented with the “Annex to the NHP Compliance and Enforcement Policy for exempt NHPs under the Natural Health Products (Unprocessed Product Licence Applications) Regulations (NHP-UPLAR)”. The annex has been developed in order to provide clarification on the compliance and enforcement approach for products that are exempt under the NHP-UPLAR. This Annex is meant to be used in conjunction with the new NHP Compliance and Enforcement Policy, and will remain in effect for 30 months until the NHP-UPLAR are repealed.
In May and June 2010, these policies were presented to stakeholders as part of the Natural Health Products Program Workshops held in various cities across Canada.
Attached below are these documents for your reference.
The Health Products and Food Branch Inspectorate,