On December 22, 2010 the Natural Health Products Industry was informed by the NHPD that the compliance promotion transition period which was slated to end on March 1, 2011 is being extended and that the implementation of the new Compliance and Enforcement (C&E) Policy is postponed until further notice.
This deferral is the result of NHPD’s ongoing discussions with the Natural Health Products Program Advisory Committee (NHP-PAC) regarding the Standards of Evidence (SOE) for Non-traditional NHPs. The NHPD published a report in September 2010 responding to the NHP-PAC’s 33 recommendations on the SOE for Non-Traditional NHPs (http://www.hc-sc.gc.ca/dhp-mps/prodnatur/activit/com/soe-rep-npr-rap-fin-eng.php ). The NHPD is currently considering revisions to the guidance document to clarify and elaborate the SOE, and also plans to meet with the NHP-PAC in January.
In contrast to the policy enforced during the compliance promotion transition period, under the C&E Policy for NHPs, products with submission numbers are not recognized as lower enforcement priorities and are, therefore, subject to recalls and stop sales if sold within Canada. Once the C&E policy is implemented only products with licenses (NPNs, DIN-HMs) and exemption numbers (ENs) are legally permitted to be imported and sold in Canada.
We can all breathe a sigh of relief that the C&E policy will not be implemented as of March 1 as this will allow the NHPD to finalize the SOE for Non-traditional NHPs and will afford industry additional time to come into compliance with the Natural Health Product Regulations.
It is still quite imperative to file your NHP applications as soon as possible to maximize the chances that you will have your ENs by the date on which the C&E policy is implemented. As always, Dicentra is here to ensure that your applications are of the utmost quality. Please let us know how we can help you in 2011 and in the years to come.
The Dicentra Team