Health Canada has issued a notice regarding its approach to the refusal of Product License Applications. The approach is posted at http://www.hc-sc.gc.ca/dhp-mps/prodnatur/bulletins/pl-ref-lp_e.html.
If a product licence application (PLA) has been refused by the Natural Health Products Directorate, the submission number associated with that product becomes invalid. The Notice of Refusal issued to the applicant will indicate the reason(s) for the refusal and will also make reference to compliance and enforcement actions applied by Health Canada.
Unapproved natural health products (NHPs) that are for sale in Canada and have had their product licence applications refused will be subject to compliance action in accordance with the Compliance Policy for Natural Health Products. In the event that an application is refused due to concerns with the product's safety, efficacy and/or quality, the applicant must stop sale and recall the product from the market or face immediate compliance and enforcement action.
In accordance with section 9(2) of the Natural Health Products Regulations, applicants receiving a Notice of Refusal have 30 days to appeal the decision and request that their application be reinstated. Should applicants fail to submit their appeal within the 30-day timeframe or, if following a review of the appeal, the refusal of the application stands, the compliance and enforcement approach described above will be applied.
Applicants intending to resubmit a product licence application are encouraged to carefully read the Notice of Refusal and ensure that the issues which lead to the refusal of their initial application are addressed in their new product licence application or else it will also be refused.
Applicants should refer to the following table for information on what constitutes a "complete" product licence application: Information Requirements for Product Licensing