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Current Natural Health Product Regulation – The Main Points You Need to Know

 -2014-04-10


The Natural Health Products Directorate (NHPD) is a branch of Health Canada tasked with the responsibilities of framing legislation and assessing new products prior to marketing to help ensure the safety, quality, and efficacy (effectiveness) of natural health products (NHP) for sale in Canada, under federal and Health Canada mandates. Natural health products that have completed the process of NHPD/Health Canada assessment for safety, quality, and efficacy are granted Natural Product Numbers (NPN), or for homeopathic medicines, a DIN-HM. Exemption numbers (EN) used to be assigned to products that had been in the process of product assessment by NHPD (but not yet approved) for at least 6 months, which would allow the marketing of the product in the interim, until completion of assessment resulting in either an approval (product licensing by granting of an NPN or DIN-HM) or a refusal (product recall if being sold). NHPD no longer granted ENs as of March 2013.

As of December 1st, 2013, only approved products with NPNs /DIN-HMs can be sold by manufacturers. So, retailers/distributors take note – manufacturers should only be selling you products with full NPNs/DIN-HMs.  No ENs, and no products without a number! Checking whether a product has authorization can be done by looking for a number preceded by the letters ‘NPN’ or ‘DIN-HM’ on the product label. To observe a product label that has completed full safety and efficacy assessment and has been approved by the NHPD, visit the NHPD Licensed  Natural Health Products Database (the search webpage for authorized NHPs by Health Canada) http://webprod5.hc-sc.gc.ca/lnhpd-bdpsnh/index-eng.jsp , and search using the numbers that follow the letters ‘NPN’ or ‘DIN-HM’, or the brand name.

Coming up in the third quarter of the year, September 1st, 2014 will mark the end of the transition period for distributors/retailers, after which distributors/retailers can only sell NHPs that have regulatory market authorization (NPNs/DIN-HMs, but no ENs). Essentially, September 1st, 2014 is when NHP Regulations and Compliance and Enforcement Policy come into full effect.


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