New approval process for natural health products
March 5, 2013
As of Feb. 4, the Natural Health Products (Unprocessed Product Licence Applications) Regulations were repealed. Now, only products that have received a market authorization or product licence from Health Canada are approved for sale in Canada. Authorized products in Canada will bear a Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM).
The Natural Health Products (Unprocessed Product Licence Applications) Regulations (NHP-UPLAR) were put into effect two-and-a-half years ago to address unprocessed natural health product applications.
- From Aug. 4, 2010 to Feb. 3, 2013, the Regulations allowed for the sale of a category of products for which Health Canada had not yet issued a product license but had completed an initial assessment to ensure that information supporting the safety, efficacy and quality of the product had been provided and that specific safety criteria had been met. These products received an Exemption Number (EN).
- With the repeal of the NHP-UPLAR, Exemption Numbers will no longer be used. However, it is possible that some products that still display an EN may have received an NPN or DIN-HM because the change in labelling of the product has not been completed. Health Canada offered a period of transition (until September 2014) to retailers to phase out their stock of approved products with non-compliant labeling.
- When presented with a product with an EN number, pharmacists should verify its status by searching for the product on Health Canada’s Natural Health Products Exempted Products Database. Once the product information is displayed, pharmacists should verify the status field for that product. Below is a chart outlining how to interpret the information provided on the Exempted Products Database.
Links to Health Canada’s Databases for natural health products:
Natural Health Products (NHP) Exempted Products Database (for products with EN)
Licensed Natural Health Products (NHP) Database (for products with NPN or DIN-HMs)
If you are unsure about the status of a product, you may want to contact Health Canada at firstname.lastname@example.org or call 613-960-8827 or toll-free at 1-800-OCANADA (1-800-622-6232) to obtain clarification.