Since the Natural Health Products Regulations took effect in January 2004, the applicability of NAPRA’s National Drug Schedules (NDS) to natural health products (NHPs) has been raised a number of times with NAPRA’s Board, the Council of Pharmacy Registrars of Canada (CPRC), the National Drug Scheduling Advisory Committee (NDSAC) and Health Canada.
In April 2006, NAPRA’s Board of Directors clarified that natural health products, as designated by a Natural Product Number (NPN) or Drug Identification Number-Homeopathic Medicine (DIN-HM), are beyond the scope of NAPRA’s NDS. The principle rationale was that the requirements for obtaining market authorization for NHPs were based on a different paradigm than for traditional pharmaceuticals, and that the monitoring and enforcement of conditions for sale of NHPs were beyond the scope of pharmacy regulatory authorities.
To support this decision, NAPRA’s Policy for Natural Health Products was approved by the Board of Directors in November 2006.
As a result of new information provided by Health Canada’s Natural Health Products Directorate, the Board of Directors decided at its April 2009 meeting to reexamine the Policy for Natural Health Products. The review was completed in 2011.
At the conclusion of the review process, the Board maintained its decision that NHPs are not considered products for scheduling within the NDS. However after consultation with stakeholders, the Board agreed that NHPs currently listed in the NDS be maintained in the drug schedules on an interim basis. This means that a product currently listed in the NDS will remain there for the time being even though the product may have received a Natural Product Number.
NAPRA's Policy for Natural Health Products
Sale of Non-Approved Marketed Health Products
Once a marketed health product is approved for sale - approval follows a review by Health Canada for the product’s safety, efficacy and quality - a number is provided to identify the marketed health product.
Only products that have received a market authorization or product licence from Health Canada are approved for sale in Canada. Authorized products will bear a Drug Identification Number (DIN) or a Natural Product Number (NPN) or a Drug Identification Number for Homeopathic Medicine (DIN-HM). These numbers serve as a means for the public and health care professionals to know that the product is authorized to be sold on the Canadian market.
The Natural Health Products (Unprocessed Product Licence Applications) Regulations promulgated by Health Canada in August 2010 have now been repealed eliminating the temporary category of authorized products known as Exempted, having an Exemption Number (EN). More information regarding the repeal of the NHP-UPLAR can be found on the Health Canada website.