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.
Products have already been approved for sale as natural health products while concurrently appearing in the NDS. This situation creates confusion for pharmacists and other stakeholders over the condition of sale for such products, and will only worsen over time as all DIN-labeled products that qualify as NHPs will fall under the NHP Regulations by January 1, 2010 at the latest.
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. Therefore these designated medicinal ingredients will be removed from the NDS once all eligible DIN-identified products become regulated under the NHP Regulations.
To assist in this transition, in the summer of 2006, NAPRA embarked on a project to identify all NHPs that were currently listed in the NDS. With the collaboration of staff from the Natural Health Product Directorate (NHPD), a total of 116 items were identified in the report entitled Identifying Natural Health Products Listed in NAPRA’s National Drug Schedules. The PDF version of the report contained on this page provides details on the study approach and results.
In October 2006, a joint meeting was held between NAPRA and Health Canada (NHPD and Therapeutic Products Directorate). It was agreed that further collaborative work would take place to ensure the full scope of the implications are understood. Health Canada officials recognized and acknowledged the Department’s role in ensuring the safe use of these natural health products, cognizant that they would be removed from the NDS.
NAPRA’s Policy for Natural Health Products was approved by the Board of Directors in November 2006.
July 2009
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 re-examine the policy for Natural Health Products. This review should be completed by spring 2010.
In the interim, the Board agreed that NHPs currently listed in the NDS be maintained in the drug schedules until the Board of Directors is apprised of the results of the re-examination and have made a decision. 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.
Policy for Natural Health Products
Identifying Natural Health Products Listed in NAPRA's National Drug Schedules
January 2010
In the fall of 2009, NAPRA’s Board of Directors discussed the issue of natural health products entering the market without a product licence from Health Canada. Under the federal drug approval process, natural health products and homeopathic products must complete a review process and obtain a product licence from Health Canada in order to be sold. The requirement of a product licence is a condition outlined in the Natural Health Products Regulations.
Once 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. Natural health products are identified by a Natural Product Number (NPN) and homeopathic products by 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 completed Health Canada’s review and is approved for sale.
NAPRA prepared a Position Statement to reinforce the fundamental requirement as outlined in federal regulations whereby marketed health products that have not been issued a product license by Health Canada for their sale should not be sold by pharmacists.
NAPRA Position Statement - Sale of Non-Approved Marketed Health Products
Déclaration de principe de l'ANORP - Vente de produits de santé commercialisés non autorisés