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Background on Update to NAPRA NHP Policy

NAPRA’s National Drug Schedules (NDS) were developed before Health Canada began regulating the sale of Natural Health Products (NHPs) in Canada. When the Natural Health Products Regulations came into force in 2004, many products that were included in the NDS became re-classified as NHPs by Health Canada. NAPRA determined that NHPs were beyond the scope of NAPRA’s NDS but agreed to maintain the ingredients that were already listed in the NDS on an interim basis, until direction could be provided regarding a framework for determining conditions of sale for NHPs in Canada. 

Only NHPs that were classified as drugs prior to 2004 have been part of the NDS. NHPs that have always existed as NHPs or new NHPs introduced into the market since then are not listed on the NDS. 

Given that the interim measure initiated many years ago only addresses the risk of a small subset of NHPs while others are available to consumers without directed conditions of sale, NAPRA has determined that this disparate approach is no longer in the best interest of the public. 

The requirements for authorizing NHPs for sale in Canada are significantly different than for traditional non-prescription drugs. The conditions of sale of NHPs cannot be fully addressed against the NDS scheduling processes. 

NAPRA will remove all NHPs currently listed within NAPRA’s National Drug Schedules (NDS) in a stepwise, risk-based approach:

  1. Effective January 2, 2020: NHPs that were listed within the Unscheduled category and within Schedule III were removed from the NDS. At Health Canada’s request, ephedrine and pseudoephedrine were to continue to be subject to the conditions of sale as outlined in NDS Schedule III until January 2, 2021. However, at Health Canada’s further request due to its focus in 2020 on a COVID-19 pandemic response, ephedrine and pseudoephedrine will remain subject to the conditions of sale as outlined in NDS Schedule III until January 2, 2022.
  2. Effective January 2, 2022: NHPs currently listed within Schedule I and II will be removed from the NDS. 

As of 2022, all products with a Natural Product Number (NPN) or Drug Identification Number-Homeopathic Medicine (DIN-HM) from Health Canada will be considered outside the scope of NAPRA’s National Drug Schedules. 

The number of NHP substances to be removed from or changed within NAPRA’s NDS:

Chart - NHP Changes

NAPRA has encouraged and continues to recommend the development of a framework that addresses the risks of the entire class of NHPs which would provide the public with a consistent and comprehensive approach to the sale of all NHPs in Canada. NAPRA will continue to work collaboratively with Health Canada and other relevant stakeholders to achieve an approach that better protects Canadians from the risks of all NHPs.