Important Changes to the NHPs listed in NAPRA’s National Drug Schedules

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The National Association of Pharmacy Regulatory Authorities (NAPRA) is updating its policy on and approach to Natural Health Products (NHPs) in NAPRA’s National Drug Schedules (NDS) with the best interest of the public as its first and foremost concern.

NAPRA will be removing NHPs currently listed within the NDS in a stepwise, risk-based approach:

  1. Effective January 2, 2020: NHPs currently listed within the Unscheduled category and within Schedule III will be removed from the NDS
  2. Effective January 2, 2022: NHPs currently listed within Schedules I and II will be removed from the NDS

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.

NAPRA’s NDS were developed before Health Canada began regulating the sale of 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 products that were already in the NDS on an interim basis, until direction could be provided regarding a framework for determining conditions of sale for NHPs in Canada. Since the NHPs in NAPRA’s NDS represent only a small percentage of all NHPs currently regulated by Health Canada, the interim measure only addressed the risk of this small subset of NHPs.

NAPRA has determined that this approach is no longer in the best interest of the public and continues to encourage the development of a framework that addresses the risks of the entire class of NHPs.

Information regarding these important changes are available at napra.ca.