Policy for Drugs Not Reviewed

Since the establishment of the National Drug Schedules (NDS), there have been a few cases in which a manufacturer of a new non-prescription drug or deregulated drug (one that was switched from prescription to non-prescription status) has not requested a national drug scheduling recommendation by the National Drug Scheduling Advisory Committee (NDSAC) and accordingly, a national drug schedule assignment has not been made. This may occur because, among other reasons, the manufacturer decides not to market the new non-prescription drug in Canada or is unaware of the national scheduling process.

In the absence of an NDSAC review and information to support a specific non-prescription drug status, federally deregulated and newly approved non-prescription drugs are placed in Schedule I of the national drug scheduling model and identified accordingly.

Policy for Natural Health Products

Natural health products (NHPs) approved for sale under the Natural Health Product Regulations are not considered products for scheduling within the National Drug Schedules (NDS).

As of 2024, 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 NDS.

The Background on Update to NAPRA NHP Policy (see below) explains the history of natural health products as they relate to the NDS and the NAPRA Policy for Natural Health Products. 

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

Given that NHPs were determined to be outside the scope of the NDS and that the interim measure only addressed the risk of a small subset of NHPs while others were available to consumers without directed conditions of sale, NAPRA determined that this disparate approach was no longer in the best interest of the public. In 2019, NAPRA updated its Policy on Natural Health Products to remove the small subset of NHPs remaining in the NDS. This decision was meant to clarify for the public that Health Canada is responsible for ensuring the safety of NHPs available for sale in Canada and to further encourage the development of a more comprehensive framework that would better protect Canadians from the risks of all NHPs.

To allow time for stakeholders to adapt, NAPRA implemented a stepwise, risk-based approach to the removal of NHPs from the NDS. NHPs in lowest risk categories were removed from the NDS in January 2020, while NHPs in the other categories were removed in January 2022.

In consideration of the impact of the COVID-19 pandemic and the substance use crisis in Canada, a decision was made to delay the removal of two ingredients with higher risk, ephedrine and pseudoephedrine, until January 2024, to allow time for the federal government to consider the most appropriate risk mitigation measures for these ingredients.

NAPRA will remove 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, with the exception of ephedrine and pseudoephedrine.
  2. Effective January 2, 2022: NHPs that were listed within Schedule I and II were removed from the NDS, with the exception of ephedrine and pseudoephedrine.
  3. Effective January 2, 2024: ephedrine and pseudoephedrine will be removed from the NDS.

As of 2024, 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 NDS.

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

NAPRA believes the public interest will be best served through the development of a more comprehensive framework from the federal government that would better protect Canadians from the risks of the entire class of NHPs. As such, NAPRA will continue to engage in ongoing opportunities to further encourage the development of such a framework.