NAPRA is frequently asked what the role of Health Canada is with respect to drug scheduling and where NAPRA fits in. In short, Health Canada is responsible for market authorization and, within certain parameters, NAPRA determines where the product may be sold. The specific and distinct roles of Health Canada and NAPRA are outlined below to better clarify each organization’s role in the drug scheduling process.
Health Canada has the authority and responsibility to evaluate products for safety and efficacy and to approve health products (e.g. drugs, natural health products, medical devices) for sale in Canada. Only with an authorization or licence from Health Canada would a manufacturer be permitted to sell its products in Canada.
NAPRA’s role in the drug scheduling process occurs after the product receives Health Canada approval for market authorization. NAPRA does not have any role or authority in the approval of new health products for the Canadian market.
In addition, Health Canada decides what medicinal ingredients when found in a drug require a prescription. These medicinal ingredients are found in a Prescription Drug List maintained by Health Canada or are listed in the schedules of the Controlled Drugs and Substances Act and its regulations.
NAPRA and the National Drug Schedules
NAPRA’s role in drug scheduling begins after Health Canada has authorized a health product for sale in Canada and determined whether a medicinal ingredient requires a prescription to be sold. Beyond whether a medicinal ingredient requires a prescription, all other decisions about the conditions of sale for drug products are a provincial/territorial responsibility. NAPRA’s members, the pharmacy regulatory authorities throughout Canada, are the bodies with the responsibility to determine the conditions of sale of drug products.
In 1995, NAPRA’s members endorsed a proposal for a national drug scheduling model, to align the provincial drug schedules so that the conditions for the sale of drugs would be consistent across Canada. This harmonized national model is administered by NAPRA and is called the National Drug Schedules program. The program consists of three schedules or four categories of drugs, consistent scheduling factors, a standard process, and a National Drug Scheduling Advisory Committee which makes scheduling recommendations to NAPRA.
In general, the National Drug Schedules encompass the scheduling of drug products that have been approved for sale and classified as over-the-counter by Health Canada. Other products approved by Health Canada (e.g. natural health products, medical devices) are outside of the scope of the program and are not considered products for scheduling within the National Drug Schedules, with the exception of a few older products with a Natural Product Number (NPN).
When NAPRA reviews a product that has been approved by Health Canada, NAPRA’s decision on scheduling can be more restrictive than Health Canada’s but never less restrictive than Health Canada’s. For example, Health Canada may make a drug a non-prescription drug, but upon considering a range of factors, NAPRA may decide to have it sold by prescription.
For more information about the National Drug Schedules program, please explore this section in more detail. In addition, questions can be directed to the Manager of Professional and Regulatory Affairs.