Health Canada and the National Association of Pharmacy Regulatory Authorities (NAPRA) both have roles related to drug scheduling in Canada. These roles are separate and distinct, with each organization performing specific functions within the drug scheduling process.
Health Canada has the authority and responsibility to authorize health products (e.g., drugs, natural health products, medical devices) for sale in Canada. It is the responsibility of Health Canada to evaluate the safety, efficacy and quality of health products and to provide an authorization for sale in Canada. Only with an authorization and/or licence from Health Canada would a manufacturer be permitted to sell a health product in Canada.
During its review of a particular health product, Health Canada will also classify the health product into various types, such as medical device, natural health product or drug product. Health Canada will further classify drug products into additional categories, such as controlled substance, biologic product, prescription drug, or non-prescription drug. This can occur by placing a drug on the schedules that are part of federal laws and regulations and thus is sometimes called drug scheduling. This is a separate and distinct process from the NAPRA drug scheduling process, which is explained in the next section.
During its evaluation of the safety, efficacy and quality of each drug product, Health Canada will determine whether or not a prescription is required for sale of the drug in Canada. Drugs that Health Canada has determined require a prescription for sale in Canada are listed on the Health Canada Prescription Drug List (PDL) or in the schedules to the Controlled Drugs and Substances Act and its regulations. Once Health Canada classifies a drug as requiring a prescription for sale, then it requires a prescription for sale in all of Canada.
More information on Health Canada’s role in drug scheduling and in the authorization of health products for sale in Canada can be found on the Health Canada website.
NAPRA and the National Drug Schedules
NAPRA’s role in the drug scheduling process occurs after Health Canada has authorized a drug for sale in Canada and determined whether the drug requires a prescription for sale. NAPRA does not have any role or authority in the authorization of new health products for the Canadian market and does not review products that have been classified as requiring a prescription by Health Canada.
While the federal government determines certain conditions of sale, such as the need for a prescription, provincial/territorial governments have the ability to further specify the conditions of sale of drug products. Prior to 1995, each province and territory had its own system for determining the conditions of sale for non-prescription drugs in Canada, leading to wide variability in the way drugs were sold across Canada.
In 1995, NAPRA’s members, the pharmacy regulatory authorities across Canada, endorsed a proposal for a national drug scheduling model, to align the provincial/territorial drug schedules so that the conditions of sale for drugs would be more consistent across Canada. This harmonized national model is administered by NAPRA and is called the National Drug Schedules (NDS) program.
All of the provinces and territories, except Quebec, have adopted the NDS in some manner. The NDS come into force in each province/territory through provincial/territorial legislation. In some cases, the NDS are directly referenced in provincial/territorial legislation, while in others additional actions are required to implement the NDS recommendations. See the section on the Implementation of the NDS Across Canada for more information.
In general, the NDS capture drugs that have been authorized for sale and classified as non-prescription by Health Canada. Other products approved by Health Canada (e.g., natural health products, medical devices) are outside the scope of the program and are not considered products for scheduling within the NDS.
The NDS program, which consists of three schedules and four categories of drugs (Schedule I, Schedule II, Schedule III and Unscheduled), outlines the conditions of sale for each drug schedule.
The chart* below outlines the classification system used by Health Canada and NAPRA.