In general, the NDS capture drugs that have been authorized for sale and classified as non-prescription by Health Canada. See the section on the Implementation of the NDS Across Canada for more information. In some cases, the NDS are directly referenced in provincial/territorial legislation, while in others additional actions are required to implement the NDS recommendations. The NDS come into force in each province/territory through provincial/territorial legislation. This harmonized national model is administered by NAPRA and is called the National Drug Schedules (NDS) program.Īll of the provinces and territories, except Quebec, have adopted the NDS in some manner. 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. 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. 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. 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. 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.
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. Once Health Canada classifies a drug as requiring a prescription for sale, then it requires a prescription for sale in all of 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. This is a separate and distinct process from the NAPRA drug scheduling process, which is explained in the next section.ĭuring 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. 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. Health Canada will further classify drug products into additional categories, such as controlled substance, biologic product, prescription drug, or non-prescription drug.
Only with an authorization and/or licence from Health Canada would a manufacturer be permitted to sell a health product in Canada.ĭuring 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.
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. Health Canada has the authority and responsibility to authorize health products (e.g., drugs, natural health products, medical devices) for sale in Canada.
These roles are separate and distinct, with each organization performing specific functions within the drug scheduling process. Health Canada and the National Association of Pharmacy Regulatory Authorities (NAPRA) both have roles related to drug scheduling in Canada.
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