Health Canada

What you need to know about self-care products and Health Canada.

This guide is for anyone working with drugs or natural health products. It will help facilitate understanding and compliance with sections of the Food and Drugs Act (the Act), the Food and Drug Regulations (FDR) and Natural Health Products Regulations (NHPR) that relate to recalls.

Anyone can report a side effect to a health or cannabis product. Your report can help make these products safer for all Canadians. Report the issue as soon as possible after the reaction or problem occurred. You should do this even if you are not sure if a particular health or cannabis product...

This labelling standard describes the requirements necessary to receive marketing authorization (Drug identification number (DIN)) for oral expectorant nonprescription product containing guaifenesin as a single ingredient for use in adults and children 12 years of age and older to relieve...

This policy outlines Health Canada's current approach with respect to compounding of NHPs. The NHP Compounding Policy distinguishes between the manufacturing of natural health products, an activity regulated by the Natural Health Products Regulations (NHP Regulations), and the compounding of...

The Natural Health Products Regulations (NHP Regulations) do not specify whether raw materials are or are not included in the definition of a natural health product (NHP). The NHP definition mentions neither raw material (e.g., ginger root that has just been harvested) nor finished product (e.g.,...

This labelling standard describes the requirements necessary to receive market authorization (a Drug Identification Number (DIN)) for non-prescription oral antitussive products containing dextromethorphan or dextromethorphan hydrobromide as a single ingredient for use in adults and children 12...

To help facilitate the free-flow of natural health products across Canada's borders, Health Canada has established several Mutual Recognition Agreements (MRAs) and Memoranda of Understanding (MOUs) with foreign regulatory bodies on matters of common interest. The following section provides...

Natural toxins are chemicals that are naturally produced by living organisms. These toxins are not harmful to the organisms themselves but they may be toxic to other creatures, including humans, when eaten.

When you buy non-prescription (over-the-counter) medications for you and your family, you need information to help you make an informed choice.

The Government of Canada is committed to oversight for natural health products that protects consumers' health and safety while enabling them to choose from a wide range of alternative products that have been assessed for safety, effectiveness and quality.

A non-prescription drug Category IV Monograph outlines the permissible conditions of use and labelling requirements, such as dose, intended use, directions for use, warnings, active ingredients and combinations thereof.

Labelling standards are developed for drugs that have a well characterized safety and efficacy profile under specific conditions of use. A manufacturer may reference a labelling standard in a drug submission when the product and its labelling are consistent with the information set out in the...

Under this Framework, Health Canada will advance a new approach to the regulation of consumer health products. The key enabler of the approach is the proposal to create new regulations for non-prescription drugs, supported by ongoing operational improvements.

Health Canada assesses NHPs for their safety, effectiveness and quality before they are authorized for sale in Canada. NHPs that have been licensed by Health Canada are labelled with either a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM). Despite this licensing process,...

Alcohol-based hand sanitizers must comply with: the Alcohol-based hand sanitizers in beverage and food containers: Packaging and labelling requirements to reduce unintentional ingestion risk

Health Canada information for the public on natural health products

When a company decides it would like to sell a drug or vaccine in Canada, it files a submission with Health Canada. A new drug submission contains detailed scientific information about the drug's safety, efficacy and quality. Health Canada scientific reviewers evaluate data to assess the...

The list below includes all applications received by Health Canada for drugs and vaccines used for the COVID-19 pandemic. This list includes applications received under the interim order and those received under the Food and Drug Regulations. The current status of each application is also noted.

Drugs and vaccines that have been authorized by Health Canada for use in relation to the COVID-19 pandemic are listed here.