2,810 datasets found

Guidance to market authorization holders on issuing health product risk communications: Definitions.

Any drugs sold to Canadians must remain safe and effective after they are approved for prescription and sale. Learn about good pharmacovigilance practices (GVP) and how Canada...

This document includes guidance for companies (applicants) who wish to put forward submissions/applications to request a switch of an ingredient from prescription to non-...

This document provides guidance on how fees for the right to sell drugs will be administered in accordance with the Food and Drugs Act and as stipulated in the Fees in Respect...

Clinical trials can be an important treatment option. However, like all drugs, the drugs used in clinical trials have possible benefits and risks. There is often less...

The term Medical Devices covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical...

The Cannabis Regulations define an adverse reaction, also known as a side effect, as a noxious (harmful, unpleasant) or unintended response to a cannabis product.

This guideline technical document evaluated the available information on antimony with the intent of updating the guidelines for antimony in drinking water. The purpose of this...

When outdoor air quality is poor, Health Canada recommends that individuals, particularly children, the elderly and those with pre-existing health conditions remain indoors as...

Canadians want the facts. Their question to experts: What are the risks of driving high? Find out the response.

Heroin is made from morphine, a substance that comes from the opium poppy. It is highly addictive. The withdrawal symptoms can be painful. An overdose can be fatal.

Health Canada develops and enforces regulations under Government of Canada legislation. The Department consults with the Canadian public, industry and other interested parties...

There are diagnostics tests, masks and a thermal camera now available through an Interim Order that allows expedited access to COVID-19-related medical devices. Health Canada...

As a result of the screening assessment, the Government concluded that used oil residue, used vacuum gas oil, C12-25 used distillate, C5-18 used distillate, used light oil,...

To develop options for the registration and disclosure of clinical trial information of health products in Canada, Health Canada began consulting with Canadians in 2005.

This safety review was carried out to look at new information in the scientific literature that has emerged since the completion of a previous review in 2012 about the risk of...

Source water characterization should be part of routine system assessments. Boron is not widely distributed in source water in Canada and tends to be present at elevated...

This section of the guidance provides criteria and examples to help you classify a safety or efficacy related change. Examples are not exhaustive and are meant to provide...

The table below lists the clinical trials authorized by Health Canada for COVID-19-related medical devices.

Acetaminophen is safe and effective when used as directed, but there is a limit to how much you can take in one day. Taking more than the recommended dose can cause severe or...