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Module 2: Reporting processes to Health Canada
Educational module includes considerations for mandatory reporting of adverse drug reactions and medical device incidents, reporting options to Health Canada, differentiating... -
Proposed Registration Decision PRD2020-11, Silicon Dioxide (Present as 100%...
This summary describes the key points of the evaluation, while the Science Evaluation of Proposed Registration Decision PRD2020-11, Silicon Dioxide (Present as 100% Diatomaceous... -
Guidance document - Nonprescription oral adult expectorant cough and cold...
This labelling standard describes the requirements necessary to receive marketing authorization (Drug identification number (DIN)) for oral expectorant nonprescription product... -
Novel Food Information: Highly Refined DHA-Enhanced Oil Derived from...
Health Canada has notified Nuseed Americas that it has no objection to the food use of highly refined oil derived from NS-B5ØØ27-4 canola. The Department conducted a... -
Completed requests for disclosure of confidential business information under...
The list below summarizes completed requests for Health Canada to use its authority to disclose confidential business information (CBI). -
Label Process Changes: Part 2: Guidance for Industry
The purpose of this document is to provide guidance to industry on the implementation of the label process changes described in the companion document LPS2003-01, Label Process... -
Summary Safety Review - AUBAGIO (teriflunomide) - Assessing the potential...
Health Canada reviewed the potential risk of colitis with Aubagio use after finding reports (since being marketed) of colitis as part of routine review of information received... -
Canada Consumer Product Safety Act: Protecting Consumers through Product Safety
Brochure on protecting consumers through product safety. This document is a summary provided for convenient reference but should not be interpreted as Health Canada policy or a... -
Science Policy Note: Assigning Values to Nondetected/Nonquantified Pesticide...
The following document is a policy/guidance document that reflects the United States Environmental Protection Agency's (U.S. EPA's) recent dietary risk assessment science... -
Human Health Risk Assessment for Diesel Exhaust – summary
Health Canada completed the Human Health Risk Assessment for Diesel Exhaust, a comprehensive review and analysis of the potential adverse health effects associated with diesel... -
Summary Safety Review - Viscous Lidocaine 2% - Assessing the Potential Risk...
Health Canada carried out a safety review to assess the potential risk of severe side effects in infants and young children with the use of viscous lidocaine. The issue was... -
Official Method: Determination of the Disintegration Time of Tablets
1989 Health Canada method to be used to measure the disintegration time of uncoated, plain coated and enteric coated tablets, intended to be swallowed whole, as described in the... -
Chlorocresol - information sheet
As a result of the screening assessment, the Government concluded that chlorocresol is harmful to human health, but not to the environment, at levels of exposure considered in... -
2. List of Permitted Bleaching, Maturing or Dough Conditioning Agents (Lists...
This List of Permitted Bleaching, Maturing or Dough Conditioning Agents sets out authorized food additives that act on flour or dough to improve dough handling properties or... -
Cross-Canada Survey of Radon Concentrations in Homes - Final Report
Radon is a radioactive gas that is found naturally throughout our environment. It is produced by the decay of uranium found in rocks and soil. Since radon is a gas, it can move... -
Guidelines for environmental control of drugs during storage and...
These guidelines will help all persons (individuals and companies) who store and/or transport drugs to comply with Canada’s Food and Drugs Act (the Act) in accordance with... -
Drug product announcements
COVID-19 and other drug product announcements until July 2023. -
Federal Contaminated Site Risk Assessment in Canada, Part VI: Guidance on...
This guidance document was prepared to provide guidance for federal departments. -
Guidelines for Canadian Recreational Water Quality: Indicators of Fecal Contamination
This guideline technical document evaluated the available information on fecal indicator organisms in recreational waters with the intent of updating/recommending guideline... -
Microwave ovens
Microwave ovens provide a convenient way to thaw, cook, and reheat food. They are now common in most Canadian homes and restaurants, and are found in many commercial and...