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Benefits for companies participating in Canada's Access to Medicines Regime
Canada's Access to Medicines Regime is intended to address public health problems afflicting many developing and least-developed countries, especially those resulting from... -
Annex: About the Consumer Product Safety Program
Mission: Contribute towards a safe marketplace for consumer products and cosmetics by preventing, detecting and responding to adverse health occurrences to Canadians. -
Guidance Document - Human-Use Antiseptic Drugs
An antiseptic product is considered to be one that inactivates, reduces, prevents or arrests growth of microorganisms with the inherent intent to mitigate or prevent disease.... -
Transition Book for the Deputy Minister – Heath Canada
Deputy Minister Briefing Material – September 2019 - Overview of Health Canada as well as information on Governance and Operations. -
Reduce noise from consumer products
Some consumer products make noise loud enough to damage your hearing. -
Health Canada’s Proposal to Lower the Maximum Levels of Lead in Concentrated...
foods. These substances can either be inadvertently or naturally present in foods or, in some cases, intentionally added for fraudulent purposes. Establishing a prohibition or a... -
A guide to the new disaggregated data questionnaire for drug submissions
Health Canada uses disaggregated data to analyze the safety and efficacy of health products. The collection and analysis of disaggregated data in clinical trials is key to... -
Notice of Amendment: Tramadol removed from the Prescription Drug List (PDL)
The purpose of this Notice of Amendment is to notify that Health Canada has removed tramadol from the Prescription Drug List (PDL) and added it to Schedule I of the Controlled... -
Guidance Document: Part C, Division 5 of the Food and Drug Regulations...
This guidance document will help anyone who is involved in the conduct of clinical trials of drugs in humans to understand and comply with Part C, Division 5 of the Food and... -
Guidance Document - Quality (Chemistry and Manufacturing) Guidance: Clinical...
To assist submission sponsors in preparing Clinical Trial Applications (CTAs) filed with Health Canada by outlining the Quality (chemistry and manufacturing) technical... -
Proposed regulations for additional cannabis products
Types of cannabis product and proposed regulations associated -
Post-Notice of Compliance changes: Guidance for safety and efficacy of...
This guidance helps to classify safety and efficacy changes made to new drugs that have received a Notice of Compliance (NOC) pursuant to section C.08.004 of the Food and Drug... -
Stay Informed Medeffect Canada
MedEffect Canada uses a variety of mechanisms to share information and to help you stay informed about advisories and recalls that are issued by Health Canada, as well as by... -
Cyclical Enforcement Project 2019-2020: Toys Regulations
The purpose of this Cyclical Enforcement (CE) project was to verify industry’s compliance of toys with the specific requirements of the Toys Regulations. -
Health Product InfoWatch: July 2023
The following is a list of health product advisories, type I recalls and summaries of completed safety reviews published in July 2023 by Health Canada. -
Medical devices for COVID-19: Conducting a clinical trial
Manufacturers of medical devices intended to treat COVID-19 can choose between 2 different processes to apply for a trial authorization: process for investigational testing... -
Registration and notification guide for donor sperm and ova establishments (GUI-0128)
This document provides guidance related to the registration and notification requirements under the Safety of Sperm and Ova Regulations (Safety Regulations) which are made under... -
Guidelines for Canadian recreational water quality: Microbiological...
Numerous pathogenic microorganisms can potentially be found in recreational environments. The three main types are bacteria, viruses and protozoa. Many occur as a result of... -
Adulteration of Natural Health Products
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...