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Catalogue Entry: Canadian Health Measures Survey (CHMS) Human Biomonitoring Data for...
Human biomonitoring is used to estimate exposure to environmental chemicals by measuring the chemical, its metabolites, or reaction products in biological specimens. Since 2007,... -
Catalogue Entry: Filing a drug or device marketing complaint
You may see or receive drug or device marketing. You can help us identify and report any suspected illegal marketing by: submitting a complaint using the complaint form or...-
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Catalogue Entry: Education modules to meet requirements for mandatory hospital reporting
Hospitals must report all serious adverse drug reactions (ADRs) and medical device incidents (MDIs).-
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Catalogue Entry: Data extracts from the Canada Vigilance adverse reaction online database
The data set is updated on a monthly basis and currently covers the following time period: 1965 to 2023-10-31. The data extract is a series of compressed ASCII text files of the...-
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Catalogue Entry: Clarification of section 4.3 (Regulatory Authority Sources) of the Reporting...
The intent of this notice is to clarify Health Canada’s expectations with respect to the re-reporting of cases identified from the Canada Vigilance (CV) Online Database by...-
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Catalogue Entry: Canada Vigilance Program - Collecting and Assessing Adverse Reaction Reports
The Canada Vigilance Program collects and assesses reports of suspected adverse reactions to marketed health products in Canada, including prescription and non-prescription...-
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Catalogue Entry: Advisories, Warnings and Recalls – Drugs and health products
The Recalls and Safety Alerts Database provides easy access to a comprehensive list of recalls, advisories, and safety alerts. This database includes recalls from Health Canada,...-
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Catalogue Entry: Advisories and Recalls – MedEffect Canada
The Recalls and Safety Alerts Database provides easy access to a comprehensive list of recalls, advisories, and safety alerts. This database includes recalls from Health Canada,...-
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Catalogue Entry: Advertising requirements for drugs and medical devices
Health product advertising directly or indirectly promotes the sale or use of any health product. This can be done by any means including: print, Internet, and broadcast. Only...-
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Catalogue Entry: Adverse Reaction Reporting Information
Health Canada information related to adverse reaction reporting of drugs and health products on the Canadian market-
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Catalogue Entry: Adverse Reaction Reporting and Health Product Safety Information - Guide for...
MedEffect™ Canada provides a simple and efficient means for health professionals to report an adverse reaction to the Canada Vigilance Program. It also serves as a centralized...-
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Catalogue Entry: About medical device problems
A medical device is any instrument or component used to treat, diagnose or prevent a human disease or abnormal physical condition. Page about what medical device problems are...-
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Catalogue Entry: About Health Product Surveillance
Health Canada makes sure that the known serious risks are written on the product label or product monograph, as well as provides information on how to manage these risks, so...-
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Catalogue Entry: About adverse reactions (side effects)
An adverse reaction or side effect is a harmful and unintended response to a health product. The reaction occurs at doses normally used.-
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Catalogue Entry: A strategy to optimize the use of real-world evidence across the medical...
This strategy document outlines the steps to be taken in order to optimize the use of RWE to improve the safety and effectiveness of medical devices across the product life...-
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Catalogue Entry: A Patient Guide for Reporting Side Effects from Health Products
2011 Health Canada brochure-
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Catalogue Entry: Guidance to market authorization holders on issuing health product risk...
The timeline to develop and disseminate an HPRC should be based on an assessment of the risk associated with a health product.-
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Catalogue Entry: Guidance to market authorization holders on issuing health product risk...
The purpose of this document is to assist market authorization holders (MAHs) develop and disseminate health product risk communications (HPRCs).-
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Catalogue Entry: Guidance to market authorization holders on issuing health product risk...
Guidance to market authorization holders on issuing health product risk communications: Definitions.-
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Catalogue Entry: Guidance on summary reports and issue-related analyses for medical devices:...
This guidance document was prepared to help medical device manufacturers understand and comply with the Medical Devices Regulations. Two new requirements in the Regulations were...-
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