Open Government Portal

Open Data Portal Catalogue Dataset
Found 19508 records
Guidance to market authorization holders on issuing health product risk communications: Timelines
Federal

The timeline to develop and disseminate an HPRC should be based on an assessment of the risk associated with a …

Last Updated: Mar 30, 2024
Date Published: Mar 28, 2024
Publisher: Health Canada
Formats: HTML
Keywords: Guidance market authorization holders health-product risk communications HPRC timeline develop-and-disseminate HPRC
A Patient Guide for Reporting Side Effects from Health Products
Federal

2011 Health Canada brochure

Last Updated: Mar 30, 2024
Date Published: Mar 28, 2024
Publisher: Health Canada
Formats: HTML
Keywords: patient guide reporting side effects health products adverse reactions troublesome canada vigilance program safety concerns medeffect canada
A strategy to optimize the use of real-world evidence across the medical …
Federal

This strategy document outlines the steps to be taken in order to optimize the use of RWE to improve the …

Last Updated: Mar 30, 2024
Date Published: Mar 28, 2024
Publisher: Health Canada
Formats: HTML
Keywords: Real world evidence Health Canada medical devices Pan-Canadian Health-Technology-Assessment (HTA) Collaborative Guidance documents
About adverse reactions (side effects)
Federal

An adverse reaction or side effect is a harmful and unintended response to a health product. The reaction occurs at …

Last Updated: Mar 30, 2024
Date Published: Mar 28, 2024
Publisher: Health Canada
Formats: HTML
Keywords: Adverse reaciton health product drug medication side effect
About Health Product Surveillance
Federal

Health Canada makes sure that the known serious risks are written on the product label or product monograph, as well …

Last Updated: Mar 30, 2024
Date Published: Mar 28, 2024
Publisher: Health Canada
Formats: HTML
Keywords: Health Product Surveillance Safety Reviews Summary Safety Reviews product label product monograph provides information manage risks patients health professionals informed choices
About medical device problems
Federal

A medical device is any instrument or component used to treat, diagnose or prevent a human disease or abnormal physical …

Last Updated: Mar 30, 2024
Date Published: Mar 28, 2024
Publisher: Health Canada
Formats: HTML
Keywords: Medical devices medical device problem medical device incident medical device label report health treatment malfunction
Adverse Reaction Reporting and Health Product Safety Information - Guide for Health …
Federal

MedEffect™ Canada provides a simple and efficient means for health professionals to report an adverse reaction to the Canada Vigilance …

Last Updated: Mar 30, 2024
Date Published: Mar 28, 2024
Publisher: Health Canada
Formats: HTML
Keywords: health professionals guide reporting health products adverse reactions canada vigilance program medeffect canada
Adverse Reaction Reporting Information
Federal

Health Canada information related to adverse reaction reporting of drugs and health products on the Canadian market

Last Updated: Mar 30, 2024
Date Published: Mar 28, 2024
Publisher: Health Canada
Formats: HTML
Keywords: adverse effects report form medeffect industry mandatory
Advertising requirements for drugs and medical devices
Federal

Health product advertising directly or indirectly promotes the sale or use of any health product. This can be done by …

Last Updated: Mar 30, 2024
Date Published: Mar 28, 2024
Publisher: Health Canada
Formats: HTML
Keywords: Advertising requirements advertising drugs advertising drugs medical devices advertising medical devices medical devices advertising requirements drugs drugs
Advisories and Recalls – MedEffect Canada
Federal

The Recalls and Safety Alerts Database provides easy access to a comprehensive list of recalls, advisories, and safety alerts. This …

Last Updated: Mar 30, 2024
Date Published: Mar 28, 2024
Publisher: Health Canada
Formats: HTML
Keywords: advisories and recalls MedEffect Canada Safety alerts safety alerts database public health advisories