Reports and Publications - MedEffect Canada

In this section, you will find reports and publications related to reporting adverse reactions or side effects, obtaining new safety information on drugs and other health products, and other information related to risk communications.

Publications that no longer appear on this Web site may be found on the Government of Canada publications site.

• Fact Sheets, Brochures, Pamphlets
• Guidance Documents and Guidelines
• Reports

Fact Sheets, Brochures, Pamphlets

2019

• Suspect a serious adverse drug reaction or medical device incident (poster)

2012

• Health Product Vigilance Framework

2011

• Patient Guide for Reporting Side Effects
• Adverse Reaction Reporting and Health Product Safety Information - Guide for Health Professionals
  • Insert - Adverse Reaction Reporting for Natural Health Products
• MedEffect^TM Canada Initiative - The Public Interface to Post-Market Surveillance Programs and Information
• Canada Vigilance Program - Collecting and Assessing Adverse Reaction Reports
• Risk Communication - Protecting Canadians through Information
• Regulating Advertising of Health Products

2010

• Your Child's Prescription: Important Questions to Ask

2009

• Opioid Pain Medications (It's Your Health)
• Opioid Pain Medications - Frequently Asked Questions (It's Your Health)

2008

• Poster - Cough and Cold Medicine for Children
• Tear Sheet - Cough and Cold Medicine for Children

Guidance Documents and Guidelines

2022

• Guidance on releasing information from adverse reaction and medical device incident reports to the public [2022-08-31]
• Guidance to market authorization holders on issuing health product risk communications [2022-05-25]
  • Standardized Health Product Risk Communication Template [2015-11-23]
  • Guide for using the Standardized Health Product Risk Communication Template [2015-11-23]

2021

• Foreign risk notification for medical devices guidance document: Background [2021-01-14]
• Amendments to the Food and Drugs Act: Guide to new authorities [2021-01-14]
• Incident reporting for medical devices: Guidance document [2021-01-14]
• Guidance on summary reports and issue-related analyses for medical devices: Overview [2021-01-14]

2019

• Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals - Guidance document [2019-06-26]
• Good Label and Package Practices Guide for Prescription Drugs [2019-06-21]
• Format and content for post-market drug benefit-risk assessment in Canada - Guidance document [2019-02-28]

2018

• Notifying Health Canada of Foreign Actions - Guidance Document for Industry [2018-11-20]
• Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products  [2018-09-28]
• Reporting Adverse Reactions to Marketed Health Products - Guidance Document for Industry [2018-05-23]
• Preparing and Submitting Summary Reports for Marketed Drugs and Natural Health Products - Guidance Document for Industry [2018-05-23]
• Submission of targeted risk management plans and follow-up commitments for prescription opioid-containing products - Guidance for industry  [2018-05-02]
  • List of Opioids:
    • Part A - Opioids subject to the prescription labelling provisions
    • Part B - Opioids that are subject to market authorization terms and conditions

2015

• Guidance Document- Submission of Risk Management Plans and Follow-up Commitments

2014

• Guidance Document for Industry - Review of Drug Brand Names [2014-07-02]
  • Frequently Asked Questions [2014-10-22]

2011

• Guidance Document for Mandatory Problem Reporting of Medical Devices [2011-10-03]

2010

• Guidance Document for Source Establishment - Reporting Adverse Reactions to Human Cells, Tissues and Organs [2010-05-25]

Related Links

• E15: Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories
• Guidance document: Electronic Canadian Drug Facts Table Technical Standards
• Guidance Document: Submission of Pharmacogenomic Information

Reports

2022

• Summary reporting provisions of the Medical Devices Regulations: Notice to industry [2022-11-21]

2020

• Adverse reactions, medical device incidents and health product recalls in Canada: 2019 summary report [2020-12-11]

2018

• Annual trends for the adverse reaction case reports of health products and medical device problem incidents to Health Canada (2008-2017) [2018-10-31]

2017

• What we heard - Responses to the public consultation paper entitled Toward mandatory reporting of serious adverse drug reactions and medical device incidents by health care institutions [2017-12-22]

2007

• Adverse Reaction Reporting - Survey with Health Professionals
• Underutilization of the adverse reaction reporting system, final report

2006

• Public opinion survey on key issues pertaining to post-market surveillance of marketed health products in Canada, final report