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.

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

Fact Sheets, Brochures, Pamphlets

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
• The Canadian Adverse Reaction Newsletter - Keeping health Professionals Informed
• Regulating Advertising of Health Products
• The Expert Advisory Committee on the Vigilance 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

• An Overview of the Marketed Health Products Directorate
• Health Product Review: An Ongoing Process
• The Post-Market Surveillance Continuum - Maximizing Safety, Minimizing Risk
• Working Together for a Better Post-Market Surveillance Program
• Reaching out - Programs, Resources and Tools
• Looking Ahead
• Poster - Cough and Cold Medicine for Children
• Tear Sheet - Cough and Cold Medicine for Children

2006

• Fact Sheet: Health Canada Risk Communication Products

2004

• Adverse Reaction Data on Websites
• Adverse Reaction Reporting by Health Professionals and Consumers
• Canadian Medication Incident Reporting and Prevention System (CMIRPS)
• Status of Astemizole (Hismanal ™) in Canada
• Status of Terfenadine-Containing Drugs in Canada

2003

• Casodex 150 mg Fact Sheet
  • Advisory for Health Professionals
  • Advisory for the Public
• Look-alike Sound-alike Health Product Names

2002

• Medical Device Problem Reporting by Health Care Facilities, Medical Professionals and Other Device Users
• Status of Levothyroxine Products in Canada

Guidance Documents and Guidelines

2011

• Guidance Document for Mandatory Problem Reporting of Medical Devices [2011-10-03]
• Procedure - The Release to the Public of Information Obtained from Adverse Reaction and Medical Device Incident Reports [2011-08-11]
• Guidance Document for Industry - Reporting Adverse Reactions to Marketed Health Products [2011-03-17]
• Guidelines for Reporting Suspected Adverse Reactions to Antiviral Drugs During an Influenza Pandemic [2011-03-17]

2010

• Guidance Document for Industry - Issuance of Health Professional Communications and Public Communications by Market Authorization Holders [2010-05-28]
  • Dear Health Care Professional Letter Templates
    • Health Products - Dear Health Care Professional Letter Template [2012-07-27]
    • Medical Devices - Dear Health Care Professional Letter Template [2012-07-27]
    • Vaccines - Dear Health Care Professional Letter Template [2012-07-27]
  • Notice to Hospitals Templates
    • Health Products - Notice to Hospitals Template [2012-07-27]
    • Medical Devices - Notice to Hospitals Template [2012-07-27]
    • Vaccines - Notice to Hospitals Template [2012-07-27]
  • Public Communication Templates
    • Health Products - Public Communication Template [2012-07-27]
    • Medical Devices - Public Communication Template [2012-07-27]
    • Vaccines - Public Communication Template [2012-07-27]
• Guidance Document for Source Establishment - Reporting Adverse Reactions to Human Cells, Tissues and Organs

2009

• Interim Guidance on Fair Balance in Direct-to-Consumer Advertising of Vaccines

2008

• Canadian Adverse Reaction Newsletter Production Procedures [Stakeholder Information]
• Guidance Document - Description of Current Risk Communication Documents for Marketed Health Products for Human Use
• Guidelines - Voluntary Reporting of Suspected Adverse Reactions to Health Products by Health Professionals and Consumers

Related Links

• Compliance and enforcement documents for medical devices and equipment
• Voluntary Problem Reporting for Medical Devices (GUI-0060)
• Product Recall Procedures
• E15: Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories
• Guidance Document: Submission of Pharmacogenomic Information
• Guidelines for Reporting Adverse Events Associated with Vaccine Products

Reports

2008

• Overview of Marketed Health Products Directorate's Bilateral Meeting Program
• What We Heard - Key Findings from the 360° Assessment of Stakeholder Relations

2007

• Record of Decision: Canada's Research-Based Pharmaceutical Companies (Rx&D) - November 22, 2007
• Proceedings: Health Canada International Symposium on Drug, Food, Natural Product Interactions
• 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

2004

• Public Opinion Survey on Key Issues Pertaining to Post-market Surveillance of Marketed Health Products in Canada - Decima Research Inc.