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
2019
2012
2011
- Insert - Adverse Reaction Reporting for Natural Health Products
- MedEffectTM 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
2009
- Opioid Pain Medications (It's Your Health)
- Opioid Pain Medications - Frequently Asked Questions (It's Your Health)
2008
Guidance documents
2025
- Draft guidance on preparing and submitting summary reports for marketed drugs and natural health products
- Submitting risk management plans guidance document [2025-02-24]
2024
- Guidance for industry on safety monitoring and reporting requirements for marketed biocides [2024-06-19]
2023
- Guide to authorities under the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) [2023-08-30]
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]
2021
- Foreign risk notification for medical devices guidance document: Background [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]
2014
- Guidance Document for Industry - Review of Drug Brand Names [2014-07-02]
- Frequently Asked Questions [2014-10-22]
2011
2010
- Guidance Document for Source Establishment - Reporting Adverse Reactions to Human Cells, Tissues and Organs [2010-05-25]
Related links
Reports
2022
2020
- Adverse reactions, medical device incidents and health product recalls in Canada: 2019 summary report [2020-12-11]
2018
2017
2007
- Adverse Reaction Reporting - Survey with Health Professionals
- Underutilization of the adverse reaction reporting system, final report