MedEffect Canada

As part of its regulatory responsibility, Health Canada conducts consultations in the area of post-market surveillance. Participants' comments and ideas contribute to the development of strategic priorities for these programs, helping us define what they should strive to achieve in the short, medium and long-term.

Current Consultations

2025

• Consultation: Draft guidance on preparing and submitting summary reports for marketed drugs and natural health products [2025-10-24]
• Consultation for guidance on notifying Health Canada of foreign actions [2025-09-25]

Past Consultations

2021

• Consultation: Reporting adverse reactions to marketed health products – Draft guidance document for industry [2021-01-25]

2019

• Consultation on the draft guidance document: The Distinction Between Promotional and Non-promotional Messages and Activities for Health Products [2019-07-05]
• Consultation on Proposed Regulations Amending the Medical Devices Regulations (Post-market Surveillance) [2019-06-15]

2018

• Consultation: Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals - Draft guidance document [2018-07-09]

2017

• Consultation on Risk Management Plans for Opioid-containing Products [2017-06-19]
• Toward Mandatory Reporting of Serious Adverse Drug Reactions and Medical Device Incidents by Health Care Institutions [2017-06-28]

2016

• Issue Identification Paper - Mandatory Reporting of Serious Adverse Drug Reactions and Medical Device Incidents by Healthcare Institutions [2016-05-13]
• Consultation on Health Product Transparency Initiatives [2016-01-25]

For more information on the past consultations, contact the Marketed Health Products Directorate.