Guidance Document - Submission of Risk Management Plan and Follow-up Commitments

Overview

The objective of this guidance document is to assist industry and interested stakeholders (Market Authorization Holders (MAHs)) in developing a Risk Management Plan and Follow-up commitments when requested.

Notice:

As part of its transparency initiatives, Health Canada indicates for each drug in the Drug Product Database, whether a Risk Management Plan (RMP) has been reviewed and provides a list of additional risk mitigation measures (beyond labelling) and characterization activities for the drug if applicable. 

Who this guide is for

1. Market Authorization Holders (MAH) for drugs in Canada
2. Consultants who prepare Risk Management Plan

In this guide

• 1 Introduction
  • 1.1 Policy Objectives
  • 1.2 Scope and Application
  • 1.3 Background
• 2 Definitions and Acronyms
• 3 Procedures
  • 3.1 When to file a Risk Management Plan with Health Canada
  • 3.2 Acceptable Risk Management Plan Format
  • 3.3 General Considerations
  • 3.4 Submission
  • 3.5 Use of Foreign Reviews
  • 3.6 Cover Letter and Note to Reviewer
  • 3.7 Risk Management Plan Updates
  • 3.8 Canadian Specific Sections
  • 3.9 Review of Risk Management Plans and follow-up commitments
    • 3.9.1 Review of Risk Management Plans that are part of a drug submission
    • 3.9.2 Review of Risk Management Plans not "included in" OR "part of" a submission and follow-up commitments
  • 3.10 Location
  • 3.11 Status Requests
• Appendix 1 - Contact Information
• Appendix 2 - List of relevant guidance documents

View complete guide      

Download PDF (226  KB, 23 pages)

Details and history

Published: May 18, 2015

Part of topic(s): Guidance on legislation

For assistance

Marketed Health Products Directorate

Health Products and Food Branch

Health Canada

Address Locator 1912C

Ottawa, Ontario

K1A 0K9

E-mail: mhpd_dpsc@hc-sc.gc.ca

Telephone: 613-954-6522

Our service hours are Monday to Friday from 8 a.m. to 6 p.m. (local time) and closed statuary holidays.