Submission of targeted risk management plans and follow-up commitments for prescription opioid-containing products - Guidance for industry - Summary

Organization: Health Canada

Published: 2018-05-02

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Related acts and regulations

• Food and Drugs Act
• Food and Drug Regulations C.01.014.21(1)

Related program

• Drugs and health products

From Health Canada

Overview

In response to the growing public health crisis due to opioids, the Minister of Health announced the Federal Action on Opioids on June 17, 2016. One of the commitments made under the Federal Action on Opioids was mandatory Risk Management Plans (RMP) for prescription opioid-containing products.

In November 2016, a Scientific Advisory Panel on Opioids (SAP-Opioids) was convened by Health Canada to provide recommendations on the monitoring and managing of the risks related to opioids. Recommendations from this panel were taken into consideration for the development of this guidance document.

Who this guide is for

1. Pharmaceutical industry

In this guide

• Forward
• 1 Introduction
  • 1.1 Policy objective
  • 1.2 Policy statements
  • 1.3 Scope and application
• 2 Terminology and acronyms
• 3 Guidance for implementation
  • 3.1 General considerations
  • 3.2 Mandatory Canadian Specific Opioid targeted Risk Management Plan sections
    • 3.2.1 Safety specification section
    • 3.2.2 Pharmacovigilance plan section
      • 3.2.2.1 Prospective Post-Authorization Safety Study
      • 3.2.2.2 Retrospective Post-Authorization Safety Study
      • 3.2.2.3 A longitudinal or cross-sectional multi-surveillance system.
    • 3.2.3 Risk minimization plan section
      • 3.2.3.1 Educational program
      • 3.2.3.2 Review and preclearance of materials
      • 3.2.3.3 Warning sticker and patient information handout
    • 3.2.4 Evaluation of the effectiveness of the risk minimization activities
  • 3.3 Canadian Specific Opioid targeted Risk Management Plan submission process and timeline
  • 3.4 Implementation process and enforcement
  • 3.5 Consultation period and status requests
• Appendix 1 – Contact information
• Reference

View complete guide

Details and history

Published: May 2, 2018