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

From Health Canada


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

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Details and history

Published: May 2, 2018

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