Consultation on opioid warning materials and risk management plans

From Health Canada

Current status: The public consultation is now closed. Thank you for your interest.

You're invited to give your comments on proposed regulations, which would:

  • make a warning sticker and patient information handout mandatory for prescription opioids
  • give the Minister of Health power to set terms and conditions on approvals to sell opioids

The Minister of Health’s new power would be used to require opioid companies to develop and put in place risk management plans for prescription opioids.


There is growing concern over the number of deaths linked to the use of opioid drugs and the growing opioid-related public health crisis.

Patients need clear information about how to use opioids safely and the risks of using them.

Stronger oversight is needed over opioids that are on the market in Canada to help track, measure, describe and reduce their risks. 


We are looking for comments from:

  • patients
  • pharmacists and other health professionals
  • pharmaceutical industry
  • other stakeholders
  • any interested members of the public


Health Canada is looking for comments on the proposed regulations, which would:

  • require prescription opioids, at the time of sale, to have:
    • a warning sticker
    • a patient information handout
  • allow the Minister of Health to add or change terms and conditions to an authorization for the sale of an opioid, to:
    • require companies who manufacture and sell opioids to develop and put in place a plan to track, measure, describe and reduce the risks related to using their products 

When and where

The consultation document is available online at the Canada Gazette.

How to participate

Your comments will be used to help ensure that the proposed regulations reduce the harmful impacts of problematic opioid use on Canadians.

You may submit your comments by:

  • mail
  • email, in electronic files such as:
    • Microsoft Word
    • Adobe Acrobat

Related information

Contact us

Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
Holland Cross, Suite 14
11 Holland Avenue
Address Locator 3000A
Ottawa, Ontario
K1A 0K9


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