Consultation on Risk Management Plans for Opioid-containing Products

Proposed amendments to the Food and Drug Regulations  would give the Minister of Health power to impose terms and conditions on authorizations to sell opioids.

The Minister intends to use this new power to require that the manufacturers of prescription opioid products develop Canadian-Specific Opioid targeted Risk Management Plans (CSO-tRMPs) and implement specific activities described within those plans in order to gather more real-world information to help support the appropriate and safe use of these medications.

Stakeholders are invited to provide comments on the accompanying draft guidance to industry: Submission of Targeted Risk Management Plans and Follow-up Commitments for Prescription Opioid-Containing Products. The guidance document is intended to provide information for manufacturers of opioid products on how to submit their CSO-tRMPs to Health Canada and what activities should be included in the plan and conducted as part of the follow-up commitments.

Why

Canada is facing an opioid crisis. Opioid overdoses are claiming the lives of thousands of Canadians of all ages, and from all walks of life.

Mandatory Risk Management Plans for opioids are part of the Government of Canada’s commitment to addressing the opioid crisis. Stronger oversight is needed over opioids that are on the market in Canada to help track, measure, describe and reduce their risks.

Who

We are seeking feedback from:

• pharmaceutical industry
• academia and health research institutions
• health care professionals
• other stakeholders (e.g. patient groups)
• any interested members of the public

What

Health Canada is looking for comments on the draft guidance document for industry:

• Submission of Targeted Risk Management Plans and Follow-up Commitments for Prescription Opioid-Containing Products

When and Where:

The consultation period runs from June 16, 2017 until August 31, 2017. The draft guidance document is available online at the link below.

How to Participate

Stakeholders are encouraged to read the draft guidance document for more information.

You may submit your comments and ideas by:

Mail to:
Marketed Pharmaceuticals and Medical Devices Bureau
Health Canada
Address Locator 1912A
200 Eglantine Driveway
Ottawa, Ontario
K1A 0K9

Email to: mhpd_dpsc@hc-sc.gc.ca

Next Steps:

Feedback received on or before August 31, 2017, will be considered as we finalize this draft guidance document.  

Related Information

Proposed amendments to the Food and Drug Regulations

Contact us

Marketed Pharmaceuticals and Medical Devices Bureau
Health Canada
Address Locator 1912A
200 Eglantine Driveway
Ottawa, Ontario
K1A 0K9

Email: mhpd_dpsc@hc-sc.gc.ca