Consultation on the Draft Guidance Document: Tamper-Resistant Formulations of Opioid Drug Product Submissions

Notice to the reader:

The online consultation is now closed.

This guidance document is intended to provide guidance to sponsors seeking a Notice of Compliance for their tamper-resistant controlled-release opioid products. It provides information on what evidence is required to demonstrate tamper-resistance of the product to support a drug submission under the Food and Drug Regulations, in response to the steady increase in the number of drug submissions received for opioid drug products with tamper-resistant formulations.

How to Get Involved

This consultation is open for comment starting December 22nd, 2014 until March 7th, 2015. Please select and read through the link below titled "consultation document". Once read please submit your comments via email, fax or by mail to:

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Products and Food Branch
Health Canada
1600 Scott Street
Holland Cross, Tower B
2nd Floor, Address Locator 3102C1
Ottawa, Ontario
K1A 0K9

Fax: 613-941-1812

Interested parties are encouraged to provide comments and suggestions by March 7th, 2015.

Reporting to Canadians

Health Canada will make the results of this consultation available on this web site.

If you have any questions, contact us at Bureau of Policy, Science and International Programs.

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