Notice: Guidance Document: Tamper-resistance Formulations of Opioid Drug Products

March 30, 2016
Our file number: 16-103566-811

Opioid drugs are subject to the Food and Drugs Act and the Controlled Drugs and Substances Act (CDSA). An opioid drug may be sold in Canada following a decision by Health Canada that the scientific evidence submitted by its manufacturer meets established standards for safety, efficacy and quality for the drug under the recommended conditions of use.

In recent years, the Therapeutic Products Directorate (TPD) has seen a steady increase in the number of drug submissions received for opioid drugs with tamper-resistance formulations. These formulations are designed to resist a number of common tampering methods and potentially provide barriers to certain methods of drug abuse.

This document is intended to provide guidance to sponsors seeking statement or claims of tamper-resistance aimed at reducing abuse of controlled-release opioid products. It provides information on what evidence is required to demonstrate the tamper-resistance properties of the product to support such claims or statements within Product Monographs.

Bureau of Cardiology, Allergy and Neurological Sciences (BCANS)
Therapeutic Products Directorate
Health Products and Food Branch
Health Canada
1600 Scott Street, Address Locator: 0202A1
Holland Cross, Tower B, 2nd Floor
Ottawa, Ontario
K1A 0K9

Telephone: 613-941-1499
Fax: 613-941-1668

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