Here's a look at what's new with the Canada Consumer Product Safety Act and regulations to the Food and Drugs Act and Controlled Drugs and Substances Act.
1. New Incident Reporting Forms On Their Way
Health Canada has announced that it will be replacing the PDF forms used to report consumer product incidents under the CCPSA, cosmetic notifications under the Cosmetics Regulations and to provide additional documents.
The forms will be replaced with HTML, which are expected to be released this summer. Once the new forms are released, it will not be possible to submit the PDF forms online. We will circulate links to the new forms once they become available.
2. Update on Administrative Monetary Penalties
The CCPSA regime provides Health Canada with the power to require companies to pay financial penalties called administrative monetary penalties (AMPs) for failing to comply with certain Health Canada-issued orders. The amount of an AMP is determined on the basis of whether violation is "minor," "serious" or "very serious" having regard to specific factors spelled out in the Administrative Monetary Penalties Regulation. These factors address both the type of violation and the company's history of compliance.
AMPs range from $1,000 to $5,000 for non-profit organizations or any other person for non-commercial purposes. They range from $10,000 to $25,000 for all other cases. Each day on which non-compliance continues constitutes a separate violation, so these AMP amounts can quickly escalate.
Health Canada has recently issued its first AMP Report with respect to a Notice of Violation. The company in question was determined to have committed "serious" violations in 2015 and 2016 by failing to comply with a recall notice in respect of improperly packaged and labelled cleaning products and not providing requested information regarding customers, etc. The company was assessed AMPs of $15,000 to $20,000 per violation (for a total of $95,000). Health Canada's reports on this matter can be found here and here.
3. Postponement of Tamper-Resistant Properties of Drugs Regulations
Health Canada has announced that it will not move forward with the previously proposed Tamper-Resistant Properties of Drugs Regulations on which consultations were conducted last summer.
Health Canada has released guidance to drug manufacturers seeking claims of tamper-resistance, which can be found here.
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