The CCPSA has designed a draft guidance on the requirements for Adverse Event Reporting by industry.
Section 14 of the guidance describes the duties in the event of an incident. We have summarized the types of adverse events classified under section 14.
The following are the main categories to classify an incident:
- An occurrence in Canada or elsewhere,
- A defect or characteristic,
- Incorrect or insufficient information on a label or in instructions – or the lack of a label or instructions, or
- A recall or measure that is initiated for human health or safety reasons.
Two types of reports are to be submitted upon awareness of an incident. One report compiles all information regarding the incident. This report is to be submitted within two days after the day on which they become aware of the incident.
The second report outlines all proposed corrective measures surrounding the product incident. The report is prepared by the manufacturer and is to be submitted within 10 days after the day on which they become aware of the incident.
If you have any questions about how to manage your product reporting, ask a FPR consultant. We would be more than happy to assist you with your consumer product, cosmetic, drug, medical device, and natural health product needs.