Many companies do not have the in-house expertise to properly assess and classify adverse events and may not keep appropriate records to fulfill these reporting obligations. With our in-house medical doctor and regulatory staff, we have both the scientific and regulatory expertise to assist you adhere to mandatory reporting. Let us take simplify this necessary requirement and ensure you comply with the regulations.
What to report?
Depending if you are a seller or distributor, there are different reporting requirements. Health Canada expects swift industry action to address health or safety issues. Minimize legal risk and let us take care of your Adverse Event Reporting.
Who must report?
The appropriate monitoring and reporting of adverse events are a requirement for cannabis products (all classes of products) and consumer vaping products (not cannabis) to Health Canada and to the person who supplied you the product. Under the Act, ‘sell’ includes giving away or distributing consumer products and homemade items.
If you’re an importer who imports from a manufacturer and sells products in Canada, you must report any incidents to both Health Canada and to the manufacturer.
When mandatory reporting is required?
Health Canada requires “all incidents involving consumer products must be reported.” Let dicentra Cannabis Consulting help you with expert advice on how to comply with Adverse Event Reporting within the expected timeframe. It can sometimes be confusing to determine what constitutes an adverse reaction or a serious adverse reaction.
You must report incidents within the timelines specified by section 14 of the Act. Not reporting an incident is an offence under the Act and may result in further enforcement actions.