When you start filling out the Notification Form, you will be asked to select the product’s active and excipient ingredients from the List of Substances. Not all substances have been considered for admissibility. You can find out if Health Canada can make a quick decision about the substance or if an Application to Add a Substance will be required, by either emailing an inquiry to firstname.lastname@example.org or using the submit request option from within the application form.
We recommend that you review all the documents explaining the program.
An account is required to create an application.
Also visit the Health Canada sites to read their announcements and their Questions and Answers documents.
Submission fee is $250 to be paid when submitting the Notification request.
At the time of receiving your Notification Number a fee of $500 will be required.
Annual renewals will be $250 and should be accompanied with an annual summary adverse event report referring to any adverse event observed in the previous 12 months. It should be noted that adverse events should be reported to the Administrator by using the Adverse Event Tracking System.
To amend a submission, there will be a fee of $250.
We are committed to:
● acknowledge receipt of the submission and $250 payment within 5 working days
● handling all completed submissions in the order they are received
There will be a choice of credit card payments or requesting an invoice. For details contact email@example.com.
If your product contains an ingredient that is not listed, you may still proceed with a new application. You will be guided to complete a request for approval.
North American Compendiums will inform Health Canada about your request. Health Canada will determine if the substance meets the criteria for addition to the List.
If Health Canada requires more data/information for an ingredient to be added to the substance list, we will request you to complete a new Substance Application Form.
As Administrator, we will check that all required fields are completed correctly. Special attention will be paid to the ingredients, appropriate cautions/warnings and claims.
To complete the process, we will ask you to attest that you comply with all the requirements of the program as stated.
For more information, please email firstname.lastname@example.org.
PDF versions of the application are available upon request.