Health Product Complaint Process - Questions and Answers

1. What are the changes to the new complaint process?
2. Why was a new complaint form developed?
3. How do I submit a complaint?
4. What happens when my complaint is submitted?
5. Whom should I contact if I have additional comments regarding this new complaint process?

1. What are the changes to the new complaint process?*

In order to streamline the submission of health product complaints, the Regulatory Operations and Enforcement Branch (ROEB) has developed a new complaint form (Health Product Complaint Form (FRM-0317)). This form provides step-by-step instructions on how to submit complaints to the ROEB Program Office responsible for your geographical area.

* Note: In the past, complainants were directed to the one of the following documents which have been removed from the ROEB Web site:

• GUI-0038 How to Submit a Trade Complaint
• GUI-0044 How to Submit a Consumer Complaint
• GUI-0060 User Problem Reporting for Medical Devices
• FRM-0029 User Problem Report Form

2. Why was a new complaint form developed?

The new complaint form was developed to allow users to easily provide the necessary information that is required when submitting complaints to Health Canada. The new Health Product Complaint Form (FRM-0317) is a single form that can be used for all complaints that fall under ROEB's mandate. This includes consumer and trade complaints.

3. How do I submit a complaint?

Complete the Health Product Complaint Form (FRM-0317), available online on the Health Canada website, and then use the "Submit" button located at the bottom of the form. If you require assistance in completing and/or submitting your form, please contact the ROEB Program Office responsible for your Province/Territory.

If your location is outside of Canada, refer to the ROEB Program Office table in the Health Product Complaint Form (FRM-0317) to find the office responsible for your Province/Territory.

4. What happens when my complaint is submitted?

If the complaint falls under ROEB's mandate, an acknowledgment letter will be sent with a reference number. You will only be re-contacted if additional information is required. Complaints that do not fall under ROEB's mandate will be redirected to the appropriate authority or you will be provided with their contact information.

5. Whom should I contact if I have additional comments regarding this new complaint process?

Contact the ROEB Program Office responsible for your geographical area to provide any additional comments.

If your location is outside of Canada, refer to the ROEB Program Office table in the Health Product Complaint Form (FRM-0317) to find the office responsible for your Province/Territory.