Health Product Complaint Form (FRM-0317)

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Health Product Complaint Form (FRM-0317)

Protected when completed and received by Health Canada. Treasury Board Secretariat Government Security Policy.

IMPORTANT: Before submitting a complaint to Health Canada’s Regulatory Operations and Enforcement Branch on this form, please visit Problem Reporting, to review information on types of health products, how to submit complaints, how we handle complaints and what to expect following your submission.

Report

Product Type (required)

Who is reporting

When submitting a complaint, including an email and/or phone number is important. This ensures we can reach you if additional information is required to further your complaint.

Who are you (required)

Name (first name and last name)

Your Business/Organization Name (full legal name), if applicable

Telephone (including area code)

Address (number and street)

City

Country

Province

State

Other Country

Region

Postal Code/ZIP Code/PIN Code

Privacy Notice

I authorize Health Canada to provide my personal information contained in this form, to the manufacturer, importer, distributor, or supplier, if necessary, to facilitate follow-up on my complaint (required)

I authorize Health Canada to provide my personal information contained in this form, to another organization outside Health Canada such as provincial, territorial, or federal regulatory agencies or departments, if necessary, to facilitate follow-up on my complaint. (required)

Privacy Notice Statement

The personal information you provide to Health Canada is governed in accordance with the Privacy Act. We only collect the information we need to administer national compliance and enforcement activities for health products under Health Canada’s mandate authorized under the Food and Drugs Act.

Purpose of collection: To contact you for additional information regarding your complaint and/or, with your consent, follow up with or refer your complaint to another organization outside Health Canada.

Other uses or disclosures: In limited and specific situations, your personal information may be disclosed without your consent in accordance with subsection 8(2) of the Privacy Act.

For more information: The collection of your personal information is described in Info source. Refer to the personal information bank (PIB): Compliance and Enforcement – Natural Health Products (HC PPU 406), Compliance and Enforcement – Pharmaceutical Drugs (HC PPU 407), and Compliance and Enforcement – Biologics & Radiopharmaceuticals (HC PPU 408).

Your rights under the Privacy Act: In addition to protecting your personal information, the Privacy Act gives you the right to access and request a correction and/or notation to your personal information. For more information about these rights, or about how we handle your personal information, please contact Health Canada’s Health Product Compliance Directorate at hpcd.stakeholder.engagements-intervenants.dcps@hc-sc.gc.ca. You also have the right to file a complaint with the Privacy Commissioner of Canada if you think your personal information has been handled improperly.

Incident/Complaint

Nature of Complaint (required) Nature of Complaint (required)

If there are multiple issues, select the most important issue. Please include all other issues in the description text field below.

Is the complaint associated with a side effect, injury or death?

Has the side effect, injury or death been reported to the Canada Vigilance Program or Office of Clinical Trials?

Date of Incident (YYYY-MM-DD)

Description of incident or complaint (include establishment, supplier, importer and/or distributor contact information, and clinical trial protocol number and title, if available) {{incident.lkpNatureOfComplaintId}}(required)
You have selected ‘Other’ in the nature of complaint field, please provide detailed description of the issue in the ‘Description’ field to facilitate appropriate follow-up

Characters remaining: {{2000-incident.incidentDescription.length}}

Product

Enter the product details and information regarding the manufacturer and where it was purchased. To enter additional products, click on the “Add Product” button. To remove one product and its related information, click on the “Remove Product” button.

Product {{$index + 1}}

Case Number assigned by Health Canada

Product Name (required)

Is this product authorized for sale by Health Canada?

Product Licence Number (DIN, NPN, DIN-HM, or VHP Notification Number) or Clinical Trial Application (CTA) Control Number

Expiry Date

Lot/Batch Number

Is the Health Product or other physical component associated with this complaint available for evaluation? (by selecting “Yes”, I authorize Health Canada, upon submission of the health product or other sample, to evaluate it and/or release it to the manufacturer/importer for evaluation). NOTE: Submission of sample(s) to Health Canada relinquishes your ownership rights to the sample. (required)

Manufacturer of the Product / Blood or CTO Establishment / Clinical Trial Sponsor

Do you have information about Manufacturer of the Product / Blood or CTO Establishment / Clinical Trial Sponsor? (required)

Does this product have the same manufacturer as the previous product?

Business Name (full legal name – no abbreviations)

Address (number and street)

City

Postal Code

Country

Other Country

Province

State

Region

Website Address

Telephone (including area code)

Was the complaint reported to the manufacturer/establishment/clinical trial sponsor?

Date reported to this manufacturer (YYYY-MM-DD) (required if the complaint was reported to this organization)

Where was the health product advertised, purchased, obtained, used or seen available for sale

Do you have information about where the health product was advertised, purchased, obtained, used or seen available for sale? (required)

Is the purchase location information the same as the manufacturer information?

Was this product purchased at the same location as the previous product?

Business Name (full legal name – no abbreviations)

Address (number and street)

City

Postal Code

Country

Other Country

Province

State

Region

Website Address

Telephone (including area code)

Was the complaint reported to this organization?

Date acquired (YYYY-MM-DD)

Date reported to this organization (YYYY-MM-DD) (required if the complaint was reported to this organization)

Remove Product # {{$index + 1}}

Health Product Complaint Form

Health Product Complaint Form (FRM-0317)

Report

Who is reporting

Privacy Notice

Privacy Notice Statement

Incident/Complaint

Product

Product {{$index + 1}}

Manufacturer of the Product / Blood or CTO Establishment / Clinical Trial Sponsor

Where was the health product advertised, purchased, obtained, used or seen available for sale

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