Orms should be faxed to: 613-957-0335 or mailed to: Canada Vigilance Program Marketed Health Products Directorate Health Canada Postal Locator 0701E Ottawa, Ontario K1A 0K9 Submission of a report does not constitute an admission that medical personnel or the health product caused or contributed to the adverse reaction. For further information on adverse reaction reporting by Market Authorization Holders (MAHs) and source establishments, please refer to: Drugs and Natural Health Products.
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How to fill out the Canada Mandatory Adverse Reaction Reporting Form For Industry online
The Canada Mandatory Adverse Reaction Reporting Form for Industry is an essential document for reporting suspected adverse reactions to marketed health products in Canada. This guide provides clear, step-by-step instructions to help users complete the form accurately and efficiently.
Follow the steps to complete the form online.
- Press the ‘Get Form’ button to access the form and open it in your browser.
- Fill out Section A - Reporter Information. Specify the report source, the reporter's qualification, and contact details. Ensure that you include your identification number and specify if this is an initial or follow-up report.
- Complete Section B - Patient Information. Provide a unique identifier, the patient's age, sex, height, and weight. This information is crucial for tracking and assessing the adverse reaction.
- Proceed to Section C - Adverse Reaction. Indicate where the reaction occurred, the date of the reaction, and whether it is serious. Describe the reaction in detail and provide the outcome.
- In Section D - Health Products, list up to two suspected health products related to the adverse reaction. Include the name, type, dosage form, and any relevant identifiers. If there are additional products, attach extra forms.
- Provide information regarding concomitant health products and treatment for the adverse reaction in the designated sections. Include all necessary details to ensure comprehensive reporting.
- Once all sections of the form are accurately filled out, you can save your changes. Depending on your preference, choose to download, print, or share the completed form as needed.
Take action and complete the Canada Mandatory Adverse Reaction Reporting Form online today.
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