The intent of this notice is to clarify Health Canada’s expectations regarding the reporting of cases identified from the Canada Vigilance (CV) Adverse Reaction (AR) Online Database by MAHs. In particular, this notice replaces section 4.3 of the Reporting Adverse Reactions to Marketed Health Products – Guidance Document for Industry (2018) and the Notice to Industry (2020).
The primary objective of this notice is to eliminate duplicate reporting. Previously, MAHs were spending significant resources reporting data that Health Canada already possessed. This update streamlines that process.
| Feature | Previous Requirement (2018/2020) | New Requirement (2026 Notice) |
| Canada Vigilance (CV) Online Database | MAHs were expected to “scan” or monitor the CV database to find reports submitted directly to Health Canada by consumers/doctors. | REMOVED: MAHs are not required to scan the CV Online Database or the Health Product InfoWatch for reporting obligations. |
| Foreign Regulatory Databases | Requirements were less specific regarding when a MAH could skip a report found in a foreign database. | CLARIFIED: You do not need to submit reports from foreign databases if you can prove the product isn’t yours using the “Exclusion Criteria.” |
| Scientific Literature Reports | Guidelines in sections 2.1.2 and 4.1.3 of the 2018 guidance applied. | OVERRIDDEN: The new “Exclusion Criteria” now also apply to literature searches, making it easier to exclude non-relevant cases. |
| Presumption of Ownership | If the brand was unknown, reporting expectations were sometimes ambiguous. | STRENGTHENED: If you cannot definitively prove the product isn’t yours using the criteria, you must assume it is yours and report it. |
