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Commonly Asked Questions about Community based reporting health Canada Forms

How do I submit to Health Canada?

Companies are required to file submissions electronically to Health Canada in either Electronic Common Technical Document (eCTD) format or non-eCTD format, depending on the regulatory activity type. Filing submissions electronically - Canada.ca Canada.ca services guidance-documents Canada.ca services guidance-documents

How do I report serious adverse events to Health Canada?

To report an adverse reaction, contact Health Canada directly at 1 866 234-2345 or visit the reporting website at .health.gc.ca/medeffect. The site also provides access to advisories and recalls, the Canadian Adverse Reaction Newsletter, MedEffect Canada RSS feeds, and the MedEffect e-Notice. Report adverse reactions to Health Canada - BC Medical Journal BC Medical Journal news report-adverse-reactions-health BC Medical Journal news report-adverse-reactions-health

What is the ADR reporting system in Canada?

The Canada Vigilance Adverse Reaction Online Database contains information about suspected adverse reactions (also known as side effects) to health products. Adverse reaction reports are submitted by: consumers and health professionals, who submit reports voluntarily. Canada Vigilance Adverse Reaction Online Database Canada.ca services medeffect-canada a Canada.ca services medeffect-canada a

How do I report a serious adverse event?

Related Information for Consumers. If you need information or if you have questions or comments about a medical product, please call the FDAs toll-free information line, 1-888-INFO-FDA (1-888-463-6332) Press 2 to report into MedWatch or for instructions.

Where do I report adverse events?

Suspected unexpected serious adverse reactions (SUSARs) should be submitted to the MHRA as per the guidance on the MHRA website.

Where must all serious adverse events be reported to?

Serious Adverse Event Reporting An expedited report of an SAE can be submitted by telephone, fax, or email and must be reported to the independent safety monitoring body (i.e., DSMB or Safety Officer) and the NIA within 24 hours of the event being reported to the Investigator or as specified in the DSMP.

How do I report ADR in Canada?

Reports can be faxed to 1-866-678-6789 (toll-free) or mailed to: Canada Vigilance Program, Marketed Health Products Directorate, Health Canada, Postal Locator 0701E, Ottawa, Ontario K1A 0K9. Postage paid labels are available at .health.gc.ca/medeffect or by calling 1-866-234-2345 (toll-free).

What are the requirements for medical device reporting in Canada?

Reporting by hospitals is required Section C. 01.020. 1 of the Food and Drug Regulations and section 62 of the Medical Devices Regulations, require hospitals to report to Health Canada all serious adverse drug reactions (ADRs) and medical device incidents (MDIs) within 30 days of being documented within the hospital. Report a medical device problem (for health care professionals) Drug and Health Product Register side-effects-reporting-form Drug and Health Product Register side-effects-reporting-form