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Consultation on the Regulatory Amendment to the Adverse Drug Reaction Reporting Section of the Food and Drug Regulations - Canada Gazette Part I

The Marketed Health Products Directorate (MHPD) of the Health Products and Food Branch of Health Canada has identified the need to amend sections C.01.016 and C.01.017 of Division 1 of the Food and Drug Regulations. These proposed changes pertain to drugs for human use, including biologics and pharmaceuticals, as well as veterinary drugs. Market Authorization Holders (MAH) will be required to notify the Minister if they conclude from the annual summary report that there is a significant change in the risk-benefit profile of one of their products. The amendment will also clarify the Minister's authority to require summary reports or case reports whenever the Minister decides to examine the safety and effectiveness of a drug. The Minister will be able to impose a deadline of less than 30 days for submitting these reports if a shorter deadline is necessary to respond to a serious and imminent risk to health. MAHs will also be required to: 1) maintain individual ADR reports, case reports, annual summary reports, and issue-related summary reports over a specified retention period, and 2) to provide these records to the Minister upon request. A letter to stakeholders seeking comments on this proposal was posted on the Health Canada Web site on July 7, 2008 advising of the "Proposal to Amend the Food and Drug Regulations with respect to Annual Pharmacovigilance Reports". After taking the results of this consultation into account, MHPD is inviting stakeholders to comment on this proposed regulatory amendment, which is currently published in Canada Gazette Part I.

How to Get Involved

This consultation is open from June 13, 2009 to September 7, 2009. Please select the link entitled "Canada Gazette Part I" to read the notification. Interested parties are encouraged to provide comments and suggestions by contacting the Marketed Health Products Directorate.

Reporting to Canadians

Health Canada will make the results of this consultation available on this Web site.  For additional information, please contact the Marketed Health Products Directorate.