Archived Online Consultation on the Proposed Regulations for Whole Blood and Blood Components!

The online consultation is now closed. The final consultation report is available now. Health Canada wishes to thank participants who submitted information via the Regulatory Workbook and Hospital Blood Bank Survey. The content found on this page is a snapshot of the live consultation as it was presented to the public and contains the content that was open for submissions during the consultation period.

Reporting to Canadians

All input gathered through this online consultation will be considered and become part of the consultation report, to be made available on this website. Please check back for any updates or reports as they become available. The findings will be used to further develop the proposed Regulatory Framework for Whole Blood and Blood Components for publication in Canada Gazette, Part I, in Fall 2007.

Additional Information

For additional information on this regulatory initiative please visit the Blood and Blood Components section of the Health Canada website or contact us.

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Health Canada's blood regulatory framework under the Food and Drugs Act is being revised as one element of a renewed Canadian Blood System to address the safety of whole blood and blood components for transfusion. This initiative will result in updated and/or new specific regulations that reflect current practices and technology.

This online consultation aims to ensure that the regulatory development process is open and transparent. By participating you will:

• learn about the proposed regulations, and what these changes may mean to your organization,
• provide input into specific areas of the proposed regulations, and
• help identify and address potential challenges to implementation of and compliance with the proposed regulations.

This consultation may be of particular interest to any establishment that will have to comply with the new regulations, including hospitals, health institutions and commercial enterprises that undertake federally regulated activities related to whole blood and blood components for transfusion.

How to get Involved

This consultation includes two areas for input: a Regulatory Workbook and a Hospital Blood Bank Survey.

The Regulatory Workbook presents information on various aspects of federal regulation of the blood system in Canada, and asks open ended questions in areas where we'd like to learn from you, such as your opinion on proposed approaches and how we might be able to address your concerns. Anyone interested in or working within the blood system is invited to read the workbook and answer the questions. It should take about 45 minutes to complete.

The Hospital Blood Bank Survey asks specific questions regarding activities related whole blood and blood components that may take place within your hospital blood bank. This survey is intended for people who work in a hospital blood bank. You may find it beneficial to review the Regulatory Workbook before filling out the Hospital Blood Bank Survey. It should take about 30 minutes to complete.

A glossary of technical terms (also available in PDF format) and an overview of the proposed regulations (also available in PDF format) are included as reference materials. These documents will open in a new window for easy reference.

You must complete the workbook in one sitting and the survey in one sitting, but they may be done at different times. If you close the workbook or survey without submitting your responses they will be lost. You must press the submit button at the end of the workbook and survey to send your input to Health Canada.

Please note that this consultation closes at midnight on Friday July 6, 2007.

If you would prefer to fax or mail your input, please select the printable version: workbook and survey. When completed, please return your responses by fax to (613) 952-5364 or mail them to:

Consultation Unit
Policy and Promotion Division
Biologics and Genetic Therapies Directorate
Health Canada
200 Tunney's Pasture Driveway
Ottawa ON
K1A 0L2
AL 0702A

How is my privacy protected when I participate online?